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0990-0305Attachments to Memo.pdf

Research Integrity Officer (RIO) Study

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OMB: 0990-0305

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Attachments for the Memo
Request to OMB for
Modification of Previous
Clearance

Attachment 1:

OMB clearance approved for RIO
telephone interview; this document
also directs us to submit an
administrative request for changes
with a copy of the web-based
questionnaire and revised work plan.

NOTICE OF OFFICE OF MANAGEMENT AND BUDGET ACTION
Date 01/09/2007
Department of Health and Human Services
Departmental Management
FOR CERTIFYING OFFICIAL: Charles Havekost
FOR CLEARANCE OFFICER: Seleda Perryman
In accordance with the Paperwork Reduction Act, OMB has taken action on your request received
08/30/2006
ACTION REQUESTED: New collection (Request for a new OMB Control Number)
TYPE OF REVIEW REQUESTED: Regular
ICR REFERENCE NUMBER: 200608-0990-004
TITLE: Research Integrity Officer (RIO) Study
LIST OF INFORMATION COLLECTIONS: See next page
OMB ACTION: Approved with change
OMB CONTROL NUMBER: 0990-0305
The agency is required to display the OMB Control Number and inform respondents of its legal significance in
accordance with 5 CFR 1320.5(b).
EXPIRATION DATE: 01/31/2009

DISCONTINUE DATE:

BURDEN:

RESPONSES

HOURS

COSTS

2,556

647

Change due to New Statute

Change due to Agency Discretion

2,556

647

Previous
New
Difference

Change due to Agency Adjustment
Change Due to Potential Violation of the PRA

TERMS OF CLEARANCE: Approved consistent with the following terms of clearance: OMB approves phase
one of the survey, however, prior to initiating phase two HHS shall submit an administrative request change to
OMB including the finalized phase two questionnaire and study plan. HHS shall not begin phase two prior to
OMB approval of the requested change.
OMB Authorizing Official:

John F. Morrall III
Acting Deputy Administrator,
Office Of Information And Regulatory Affairs

List of ICs
IC Title
Research Integrity Officer
(RIO) Study
Research Integrity Officer
(RIO) Study
Research Integrity Officer
(RIO) Study
Research Integrity Officer
(RIO) Study

Form No.
1
1
1
1

Form Name
Semi-Structured
Telephone Interview
Semi-Structured
Telephone Interview
Semi-Structured
Telephone Interview
Semi-Structured
Telephone Interview

CFR Citation
42 CFR 93.300
42 CFR 93.300
42 CFR 93.300
42 CFR 93.300

Attachment 2:

OMB approved RIO telephone
interview.

Form Approved
OMB Control No.: 0990-0305
Expiration Date: 1/31/2009

Interviewer Name_______________________
Respondent Name______________________
Institution Name________________________
Phone Number_________________________
Date and Time_________________________
Identification Number___________________
Final (Revision 7) Draft of the Semi-Structured Telephone Interview
Introduction
Hello (respondent’s name), this is (your name) calling from RTI. As we told you in an earlier email, RTI is a not-for-profit research organization headquartered in North Carolina. I want to
thank you for agreeing to talk to us at this time about the things you do when there are
allegations of research misconduct at your institution. Our questions will ask about your training,
experience, and about what you do as the RIO in particular scenarios. For this discussion,
research misconduct includes falsification, fabrication, and plagiarism of research. You were
identified as the person with responsibility for carrying out the policies and procedures for
handling research misconduct allegations at your institution. Persons in this role are often
referred to as the Research Integrity Officer or RIO. I just want to be sure. Are you the person
doing that job at your institution?
Yes….… [Continue.]
No…….. [Do Not Continue. Identify the correct person [RIO] to contact.]
The purpose of this research is to understand how you and other RIOs carry out the
responsibilities associated with these activities and to identify areas where the DHHS Office of
Research Integrity or ORI may be able to provide additional training or support to make this job
easier. As we indicated in our earlier letter, this interview should take about an hour to complete.
Of course, your participation is voluntary and you may refuse to answer any question. Because
your identity is protected we see little risk with participation and opportunities for RIO training
as potential benefits that could result.
Before we begin, I would like your permission to record our interview so we can have an
accurate record that is more complete than the notes I could take as we talk. We will destroy the
recording when the project is completed. I want to assure you that the information from the
interview that we use to prepare our report to ORI will not contain material that can be used to
identify you or your institution. Information from this interview will be reported aggregated with
the responses of RIOs from 100 other institutions. [Await response for a moment, re-ask if
needed, and turn on recorder if affirmative.]
1

START TIME______________

Identification Number___________________

I. First, I would like to ask you some questions about your Current Organizational
Position and Professional Background
1. What is your usual title, office, or position in the organization when you are not performing
activities related to allegations of research misconduct?
___________________________________________________________
1a. When functioning in your usual position, would you say that you are very involved,
somewhat involved, only slightly involved, or not at all involved in seeking opportunities to
financially support research at your institution?
Very Involved………..…1
Somewhat Involved….…2
Only Slightly Involved....3
Not at All Involved….….4
2. What is the title, office, or position of the person to whom you ordinarily report when you are
not performing activities related to research misconduct?
______________________________________________________________

3. Do you have a special title or hold an identified position or office in the organizational
structure when you are performing activities related to research misconduct issues?
Yes……………………....1
No…(Same title as in 2)……..2 [Go To 3b.]
3a. What is the title, office, or position you hold when you are performing activities
related to research misconduct?
______________________________________________________________
3b. Do your institution’s written policies and procedures identify the title, office, or
position of the person responsible for handling allegations of research misconduct?
Yes……………………………....1
No……………………………….2
No Written Policies/Procedures…3

3c. What is the title, office, or position of the person to whom you report in the
institutional structure when you are performing activities related to research
misconduct?
President/CEO….1 [Go To 3e.]
Other [Specify.] ______________________________________________

3d. How far removed is that person from the Office of the President/CEO; in other words,
how many people are there in the organizational structure between your supervisor and
the President’s office?
[Enumerate/List the Titles/Offices/Positions between PRESIDENT/CEO and the RIO.
Make notes as needed to create a branch of an organization chart.]

