IRB Letter

Matose, Takunda (NIH/OD) [C]
From:
To:
Cc:
Subject:
Attachments:

OHSR (NIH/DDIR)
Lahl, Lynda (NIH/NIAID) [E]
Lohse, Pia (NIH/NIAID) [E]; Washington, Dione (NIH/NIAID) [E]
Determination for OHSRP 12268
Request for Amendment OHSRP #____

Good afternoon, Lyndi, Pia, and Dione, 

Attached is the OHSRP determination of Excluded from IRB Review per 45 CFR 46 and NIH policy for your 
project Process Evaluation of the DAIDS Critical Events Policy Implementation (CEPI) Program. You may 
proceed with the project. 

Please retain this documentation as you would other research records. Amendments and or changes to the 
research must be submitted to OHSRP for review as changes may affect the determination. Please refer to 
OHSRP #12268 for future amendments to this activity. To request future amendments, please use the 
attached email template modified to meet the specific changes needed for your project. If you have any 
questions or need further assistance, please feel free to contact us. 

Best, 

Takunda Matose 
OHSRP ‐ National Institutes of Health 
Bldg 10, Suite 2C146 
Bethesda, MD 20892 
Office Telephone: 301‐402‐3444 
Office Fax: 301‐402‐3443 

From: OHSR (NIH/DDIR)
Sent: Thursday, January 23, 2014 1:10 PM
To: Lahl, Lynda (NIH/NIAID) [E]
Subject: Req for Determination Rec'd_OHSRP 12268

Good afternoon Lyndi, 

This email is to verify that OHSR has received your Request for Determination and it is currently being processed as 
OHSRP #12268. Please use this number in any future correspondence regarding this study.  We will contact you via 
email if any additional information is needed. If you have not heard from OHSR within 7 business days, please contact 
us. 
Protocol Title: Process Evaluation of the DAIDS Critical Events Policy Implementation (CEPI) Program 

**As per a new requirement for PIs, please fill in attached planned enrollment worksheet and return. We will need 
this before we can issue a determination. Please contact OHSRP with any questions. 
Thank you. 
Sincerely, 
OHSRP ‐ National Institutes of Health 
1

OHSRP #12268

REQUEST FORM: OHSRP DETERMINATION FORSURVEYS, INTERVIEW PROCEDURES, 
PROGRAM EVALUATION, EDUCATIONAL TESTING AND RESEARCH 
Date of Request:    ____01/13/2014______________ 

Requestor’s name: ___Lynda Lahl_______________ e‐mail: 
__________lahll@niaid.nih.gov ____________________ 

Role: __Administrative support   _X_Investigator  Other, explain: ________________ 

Name of NIH Senior Investigator: ____Lynda Lahl__________________________ 
             (The investigator must be an NIH employee) 

IC ___NIAID _____ Laboratory/Branch __DAIDS/OPCRO/ProPEP_______________ 

Building & Room No. _6700 B Rockledge Dr.  Tel. No. (301) 435‐3756                               
FAX No. 301.402.1505 

Is the NIH Senior Investigator an NIH employee (FTE)?  ___X__Yes  _______No 

Senior Investigator Signature:  _____________________________________________ 

   (Signature of Investigator who will conduct research) 
 Supervisor Signature: ____________________________________________________ 
                                         (Signature of official for IC, e.g., Lab/Branch Chief) 

Name of NIH investigator conducting research if not the NIH Senior Investigator:  (i.e, 
junior investigator, contractor investigator, fellow, student) 
_NA____________________________________________________________________ 

Please provide the name and e‐mail of any others who should receive a copy of the 
OHSRP determination:  _Pia Lohse, lohsep@niaid.nih.gov; Dione Washington,
washingtondi@niaid.nih.gov _____________________________________ 

1. What role will the NIH investigator(s) have in this research project? (check all that 
apply) 
__ Conduct research activity 
_X_ Analyze samples/data only 
_X_ Consultant/advisor to collaborator(s)  
__ Author on publication(s)/manuscript(s) pertaining to this research 
__ Other, please describe: ______________________________________________ 

2. Title: Process Evaluation of the DAIDS Critical Events Policy Implementation (CEPI) 
Program  

3. Describe in lay terms the research activity that will be performed:  
Page 1 of 3

REQUEST FORM: OHSRP DETERMINATION FORSURVEYS, INTERVIEW PROCEDURES, 
PROGRAM EVALUATION, EDUCATIONAL TESTING AND RESEARCH 
Web‐based surveys using Survey Monkey will collect data from DAIDS staff (FTEs and 
HJF contractor)and extramural researchers/external stakeholders that receive support 
through NIAID/DAIDS.  A pilot survey will be done to test the survey instrument (up to 
10 DAIDS staff, and 8 extramural researchers/external stakeholders) to assess the 
understandability, reliability, and validity of the survey questions. After the pilot surveys 
are completed, the survey questions are finalized, and IRB approval and OMB clearance 
is obtained, DAIDS staff in the Protection of Participants, Evaluation, and Policy Branch 
will send emails to individuals in the target populations, inviting their participation in the 
survey. 100 DAIDS staff and 400 extramural researchers/ external stakeholders will 
complete the survey, up to two times over a 15‐month period. With both the pilot 
survey and regular survey, all participants will be asked to read the informed consent 
statement; if potential participants wish to participate, they will be prompted to 
consent to complete the survey by clicking on the “agree” or “disagree” button at the 
conclusion of the informed consent statement. After agreeing to participate, 
participants will be prompted to enter their contact information. The evaluation 
contractor will manually create a unique link to the full survey for each participant, 
which will be emailed to individual participants. Survey data is coded and maintained 
separate from contact information, to protect the participant’s privacy and maintain 
data confidentiality. Extramural researchers/external stakeholders will receive $15 for 
completing the pilot survey and $10 for each completed survey. 

Nine 90‐minute focus groups (two‐ DAIDS staff, seven‐ extramural researchers/external 
stakeholders) will be conducted with up to nine participants each. The extramural 
researchers/external stakeholders focus groups will be conducted during local (n=5), 
domestic (n=1), or international (n=1) DAIDS or Network meetings. DAIDS staff focus 
groups will be conducted locally. Emails will be sent to individuals in the target 
populations, inviting their participation in the focus groups. Persons scheduled to attend 
a focus group will be emailed the informed consent form. Written informed consent will 
be obtained from all focus group participants prior to their participation. Extramural 
researchers/external stakeholders will receive $30 for their participation in a focus 
group.     

4. Proposed start date   01/15/2014      Proposed completion date   09/30/2016 

5.  Specify the nature of the data: (select all that apply) 
__ Interview procedure   
_X_ Survey   
__ Educational Testing      

__ Educational Research        
__ Research on public benefit or service programs 
_X_ Other, describe: _Focus group______________________________________    

Page 2 of 5

REQUEST FORM: OHSRP DETERMINATION FORSURVEYS, INTERVIEW PROCEDURES, 
PROGRAM EVALUATION, EDUCATIONAL TESTING AND RESEARCH 
6. What kind of human data (e.g., private information, responses to questionnaires, 
test results, recordings) will be collected in your research? 
Online surveys and Focus groups will be used to collect data on awareness and 
accessibility, understandability, and applicability of the DAIDS Critical Events Policy. 
Name and contact information will be collected separate from the data collection survey 
and participant incentive distribution logs. The purpose for recording names is the 
confirm consent and verify the incentive amount given to each participant. Access to 
these names will be restricted to a limited number of SSI staff. Participant names will 
not be given to DAIDS.      

7. Will human data be? (select all that apply) 
Collected     Yes X___ No ___ 
  Received  Yes_ X _ No _X_ 
  Sent 
Yes__ No _X_ 
Responses from participants will be obtained through online surveys (coded, no names). 
In addition, audio transcripts of participants in the focus group discussions will be 
collected.  

8. If receiving or sending, list the collaborating investigator(s): 
Name       Institution/IC    
Address/e‐mail   

FWA number* 
Social Solutions International, Inc., 8070  Georgia Ave, Su 201, Silver Spring, MD, 20910, 
FWA00008632  

9.  Where are the subjects of this research activity located? (Provide a general 
description or complete the institutional information below) 

Institution: DAIDS staff (FTEs and contract employees) are local to the DC Metro area. 
Extramural researchers (e.g., domestic and international PIs, site coordinators), and 
external stakeholders (e.g., clinical site monitors, DAIDS Network leadership, Operations 
center staff, data management staff, protocol teams) are located around the world, 
including the U.S., sub‐Saharan Africa, South America, and Asia. Surveys will be 
completed through the participants’ computer. The extramural researchers/external 
stakeholders focus group interviews will be done at local (n=5), domestic (n=1), and 
international (n=1) DAIDS Network meetings. DAIDS staff focus groups will be conducted 
locally.   
Contact Name: _____Lynda Lahl__________________ 

Address: NIAID/DAIDS/OPCRO/ProPEP 
Phone: (301) 435‐3756                                

10.  Will NIH investigator(s) have direct contact or intervention with the subjects of 
the study?  (For example, by interviewing, surveying or recording the subjects?)   
Yes X__ No __ 

Page 3 of 5

REQUEST FORM: OHSRP DETERMINATION FORSURVEYS, INTERVIEW PROCEDURES, 
PROGRAM EVALUATION, EDUCATIONAL TESTING AND RESEARCH 
If yes, what is the age range of subjects involved in the research?  
___ Children aged < 18 years 
_X_ Adults aged > 18 years 

11.  Who will collect the data or information? 
(a) ___ NIH Investigator  
(b) ___ non‐NIH Collaborator  
(c) __X_ NIH Contractor  
(d) ___ Other, specify__________________________________________ 

If b or c, will an Honest Broker or data use agreement be used? Yes__ No_X_ 

If yes, complete and attach the Honest Broker Assurance or data‐use agreement to 
this submission; e‐mail ohsr_nih_ddir@od.nih.gov to request a form. 

12.  Select the best description that applies to the human data or information:  
_ _ Data or information will not contain any identifiable information, nor can it be 
linked to individual subjects by you or your collaborators. 
X__ Data or information will be recorded in such a manner that subjects can be 
identified directly or through identifiers linked to the subjects* 
* All identifying information will be stored separate from study data. Any electronic
data is encrypted and stored on a password protected computer in the SSI
offices. Only Social Solutions’ project staff with the appropriate security levels
and completed security and privacy training are able to access the computer. 