1_______________
2_______________
3_______________
4_______________
5_______________

PRESIDENT/CEO
___________________ __________________
___________________ __________________
___________________ __________________
___________________ __________________
___________________ __________________
RESEARCH INTEGRITY OFFICER

3e. Do you have a written job description of what you are expected to do as the RIO
(person handling allegations of research misconduct) at your institution?
Yes……….1
No………..2 [Go To 3g]
3f. Would you be willing to e-mail or fax me a copy of your written RIO job description
after we finish the interview?
Yes……….1
No………..2
3g. In your position as RIO, do you have a separate budget to pay for activities related to
investigation of alleged research misconduct?
Yes……….1
No………..2
3h. How many persons do you have assisting you in your RIO duties?
None……………..0 [Go To 4.]
Number of persons__________
3i. How would you describe their positions/roles, including their percentage time
commitment?
________________________________________________________
________________________________________________________
4. For how long have you been involved in any way with activities related to investigating and
reporting on research misconduct at your institution? _____________________
4a. For how much of that time have you been the RIO (person responsible for carrying
out your institution’s policies and procedures for investigating and reporting on research
misconduct)? _________________________________
4b. Approximately what proportion of your time do you commit to carrying out
responsibilities related to research misconduct?
______________________________________________________________

4c. What special training, conferences, workshops, or job experiences have you had that
helped to prepare you to discharge your research misconduct responsibilities?
_____________________________________________________________
_____________________________________________________________
4d. Prior to joining your current institution, were you involved in any activities related to
investigating and reporting on allegations of research misconduct at some other
institution?
Yes……….1
No………..2
5. For how long have you been employed at your current institution?______________
6. How did you come to be the person responsible for investigating and reporting on research
misconduct there? ___________________________________________________________
____________________________________________________________________
____________________________________________________________________
____________________________________________________________________
[ONLY ASK QUESTION 7 OF PERSONS IN ACADEMIC INSTITUTIONS, OTHERWISE GO
TO QUESTION 8.]
7. Are you a tenured member of the faculty?
Yes……….1
No………..2
8. In what field(s) did you receive your professional training? (a)_________________
(b)_______________________________ (c)_________________________________
9. What advanced degrees do you hold? (a)_________(b)_________(c)__________
(d) None………..99
10. Do you consider yourself primarily a researcher?
Yes……….1 [Go To 10b.]
No………..2
10a. Did you ever consider yourself to be primarily a researcher?
Yes……….1
No………..2 [Go To SECTION II.]
10b. On approximately how many research grants have you been a Principal
Investigator (PI)?
None……………0 [Go To SECTION II.]
Number of Grants ________
10c. Approximately how much was the total dollar funding from those research grants?
______________________________________________
10d. Of the research grants on which you were a PI, approximately how much was the
total dollar funding from PHS/NIH? ________________

II. Next, I would like to learn more about your Responsibilities and Experiences in the RIO
Position. When I ask about being responsible, I mean that according to your job
description, either as it is written or from your supervisor’s directives, you are identified as
the person with the authority and independence to do whatever is necessary to carry out
the specified functions.
1. In addition to your responsibility for carrying out your institution’s policies and procedures for
handling research misconduct, are you responsible for any of the following areas as well? (Read
list a-f.)
2. In which of those areas do you participate in any way, even though you are not responsible for
the area? By participate, I mean that you are involved in some way, but not in charge of the area.
(Read list of a-f for which the response to item 1. Responsible is No, and code response for
whether participates under 2. Participate.)
1. Responsible
2. Participate
a. Financial conflicts of interest.

Y..1 N..2

Shared..3

Y..1

N..2

b. Protection of human research subjects.

Y..1 N..2

Shared..3

Y..1

N..2

c. Protection of animal research subjects.

Y..1 N..2

Shared..3

Y..1

N..2

d. Hazardous waste and radioactive materials. Y..1 N..2

Shared..3

Y..1

N..2

e. Recombinant DNA.

Y..1 N..2

Shared..3

Y..1

N..2

f. Grants management issues.

Y..1 N..2

Shared..3

Y..1

N..2

g. Are there any other administrative or regulatory areas that you are responsible for?
Yes……….1 [Specify.] ______________________________________
Shared..…..2
No…..……3
[If responsible for all areas, Go To 4.]
h. Are there any other administrative or regulatory areas in which you participate but for which
you are not responsible?
Yes……….1 [Specify.] ______________________________________
No………..2
3. Does the person who is responsible for the areas that you are not responsible for report to
you? (Refer if needed to areas in 2a -2f that are both marked no)
Yes……….1
No………..2 [Go To 3b.]
3a. Which area(s)?
None………..0 [Go To 4.]
Specify Letter(s)______________________________

3b. Do any of the persons responsible for these areas, who do not report to you, report
directly to the same person you report to?
Yes……….1
No………..2 [Go To 4.]
3c. Which area(s)?
None………..0
Specify Letter(s)______________________________
4. Since you began in the RIO position, about how many allegations of research misconduct
would you estimate have been received concerning externally sponsored research projects?
None………..0 [Go To 5.]
Number________________________
4a. How many of those allegations would you say actually had an initial inquiry
conducted?
None………..0 [Go To 5.]
Number________________________
4b. About how many of those initial inquiries led to formal investigations?
None………..0 [Go To 5.]
Number________________________
4c. How many of the allegations investigated would you say involved PHS/NIH-funded
research projects?
None………..0 [Go To 5.]
Number________________________
5. Since you became a RIO, approximately how many times would you say that you have
conferred with RIOs at other institutions about difficulties you faced/might face in handling
cases?
None………..0 [Go To 6.]
Number of Times________________________[If only once, Go To 6.]
5a. With approximately how many different RIOs have you conferred over difficulties
you faced or thought you might face in handling cases since becoming a RIO?
One………..1
Number of RIOs________________________
6. Since you became a RIO, about how often would you say that you have conferred about
“hypothetical cases” or spoken off the record with someone at a Federal oversight agency, like
the Office of Research Integrity, about how to handle difficult cases?
None………..0
Number of Times________________________
7. Does your institution have a policy, educational program, or other mechanism for promoting
the Responsible Conduct of Research?
Yes……….1
No………..2 [Go To SECTION III.]

7a. Does your institution require all persons conducting research to receive training
in the Responsible Conduct of Research?
Yes……….1
No………..2
7b. Please describe what this training involves and how it is implemented (What are its
key components, and who implements it)?
________________________________________________________________________
________________________________________________________________________
________________________________________________________________________
____________________________________________________
7c. Is administering that policy or program part of your responsibility as the RIO?
Yes……….1
No………..2
7d. Are you involved in its implementation in any way?
Yes……….1 [Go To SECTION III.]
No………..2
7e. Does the person who is responsible for implementing it report to you?
Yes……….1 [Go To SECTION III.]
No………..2
7f. Does the person who implements it report to the same person you report to?
Yes……….1
No………..2
III. We know that the scope of RIO’s responsibilities differ from institution to institution.
Now I want to try to better understand your specific responsibilities and how you carry
them out.

1. Are you the primary person identified by your institution to receive allegations of research
misconduct directly from members of your institution?
Yes……….1 [Go To 2.]
No………..2
1a. Who (is/are) the primary person(s) identified to receive allegations of research
misconduct (What Office, Title, or Position)?_______________________________
1b. (Does/Do) the other person(s) designated to receive allegations report to
you or to someone else in the institutional structure?
Yes, to me………………….1 [Go To 2.]
No, to someone else………..2
1c. To whom (what Office, Title, or Position) do they report?_______________
2. Are there other persons at your institution who are also authorized to receive allegations of
research misconduct?
Yes……….1
No………..2 [Go To 3.]
7

2a. Are these persons who receive allegations of misconduct required to report all of
them to you?
Yes……….1
No………..2
2b. Through what process do allegations of misconduct get from those persons to you as
the RIO? (Probe for means of communication.)
_____________________________________________________
2c. Normally, how soon after an allegation is made does notification of the
allegation from them reach you? (Probe for number of hours.)
__________________________________________________________________
3. Are you the person responsible for informing persons who conduct research about the
institution’s research misconduct policy and explaining what constitutes falsification, fabrication,
and plagiarism, including the procedures for reporting them?
Yes……….1 [Go To 3b.]
Done with someone else…2 (Specify person’s Title, Office, or Position)
_______________________________________________________[Go To 3b.]
No………..3
3a. Does the person who is responsible report to you?
Yes……….1
No………..2 [Go To 4.]
3b. By what means or mechanisms do you do that? (Do not read list)
1. Provide Orientation to New Members
Y
2. Provide Handbook for Faculty, Staff, and Students Y
3. Website on Research Misconduct Policy
Y
4. Publicize Institutional Policies and Guidelines
Y
5. Announce in Newsletters
Y
6. Give Presentations
Y
7. Do On-Line Training
Y
8. Hold Workshops
Y
9. Organize Classes or Courses
Y
10. Work through Advisors
Y
11. Model through Mentors
Y
12. Other (Specify)_______________________________
3c. Does your institution require researchers to sign something saying that they are
aware of your institution’s research misconduct policy?
Yes……….1
No………..2
4. In the process of handling a typical allegation of research misconduct, with whom (what
positions, titles, or offices) at your institution do/would you normally interact? (Specify)
_________________________________________________________________________

5. Are you responsible for informing key institutional officials when an allegation of research
misconduct has been received?
Yes……….1
No………..2
6. If an allegation involves more wrongdoing than just research misconduct, are you responsible
for deciding who deals with which parts of the allegation and in what order they get handled?
Yes……………………………….…...………….1
Done in collaboration with the others involved….2
No…………………………………..…………….3
7. Are you the person responsible for sequestering evidence when an allegation of research
misconduct has been filed?
Yes……….1
No………..2 [Go To 8.]
7a. About how many times have you actually done it?
Never……………………0
Number of Times_____________________________
8. Are you responsible for reminding potential whistleblowers/persons making allegations of
their vulnerability and informing them of the institution’s responsibility to protect them from
retaliation?
Yes……………………....1 [Go To 8b.]
Done with someone else…2 (Specify person’s Office, Title, or Position)
_______________________ [Go To 8b.]
No……………………....3
8a. Does the person who is responsible for informing them report to you?
Yes……….1
No………..2 [Go To 8c.]
8b. (Are you/Is the person who reports to you) responsible for telling whistleblowers
specifically what measures will be used to protect them if they file an allegation?
Yes……………………….1
Done with someone else…2 (Specify Person’s Office, Title, or Position)
_______________________
No………………………..3
8c. Whose responsibility (what Title, Office, or Position) is it to formulate and implement
the specific measures to protect the whistleblower from retaliation?
Formulate_________________________________________________________
Implement_________________________________________________________

9. Do you conduct the assessment of allegations to decide if there should be an inquiry?
Yes……………………….1
Done with someone else…2 (Specify Person’s Title, Office, or Position)
_______________________________________________________
No………………………..3 [Go To 10.]
9a. Do you interview the person making the allegation in that assessment process?
Yes……….1
Done with someone else…2 (Specify Person’s Office, Title, or Position)
_______________________
No………..3
9b. Do you interview any witnesses in that assessment process?
Yes……….1
No………..2
10. Is it your responsibility to select the persons who will serve on the inquiry panel?
Yes……….1 [Go To 11.]
Done with someone else…2 (Specify Person’s Title, Office, or Position)
_______________________________________________________[Go To 11.]
No………..3
10a. How are the members of the inquiry panel selected? _____________________
___________________________________________________________________
11. If the inquiry panel recommends a formal investigation, is it your responsibility to select the
persons who will serve on the investigation committee?
Yes……………………….1 [Go To 12.]
Done with someone else…2 (Specify person’s Title, Office, or Position)
_______________________________________________________[Go To 12.]
No………………………..3
11a. How are the members of the investigation committee selected? ____________
___________________________________________________________________
12. Are you responsible for training or briefing the panel and committee members on how to
conduct a proper inquiry or investigation?
Yes……………………….1
Done with someone else…2 (Specify person’s Title, Office, or Position)
_______________________________________________________
No………………………..3 [Go To 13.]

12a. What do you train/brief them to be able to do?
(Do not read list)
Mentioned
How to:
1. Develop an investigation strategy
Yes 1 No 2
2. Interview witnesses as well as the accused and accuser Yes 1 No 2
3. Identify needed technical expertise
Yes 1 No 2
4. Identify available forensic techniques
Yes 1 No 2
5. Work with legal counsel
Yes 1 No 2
6. Handle exigencies
Yes 1 No 2
7. Draft the panel/committee report
Yes 1 No 2
8. Other (Specify)__________________________________
13. Would you say that you are extremely satisfied, very satisfied, satisfied, or not satisfied with
the amount of authority and independence you have to carry out your duties as RIO?
Extremely Satisfied………1
Very Satisfied…………….2
Satisfied…………………..3
Not Satisfied……………...4
14. Since becoming the RIO in your institution, have you ever had concerns that research
misconduct has not come to your attention because it was being handled by other persons
through different mechanisms?
Yes……….1
No………..2 [Go To 15.]
14a. Are there policies or unofficial norms at play in your institution that direct
allegations of scientific misconduct to alternative ways of resolution that do not involve
you in your role as RIO?
Yes……….1
No………..2 [Go To 15.]
14b. Please describe these alternative ways of resolving alleged research misconduct.
_________________________________________________________________
_________________________________________________________________

15. In the past five years, are you aware of any cases in which your institution has mishandled an
allegation of research misconduct in any way? Mishandled includes things such as allowing the
person making the allegation to be discredited, not sequestering evidence quickly enough, or
having the head of a department fail to pass allegations to the appropriate person.
Yes…………1
No………….2 [Go To Section IV.]
15a. In what way (or at what point in the process) was it mishandled (the most recent
time). Please just give a general description and do not mention names?
______________________________________________________________
_______________________________________________________________

IV. In this next section of the interview I am going to read you several scenarios involving
situations in which RIOs sometimes find themselves. Such scenarios can be helpful in
pointing out areas for further RIO development through workshops or conferences.
Because we know that RIOs in different institutions may act differently in similar
situations, we would like you to comment on these fictitious cases. To make it easier for
you, the RIO is always unnamed, the person making the allegation or whistleblower has a
name beginning with “W”, and the person being accused or respondent’s name begins with
“R”.

Scenario 1
The RIO receives a phone call from a very upset third year graduate student. As best the RIO
can understand through the student’s accent, she is upset that her thesis advisor is attempting to
publish some of her data without naming her an author or giving her adequate credit, and in
addition, he is misrepresenting her data. She also complained that he is assigning her work to do
in the lab that is unrelated to her dissertation, thereby impeding progress on her degree. The RIO
invites the student to come by her office to discuss these allegations, but the student declines.
During that initial call, the RIO advises the student to call the assistant dean of the graduate
school who deals with mentor-trainee problems to discuss progress toward her degree. She then
asks the student for more details on the alleged misrepresentation of her data. The student
alleges that her advisor is making claims in proposals and manuscripts that her data do not
support and that he is selectively using bits of her data that make it appear like the data do
support his claims. She tells the RIO that she and a “post doc” in the lab have argued with the
advisor over this, but that the “post doc” is reluctant to join her in this complaint because he
needs a letter of reference from the advisor. The RIO encourages the student to come see her
and to bring her lab books so she can better understand the situation. The student says she will
think about it.
Two days later, the student calls the RIO again, very agitated. She says that the “post doc” had
an argument with the advisor over the integrity of the data, and that he wants her to join him in
writing to a journal editor about it. She notes that the advisor is in the lab at that time shredding
films and printouts.
If you were the RIO, what actions, if any, would you take in response to this second call?