13. Per NIH guidance, are all conflicts of interest by NIH employees (sender or 
receiver), if any, resolved?  _X____Yes   _____No** 

*A Federalwide Assurance (FWA) is issued by the U.S. Department of Health and Human 
Services (DHHS)/ Office of Human Research Protections (OHRP) to institutions which 
receive Federal funds/support to conduct human subjects research. To search for the 
FWA# for domestic or international institutions go to 
http://ohrp.cit.nih.gov/search/fwasearch.aspx?styp=bsc  

**If the answer is “No”, note that OHSRP will be unable to make a determination and 
research may not proceed until all conflicts are resolved. For more information, see the 
October 2011, A Guide to Preventing Financial and Non‐Financial Conflict of Interest  in 
Human Subjects Research at NIH. For assistance review the list of Ethics Coordinators 
and find the contact for your IC: http://ethics.od.nih.gov/coord.pdf 

Page 4 of 5

REQUEST FORM: OHSRP DETERMINATION FORSURVEYS, INTERVIEW PROCEDURES, 
PROGRAM EVALUATION, EDUCATIONAL TESTING AND RESEARCH 

List of Attachments: 
A‐ Pilot Survey Informed consent for DAIDS staff 
B‐ Pilot Survey Informed consent for Extramural Researcher/External Stakeholders 
C‐ DAIDS staff recruitment email for pilot survey 
D‐ Extramural Researcher/External Stakeholders recruitment email for pilot 
survey 
E‐ DAIDS staff recruitment email for potential survey participants 
F‐ Extramural Researcher/External Stakeholders recruitment email for potential 
survey participants 
G‐ Survey participants informed consent (all) 
H‐ Email to participants with unique link to survey 
I‐ DAIDS staff and PPD site monitor pilot survey questionnaire 
J‐ Extramural Researcher/External Stakeholders pilot survey questionnaire 
K‐ DAIDS staff survey 
L‐ Extramural Researcher/External Stakeholders survey 
M‐ Recruitment email for potential focus group participants 
N‐ DAIDS staff focus group consent form 
O‐ Extramural Researcher/External Stakeholders focus group consent form 
P‐ Focus group details and preparations 
Q‐ Focus group opening script 
R‐ Focus group probes/questions 

Page 5 of 5

Attachment A: Landing Page with Study Details and Informed Consent
Statement for Pilot Survey of DAIDS Staff

In order to register to take the pilot survey, participants will follow a link to Survey Monkey
providing the following study details and informed consent statement. To provide consent,
potential participants will click “Agree” or “Disagree” with the informed consent statement. If
they disagree, they can exit Survey Monkey. If they agree, they will be prompted enter their
email address and incentive distribution contact information. This information will be stored
separately from any survey responses.
Social Solutions International, Inc. has been contracted by the National Institute of Allergy and
Infectious Diseases (NIAID), Division of AIDS (DAIDS) to conduct a process evaluation of the
Critical Events Policy Implementation (CEPI) program. Critical Events may occur during the
conduct of clinical research that deviates from Institutional Review Board (IRB)/Ethics
Committee (EC) – approved protocols and may adversely affect risks to research participants, or
study outcomes and integrity. DAIDS created this policy to provide guidance on how to report
critical events. Social Solutions is conducting this research in order to assess DAIDS staff,
extramural researchers and external stakeholders’ awareness of the policy and supplemental
resources, as well as the accessibility, understandability, and applicability of the Critical Events
policy and related documents. This research will also provide insight into the success of training
efforts in increasing knowledge of the policy, and satisfaction with available training and
support.
An important part of this research involves the collection of surveys from DAIDS staff,
extramural researchers, and external stakeholders at two points throughout the next two years.
We are asking for your participation in a pilot survey to determine the clarity of instructions,
readability, understandability, reliability, and validity of the draft survey instrumentation, as well
as the order and format of questions. Once you have completed the pilot survey, we are asking
for you participation in a questionnaire on your opinions about the survey instrumentation.
The survey consists of a series of questions designed to help us better understand your awareness
of the Critical Events policy and supplemental resources, as well as your opinion on the
accessibility, understandability, and applicability of the policy and your related responsibilities.
The information that you provide in this pilot survey will be used to improve and adjust the final
survey instrumentation that will be sent to over 500 participants. Your opinions, experiences, and
ideas are very important.
If you would like to participate, please read the informed consent statement below and select
“Agree” to provide your consent to participate in the survey. You will then be prompted to enter
your email address and if applicable, your mailing address so that we may send you a stipend for
your time to complete the survey. DAIDS staff (including HJF-DAIDS staff) and Site monitors
will not receive a stipend for their completion of the survey. All information collected will be
kept confidential and secure. No personally identifiable information will be stored with your
Social Solutions International, Inc.
8070 Georgia Ave; Suite 201 * Silver Spring, Maryland * 20910
(T) 301.774.0897 (F) 301.570.4772
FWA #: 00013212
12/5/2013
page 1 of 47

responses to the survey. Your contact information will be used only to send you a unique link to
the full survey and/or to provide your stipend.
Once you have consented to participate and provided your information, Social Solutions
researchers will send you an email with a unique link to the Survey Monkey survey within 2
business days. No individual will participate in the focus group without prior completion of the
consent form.
Informed Consent Statement
The survey consists of a series of questions designed to help us better understand your awareness
of the Critical Events policy and supplemental resources, as well as your opinion on the
accessibility, understandability, and applicability of the policy and your related responsibilities.
The information that you provide in the survey may be used by NIAID/DAIDS to improve
policy implementation and dissemination. Your opinions, experiences, and ideas are very
important.
PROCEDURES
The survey will each take approximately 30-35 minutes to complete. You do not have to do
anything to prepare for the survey. We will ask questions about the Critical Events policy,
including how easy you find the policy to understand and apply to your work, your satisfaction
with trainings on the policy, and recommendations for policy improvement.
PARTICIPATION AND WITHDRAWAL
Participation in this survey is completely voluntary. There is no consequence if you decide not to
complete the survey.
POTENTIAL RISKS
We anticipate very few risks to you from participation in this survey. There is a small chance
that you may feel uncomfortable with a question and not want to respond. If you do experience
negative feelings as a result of the survey, a clinical psychologist will be available to discuss
those feelings. In the unlikely event of physical or other injury resulting from the survey,
emergency medical treatment will be provided, but financial compensation will not be available.
Social Solutions will not provide compensation if you experience injury or other adverse effects,
which are not the fault of the investigators.
ANTICIPATED BENEFITS
If you decide to participate in the survey, you may gain a better understanding of the Critical
Events policy and resources and trainings available. This information may motivate you to obtain
more information about the policy, about clinical research protocols, and/or change your
behavior to positively improve clinical research and reporting. Additionally, the information that
you provide will be used to improve the program’s policy dissemination efforts.
PRIVACY AND CONFIDENTIALITY
To protect your identity, none of the information you provide will be associated with any
statement or identified personally in any way. Other than the signed consent form, no personal
Social Solutions International, Inc.
8070 Georgia Ave; Suite 201 * Silver Spring, Maryland * 20910
(T) 301.774.0897 (F) 301.570.4772
FWA #: 00013212
12/5/2013
page 2 of 47

identifiable information will be collected. The consent form will be kept separate from the other
information we collect to make sure that the data cannot be identified.
Any survey information collected by paper will be kept in a locked cabinet. Information
transferred and stored electronically will be stored only on password-protected computers. Only
specified researchers at Social Solutions will have access to this information, and all researchers
are trained in secure and private research protocols. All files will be destroyed 7 years after the
study concludes.
Information provided during the research will only be disclosed to others if necessary to protect
your rights or welfare, or if required by law. When the results of the research are published or
discussed in conferences, no information will be included that would reveal your identity.
QUESTIONS AND CONCERNS
If you have any questions about this project, you may contact:
Jenny Namur Karp
President and Principal Investigator
Social Solutions International, Inc.
Email: jnkarp@socialsolutions.biz
Phone: 202.491.4954

Kristen Stier
Project Coordinator/Research Associate
Social Solutions International, Inc.
Email: kstier@socialsolutions.biz
Phone: 202.870.2226

If you have any questions about your rights as a research participant, please call Karen Chen at
703-738-6684.
CONSENT
Informed consent shall be documented, as approved by the IRB, by your agreement with the
informed consent statement. Agreement must be selected by the participant or the participant’s
legally authorized representative. The investigator should provide either the participant or the
representative adequate opportunity to read the consent form and pose questions to the
investigator prior to signing the form.
Please read and show that you understand what you have read by selected agree below.
I have read this form and understand all of the information about my involvement in the survey.
By clicking below, I agree to participate.
Agree

Disagree

Social Solutions International, Inc.
8070 Georgia Ave; Suite 201 * Silver Spring, Maryland * 20910
(T) 301.774.0897 (F) 301.570.4772
FWA #: 00013212
12/5/2013
page 3 of 47

Attachment B: Landing Page with Study Details and Informed Consent
Statement for Pilot Survey of Extramural Researchers and External
Stakeholders

In order to register to take the pilot survey, participants will follow a link to Survey Monkey
providing the following study details and informed consent statement. To provide consent,
potential participants will click “Agree” or “Disagree” with the informed consent statement. If
they disagree, they can exit Survey Monkey. If they agree, they will be prompted enter their
email address and incentive distribution contact information. This information will be stored
separately from any survey responses.
Social Solutions International, Inc. has been contracted by the National Institute of Allergy and
Infectious Diseases (NIAID), Division of AIDS (DAIDS) to conduct a process evaluation of the
Critical Events Policy Implementation (CEPI) program. Critical Events may occur during the
conduct of clinical research that deviates from Institutional Review Board (IRB)/Ethics
Committee (EC) – approved protocols and may adversely affect risks to research participants, or
study outcomes and integrity. DAIDS created this policy to provide guidance on how to report
critical events. Social Solutions is conducting this research in order to assess DAIDS staff,
extramural researchers and external stakeholders’ awareness of the policy and supplemental
resources, as well as the accessibility, understandability, and applicability of the Critical Events
policy and related documents. This research will also provide insight into the success of training
efforts in increasing knowledge of the policy, and satisfaction with available training and
support.
An important part of this research involves the collection of surveys from DAIDS staff,
extramural researchers, and external stakeholders at two points throughout the next two years.
We are asking for your participation in a pilot survey to determine the clarity of instructions,
readability, understandability, reliability, and validity of the draft survey instrumentation, as well
as the order and format of questions. Once you have completed the pilot survey, we are asking
for you participation in a questionnaire on your opinions about the survey instrumentation.
The survey consists of a series of questions designed to help us better understand your awareness
of the Critical Events policy and supplemental resources, as well as your opinion on the
accessibility, understandability, and applicability of the policy and your related responsibilities.
The information that you provide in this pilot survey will be used to improve and adjust the final
survey instrumentation that will be sent to over 500 participants. Your opinions, experiences, and
ideas are very important.
If you would like to participate, please read the informed consent statement below and select
“Agree” to provide your consent to participate in the survey. You will then be prompted to enter
your email address and if applicable, your mailing address so that we may send you a stipend for
your time to complete the survey. DAIDS staff (including HJF-DAIDS staff) and Site monitors
will not receive a stipend for their completion of the survey. All information collected will be
kept confidential and secure. No personally identifiable information will be stored with your
Social Solutions International, Inc.
8070 Georgia Ave; Suite 201 * Silver Spring, Maryland * 20910
(T) 301.774.0897 (F) 301.570.4772
FWA #: 00013212
12/5/2013
page 4 of 47

responses to the survey. Your contact information will be used only to send you a unique link to
the full survey and/or to provide your stipend.
Once you have consented to participate and provided your information, Social Solutions
researchers will send you an email with a unique link to the Survey Monkey survey within 2
business days. No individual will participate in the focus group without prior completion of the
consent form.
Informed Consent Statement
The survey consists of a series of questions designed to help us better understand your awareness
of the Critical Events policy and supplemental resources, as well as your opinion on the
accessibility, understandability, and applicability of the policy and your related responsibilities.
The information that you provide in the survey may be used by NIAID/DAIDS to improve
policy implementation and dissemination. Your opinions, experiences, and ideas are very
important.
PROCEDURES
The survey will each take approximately 30-35 minutes to complete. You do not have to do
anything to prepare for the survey. We will ask questions about the Critical Events policy,
including how easy you find the policy to understand and apply to your work, your satisfaction
with trainings on the policy, and recommendations for policy improvement.
PARTICIPATION AND WITHDRAWAL
Participation in this survey is completely voluntary. There is no consequence if you decide not to
complete the survey.
POTENTIAL RISKS
We anticipate very few risks to you from participation in this survey. There is a small chance
that you may feel uncomfortable with a question and not want to respond. If you do experience
negative feelings as a result of the survey, a clinical psychologist will be available to discuss
those feelings. In the unlikely event of physical or other injury resulting from the survey,
emergency medical treatment will be provided, but financial compensation will not be available.
Social Solutions will not provide compensation if you experience injury or other adverse effects,
which are not the fault of the investigators.
ANTICIPATED BENEFITS
If you decide to participate in the survey, you may gain a better understanding of the Critical
Events policy and resources and trainings available. This information may motivate you to obtain
more information about the policy, about clinical research protocols, and/or change your
behavior to positively improve clinical research and reporting. Additionally, the information that
you provide will be used to improve the program’s policy dissemination efforts.
INCENTIVES
Participants (excluding PPD-DAIDS Site monitors) will receive $15 as a token of appreciation
for their completion of the survey.
Social Solutions International, Inc.
8070 Georgia Ave; Suite 201 * Silver Spring, Maryland * 20910
(T) 301.774.0897 (F) 301.570.4772
FWA #: 00013212
12/5/2013
page 5 of 47