Scenario 2
Dr. Rivers is a renowned professor emeritus at a university. He discovered a drug that made
millions of dollars for him and the university. Upon retiring from the university, Dr. Rivers
founded a pharmaceutical research company called Biostart, and he has the company developing
a promising new drug. Dr. Rivers entered into a research agreement with the university under
which Biostart received partial funding and the collaboration of some scientists from the
university. The agreement stated that in return the university would have partial ownership of
any intellectual property that its funds or staff helped Biostart to develop. The agreement
stipulates that the university’s research regulations and procedures have jurisdiction over any
work at Biostart involving university funds or staff.
A claim of misconduct has been brought against Dr. Rivers by a university scientist, Dr.
Wheeler, who has been working with Biostart on a new drug. He alleges that the Biostart
scientists did not do the work it claimed, but had rather “stolen” university scientists’ data and
falsified data to mask the theft. In addition, Dr. Wheeler claims that Dr. Rivers is retaliating
against him for making the allegation by refusing to renew his “guest” appointment at Biostart.
Upon receiving the allegations from Dr Wheeler, the RIO, as required by university procedures,
informed the university’s General Counsel, President, Provost, and Vice President for Research
of the allegations and prepared to visit Biostart to sequester data and inform the Biostart
scientists and Dr. Rivers of the allegations against them. Before the RIO could contact Dr.
Rivers and Biostart about the allegations, however, the university’s General Counsel came to the
RIO’s office. The General Counsel told the RIO that he had just spoken with the President and
they both agreed that the RIO should not pursue the allegations because the university had no
effective way to sanction the Biostart scientists or Dr. Rivers if the allegations were confirmed.
The RIO reminded the General Counsel of the agreement in which Biostart agreed that the
university’s regulatory policies and procedures would apply to all research at Biostart in which
the university was involved. The General Counsel said that he had considered that. Then the
RIO asked the General Counsel whether he and the President might not have a conflict of interest
in making that decision because they wanted to preserve their partnership with Biostart in
anticipation of another financial bonanza for the university from the new drug. The General
Counsel declined to respond.
What would you do now if you were the RIO? Please explain your rationale for doing
that.

Scenario 3
The RIO receives a telephone call from a person identifying herself only as a lab technician. She
wants to know what the “rules” are for filing an allegation of research misconduct. Specifically,
she wants to know whether she would be identified as the person making the allegation and what
would happen to her job if the head of the lab learned that she had accused him of fabricating
data. She also asked what would happen to her job if the head of her lab was found “guilty” of
misconduct.
The RIO explains that she can remain officially anonymous unless or until her testimony is
needed in a proceeding reviewing the allegation. The RIO adds that if she declines to testify,
while the institution would not compel her, it might not be able to continue to investigate the
allegation. As to what would happen to her if the head of the lab learned that she had made the
allegation, the RIO tells her that, in the small world of a laboratory, it is very likely that the head
of the lab will guess who made the allegation, even if everyone maintains confidentiality.
However, the RIO tells her that as long as she is acting in good faith, the institution will take
steps to protect her.
The caller eventually identifies herself as Wendy West and she decides to make a formal
allegation, but asks for anonymity. The RIO goes to the laboratory to inform the head of the lab,
Dr. Ralston, of the allegation and to sequester the pertinent data.
The next week Ms. West is invited to come to the RIO’s office to provide more details on the
allegation. As she is leaving, Dr. Ralston happens to come into the RIO’s office, he says, to ask
about his rights under the institution’s research misconduct procedures. There is an awkward
moment in the hallway as Ms. West leaves and Dr. Ralston enters. The next week, Ms. West
calls the RIO to report that Dr. Ralston accused her of making the allegation and upset her so
much that she had to go home “sick.” But, even as she tried to leave work, Dr. Ralston followed
her down the hall screaming at her.
What, if anything, would you have done as the RIO in response to the chance encounter?

What would you do now in response to the second phone call if you were the RIO?

Scenario 4
The University’s RIO receives a telephone call from the chair of the Medical School’s IRB who
requests an immediate meeting. On arriving at the RIO’s office, the IRB chair explains that IRB
staff had been concerned for some time about a Phase 1 clinical trial operating at an affiliated
Cancer Center. The protocol involves a new oncology drug, developed by the investigators, in
combination with experimental radiation therapy. The University’s Medical School IRB is the
IRB of record.
The IRB chair explains that IRB staff had noted for some time that the project submitted tardy
adverse event reports and incomplete annual reports accompanying their requests for renewed
approval of the protocol. Consequently, IRB staff had decided to conduct an audit of the project
over the past two days. They found that where patient records appeared to be complete, there
were numerous protocol violations, including some involving inclusion and exclusion criteria. In
addition, many of the patient records had incomplete enrollment information and were missing
consent forms.
On learning of these initial audit results, the IRB chair went to the Cancer Center to examine the
records. While there, a medical resident who had worked briefly on the project asked to speak to
him in private. The resident told the IRB chair that some of the consent forms had been
completed and back-dated only when the project staff learned of the impending IRB audit, some
many months after the patient had been enrolled. Further, the resident alleged that a terminallyill woman had been enrolled in violation of protocol rules. She did not meet the inclusion
criteria because she had recent non-protocol radiation therapy which in combination with the
radiation therapy and drug that were part of the study was potentially cardio-toxic. The patient
died after protocol radiation therapy, but the death was not reported to the IRB. Further, the
resident alleged, the record of her having been enrolled in the project had been destroyed.
If you were the RIO, what, if anything, would you do in response to the alarming audit
report and the allegations made by the medical resident?

Scenario 5
The institute’s RIO receives an allegation of research misconduct —falsification of data—
against Dr. Rogers. The RIO, an assistant, and the general counsel immediately visit Dr. Rogers’
office to inform him of the allegation, and to sequester data that could constitute evidence in any
eventual investigation of the allegation. Dr. Rogers reacts angrily to being informed of the
allegation, and states he’s being unfairly accused. He further claims that by pursuing this
allegation the institute is “persecuting” him. He refuses to cooperate with the sequestration of
the data in question. Accordingly, the RIO, the assistant, and a member of the security force
consult Dr. Rogers’ lab assistant as discreetly as possible to identify and sequester the pertinent
data, all the while making every effort to not disrupt Dr. Rogers’ lab. Nevertheless, the next day,
Dr. Rogers sends a letter to the institute’s president accusing the RIO of abusing him, disrupting
his work, and interfering with his academic freedom.
Meanwhile, as part of the initial assessment of the allegation, the RIO invites Dr. Rogers to meet.
However, Dr. Rogers does not respond to the RIO’s telephone messages, e-mails, or registered
letter. Unable to talk with Dr. Rogers and get his explanation of the alleged data falsification, the
RIO confers with general counsel and decides that a formal inquiry is needed to assess the
allegation.
Upon being informed that the allegation has resulted in a formal inquiry, Dr. Rogers files a
grievance against the RIO. The grievance claims that the RIO has taken the side of the
whistleblower, is therefore not impartial, and should be removed from any involvement with the
case.
While the grievance is pending, the inquiry begins. When invited to an interview by the inquiry
committee, Dr. Rogers responds that he will only attend if his lawyer can speak for him and
cross-examine witnesses. In response, the RIO sends a letter to Dr. Rogers explaining that under
institute policy he may be accompanied by counsel, but that counsel may not speak for him. In
addition, the letter explains that inquiries are conducted through sequential, confidential
interviews as opposed to in an open hearing where cross-examination might be appropriate. Dr.
Rogers does not respond to the RIO’s letter or to subsequent invitations from the inquiry
committee for an interview. However, Dr. Rogers sends an e-mail to hundreds of colleagues
attacking the RIO’s integrity and competence. His lawyer writes a letter to the institute’s general
counsel threatening a law suit if the inquiry into the allegation continues, claiming it is untrue
and has already injured his client.
How would you respond as the RIO in this situation?

Thank you very much for the time you took to answer our questions.
IF RELEVANT: Please remember to e-mail (or FAX) me your RIO job description. [Give your
e-mail address/fax number to the respondent]
Now that we are done, are there any questions that you think we should have asked that we did
not?
Yes…….1 [Specify] ______________________________________________________
No……..2
Were there any questions that we asked that you thought we should not have asked?
Yes…….1 [Specify] _______________________________________________________
No……..2
THANK YOU AGAIN

END TIME _______________________

Attachment 3:

Questionnaire for the proposed RIO
web-based survey.

Form Approved
OMB Control No.: 0990-0305
Expiration Date: 1/31/2009

Web-Based Version of Revision 7 of the Semi-Structured Telephone Interview
Identification Number___________________
Introduction
RTI is a not-for-profit research organization headquartered in North Carolina. The Department of
Health and Human Services’ (DHHS) Office of Research Integrity (ORI) has engaged RTI to
conduct a study of what occurs when there are allegations of research misconduct at institutions
performing federally-funded research. For this study, research misconduct refers to falsification,
fabrication, and plagiarism of research. You were identified as the person with responsibility for
carrying out the policies and procedures for handling research misconduct allegations at your
institution. Persons in this role are often referred to as the Research Integrity Officer or RIO.
We want to be sure you are the person doing that job at your institution?
Yes, I am the RIO….…O [Continue.]
No, I am not the RIO…O [Do Not Continue. Go to page to identify the correct
person to contact.]
The purpose of this research is to understand how you and other RIOs carry out the
responsibilities associated with these activities and to identify areas where ORI may be able to
provide additional training or support to make this job easier. This survey contains questions
about your training, experience, and about what you do as the RIO, including some scenarios to
address. This survey should take about 30 minutes to complete. Of course, your participation is
voluntary and you may refuse to answer any question. We pledge to keep your identity and that
of your institution confidential. Because your identity is protected, we see little risk with
participation and opportunities for RIO training as potential benefits that could result.
If you have any questions about the interview, you may e-mail or call Dr. Arthur J. Bonito at RTI
(ajb@rti.org or 919-541-6377) or Dr. Sandra Titus at ORI (stitus@osophs.dhhs.gov or 240-453-8437). If
you have any questions about your rights as a study participant, you can call RTI's Office of Research
Protection at 1-866-214-2043 (a toll-free number).

Instructions to respondents for completing information collection:

Public reporting burden of this collection of information is estimated to average 30 minutes per response, including
the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and
completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not
required to respond to a collection of information unless it displays a currently valid OMB control number. Send
comments regarding this burden estimate or any other aspect of this collection of information, including suggestions
for reducing this burden to Ms. Seleda Perryman, HHS Departmental Records Official; HHS Building, 537H, 200
Independence Avenue S.W., Washington, D.C. 20201; ATTN: PRA (0990-0305).

START TIME______________
I. Current Organizational Position and Professional Background
1. What is your usual title, office, or position in the organization when you are not performing
activities related to allegations of research misconduct?
___________________________________________________________
1a. When functioning in your usual position, how involved would you say you are in seeking
opportunities to financially support research at your institution?
Very Involved………..…1
Somewhat Involved….…2
Only Slightly Involved....3
Not at All Involved….….4
2. What is the title, office, or position of the person to whom you ordinarily report when you are
not performing activities related to research misconduct?
______________________________________________________________
3. Do you have a different title or hold an identified office or position in the organizational
structure when you are performing activities related to research misconduct issues?
Yes……………………....1
No…(Same title as in item 2)……..2 [Go To 3b.]
3a. What is the title, office, or position you hold when you are performing activities related to
research misconduct?

3b. Do your institution’s written policies and procedures identify the title, office, or position of
the person responsible for handling allegations of research misconduct?
Yes…………………………………………………....1
No…………………………………………………….2
3c. What is the title, office, or position of the person to whom you report in the institutional
structure when you are performing activities related to research misconduct?
President/CEO….1 [Go To 3e. and Fill in 3d with 0]
Other [Specify title, office, or position .] _______________________________________
3d. How far removed is that person from the Office of the President/CEO; in other words, how
many people are there in the institutional structure between you as the RIO and the President’s
office (including your supervisor)?
Number of persons in structure between you (RIO) and the President/CEO ___________

3e. Do you have a written job description of what you are expected to do as the RIO (person
handling allegations of research misconduct) at your institution?
Yes……….1
No………..2
3g. In your position as RIO, do you have a separate budget to pay for activities related to
investigation of alleged research misconduct?
Yes……….1
No………..2
3h. How many persons do you have assigned to assist you in your RIO duties?
None……………..0 [Go To 4. and fill number with 0]
Number of persons__________
3i. How would you describe their positions/roles, including their percentage time commitment?
Position/Role Description
1.______________________________________
2.______________________________________
3.______________________________________
4.______________________________________

% Time Committed
___________%
___________%
___________%
___________%

4. For how long have you been involved in any way with activities related to investigating and
reporting on research misconduct at your institution?
_______________ O Months…1 O Years…2
4a. For how much of that time have you been the RIO (person responsible for carrying out your
institution’s policies and procedures for investigating and reporting on research misconduct)?
_______________O Months…1 O Years…2
4b. Approximately what proportion of your time each year do you commit to carrying out
responsibilities related to research misconduct?
____________%
4c. What special training, conferences, workshops, or job experiences have you had that helped
to prepare you to discharge your research misconduct responsibilities?
(1)_____________________________________________________________
(2)_____________________________________________________________
(3)_____________________________________________________________
(4)_____________________________________________________________
(5)_____________________________________________________________
4d. Prior to joining your current institution, were you involved in any activities related to
investigating and reporting on allegations of research misconduct at some other institution?
Yes……….1
No………..2
5. For how long have you been employed at your current institution?
3