PRIVACY AND CONFIDENTIALITY
To protect your identity, none of the information you provide will be associated with any
statement or identified personally in any way. Other than the signed consent form, no personal
identifiable information will be collected. The consent form will be kept separate from the other
information we collect to make sure that the data cannot be identified.
Any survey information collected by paper will be kept in a locked cabinet. Information
transferred and stored electronically will be stored only on password-protected computers. Only
specified researchers at Social Solutions will have access to this information, and all researchers
are trained in secure and private research protocols. All files will be destroyed 7 years after the
study concludes.
Information provided during the research will only be disclosed to others if necessary to protect
your rights or welfare, or if required by law. When the results of the research are published or
discussed in conferences, no information will be included that would reveal your identity.
QUESTIONS AND CONCERNS
If you have any questions about this project, you may contact:
Jenny Namur Karp
President and Principal Investigator
Social Solutions International, Inc.
Email: jnkarp@socialsolutions.biz
Phone: 202.491.4954

Kristen Stier
Project Coordinator/Research Associate
Social Solutions International, Inc.
Email: kstier@socialsolutions.biz
Phone: 202.870.2226

If you have any questions about your rights as a research participant, please call Karen Chen at
703-738-6684.
CONSENT
Informed consent shall be documented, as approved by the IRB, by your agreement with the
informed consent statement. Agreement must be selected by the participant or the participant’s
legally authorized representative. The investigator should provide either the participant or the
representative adequate opportunity to read the consent form and pose questions to the
investigator prior to signing the form.
Please read and show that you understand what you have read by selected agree below.
I have read this form and understand all of the information about my involvement in the survey.
By clicking below, I agree to participate.

Social Solutions International, Inc.
8070 Georgia Ave; Suite 201 * Silver Spring, Maryland * 20910
(T) 301.774.0897 (F) 301.570.4772
FWA #: 00013212
12/5/2013
page 6 of 47

Attachment C: NIAID DAIDS Staff Recruitment Email for Pilot Survey
[DATE]

DAIDS Critical Events
Policy Implementation
Program (CEPI) Pilot
Survey

Welcome to the DAIDS Critical
Events Policy Implementation
Program (CEPI) Pilot Survey!
Why

Please respond to this
survey by January 29,
2014

Contact Us
Lyndi Lahl, Policy Health
Specialist
Protection of Participants,
Evaluation, and Policy
Branch
OPCRO/DAIDS/NIAID/NIH
Lynda.Lahl@nih.gov

The use of a web‐based survey will
help to ensure survey responses are
kept private . The survey will
request no individual identifiers.

should you respond to this pilot
survey?
As professionals who actively utilize DAIDS policies, we ask
that you participate in the CEPI pilot survey so that we
learn more about:
 Awareness, accessibility, understandability, and

experience with the DAIDS Critical Events Policy and
Manual
 Applicability of the DAIDS Critical Events Policy and

Manual to clinical research
 Recommendations to improve the critical event

reporting and question submission process
 Your experience taking the survey

 The entire survey and questionnaire is voluntary
and will take no more than 30-35 minutes to
complete. I encourage you to participate. Please click
here to provide your consent to take the short, webbased, confidential survey by January 29, 2014. You be
prompted to enter your email address and a unique link
to the full, confidential web-based survey will be emailed
to you within 2 business days.

Social Solutions International, Inc.
8070 Georgia Ave; Suite 201 * Silver Spring, Maryland * 20910
(T) 301.774.0897 (F) 301.570.4772
FWA #: 00013212
12/5/2013
page 7 of 47

Attachment D: NIAID Extramural Researcher and External Stakeholder
Recruitment Email for Pilot Survey
[DATE]

DAIDS Critical Events
Policy Implementation
Program (CEPI) Pilot
Survey

Welcome to the DAIDS Critical
Events Policy Implementation
Program (CEPI) Pilot Survey!

Please respond to this
survey by January 29,
2014

Contact Us
Lynda Lahl, Policy Health
Specialist
Protection of Participants,
Evaluation and Policy and
Branch
OPCRO/DAIDS/NIAID/NIH
Lynda.Lahl@nih.gov

The use of a web‐based survey will
help to ensure survey responses are
kept private . The survey will
request no individual identifiers.

Why should you respond to this pilot survey?
As professionals who actively utilize DAIDS policies, we ask
that you participate in the CEPI pilot survey so that we learn
more about:
 Awareness, accessibility, understandability, and

experience with the DAIDS Critical Events Policy and
Manual
 Applicability of the DAIDS Critical Events Policy and

Manual to clinical research
 Recommendations to improve the critical event reporting

and question submission process
 Your experience taking the survey

You will receive a small stipend as compensation for your
time in completing this survey, excluding PPD-DAIDS Site
monitors.
The entire survey and questionnaire is voluntary
and will take no more than 30-35 minutes to
complete. I encourage you to participate. Please click here
to provide your consent to take the short, web-based,
confidential survey by January 29, 2014. You be prompted
to enter your email address and a unique link to the full,
confidential web-based survey will be emailed to you within 2
business days.

Social Solutions International, Inc.
8070 Georgia Ave; Suite 201 * Silver Spring, Maryland * 20910
(T) 301.774.0897 (F) 301.570.4772
FWA #: 00013212
12/5/2013
page 8 of 47

Attachment E: NIAID DAIDS Staff Recruitment Email to Potential Survey
Participants

Welcome to the DAIDS Critical Events
Policy Implementation Program
(CEPI) Survey!

[DATE]

Why should you respond to this survey?
As professionals who actively utilize DAIDS policies, we ask that
you participate in the CEPI survey so that we learn more about:





Awareness, accessibility, understandability, and
experience with the DAIDS Critical Events Policy and
Manual
Applicability of the DAIDS Critical Events Policy and
Manual to clinical research
Recommendations to improve the critical event reporting
and question submission process.

The entire survey is voluntary and will take no more
than 30 minutes to complete. I encourage you to participate.

To Sign Up for the Survey:





Click this link to read more about the study and consent to
take the survey.
You will then be prompted to enter your email address.
A unique link to the full, confidential web-based survey
will be emailed to you within 2 business days.

Social Solutions International, Inc.
8070 Georgia Ave; Suite 201 * Silver Spring, Maryland * 20910
(T) 301.774.0897 (F) 301.570.4772
FWA #: 00013212
12/5/2013
page 9 of 47

Attachment F: NIAID Extramural Researcher and External Stakeholder
Recruitment Email to Potential Survey Participants
[DATE]

Welcome to the DAIDS Critical Events Policy
Implementation Program (CEPI) Survey!

DAIDS Critical
Events Policy
Implementation
Program (CEPI)
Survey

Contact Us
Lynda Lahl, Policy
Health Specialist
Protection of
Participants, Evaluation
and Policy and Branch
OPCRO/DAIDS/NIAID/
NIH
Lynda.Lahl@nih.gov

The use of a web‐based survey
will help to ensure survey
responses are kept private .
The survey will request no
individual identifiers.

Why should you respond to this survey?
As professionals who actively utilize DAIDS policies, we ask that
you participate in the CEPI survey so that we learn more about:




Awareness, accessibility, understandability, and experience
with the DAIDS Critical Events Policy and Manual
Applicability of the DAIDS Critical Events Policy and
Manual to clinical research
Recommendations to improve the critical event reporting
and question submission process
You will receive a small stipend as compensation for your
time in completing this survey, excluding PPD-DAIDS Site
monitors.

The entire survey is voluntary and will take no more than
30 minutes to complete. I encourage you to participate.

To Sign Up for the Survey:





Click this link to read more about the study and consent to
take the survey.
You will then be prompted to enter your email address, and
mailing address to receive your incentive.
A unique link to the full, confidential web-based survey will
be emailed to you within 2 business days.

Social Solutions International, Inc.
8070 Georgia Ave; Suite 201 * Silver Spring, Maryland * 20910
(T) 301.774.0897 (F) 301.570.4772
FWA #: 00013212
12/5/2013
page 10 of 47

Attachment G: Landing Page with Study Details and Informed Consent
Statement

In order to register to take the survey, participants will follow a link to Survey Monkey providing
the following study details and informed consent statement. To provide consent, potential
participants will click “Agree” or “Disagree” with the informed consent statement. If they
disagree, they can exit Survey Monkey. If they agree, they will be prompted enter their email
address and incentive distribution contact information. This information will be stored
separately from any survey responses.
Social Solutions International, Inc. has been contracted by the National Institute of Allergy and
Infectious Diseases (NIAID), Division of AIDS (DAIDS) to conduct a process evaluation of the
Critical Events Policy Implementation (CEPI) program. Critical Events may occur during the
conduct of clinical research that deviates from Institutional Review Board (IRB)/Ethics
Committee (EC) – approved protocols and may adversely affect risks to research participants, or
study outcomes and integrity. DAIDS created this policy to provide guidance on how to report
critical events. Social Solutions is conducting this research in order to assess DAIDS staff,
extramural researchers and external stakeholders’ awareness of the policy and supplemental
resources, as well as the accessibility, understandability, and applicability of the Critical Events
policy and related documents. This research will also provide insight into the success of training
efforts in increasing knowledge of the policy, and satisfaction with available training and
support.
As part of the evaluation, we will be conducting surveys and focus groups with DAIDS Staff,
Extramural Researchers and External Stakeholders. Your involvement in the evaluation will be
the key to our success. As one of those key stakeholders, on behalf of NIAID/DAIDS, we would
like to request your participation in a survey. We are looking for participants who can complete
the survey on 2 separate occasions – one during the months of October – December 2014 and
another during the months of October-December 2015.
If you would like to participate, please read the informed consent statement below and select
“Agree” to provide your consent to participate in the survey. You will then be prompted to enter
your email address and if applicable, your mailing address so that we may send you a stipend for
your time to complete the survey. DAIDS staff (including HJF_DAIDS staff) and Site monitors
will not receive a stipend for their completion of the survey. All information collected will be
kept confidential and secure. No personally identifiable information will be stored with your
responses to the survey. Your contact information will be used only to send you a unique link to
the full survey and/or to provide your stipend.
Once you have consented to participate and provided your information, Social Solutions
researchers will send you an email with a unique link to the Survey Monkey survey within 2
business days. No individual will participate in the focus group without prior completion of the
consent form.
Social Solutions International, Inc.
8070 Georgia Ave; Suite 201 * Silver Spring, Maryland * 20910
(T) 301.774.0897 (F) 301.570.4772
FWA #: 00013212
12/5/2013
page 11 of 47