______________ O Months…1

O Years…2

6. How did you come to be the person responsible for investigating and reporting on research
misconduct there? ___________________________________________________________
____________________________________________________________________
____________________________________________________________________
____________________________________________________________________
7. Are you a tenured member of the institution/faculty?
Yes……………...…..1
No………………..…2
No tenure available…3
8. In what field(s) did you receive your professional training?
(a)_______________________________
(b)_______________________________
(c)_______________________________
9. What advanced degrees do you hold? Check All That Apply
(a) PhD…… 1
(b) MD …….2
(c) DDS/DMD/DVM…. 3
(d) MS/MA ……………4
(e) MPH/MBA/MHA/MPA …….5
(f) BS/BA/AB ………….6
(g) Other …7 [Specify.] _______________________________________
(h) None………..99
10. Do you consider yourself primarily a researcher?
Yes……….1 [Go To 10b.]
No………..2
10a. Did you ever consider yourself to be primarily a researcher?
Yes……….1
No………..2 [Go To SECTION II.]
10b. On approximately how many research grants have you been a Principal Investigator (PI)?
None……………0 [Go To SECTION II and Fill Number with 0)
Number of Grants ________
10c. Approximately how much was the total dollar funding from those research grants?
$___________________

10d. Of the research grants on which you were a PI, approximately how much was the total
dollar funding from PHS/NIH?
$________________
II. Responsibilities and Experiences
1. In addition to responsibility for carrying out your institution’s policies and procedures for
handling research misconduct, are you responsible for any of the following areas as well?
a. Financial conflicts of interest.

Yes..1

No..2

Shared..3

b. Protection of human research subjects.

Yes..1

No..2

Shared..3

c. Protection of animal research subjects.

Yes..1

No..2

Shared..3

d. Hazardous waste and radioactive materials. Yes..1

No..2

Shared..3

e. Recombinant DNA.

Yes..1

No..2

Shared..3

f. Grants management issues.

Yes..1

No..2

Shared..3

g. Are there any other administrative or regulatory areas that you are responsible for?
Yes……….1 [Specify area.] ______________________________________
Shared..…..3 [Specify area.] ______________________________________
No…..……2
[If responsible for all areas, (no “no”s to Question 1) Go To 4. Otherwise, only show the items
1a – 1f answered “no” below in question 2.]
2. In which of the following areas do you participate in some way, even though you are not
responsible for the area? By participate, I mean that you are involved in some way, but not in
charge of the area.
a. Financial conflicts of interest.

Yes..1

No..2

b. Protection of human research subjects.

Yes..1

No..2

c. Protection of animal research subjects.

Yes..1

No..2

d. Hazardous waste and radioactive materials. Yes..1

No..2

e. Recombinant DNA.

Yes..1

No..2

f. Grants management issues.

Yes..1

No..2

h. Are there any other administrative or regulatory areas in which you participate, but for which
you are not responsible?
Yes……….1 [Specify area.] ______________________________________
No………..2
3. Do any of the persons responsible for the areas that you are not responsible for report to
you?
Yes……….1
No………..2 [Go To 3b.]
3b. Do any of the persons responsible for the areas that you are not responsible for and who do not
report to you, report directly to the same person you report to?
Yes……….1
No………..2
4. Since you began in the RIO position, about how many allegations of research misconduct
would you estimate have been received concerning externally sponsored research projects?
Number________________________ [If none, go to 5 and fill Number with 0]
4a. How many of those allegations would you say actually had an initial inquiry conducted?
Number________________________ [If none, go to 5 and fill Number with 0.]
4b. Approximately how many of those initial inquiries led to formal investigations?
Number________________________ [If none, go to 5 and fill Number with 0.]
4c. How many of the allegations investigated would you say involved PHS/NIH-funded
research projects?
Number________________________ [If none, go to 5 and fill Number with 0.]
5. Since you became a RIO, approximately how many times would you say that you have
conferred with RIOs at other institutions about difficulties you faced/might face in handling
cases?
Number of Times___________[If none or one, go to 6 and fill Number in 5a with 0 or 1.]
5a. With approximately how many different RIOs have you conferred over difficulties you faced
or thought you might face in handling cases since becoming a RIO?
Number of RIOs ________________________
6. Since you became a RIO, about how often would you say that you have conferred about
“hypothetical cases” or spoken off the record with someone at a Federal oversight agency, like
the Office of Research Integrity, about how to handle difficult cases?
Number of Times______________

7. Does your institution have a policy, educational program, or other mechanism for promoting
the Responsible Conduct of Research?
Yes……….1
No………..2 [Go To SECTION III.]
7a. Does your institution require all persons conducting research to receive training in the
Responsible Conduct of Research?
Yes……….1
No………..2
7b. Please describe the key components of this RCR training and who implements it?
Key Components
(1)__________________________________________________________________________
(2)__________________________________________________________________________
(3)__________________________________________________________________________
(4)__________________________________________________________________________
(5)__________________________________________________________________________
(6)Who implements it? Specify (Person’s office, title, or position)
_______________________________
7c. Is administering that policy or program part of your responsibility as the RIO?
Yes……….1
No………..2
7d. Are you involved in its implementation in any way?
Yes……….1 [Go To SECTION III.]
No………..2
7e. Does the person who is responsible for implementing it report to you?
Yes……….1 [Go To SECTION III.]
No………..2
7f. Does the person who implements it report to the same person you report to?
Yes……….1
No………..2

III. Specific Responsibilities as RIO.
1. Are you the primary person identified by your institution to receive allegations of research
misconduct directly from members of your institution?
Yes……….1 [Go To 2.]
No………..2
1a. Who (is/are) the primary person(s) identified by office, title, or position to receive allegations
of research misconduct?
(1)_______________________________
(2)_______________________________
1b. (Does/Do) the other person(s) designated to receive allegations report to you or to someone
else in the institutional structure?
Yes, report to me………………….1 [Go To 2.]
No, report to someone else………..2
1c. To what office, title, or position do they report?_______________
2. Are there other persons at your institution who are also authorized to receive allegations of
research misconduct?
Yes……….1
No………..2 [Go To 3.]
2a. Are these persons who receive allegations of misconduct required to report all of the
allegations they receive to you?
Yes……….1
No………..2
2b. Through what process or means of communication do the allegations of misconduct get from
those persons to you as the RIO?
(1)_____________________________________________________
(2)_____________________________________________________
(3)_____________________________________________________
2c. Normally, how soon after an allegation is made does notification of the allegation from them
reach you?
_________O Hours…1 O Days….2
3. Are you the person responsible for informing persons who conduct research about the
institution’s research misconduct policy and explaining what constitutes falsification, fabrication,
and plagiarism, including the procedures for reporting them?
Yes……….1 [Go To 3b.]
Done with someone else…2 (What is the person’s title, office, or position?)
_______________________________________________________[Go To 3b.]
No………..3
8