Informed Consent Statement
The survey consists of a series of questions designed to help us better understand your awareness
of the Critical Events policy and supplemental resources, as well as your opinion on the
accessibility, understandability, and applicability of the policy and your related responsibilities.
The information that you provide in the survey may be used by NIAID/DAIDS to improve
policy implementation and dissemination. Your opinions, experiences, and ideas are very
important.
PROCEDURES
The survey will each take approximately 25-30 minutes to complete. You do not have to do
anything to prepare for the survey. We will ask questions about the Critical Events policy,
including how easy you find the policy to understand and apply to your work, your satisfaction
with trainings on the policy, and recommendations for policy improvement.
PARTICIPATION AND WITHDRAWAL
Participation in this survey is completely voluntary. There is no consequence if you decide not to
complete the survey.
POTENTIAL RISKS
We anticipate very few risks to you from participation in this survey. There is a small chance
that you may feel uncomfortable with a question and not want to respond. If you do experience
negative feelings as a result of the survey, a clinical psychologist will be available to discuss
those feelings. In the unlikely event of physical or other injury resulting from the survey,
emergency medical treatment will be provided, but financial compensation will not be available.
Social Solutions will not provide compensation if you experience injury or other adverse effects,
which are not the fault of the investigators.
ANTICIPATED BENEFITS
If you decide to participate in the survey, you may gain a better understanding of the Critical
Events policy and resources and trainings available. This information may motivate you to obtain
more information about the policy, about clinical research protocols, and/or change your
behavior to positively improve clinical research and reporting. Additionally, the information that
you provide will be used to improve the program’s policy dissemination efforts.
INCENTIVES
Non-DAIDS staff participants (excluding PPD-DAIDS Site monitors) will receive $10 as a token
of appreciation for their completion of the survey.
PRIVACY AND CONFIDENTIALITY
To protect your identity, none of the information you provide will be associated with any
statement or identified personally in any way. Other than the signed consent form, no personal
identifiable information will be collected. The consent form will be kept separate from the other
information we collect to make sure that the data cannot be identified.
Social Solutions International, Inc.
8070 Georgia Ave; Suite 201 * Silver Spring, Maryland * 20910
(T) 301.774.0897 (F) 301.570.4772
FWA #: 00013212
12/5/2013
page 12 of 47

Any survey information collected by paper will be kept in a locked cabinet. Information
transferred and stored electronically will be stored only on password-protected computers. Only
specified researchers at Social Solutions will have access to this information, and all researchers
are trained in secure and private research protocols. All files will be destroyed 7 years after the
study concludes.
Information provided during the research will only be disclosed to others if necessary to protect
your rights or welfare, or if required by law. When the results of the research are published or
discussed in conferences, no information will be included that would reveal your identity.
QUESTIONS AND CONCERNS
If you have any questions about this project, you may contact:
Jenny Namur Karp
President and Principal Investigator
Social Solutions International, Inc.
Email: jnkarp@socialsolutions.biz
Phone: 202.491.4954

Kristen Stier
Project Coordinator/Research Associate
Social Solutions International, Inc.
Email: kstier@socialsolutions.biz
Phone: 202.870.2226

If you have any questions about your rights as a research participant, please call Karen Chen at
703-738-6684.
CONSENT
Informed consent shall be documented, as approved by the IRB, by your agreement with the
informed consent statement. Agreement must be selected by the participant or the participant’s
legally authorized representative. The investigator should provide either the participant or the
representative adequate opportunity to read the consent form and pose questions to the
investigator prior to signing the form.
Please read and show that you understand what you have read by selected agree below.
I have read this form and understand all of the information about my involvement in the survey.
By clicking below, I agree to participate.
Agree

Disagree

Social Solutions International, Inc.
8070 Georgia Ave; Suite 201 * Silver Spring, Maryland * 20910
(T) 301.774.0897 (F) 301.570.4772
FWA #: 00013212
12/5/2013
page 13 of 47

Attachment H: Email to Participants with Unique Link to Survey
Dear Participant,
Thank you for your participation in the DAIDS Critical Events Policy Implementation Program
(CEPI) Survey. Please click the following link to complete the survey via Survey Monkey. This
link is unique to you. Your survey responses will be kept secure and confidential. Once you
have completed the survey, Social Solutions will mail your stipend [omitted for DAIDS staff,
including HJF-DAIDS staff, and Site monitors].
Link
If you have any questions, please contact:
Jenny Namur Karp
President and Principal Investigator
Social Solutions International, Inc.
Email: jnkarp@socialsolutions.biz
Phone: 202.491.4954
Thank you for your time,
Social Solutions Researchers

Social Solutions International, Inc.
8070 Georgia Ave; Suite 201 * Silver Spring, Maryland * 20910
(T) 301.774.0897 (F) 301.570.4772
FWA #: 00013212
12/5/2013
page 14 of 47

Attachment I: DAIDS Staff and PPD‐DAIDS Site Monitor Pilot Survey
Questionnaire

Social Solutions International, Inc.

Now that you have completed the pilot survey, we ask that you reflect back on this
experience. Please answer the following questions below.
1. Please rate the burden on your time to complete the survey instrument:
a. Not at all burdensome
b. Slightly burdensome
c. Moderately burdensome
d. Largely burdensome
e. Overly burdensome
2. How long did it take you to complete the survey?
a. 10-15 minutes
b. 15-20 minutes
c. 20-25 minutes
d. 25-30 minutes
e. More than 30 minutes
3. Please rate the clarity of instructions for the completing the survey instrument:
a. Extremely clear
b. Somewhat clear
c. Unsure
d. Somewhat unclear
e. Extremely unclear
4. Please rate the clarity of questions in the survey instrument:
a. Extremely clear
b. Somewhat clear
c. Unsure
d. Somewhat unclear
e. Extremely unclear
5. Please rate the readability of the survey questions:
a. Extremely easy to understand
b. Somewhat easy to understand
c. Unsure
d. Somewhat difficult to understand
e. Extremely difficult to understand

Social Solutions International, Inc.
8070 Georgia Ave; Suite 201 * Silver Spring, Maryland * 20910
(T) 301.774.0897 (F) 301.570.4772
FWA #: 00013212
12/5/2013
page 15 of 47

6. If there was anything unclear about the survey instrument, please describe what was
unclear in a couple of sentences below:
______________________________________________________________________________
______________________________________________________________________________
______________________________________________________________________________
______________________________________________________________________________
7. Please rate the logical order and flow of the questions:
a. Extremely logical and coherent order
b. Somewhat logical and coherent order
c. Unsure
d. Somewhat illogical and incoherent order
e. Extremely illogical and incoherent order
8. What is your preference for question format?
a. Likert Scale (participants rank their level of satisfaction or agreement with a
statement)
b. Multiple Choice Questions (participants select among alphabetized options)
c. Multiple Selection Questions (participants checks all that apply)
d. Open-ended questions (participants write full sentences)
9. Is there anything you would change about the survey? If so, please indicate below in a
couple of sentences:
_____________________________________________________________________________________ 
_____________________________________________________________________________________ 
_____________________________________________________________________________________ 
_____________________________________________________________________________________ 

Social Solutions International, Inc.
8070 Georgia Ave; Suite 201 * Silver Spring, Maryland * 20910
(T) 301.774.0897 (F) 301.570.4772
FWA #: 00013212
12/5/2013
page 16 of 47

Attachment J: Extramural Researcher/External Stakeholder Pilot Survey
Questionnaire

Social Solutions International, Inc.

Now that you have completed the pilot survey, we ask that you reflect back on this
experience. Please answer the following questions below.
1. Please rate the burden on your time to complete the survey instrument:
a. Not at all burdensome
b. Slightly burdensome
c. Moderately burdensome
d. Largely burdensome
e. Overly burdensome
2. How long did it take you to complete the survey?
a. 10-15 minutes
b. 15-20 minutes
c. 20-25 minutes
d. 25-30 minutes
e. More than 30 minutes
3. Please rate the clarity of instructions for the completing the survey instrument:
a. Extremely clear
b. Somewhat clear
c. Unsure
d. Somewhat unclear
e. Extremely unclear
4. Please rate the clarity of questions in the survey instrument:
a. Extremely clear
b. Somewhat clear
c. Unsure
d. Somewhat unclear
e. Extremely unclear
5. Please rate the readability of the survey questions:
a. Extremely easy to understand
b. Somewhat easy to understand
c. Unsure
d. Somewhat difficult to understand
e. Extremely difficult to understand

Social Solutions International, Inc.
8070 Georgia Ave; Suite 201 * Silver Spring, Maryland * 20910
(T) 301.774.0897 (F) 301.570.4772
FWA #: 00013212
12/5/2013
page 17 of 47

6. If there was anything unclear about the survey instrument, please describe what was
unclear in a couple of sentences below:
______________________________________________________________________________
______________________________________________________________________________
______________________________________________________________________________
______________________________________________________________________________
7. Please rate the logical order and flow of the questions:
f. Extremely logical and coherent order
g. Somewhat logical and coherent order
h. Unsure
i. Somewhat illogical and incoherent order
j. Extremely illogical and incoherent order
8. What is your preference for question format?
a. Likert Scale (participants rank their level of satisfaction or agreement with a
statement)
b. Multiple Choice Questions (participants select among alphabetized options)
c. Multiple Selection Questions (participants checks all that apply)
d. Open-ended questions (participants write full sentences)
9. If you were provided with a $10 incentive to participate in a study that asked you to fill
out this survey instrument on two occasions (for a total of $20), how likely would you be
to participate?
a. Definitely would participate
b. More likely to participate
c. Not sure
d. More than likely NOT to participate
e. Would not participate
10. Is there anything you would change about the survey? If so, please indicate below in a
couple of sentences:
_____________________________________________________________________________________ 
_____________________________________________________________________________________ 
_____________________________________________________________________________________ 
_____________________________________________________________________________________ 

Social Solutions International, Inc.
8070 Georgia Ave; Suite 201 * Silver Spring, Maryland * 20910
(T) 301.774.0897 (F) 301.570.4772
FWA #: 00013212
12/5/2013
page 18 of 47

Attachment K: DAIDS Staff Survey

Social Solutions International, Inc.

Thank you for taking the time to complete this survey. The information you provide will help us
to improve the program. Please answer each question as honestly as possible. Your name will
not be linked to the answers you provide. The information you provide will be completely
confidential.
Background Information - Please provide the following information about yourself:
Select your role with DAIDS (drop-down menu)
1. Clinical oversight staff (OCSO)
2. Program Officer (Non-Network PO)
3. Medical Officer
4. Other, please list: ____________________________________________________
Enter your number of years’ experience with clinical research:
Please rate your current level of knowledge pertaining to the Critical Events Policy and Manual:
a. Extremely knowledgeable
b. Very knowledgeable
c. Moderately knowledgeable
d. Not very knowledgeable
e. Not at all knowledgeable
On a scale from 1 to 5 (1 meaning strongly DISAGREE and 5 meaning strongly AGREE), please
indicate your level of agreement with the following statements:

1. I know where to find the Critical Events Policy and Manual.
Strongly Disagree
Disagree
Not sure
Agree
Strongly Agree

1

2

3

4

5
2. I regularly access the Critical Events Policy and Manual.
Strongly Disagree
Disagree
Not sure
Agree

1

2

4

5

Strongly Agree
3

3. For what reason(s) do you access the Critical Events Policy and Manual?
______________________________________________________________________________
______________________________________________________________________________
Social Solutions International, Inc.
8070 Georgia Ave; Suite 201 * Silver Spring, Maryland * 20910
(T) 301.774.0897 (F) 301.570.4772
FWA #: 00013212
12/5/2013
page 19 of 47

4. What information or section are you referencing?
______________________________________________________________________________
______________________________________________________________________________
5. I can access the Critical Events Policy and Manual easily.
Strongly Disagree
Disagree
Not sure
Agree

1

2

4

5

Strongly Agree
3

6. I am satisfied with the clarity and understandability of the Critical Events Policy and Manual.
Strongly Disagree
Disagree
Not sure
Agree
Strongly Agree

1

2

3

4

5
7. There are barriers that hinder my access to the Critical Events Policy and Manual.
Strongly Disagree
Disagree
Not sure
Agree
Strongly Agree