3a. Does the person who is responsible report to you?
Yes……….1
No………..2 [Go To 4.]
3b. By what means or mechanisms do you do that?
1. Provide Orientation to New Members
2. Provide Handbook for Faculty, Staff, and Students
3. Website on Research Misconduct Policy
4. Publicize Institutional Policies and Guidelines
5. Announce in Newsletters
6. Give Presentations
7. Do On-Line Training
8. Hold Workshops
9. Organize Classes or Courses
10. Work through Advisors
11. Model through Mentors
12. Other (Specify)_______________________________

Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes

No
No
No
No
No
No
No
No
No
No
No

3c. Does your institution require researchers to sign something saying that they are aware of your
institution’s research misconduct policy?
Yes……….1
No………..2
4. In the process of handling a typical allegation of research misconduct, with whom (what
positions, titles, or offices) at your institution do/would you normally interact? (Specify)
_________________________________________________________________________
5. Are you responsible for informing key institutional officials when an allegation of research
misconduct has been received?
Yes……….1
No………..2
6. If an allegation involves more wrongdoing than just research misconduct, are you responsible
for deciding who deals with which parts of the allegation and in what order they get handled?
Yes……………………………….…...………….1
Done in collaboration with the others involved….2
No…………………………………..…………….3
7. Are you the person responsible for sequestering evidence when an allegation of research
misconduct has been filed?
Yes……….1
No………..2 [Go To 8.]

7a. About how many times have you actually done it?
Never……………………0
Number of Times_____________________________
8. Are you responsible for reminding potential whistleblowers/persons making allegations of
their vulnerability and informing them of the institution’s responsibility to protect them from
retaliation?
Yes……………………....1 [Go To 8b.]
Done with someone else…2 (Specify person’s office, title,
or position) _______________________ [Go To 8b.]
No……………………....3
8a. Does the person who is responsible for informing them report to you?
Yes……….1
No………..2 [Go To 8c.]
8b. (Are you/Is the person who reports to you) responsible for telling whistleblowers specifically
what measures will be used to protect them if they file an allegation?
Yes……………………….1
Done with someone else…2 (Specify person’s title, office,
or position) _______________________
No………………………..3
8c. Whose responsibility (what title, office, or position) is it to formulate and implement the
specific measures to protect the whistleblower from retaliation?
(1) Formulate_______________________________________________________
(2) Implement_________________________________________________________
9. Do you conduct the assessment of allegations to decide if there should be an inquiry?
Yes……………………….1
Done with someone else…2 (Specify person’s title, office,
or position) ____________________________________
No………………………..3 [Go To 10.]
9a. Do you interview the person making the allegation in that assessment process?
Yes……….1
Done with someone else…2 (Specify person’s title, office,
or position)_______________________
No………..3
9b. Do you interview any witnesses in that assessment process?
Yes……….1
No………..2
10

10. Is it your responsibility to select the persons who will serve on the inquiry panel?
Yes……….1 [Go To 11.]
Done with someone else…2 (Specify person’s office, title,
or position) ____________________________________________________[Go To 11.]
No………..3
10a. How are the members of the inquiry panel selected? ___________________________
___________________________________________________________________
11. If the inquiry panel recommends a formal investigation, is it your responsibility to select the
persons who will serve on the investigation committee?
Yes……………………….1 [Go To 12.]
Done with someone else…2 (Specify person’s title, office,
or position) ___________________________________________________[Go To 12.]
No………………………..3
11a. How are the members of the investigation committee selected? ____________
___________________________________________________________________
12. Are you responsible for training or briefing the panel and committee members on how to
conduct a proper inquiry or investigation?
Yes……………………….1
Done with someone else…2 (Specify person’s title, office,
or position) ______________________________________________________
No………………………..3 [Go To 13.]
12a. What do you train/brief them to be able to do?
Does it include how to:
1. Develop an investigation strategy
Yes 1
2. Interview witnesses as well as the accused and accuser Yes 1
3. Identify needed technical expertise
Yes 1
4. Identify available forensic techniques
Yes 1
5. Work with legal counsel
Yes 1
6. Handle exigencies
Yes 1
7. Draft the panel/committee report
Yes 1
8. Other (Specify)__________________________________

No 2
No 2
No 2
No 2
No 2
No 2
No 2

13. Would you say that you are extremely satisfied, very satisfied, satisfied, or not satisfied with
the amount of authority and independence you have to carry out your duties as RIO?
Extremely Satisfied………1
Very Satisfied…………….2
Satisfied…………………..3
Not Satisfied……………...4

14. Since becoming the RIO in your institution, have you ever had concerns that research
misconduct has not come to your attention because it was being handled by other persons
through different mechanisms?
Yes……….1
No………..2 [Go To 15.]
14a. Are there policies or unofficial norms operating in your institution that direct allegations of
research misconduct to alternative ways of resolution that do not involve you in your role as
RIO?
Yes……….1
No………..2 [Go To 15.]
14b. Please describe these alternative ways of resolving alleged research misconduct.
_________________________________________________________________
_________________________________________________________________
15. In the past five years, are you aware of any cases in which your institution has mishandled an
allegation of research misconduct in any way? (Mishandled includes things such as allowing the
person making the allegation to be discredited, not sequestering evidence quickly enough, or
having the head of a department fail to pass allegations on to the appropriate person.)
Yes…………1
No………….2

IV. RIO Scenarios

Scenario 2 [Formerly3]
The RIO receives a telephone call from a person identifying herself only as a lab technician. She
wants to know what the “rules” are for filing an allegation of research misconduct. Specifically,
she wants to know whether she would be identified as the person making the allegation and what
would happen to her job if the head of the lab learned that she had accused him of fabricating
data. She also asked what would happen to her job if the head of her lab was found “guilty” of
misconduct.
The RIO explains that she can remain officially anonymous unless or until her testimony is
needed in a proceeding reviewing the allegation. The RIO adds that if she declines to testify,
while the institution would not compel her, it might not be able to continue to investigate the
allegation. As to what would happen to her if the head of the lab learned that she had made the
allegation, the RIO tells her that, in the small world of a laboratory, it is very likely that the head
of the lab will guess who made the allegation, even if everyone maintains confidentiality.
However, the RIO tells her that as long as she is acting in good faith, the institution will take
steps to protect her.
The caller eventually identifies herself as Wendy West and she decides to make a formal
allegation, but asks for anonymity. The RIO goes to the laboratory to inform the head of the lab,
Dr. Ralston, of the allegation and to sequester the pertinent data.
The next week Ms. West is invited to come to the RIO’s office to provide more details on the
allegation. As she is leaving, Dr. Ralston happens to come into the RIO’s office, he says, to ask
about his rights under the institution’s research misconduct procedures. There is an awkward
moment in the hallway as Ms. West leaves and Dr. Ralston enters. The next week, Ms. West
calls the RIO to report that Dr. Ralston accused her of making the allegation and upset her so
much that she had to go home “sick.” But, even as she tried to leave work, Dr. Ralston followed
her down the hall screaming at her.
(a) If you were the RIO, what, if anything, would you have done in response to the chance
encounter in the hallway?
1.____________________________________________________________________________
2.
3.
4.
5.
6.
7.