1

2

3

4

5
a.
If you circled Agree (4) or Strongly Agree (5), please describe these barriers.
______________________________________________________________________________
______________________________________________________________________________
8. I know where to find additional Critical Events supplemental resources, including the primer
on Critical Events, supplemental Critical Events training aids, and the Critical Events Web
Training Presentation Slides.
Strongly Disagree
Disagree
Not sure
Agree
Strongly Agree

1

2

3

4

5
a.
If you circled Agree (4) or Strongly Agree (5), please list the supplemental
resources that you know are available.
______________________________________________________________________________

9.
I regularly access additional Critical Events supplemental resources.
Strongly Disagree
Disagree
Not sure
Agree
Strongly Agree
1

2

3

4

5
10.
For what reason(s) do you access the Critical Events Policy and Manual?
______________________________________________________________________________
______________________________________________________________________________
Social Solutions International, Inc.
8070 Georgia Ave; Suite 201 * Silver Spring, Maryland * 20910
(T) 301.774.0897 (F) 301.570.4772
FWA #: 00013212
12/5/2013
page 20 of 47

11.
What information or section are you referencing?
______________________________________________________________________________
______________________________________________________________________________
12.
I can access additional Critical Events supplemental resources easily.
Strongly Disagree
Disagree
Not sure
Agree
Strongly Agree

1

2

3

4

5

13. I am satisfied with the clarity and understandability of the additional Critical Events
supplemental resources.
Strongly Disagree
Disagree
Not sure
Agree
Strongly Agree

1

2

3

4

5
14. There are barriers that restrain my access to Critical Events supplemental resources
Strongly Disagree
Disagree
Not sure
Agree
Strongly Agree

1

2

3

4

5
a.
If you circled Agree (4) or Strongly Agree (5), please describe these barriers.
_________________________________________________________________________________________________________
______________________________________________________________________________
15. I know where to locate the DAIDS Online Critical Events Training.
Strongly Disagree
Disagree
Not sure
Agree

1

2

4

5

Strongly Agree
3

16. I have accessed the DAIDS Online Critical Events Training.
Strongly Disagree
Disagree
Not sure
Agree

1

2

4

5

Strongly Agree
3

17. I can access the DAIDS Online Critical Events Training easily.
Strongly Disagree
Disagree
Not sure
Agree

1

2

4

5

Strongly Agree
3

18. I am satisfied with the clarity and understandability of the DAIDS Online Critical Events
Training.
Strongly Disagree
Disagree
Not sure
Agree
Strongly Agree

1

2

3

4

5
Social Solutions International, Inc.
8070 Georgia Ave; Suite 201 * Silver Spring, Maryland * 20910
(T) 301.774.0897 (F) 301.570.4772
FWA #: 00013212
12/5/2013
page 21 of 47

19. There are barriers that hinder my access to the DAIDS CRSS Online Critical Events
Training.
Strongly Disagree
Disagree
Not sure
Agree
Strongly Agree

1

2

3

4

5
a.
If you circled Agree (4) or Strongly Agree (5), please describe these barriers.
______________________________________________________________________________
______________________________________________________________________________
20. I know where to find information about Critical Events policy dissemination activities
(webinars, network meeting information sessions, in-person staff trainings, etc).
Strongly Disagree
Disagree
Not sure
Agree
Strongly Agree

1

2

3

4

5

21. I regularly access/participate in Critical Event policy dissemination activities.
Strongly Disagree
Disagree
Not sure
Agree
Strongly Agree

1

2

3

4

5
22. I can access/participate in dissemination activities easily.
Strongly Disagree
Disagree
Not sure
Agree

1

2

4

5

Strongly Agree

3

23. I am satisfied with the clarity and understandability of the dissemination activities.
Strongly Disagree
Disagree
Not sure
Agree
Strongly Agree

1

2

3

4

5
24. There are barriers that hinder my access/participation in dissemination activities.
Strongly Disagree
Disagree
Not sure
Agree
Strongly Agree

1

2

3

4

5
a.
If you circled Agree (4) or Strongly Agree (5), please describe these barriers.
______________________________________________________________________________
______________________________________________________________________________
25.

Did you receive any of the following communications describing the Critical Events Policy
and Manual (please circle all that apply)?
Social Solutions International, Inc.
8070 Georgia Ave; Suite 201 * Silver Spring, Maryland * 20910
(T) 301.774.0897 (F) 301.570.4772
FWA #: 00013212

12/5/2013
page 22 of 47

a.
b.
c.
d.
e.
f.
26.

HANC listserv email
HANC newsletter
HANC Conference Call
OPCRO email alert
DAIDS Training and Safety Branch email alert
Other _______________

Have you ever emailed another DAIDS staff member with questions concerning the
Critical Events Policy and Manual?
Yes

No

27.

Where was this staff member located?
a. Program
b. OCSO
c. OPCRO
d. OD

28.

Did you receive a response?
Yes

29.

If so, did you understand the response received?
Yes

30.

No

Did the response answer your question?
Yes

31.

No

No

Could the response have been clearer or easier to understand?
Yes

No

32.
What would have increased understandability and clarity of the response?
______________________________________________________________________________
______________________________________________________________________________
33. Have you ever been involved in communications regarding a Critical Event?
Yes
No
33.

Did you receive a response?
Social Solutions International, Inc.
8070 Georgia Ave; Suite 201 * Silver Spring, Maryland * 20910
(T) 301.774.0897 (F) 301.570.4772
FWA #: 00013212

12/5/2013
page 23 of 47

Yes

No

34.

What type of Critical Event did the communication entail (please circle all that apply)?
a.
Unanticipated Problem
b.
Serious Noncompliance
c.
Continuing Noncompliance
d.
Suspension or Termination of IRB approval

35.

If so, did you understand the response received?
Yes

36.

Were you able to apply the response you received to the Critical Event?
Yes

37.

No

No

Could the response have been clearer or easier to understand?
Yes

No

38.
What would have increased response understandability and clarity of the response?
______________________________________________________________________________
______________________________________________________________________________
On a scale from 1 to 5 (1 meaning strongly DISAGREE and 5 meaning strongly AGREE),
please indicate your level of agreement with the following statements:
39.

I am satisfied with my ability to apply the Critical Events Policy and Manual to DAIDS
clinical research studies.
Strongly Disagree
Disagree
Not sure
Agree
Strongly Agree

1

2

3

4

5
40.

I am satisfied that the supplemental resources and trainings improved my ability to apply
the Critical Events Policy and Manual to DAIDS clinical research.
Strongly Disagree
Disagree
Not sure
Agree
Strongly Agree

1

2

3

4

5

41. I view the Critical Events Policy and Manual as applicable to DAIDS clinical research.
Strongly Disagree
Disagree
Not sure
Agree
Strongly Agree

1

2

3

4

5
Social Solutions International, Inc.
8070 Georgia Ave; Suite 201 * Silver Spring, Maryland * 20910
(T) 301.774.0897 (F) 301.570.4772
FWA #: 00013212
12/5/2013
page 24 of 47

42.

I would benefit from additional training to improve my understanding and application of
the Critical Events Policy and Manual.
Strongly Disagree
Disagree
Not sure
Agree
Strongly Agree

1

2

3

4

5
43.

DAIDS staff critical events trainings increased my knowledge of the Critical Events Policy
and Manual.
Strongly Disagree
Disagree
Not sure
Agree
Strongly Agree NA

1

2

3

4

5
44.

Is there any policy or part of the Critical Events Policy and Manual that you do not view
as applicable?
Yes

No

If ‘Yes,’ please identify what is not applicable.
______________________________________________________________________________
______________________________________________________________________________
45.

What burdens exist in complying with the Critical Events Policy and Manual
requirements?
______________________________________________________________________________
______________________________________________________________________________
46.

What challenges or barriers exist in complying with the Critical Events Policy and
Manual requirements?
______________________________________________________________________________
______________________________________________________________________________
47.
What can be done to improve accessibility of Critical Events documents?
______________________________________________________________________________
______________________________________________________________________________
48.

Which requirement(s) are the easiest to comply with? (check all that apply)
□ Notify PI within 24 hrs of becoming aware of incident
□ Determine type of Critical Event that occurred
□ Submit initial report to DAIDS within three reporting days after becoming aware of
Critical Event
□ Reporting Critical Event to IRB/EC in accordance with institutional policies
□ Following corrective actions as directed by IRB/EC, DAIDS or other relevant entity
□ Provide update/final report to DAIDS within 15 calendar days
□ Other _______________________________
Social Solutions International, Inc.
8070 Georgia Ave; Suite 201 * Silver Spring, Maryland * 20910
(T) 301.774.0897 (F) 301.570.4772
FWA #: 00013212

12/5/2013
page 25 of 47

49.

Which requirement(s) are the most challenging to comply with? (check all that apply)
□ Notify PI within 24 hrs of becoming aware of incident
□ Determine type of Critical Event that occurred
□ Submit initial report to DAIDS within three reporting days after becoming aware of
Critical Event
□ Reporting Critical Event to IRB/EC in accordance with institutional policies
□ Following corrective actions as directed by IRB/EC, DAIDS or other relevant entity
□ Provide update/final report to DAIDS within 15 calendar days
□ Other _______________________________

50.

What recommendations do you have for Critical Events Policy Implementation
improvement?
______________________________________________________________________________
_____________________________________________________________________________

Social Solutions International, Inc.
8070 Georgia Ave; Suite 201 * Silver Spring, Maryland * 20910
(T) 301.774.0897 (F) 301.570.4772
FWA #: 00013212
12/5/2013
page 26 of 47

Attachment L: Extramural Researcher/External Stakeholder Survey

Social Solutions International, Inc.

Thank you for taking the time to complete this survey. The information you provide will help us
to improve the program. Please answer each question as honestly as possible. Your name will
not be linked to the answers you provide. The information you provide will be completely
confidential.
Background Information - Please provide the following information about yourself:
Select your role with DAIDS (check all that apply)
□ CRS Leader
□ CRS Coordinator
□ CTU Principal Investigator
□ CTU Coordinator
□ Clinical site personnel
□ Contracted site monitor
□ Network leadership
□ Operation center staff
□ Data management staff
□ Protocol team member
□ Other, please list: _____________________________________________________
If applicable, enter the DAIDS Network(s) you are affiliated with.
□ ACTG
□ HVTN
□ HPTN
□ IMPAACT
□ MTN
Are you involved with a non-network study?
Yes

No

Select the type of clinical research site you work at (check all that apply):
□ International (non-U.S. site)
□ Domestic (U.S. site)
□ Network
□ Non-Network
□ Pluripotent (a research site that conducts studies in more than one Network and may
either be domestic and/or international sites)
□ New CRS Site (site not affiliated with DAIDS research before 2013)
□ Not Applicable
Social Solutions International, Inc.
8070 Georgia Ave; Suite 201 * Silver Spring, Maryland * 20910
(T) 301.774.0897 (F) 301.570.4772
FWA #: 00013212
12/5/2013
page 27 of 47

□ Other: _____________________________________________________________
Are you a native English speaker? ________________________
Enter your number of years’ experience with clinical research: _________________________
Please rate your current level of knowledge pertaining to the Critical Events Policy and Manual:
a. Extremely knowledgeable
b. Very knowledgeable
c. Moderately knowledgeable
d. Not very knowledgeable
e. Not at all knowledgeable
On a scale from 1 to 5 (1 meaning strongly DISAGREE and 5 meaning strongly AGREE), please
indicate your level of agreement with the following statements:

1. I know where to find the Critical Events Policy and Manual.
Strongly Disagree
Disagree
Not sure
Agree
Strongly Agree

1

2

3

4

5
2. I regularly access the Critical Events Policy and Manual.
Strongly Disagree
Disagree
Not sure
Agree