(b) What would you do now in response to the second phone call from Miss West?
1.____________________________________________________________________________
2.
3.
4.
5.
6.
7.
8.

Scenario 3 [Formerly 4]
The University’s RIO receives a telephone call from the chair of the Medical School’s IRB who
requests an immediate meeting. On arriving at the RIO’s office, the IRB chair explains that IRB
staff had been concerned for some time about a Phase 1 clinical trial operating at an affiliated
Cancer Center. The protocol involves a new oncology drug, developed by the investigators, in
combination with experimental radiation therapy. The University’s Medical School IRB is the
IRB of record.
The IRB chair explains that IRB staff had noted for some time that the project submitted tardy
adverse event reports and incomplete annual reports accompanying their requests for renewed
approval of the protocol. Consequently, IRB staff had decided to conduct an audit of the project
over the past two days. They found that where patient records appeared to be complete, there
were numerous protocol violations, including some involving inclusion and exclusion criteria. In
addition, many of the patient records had incomplete enrollment information and were missing
consent forms.
On learning of these initial audit results, the IRB chair went to the Cancer Center to examine the
records. While there, a medical resident who had worked briefly on the project asked to speak to
him in private. The resident told the IRB chair that some of the consent forms had been
completed and back-dated only when the project staff learned of the impending IRB audit, some
many months after the patient had been enrolled. Further, the resident alleged that a terminallyill woman had been enrolled in violation of protocol rules. She did not meet the inclusion
criteria because she had recent non-protocol radiation therapy which in combination with the
radiation therapy and drug that were part of the study was potentially cardio-toxic. The patient
died after protocol radiation therapy, but the death was not reported to the IRB. Further, the
resident alleged, the record of her having been enrolled in the project had been destroyed.
15

(a) If you were the RIO, what, if anything, would you do in response to the alarming audit
report?
1.____________________________________________________________________________
2.
3.
4.
5.
6.
7.
8.

(b) What, if anything, would you do in response to the allegations made by the medical
resident?
1.____________________________________________________________________________
2.
3.
4.
5.
6.
7.
8.

Thank you very much for the time you took to answer our questions.
Are there any questions that you think we should have asked that we did not?
Yes…….1 [Specify] ______________________________________________________
No……..2
Were there any questions that we asked that you thought we should not have asked?
Yes…….1 [Specify] _______________________________________________________
No……..2
THANK YOU AGAIN

END TIME _______________________

Attachment 4:

Revised e-mail letter to responsible
institutional official

October 2, 2007
Dear Institutional Contact Person,
RTI International is a not-for-profit research organization located in North Carolina. The U.S.
Department of Health and Human Services’ (DHHS) Office of Research Integrity (ORI) has
contracted with RTI to gather information on how ORI can assist institutions to deal with reports of
research misconduct. We are contacting you because ORI has you listed as the person who signs the
assurance document for your institution.
We want to identify the person responsible for implementing your institution's plan for addressing
reported incidents of research misconduct - specifically fabrication, falsification, and plagiarism. By
implementing we mean the person receives and assesses reports of research misconduct, organizes
inquiries, and, if needed, oversees investigations. We want to identify this person to ask that he or she
complete a brief self-administered questionnaire about what they do in that position. We realize that
while you may be this person, many institutions have a separate research integrity officer (RIO)
performing these activities who is not the person listed in the ORI registry.
Please click on the link below to be taken to a secure web site at RTI. Then, confirm your position
as the current responsible institutional official (ORI contact person) or RIO and make any necessary
changes or corrections to the contact information. Next, if you are the RIO, you will be asked to
complete a questionnaire. If you are not the RIO, you will be asked to identify and provide contact
information for the person you believe is your institution's RIO. That process should take less than
five minutes. When you have finished, exit the site.
We expect to ask RIOs at approximately 1,300 institutions to complete the following
questionnaire. Completing the questionnaire will take about twenty-five minutes and we pledge to
keep the information collected confidential. Identifiers will be maintained separate from the data and
destroyed as soon as it is practical. The analysis will present results tabulated so that no individual
RIO or institution will be identifiable. While participation in this project is voluntary, we hope you
will see the importance of knowing more about the roles RIOs perform and will respond as soon as
possible.
Clicking on the following link will transport you to a secure site at RTI where you will be able to
complete the questionnaire: http://rio-surveydev.rti.org
If you have any questions about this survey, you may e-mail or call Dr. Arthur J. Bonito at RTI
(ajb@rti.org or 919-541-6377) or Dr. Sandra Titus at ORI (stitus@osophs.dhhs.gov or 240-4538437). If you have any questions about your rights as a study participant you may call RTI’s Office of
Research Protection toll-free at 1-866-214-2043. Thank you for your cooperation.
Sincerely,

Arthur J. Bonito, Ph.D.

Project Director

Attachment 5:

Revised e-mail letter to research
integrity officer

October 2, 2007
Dear Research Integrity Officer,
RTI International is a not-for-profit research organization located in North Carolina. The U.S.
Department of Health and Human Services’ (DHHS) Office of Research Integrity (ORI) has
contracted with RTI to gather information on how ORI can assist institutions to deal with reports of
research misconduct. We are contacting you because you were identified as your institution’s
research integrity officer or RIO by the person at your institution who signs the assurance document
for ORI.
You were identified as the person responsible for implementing your institution's plan for
addressing reported incidents of research misconduct - specifically fabrication, falsification, and
plagiarism. By implementing we mean you receive and assess reports of research misconduct,
organize inquiries, and, if needed, oversee investigations. We want to identify the RIO in order to ask
that he or she complete a brief self-administered questionnaire about what is done in that role.
Please click on the link below to be taken to a secure web site at RTI. Then, confirm your position
as the current RIO and make any necessary changes or corrections to the contact information. Next, if
you are the RIO, you will be asked to complete a questionnaire. If you are not the RIO, you will be
asked to identify and provide contact information for the person you believe is your institution's RIO.
That process should take less than five minutes. When you have finished, exit the site.
We expect to ask RIOs at approximately 1,300 institutions to complete the following
questionnaire. Completing the questionnaire will take about twenty-five minutes and we pledge to
keep the information collected confidential. Identifiers will be maintained separate from the data and
destroyed as soon as it is practical. The analysis will present results tabulated so that no individual
RIO or institution will be identifiable. While participation in this project is voluntary, we hope you
will see the importance of knowing more about the roles RIOs perform and will respond as soon as
possible.
Clicking on the following link will transport you to a secure site at RTI where you will be able to
complete the questionnaire: http://rio-surveydev.rti.org
If you have any questions about this survey, you may e-mail or call Dr. Arthur J. Bonito at RTI
(ajb@rti.org or 919-541-6377) or Dr. Sandra Titus at ORI (stitus@osophs.dhhs.gov or 240-4538437). If you have any questions about your rights as a study participant you may call RTI’s Office of
Research Protection toll-free at 1-866-214-2043. Thank you for your cooperation.
Sincerely,

Arthur J. Bonito, Ph.D.
Project Director

File Type	application/pdf
File Title	Microsoft Word - Attachments to Memo.doc
Author	lmonroe
File Modified	2007-10-10
File Created	2007-10-10