1

2

4

5

Strongly Agree

3

3. For what reason(s) do you access the Critical Events Policy and Manual?
______________________________________________________________________________
______________________________________________________________________________
4. What information or section are you referencing?
______________________________________________________________________________
______________________________________________________________________________
5. I can access the Critical Events Policy and Manual easily.
Strongly Disagree
Disagree
Not sure
Agree

1

2

4

5

Strongly Agree
3

6. I am satisfied with the clarity and understandability of the Critical Events Policy and Manual.
Strongly Disagree
Disagree
Not sure
Agree
Strongly Agree
3

1

2

4

5
Social Solutions International, Inc.
8070 Georgia Ave; Suite 201 * Silver Spring, Maryland * 20910
(T) 301.774.0897 (F) 301.570.4772
FWA #: 00013212
12/5/2013
page 28 of 47

7. There are barriers that hinder my access to the Critical Events Policy and Manual.
Strongly Disagree
Disagree
Not sure
Agree
Strongly Agree

1

2

3

4

5

a.
If you circled Agree (4) or Strongly Agree (5), please describe these barriers.
______________________________________________________________________________
______________________________________________________________________________
8. I know where to find additional Critical Events supplemental resources, including the primer
on Critical Events, supplemental Critical Events training aids, and the Critical Events Web
Training Presentation Slides.
Strongly Disagree
Disagree
Not sure
Agree
Strongly Agree

1

2

3

4

5
a.
If you circled Agree (4) or Strongly Agree (5), please list the supplemental
resources that you know are available.
______________________________________________________________________________
9.
I regularly access additional Critical Events supplemental resources.
Strongly Disagree
Disagree
Not sure
Agree
Strongly Agree

1

2

3

4

5
10.
For what reason(s) do you access the Critical Events Policy and Manual?
______________________________________________________________________________
______________________________________________________________________________
11.
What information or section are you referencing?
______________________________________________________________________________
______________________________________________________________________________
12.
I can access additional Critical Events supplemental resources easily.
Strongly Disagree
Disagree
Not sure
Agree
Strongly Agree

1

2

3

4

5

13. I am satisfied with the clarity and understandability of the additional Critical Events
supplemental resources.
Strongly Disagree
Disagree
Not sure
Agree
Strongly Agree
Social Solutions International, Inc.
8070 Georgia Ave; Suite 201 * Silver Spring, Maryland * 20910
(T) 301.774.0897 (F) 301.570.4772
FWA #: 00013212
12/5/2013
page 29 of 47

1
4

5

2

3

14. There are barriers that restrain my access to Critical Events supplemental resources
Strongly Disagree
Disagree
Not sure
Agree
Strongly Agree

1

2

3

4

5
b.
If you circled Agree (4) or Strongly Agree (5), please describe these barriers.
_________________________________________________________________________________________________________
______________________________________________________________________________

15. I know where to locate the DAIDS Online Critical Events Training.
Strongly Disagree
Disagree
Not sure
Agree
Strongly Agree

1

2

3

4

5
16. I have accessed the DAIDS Online Critical Events Training.
Strongly Disagree
Disagree
Not sure
Agree

1

2

4

5

Strongly Agree
3

17. I can access the DAIDS Online Critical Events Training easily.
Strongly Disagree
Disagree
Not sure
Agree

1

2

4

5

Strongly Agree
3

18.

I am satisfied with the clarity and understandability of the DAIDS Online Critical Events
Training.
Strongly Disagree
Disagree
Not sure
Agree
Strongly Agree

3

1

2

4

5
19. There are barriers that hinder my access to the DAIDS CRSS Online Critical Events
Training.
Strongly Disagree
Disagree
Not sure
Agree
Strongly Agree

1

2

3

4

5
b.
If you circled Agree (4) or Strongly Agree (5), please describe these barriers.
______________________________________________________________________________
______________________________________________________________________________
Social Solutions International, Inc.
8070 Georgia Ave; Suite 201 * Silver Spring, Maryland * 20910
(T) 301.774.0897 (F) 301.570.4772
FWA #: 00013212
12/5/2013
page 30 of 47

20. How did you receive training? (check all that apply)
□ In person- DAIDS Regional Training Event (DRTE)
□ In person- Network meeting
□ Online- DAIDS Learning Management System (DLMS)
□ Online- HIV Clinical Research Support Services (CRSS) Contract website
□ Webinar
□ Other_________________
21.

I know where to find information about Critical Events policy dissemination activities
(webinars, network meeting information sessions, in-person trainings, etc).
Strongly Disagree
Disagree
Not sure
Agree
Strongly Agree

1

2

3

4

5
22. I regularly access/participate in Critical Event Policy dissemination activities.
Strongly Disagree
Disagree
Not sure
Agree
Strongly Agree

1

2

3

4

5

23. I can access/participate in Critical Event Policy dissemination activities easily.
Strongly Disagree
Disagree
Not sure
Agree
Strongly Agree

1

2

3

4

5
24. I am satisfied with the clarity and understandability of the Critical Event Policy
dissemination activities.
Strongly Disagree
Disagree
Not sure
Agree
Strongly Agree

1

2

3

4

5
25. There are barriers that hinder my access/participation in Critical Event Policy dissemination
activities.
Yes
26.

No

Did you receive any of the following communications describing the Critical Events Policy
and Manual (please circle all that apply)?
a. HANC listserv email
b. HANC newsletter
c. HANC Conference Call
d. OPCRO email alert
Social Solutions International, Inc.
8070 Georgia Ave; Suite 201 * Silver Spring, Maryland * 20910
(T) 301.774.0897 (F) 301.570.4772
FWA #: 00013212

12/5/2013
page 31 of 47

e. DAIDS Training and Safety Branch email alert
27.

Have you ever emailed DAIDS staff with questions concerning the Critical Event Policy
and Manual?
Yes

No

28.

Who from DAIDS provided responses to your question(s)?
□ DAIDS PO/MO (Program Officer, Medical Officer)
□ ProPEP (Protection of Participants, Evaluation and Policy Branch)
□ I don't know
□ I didn't submit a question to DAIDS
□ Other____________

29.

Did you receive a response?
Yes

30.

No

If so, was the answer provided in a timely fashion.
Yes

31.

If so, did you understand the response received?
Yes

32.

No

Did the response answer your question?
Yes

33.

No

No

Could the response have been clearer or easier to understand?
Yes

No

34. Did the answer you receive improve your understanding of Critical Events?
Yes

No

35. What would have increased understandability and clarity of the response?
______________________________________________________________________________
______________________________________________________________________________
36.

Have you ever reported a Critical Event to DAIDS staff?
Social Solutions International, Inc.
8070 Georgia Ave; Suite 201 * Silver Spring, Maryland * 20910
(T) 301.774.0897 (F) 301.570.4772
FWA #: 00013212

12/5/2013
page 32 of 47

Yes

No

37.

What type of Critical Event did you report?
□ Unanticipated Problem
□ Serious Noncompliance
□ Continuing Noncompliance
□ Suspension or Termination of IRB approval

38.

Did you receive a response?
Yes

39.

If so, did you understand the response received?
Yes

40.

No

No

Could the response have been clearer or easier to understand?
Yes

No

41. What would have increased response understandability and clarity of the response?
______________________________________________________________________________
______________________________________________________________________________

On a scale from 1 to 5 (1 meaning strongly DISAGREE and 5 meaning strongly AGREE),
please indicate your level of agreement with the following statements:
42.

I am satisfied with my ability to apply the Critical Events Policy and Manual to DAIDS
research.
Strongly Disagree
Disagree
Not sure
Agree
Strongly Agree

1

2

3

4

5
43.

I am satisfied with the supplemental resources and trainings on my ability to apply
Critical Events Policy and Manual to my DAIDS research.
Strongly Disagree
Disagree
Not sure
Agree
Strongly Agree

1

2

3

4

5
44. I view the Critical Events Policy and Manual as applicable to my DAIDS research.
Strongly Disagree
Disagree
Not sure
Agree
Strongly Agree
Social Solutions International, Inc.
8070 Georgia Ave; Suite 201 * Silver Spring, Maryland * 20910
(T) 301.774.0897 (F) 301.570.4772
FWA #: 00013212
12/5/2013
page 33 of 47

1
4

5

2

3

45.

I would benefit from additional training to improve my understanding and application of
the Critical Events Policy and Manual.
Strongly Disagree
Disagree
Not sure
Agree
Strongly Agree

1

2

3

4

5
46. Webinars increased my knowledge of the Critical Events Policy and Manual.
Strongly Disagree
Disagree
Not sure
Agree
Strongly Agree

1

2

3

4

5

6

NA

47.

Network meeting information sessions increased my knowledge of the Critical Events
Policy and Manual.
Strongly Disagree
Disagree
Not sure
Agree
Strongly Agree NA

1

2

3

4

5

6
48.

Is there any policy or part of the Critical Events Policy or Manual that you do not view as
applicable?
Yes

No

a.
If ‘Yes,’ please identify what is not applicable.
______________________________________________________________________________
______________________________________________________________________________

49.

Have there been changes made to your site’s SOPs or routine activities to meet the
Critical Events Policy and Manual mandates?
Yes

No

a.
If ’Yes,’ please identify what changes have been made:
______________________________________________________________________________
______________________________________________________________________________
b.

How much additional time do these changes take to carry out?

c.

If ’Yes,’ please identify what changes have been made:
Social Solutions International, Inc.
8070 Georgia Ave; Suite 201 * Silver Spring, Maryland * 20910
(T) 301.774.0897 (F) 301.570.4772
FWA #: 00013212

12/5/2013
page 34 of 47

______________________________________________________________________________
______________________________________________________________________________
d.
How much additional time do these changes take to carry out?
______________________________________________________________________________

50. What burdens exist in complying with the Critical Events Policy and Manual requirements?
______________________________________________________________________________
______________________________________________________________________________
51.

What challenges or barriers exist in complying with Critical Events Policy and Manual
requirements?
______________________________________________________________________________
______________________________________________________________________________
52. What can be done to improve accessibility of Critical Events documents?
______________________________________________________________________________
______________________________________________________________________________
53.

Which Critical Events Policy and Manual requirement(s) are the easiest to comply with?
(check all that apply)
□ Notify PI within 24 hrs of becoming aware of incident
□ Determine type of Critical Event that occurred
□ Submit initial report to DAIDS within three reporting days after becoming aware of
Critical Event
□ Reporting Critical Event to IRB/EC in accordance with institutional policies
□ Following corrective actions as directed by IRB/EC, DAIDS or other relevant entity
□ Provide update/final report to DAIDS within 15 calendar days
□ Other _______________________________

54.

Which requirement(s) are the most challenging to comply with? (check all that apply)
□ Notify PI within 24 hrs of becoming aware of incident
□ Determine type of Critical Event that occurred
□ Submit initial report to DAIDS within three reporting days after becoming aware of
Critical Event
□ Reporting Critical Event to IRB/EC in accordance with institutional policies
□ Following corrective actions as directed by IRB/EC, DAIDS or other relevant entity
□ Provide update/final report to DAIDS within 15 calendar days
□ Other _______________________________

55.

What recommendations do you have for Critical Events Policy Implementation
improvement?
Social Solutions International, Inc.
8070 Georgia Ave; Suite 201 * Silver Spring, Maryland * 20910
(T) 301.774.0897 (F) 301.570.4772
FWA #: 00013212

12/5/2013
page 35 of 47

______________________________________________________________________________
______________________________________________________________________________

Social Solutions International, Inc.
8070 Georgia Ave; Suite 201 * Silver Spring, Maryland * 20910
(T) 301.774.0897 (F) 301.570.4772
FWA #: 00013212
12/5/2013
page 36 of 47

Attachment M: NIAID Recruitment Email to Potential Focus Group Participants
Dear DAIDS staff, Extramural Researchers, External Stakeholders [appropriate group will be
selected before email is sent],
A review of the DAIDS Critical Events Policy Implementation (CEPI) Program is being
conducted. The purpose of this review is to accurately gauge your perception with respect to the
awareness, accessibility, understandability, applicability and experience with the DAIDS Critical
Events Policy and Manual. DAIDS acknowledges that the ability to reliably and consistently
access, understand, apply and harmonize the Critical Event Policy and Manual is essential to the
adherence to the reporting requirements of certain U.S. regulations.
We are hoping you are able to participate in a focus group [during the time you’re attending a
Network/DAIDS meeting (for non-DAIDS participants), insert training name and date] [at this
date and time (for DAIDS staff)] to get your thoughts, ideas, and opinions on how easily research
the DAIDS Critical Event Policy and Manual may be accessed, understood, and applied in your
day-to-day research activities. Your participation is kindly requested and is not compulsory.
However, DAIDS encourages your engagement in these focus groups, which are an important
part of determining how to improve the DAIDS Critical Events Policy Implementation Program.
The input provided is fundamental to determining the effectiveness of the communication and
dissemination of DAIDS research policies. While the program review team will capture each
participant’s name, organizational affiliation, and/or role, all identifiable information will be
separated from participant response data. Furthermore, your identities will be kept private to the
extent permitted by law, and all data and findings will be reported in aggregate for analysis
purposes.
The focus group interview will be approximately 90 minutes in length. You will receive a small
stipend as compensation for your time in participating in the focus group. Please send an email to
[insert email address] to be scheduled for participating in the focus group. You will be emailed
an informed consent form to be completed and brought with you to the focus group.
We thank you for your consideration with respect to participating in the scheduled focus group
interviews. The ultimate goal is to derive a comprehensive assessment of whether the processes
currently in place meets the needs of DAIDS staff, Extramural Researchers/External
Stakeholders [appropriate group will be selected before email is sent] with the policies necessary
to effectively and accurately conduct research. From the assessment, DAIDS aims to glean what
has worked well to date, as well as where CEPI program improvements could potentially be
made.
Thank you for your time and consideration,

Social Solutions International, Inc.
8070 Georgia Ave; Suite 201 * Silver Spring, Maryland * 20910
(T) 301.774.0897 (F) 301.570.4772
FWA #: 00013212
12/5/2013
page 37 of 47

Attachment N: DAIDS Staff Focus Group Consent Form
Social Solutions International, Inc.
TITLE OF STUDY: Critical Events Policy Implementation (CEPI) Process Evaluation
Principal Investigator: Jenny Namur Karp
Phone Number:
202-491-4954
IRB Representative:
Phone Number:

Project Director: Kristen Stier
Phone Number: 202-870-2226

Karen Chen
703-738-6684

PURPOSE OF THE STUDY
Social Solutions International, Inc. (Social Solutions) has been contracted by the National
Institute of Allergy and Infectious Diseases (NIAID), Division of AIDS (DAIDS) to conduct a
process evaluation of the Critical Events Policy Implementation (CEPI) program. Critical Events
may occur during the conduct of clinical research that deviates from Institutional Review Board
(IRB)/Ethics Committee (EC) – approved protocols and may adversely affect risks to research
participants, or study outcomes and integrity. DAIDS created this policy to provide guidance on
how to report critical events. The CEPI program’s goal is to increase policy awareness,
accessibility, understandability, and applicability of the policy by target populations, including
DAIDS staff, extramural researchers, and external stakeholders. Social Solutions is conducting
research to assess DAIDS staff, extramural researchers and external stakeholders’ awareness of
the policy and supplemental resources, as well as the accessibility, understandability, and
applicability of the Critical Events policy and related documents. This research will also provide
insight into the success of training efforts in increasing knowledge of the policy, and satisfaction
with available training and support.
An important part of this research involves the focus group discussions with extramural
researchers and external stakeholders based at a different research sites domestically and
internationally. We are asking for your participation in a focus group discussion with 8 other
colleagues. The discussion will involve a series of questions designed to help us better
understand your awareness of the Critical Events policy and supplemental resources, as well as
your opinion on the accessibility, understandability, and applicability of the policy and related
responsibilities. The information that you provide may be used by NIAID/DAIDS to improve
policy implementation and dissemination. Your opinions, experiences, and ideas are very
important.
PROCEDURES
The focus group will last approximately 90 minutes. You do not have to do anything to prepare
for the discussion. We will ask questions about the Critical Events policy, including how easy
you find the policy to understand and apply to your work, your satisfaction with trainings on the
policy, and recommendations for policy improvement. We would like to hear as many
Social Solutions International, Inc.
8070 Georgia Ave; Suite 201 * Silver Spring, Maryland * 20910
(T) 301.774.0897 (F) 301.570.4772
FWA #: 00013212
12/5/2013
page 38 of 47

perspectives as possible, but you do not have to answer any questions that you do not want to
answer. There are no right or wrong answers – only different points of view.
We will be recording the discussion on audiotape, and a staff person will be taking notes. We
will not use your name during the audio recording, and no comments you make will be
personally identifiable.
PARTICIPATION AND WITHDRAWAL
Participation in this focus group is completely voluntary. There is no consequence if you decide
to leave the group. You do not have to respond to any questions that you do not want to answer.
The investigator reserves the right to terminate your participation at any time if you are not
following study protocol.
POTENTIAL RISKS
We anticipate very few risks to you from participation in this focus group. Although all
participants have been asked to keep the discussions private, there is a small chance that other
participants in the focus group may share personal information outside of the project. In addition,
there is a small chance that you may feel uncomfortable with a question and not want to respond.
Please remember that you do not have to answer any questions you do not want to. If you do
experience negative feelings as a result of the focus group discussion, a clinical psychologist will
be available to discuss those feelings.
In the unlikely event of physical or other injury resulting from the focus group, emergency
medical treatment will be provided, but financial compensation will not be available. Social
Solutions will not provide compensation if you experience injury or other adverse effects, which
are not the fault of the investigators.
ANTICIPATED BENEFITS
If you decide to participate in the focus group, you may gain a better understanding of the
Critical Events policy and resources and trainings available. This information may motivate you
to obtain more information about the policy, about clinical research protocols, and/or change
your behavior to positively improve clinical research and reporting. Additionally, the
information that you provide will be used to improve the program’s policy dissemination efforts.
PRIVACY AND CONFIDENTIALITY
To protect your identity, none of the information you provide will be associated with any
statement or identified personally in any way. Other than the signed consent form, no identifiable
information will be collected. The consent form will be kept separate from the other information
we collect to make sure that the data cannot be identified.
Any information collected by paper or on the participant incentive distribution log will be kept in
a locked cabinet. Information transferred and stored electronically will be stored only on
password-protected computers. Only specified researchers at Social Solutions will have access to
this information, and all researchers are trained in secure and private research protocols. All files
will be destroyed 7 years after the study concludes.
Social Solutions International, Inc.
8070 Georgia Ave; Suite 201 * Silver Spring, Maryland * 20910
(T) 301.774.0897 (F) 301.570.4772
FWA #: 00013212
12/5/2013
page 39 of 47

Information provided during the research will only be disclosed to others if necessary to protect
your rights or welfare, or if required by law. When the results of the research are published or
discussed in conferences, no information will be included that would reveal your identity.
QUESTIONS AND CONCERNS
If you have any questions about this project, you may call Jenny Namur Karp or Kristen Stier at
the phone numbers above. If you have any questions about your rights as a research participant,
please call Karen Chen at 703-738-6684.
WRITTEN CONSENT
Informed consent shall be documented by the use of a written consent form approved by the
IRB, and signed by the participant or the participant’s legally authorized representative. A copy
shall be given to the person signing the form. The investigator should provide either the
participant or the representative adequate opportunity to read the consent form and pose
questions to the investigator prior to signing the form.
Please read and show that you understand what you have read by signing your consent below.
I have read this form and understand all of the information about my involvement in the focus
group. By signing below, I agree to participate.
_______________________________________
Name (Printed)
Date

____________________

_______________________________________
Signature
Date

____________________

______________________________________
Signature of Investigator

____________________
Date

Social Solutions International, Inc.
8070 Georgia Ave; Suite 201 * Silver Spring, Maryland * 20910
(T) 301.774.0897 (F) 301.570.4772
FWA #: 00013212
12/5/2013
page 40 of 47

Attachment O: Extramural Researcher/External Stakeholder Focus Group
Consent Form
Social Solutions International, Inc.
TITLE OF STUDY: Critical Events Policy Implementation (CEPI) Process Evaluation
Principal Investigator: Jenny Namur Karp
Phone Number:
202-491-4954
IRB Representative:
Phone Number:

Project Director: Kristen Stier
Phone Number: 202-870-2226

Karen Chen
703-738-6684

PURPOSE OF THE STUDY
Social Solutions International, Inc. (Social Solutions) has been contracted by the National
Institute of Allergy and Infectious Diseases (NIAID), Division of AIDS (DAIDS) to conduct a
process evaluation of the Critical Events Policy Implementation (CEPI) program. Critical Events
may occur during the conduct of clinical research that deviates from Institutional Review Board
(IRB)/Ethics Committee (EC) – approved protocols and may adversely affect risks to research
participants, or study outcomes and integrity. DAIDS created this policy to provide guidance on
how to report critical events. The CEPI program’s goal is to increase policy awareness,
accessibility, understandability, and applicability of the policy by target populations, including
DAIDS staff, extramural researchers, and external stakeholders. Social Solutions is conducting
research to assess DAIDS staff, extramural researchers and external stakeholders’ awareness of
the policy and supplemental resources, as well as the accessibility, understandability, and
applicability of the Critical Events policy and related documents. This research will also provide
insight into the success of training efforts in increasing knowledge of the policy, and satisfaction
with available training and support.
An important part of this research involves the focus group discussions with extramural
researchers and external stakeholders based at a different research sites domestically and
internationally. We are asking for your participation in a focus group discussion with 8 other
colleagues. The discussion will involve a series of questions designed to help us better
understand your awareness of the Critical Events policy and supplemental resources, as well as
your opinion on the accessibility, understandability, and applicability of the policy and related
responsibilities. The information that you provide may be used by NIAID/DAIDS to improve
policy implementation and dissemination. Your opinions, experiences, and ideas are very
important.
PROCEDURES
The focus group will last approximately 90 minutes. You do not have to do anything to prepare
for the discussion. We will ask questions about the Critical Events policy, including how easy
you find the policy to understand and apply to your work, your satisfaction with trainings on the
policy, and recommendations for policy improvement. We would like to hear as many
Social Solutions International, Inc.
8070 Georgia Ave; Suite 201 * Silver Spring, Maryland * 20910
(T) 301.774.0897 (F) 301.570.4772
FWA #: 00013212
12/5/2013
page 41 of 47

perspectives as possible, but you do not have to answer any questions that you do not want to
answer. There are no right or wrong answers – only different points of view.
We will be recording the discussion on audiotape, and a staff person will be taking notes. We
will not use your name during the audio recording, and no comments you make will be
personally identifiable.
PARTICIPATION AND WITHDRAWAL
Participation in this focus group is completely voluntary. There is no consequence if you decide
to leave the group. You do not have to respond to any questions that you do not want to answer.
The investigator reserves the right to terminate your participation at any time if you are not
following study protocol.
POTENTIAL RISKS
We anticipate very few risks to you from participation in this focus group. Although all
participants have been asked to keep the discussions private, there is a small chance that other
participants in the focus group may share personal information outside of the project. In addition,
there is a small chance that you may feel uncomfortable with a question and not want to respond.
Please remember that you do not have to answer any questions you do not want to. If you do
experience negative feelings as a result of the focus group discussion, a clinical psychologist will
be available to discuss those feelings.
In the unlikely event of physical or other injury resulting from the focus group, emergency
medical treatment will be provided, but financial compensation will not be available. Social
Solutions will not provide compensation if you experience injury or other adverse effects, which
are not the fault of the investigators.
ANTICIPATED BENEFITS
If you decide to participate in the focus group, you may gain a better understanding of the
Critical Events policy and resources and trainings available. This information may motivate you
to obtain more information about the policy, about clinical research protocols, and/or change
your behavior to positively improve clinical research and reporting. Additionally, the
information that you provide will be used to improve the program’s policy dissemination efforts.
INCENTIVES
You will receive $30 as a token of appreciation for participating in the focus group, excluding
PPD-DAIDS Site monitors.
PRIVACY AND CONFIDENTIALITY
To protect your identity, none of the information you provide will be associated with any
statement or identified personally in any way. Other than the signed consent form, no identifiable
information will be collected. The consent form will be kept separate from the other information
we collect to make sure that the data cannot be identified.

Social Solutions International, Inc.
8070 Georgia Ave; Suite 201 * Silver Spring, Maryland * 20910
(T) 301.774.0897 (F) 301.570.4772
FWA #: 00013212
12/5/2013
page 42 of 47

Any information collected by paper or on the participant incentive distribution log will be kept in
a locked cabinet. Information transferred and stored electronically will be stored only on
password-protected computers. Only specified researchers at Social Solutions will have access to
this information, and all researchers are trained in secure and private research protocols. All files
will be destroyed 7 years after the study concludes.
Information provided during the research will only be disclosed to others if necessary to protect
your rights or welfare, or if required by law. When the results of the research are published or
discussed in conferences, no information will be included that would reveal your identity.
QUESTIONS AND CONCERNS
If you have any questions about this project, you may call Jenny Namur Karp or Kristen Stier at
the phone numbers above. If you have any questions about your rights as a research participant,
please call Karen Chen at 703-738-6684.
WRITTEN CONSENT
Informed consent shall be documented by the use of a written consent form approved by the
IRB, and signed by the participant or the participant’s legally authorized representative. A copy
shall be given to the person signing the form. The investigator should provide either the
participant or the representative adequate opportunity to read the consent form and pose
questions to the investigator prior to signing the form.
Please read and show that you understand what you have read by signing your consent below.
I have read this form and understand all of the information about my involvement in the focus
group. By signing below, I agree to participate.
_______________________________________
Name (Printed)
Date

____________________

_______________________________________
Signature
Date

____________________

______________________________________
Signature of Investigator
(office use only)

____________________
Date

Social Solutions International, Inc.
8070 Georgia Ave; Suite 201 * Silver Spring, Maryland * 20910
(T) 301.774.0897 (F) 301.570.4772
FWA #: 00013212
12/5/2013
page 43 of 47

Attachment P: Critical Events Policy Implementation Program Process
Evaluation
Focus Group
Details and Preparations
Location
TBD
Arrival Time/Start Time
TBD
Preparation
Water
Name Tags
Markers
Incentives
Incentive Log
2 copies of Moderator’s Guide
11 copies of consents forms
Moderation
Facilitator – Dr. Ami Lynch, Interviewer/IRB Director at Social Solutions International, Inc.
Notetaker – Kristen Stier, Project Coordinator/Research Associate at Social Solutions
International, Inc.

Social Solutions International, Inc.
8070 Georgia Ave; Suite 201 * Silver Spring, Maryland * 20910
(T) 301.774.0897 (F) 301.570.4772
FWA #: 00013212
12/5/2013
page 44 of 47

Attachment Q: CEPI Process Evaluation DAIDS Staff/Extramural
Researcher/External Stakeholder Focus Group
Opening Script

Hello and welcome. Thank you for meeting with us today. My name is Dr. Ami Lynch and I am
from Social Solutions International, Inc., a research and evaluation firm that works on a wide
range of issues to improve the health and well-being for underserved populations and
communities. Thank you for being here to share your thoughts and ideas. My role today is
simply to guide our discussion and to make sure that everyone has an opportunity to share their
experiences and opinions.
Opening Comments
Social Solutions is has been contracted by the National Institute of Allergy and Infectious
Diseases (NIAID), Division of AIDS (DAIDS) to conduct a process evaluation of the Critical
Events Policy Implementation (CEPI) program. We are researching how effective the program
has been in notifying researchers and stakeholders of the policy and supplemental resources, and
creating a policy that is accessible, easy to understand, and applicable to the work that you do.
We are talking to researchers and external stakeholders associated with both domestic and
international research sites and protocols. The purpose of this focus group is to understand your
opinions and experiences with the Critical Events policy. We are specifically interested in your
awareness of the policy, your view on its understandability and applicability to your work, your
understanding of the policy itself and additional responsibilities it requires, and your satisfaction
with supplemental policy resources, support from NIAID/DAIDS staff, and any trainings you
may have participated in.
Confidentiality
The discussion should last for approximately 90 minutes. We would like to tape record the
discussion so we can keep track of what you tell us. We will not record your names or connect
them in any way to your answers so that we protect your confidentiality. When you wish to join
in on the discussion and respond to a question, please raise your hand. What you say is very
important and we do not want to miss anything. We are only audio-taping the discussion to make
sure we don’t miss any of the information you share.
We would like to ask everyone to keep the information that you hear from the discussion group
confidential and not to discuss it outside of this room. We want you to feel comfortable sharing
your personal opinions and experiences with the group so that we can learn from you.
Your participation in this group is entirely voluntary, and you are free to leave at any point if you
find it necessary. I will be available after the session this evening to answer any questions you
may have about the discussion or the project in general. If you need to get up and stretch, get
Social Solutions International, Inc.
8070 Georgia Ave; Suite 201 * Silver Spring, Maryland * 20910
(T) 301.774.0897 (F) 301.570.4772
FWA #: 00013212
12/5/2013
page 45 of 47

food or drink, and/or use the rest room during the focus group, please feel free to do so. We just
ask that you do so quietly because of the recording.

Discussion Group Rules
First, since each and every person's comments are important, we ask that only one person speak
at a time. This will help us to hear each other. There is no such thing as a right or wrong answer
in this group. We have no expectations about what is going to be said. Tell us what you honestly
think, and feel free to share whatever is on your mind. If you disagree with something that you
hear, let us know. If you agree, don't just say, "I agree", but try to add your own perspective or
opinions. We want to hear as many different opinions, ideas, and stories as possible.
Consent
Before we begin, I would like to make sure I have a consent form for all of you. When I call your
name please let me know that you are here…. [Read names of participants from whom consents
have been collected. Any participants that do not have the consent form will be asked to sign one
at this time]
Does anyone have any questions at this time?
I am going to turn on the tape recorder now so we can get started…

Social Solutions International, Inc.
8070 Georgia Ave; Suite 201 * Silver Spring, Maryland * 20910
(T) 301.774.0897 (F) 301.570.4772
FWA #: 00013212
12/5/2013
page 46 of 47

Attachment R: CEPI Process Evaluation DAIDS Staff/Extramural
Researcher/External Stakeholder Focus Group
Probes/Questions
Questions:
1. The critical events policy was implemented in June 2012. Did you receive any
communication/information introducing the CE Policy and Manual? If so, what types of
communications?
1b. Were you satisfied with the communication surrounding how to access the CE Policy and
Manual, supplemental resources, and trainings?
2. How many of you have tried to obtain additional information/resources re: the CE Policy and
Manual?
2b. How easy is it to access resources? Are the existing resources helpful/easy to understand?
3. What questions did you/do you have regarding the CE Policy and Manual?
4. What burdens exist in complying with CE Policy and Manual requirements?
5. Do you think the CE policy and Manual is applicable to your work?
5a. Is there any policy or part of the CE Policy and Manual that you do not view as applicable?
If so, please specify?
6. Have there been changes made to your site’s SOPs or routine activities to meet CE Policy and
Manual mandates? If so, please describe.
7. Are there any challenges/barriers to successfully meeting Critical Events reporting mandates?
Why or why not?
8. Would you like more training on the CE Policy and Manual? If so, what content do you need and
in what format would you like to receive the training?
9. What recommendations do you have for CE Policy and Manual improvements?
Thank You
Thank you again for taking the time to speak with us today. The information you have provided is very
helpful. If you have any questions please feel free to contact me via email or phone. Thank you.
Social Solutions International, Inc.
8070 Georgia Ave; Suite 201 * Silver Spring, Maryland * 20910
(T) 301.774.0897 (F) 301.570.4772
FWA #: 00013212
12/5/2013
page 47 of 47

OHSR (NIH/DDIR)
From:
Sent:
To:
Subject:
Attachments:

Lahl, Lynda (NIH/NIAID) [E]
Sunday, January 12, 2014 5:37 PM
OHSR (NIH/DDIR)
application for survey, focus groups
IRB submission_DAIDS evaluation 2013.pdf; CEPI Attachments NIAID IRB.pdf

Follow Up Flag:
Flag Status:

Follow up
Flagged

Categories:

Yellow Category

Dear OHSRP staff, 

Please see the completed the request form: OHSRP determination for surveys, interview procedures, program 
evaluation, educational testing and research, along with the accompanying attachment document. My Branch Chief and 
I are attending a local meeting on January 13 & 14, 2014. I have a printed copy of all documents and plan to obtain my 
Branch Chief’s signature on pg 1. I will scan the signature page after I have the necessary signatures and will email  your 
office tomorrow evening.  

Thank you for your time. Please let me know if you have any questions.  

Lyndi Lahl 

Lyndi Lahl, RN, MS
Policy Health Specialist
Protection of Participants, Evaluation and Policy Branch (ProPEP)
OPCRO, DAIDS, NIAID, NIH, HHS
6700-B Rockledge Drive, RM 4254
Bethesda, MD 20892-7624
Tel. 301-435-3756
FAX 301-402-1506
Disclaimer
The information in this e-mail and any of its attachments is confidential and may contain sensitive information. It should not be used by anyone who is not the
original intended recipient. If you have received this e-mail in error please inform the sender and delete it from your mailbox or any other storage devices. The
National Institute of Allergy and Infectious Diseases (NIAID) shall not accept liability for any statements made that are the sender's own and not expressly made on
behalf of the NIAID by one of its representatives.

1

OHSR (NIH/DDIR)
From:
Sent:
To:
Subject:
Attachments:

OHSR (NIH/DDIR)
Thursday, January 23, 2014 1:10 PM
Lahl, Lynda (NIH/NIAID) [E]
Req for Determination Rec'd_OHSRP 12268
Intramural_planned_enrollment_report.pdf

Good afternoon Lyndi, 

This email is to verify that OHSR has received your Request for Determination and it is currently being processed as 
OHSRP #12268. Please use this number in any future correspondence regarding this study.  We will contact you via 
email if any additional information is needed. If you have not heard from OHSR within 7 business days, please contact 
us. 
Protocol Title: Process Evaluation of the DAIDS Critical Events Policy Implementation (CEPI) Program 

**As per a new requirement for PIs, please fill in attached planned enrollment worksheet and return. We will need 
this before we can issue a determination. Please contact OHSRP with any questions. 
Thank you. 
Sincerely, 
OHSRP ‐ National Institutes of Health 
Bldg 10, Suite 2C146                                                                                                                           
Bethesda, MD 20892 
Office Telephone: 301‐402‐3444 
Office Fax: 301‐402‐3443 
The NIH is committed to maintaining the highest standards for the protection of human
subjects.

Please consider the environment before printing this e-mail

1