Attachment 8 IRB Certification

Attachment 8: Institutional Review Boards (IRB's) Certifications

Department of Health & Human Services

Public Health Service
National Institutes of Health
National Cancer Institute
Bethesda, Maryland 20892

iRIS Reference Number 336566
IRB Number: OH97CN041
Study Status: Open - No Longer Recruiting - Follow-up Only
Expiration Date: 06/02/2015
05/27/2014

TO:

Robert Hoover

FROM:

Chairperson, Special Studies Institutional Review Board, NCI

SUBJECT:

Action on Clinical Research Protocol

Your Continuing Review of, “Etiologic and Early Marker Studies in the PLCO Trial,” was reviewed by
the National Cancer Institute Special Studies Institutional Review Board (NCI-SSIRB) by expedited
review and approved on 05/27/2014.
The SSIRB has taken the following action:
X

Approved. Forwarded for administrative processing by OPS, Clinical Center.
Approved with stipulations pending re-review by SSIRB Chair. See review.
Deferred pending response to stipulations and re-review by the full SSIRB. See
review.
Disapproved. See review.

Department of Health & Human Services

Public Health Service
National Institutes of Health
National Cancer Institute
Bethesda, Maryland 20892

iRIS Reference Number 336764

IRB Number: 13-C-N010
Study Status: Open to Accrual
Expiration Date: 07/07/2015
06/20/2014

TO:

Paul Pinsky

FROM:

Chairperson, Special Studies Institutional Review Board, NCI

SUBJECT:

Action on Clinical Research Protocol

Your Continuing Review of, “National Lung Screening Trial - Data and Image Access System,” was
reviewed by the National Cancer Institute Special Studies Institutional Review Board (NCI-SSIRB) by
expedited review and approved on 06/20/2014.
The SSIRB has taken the following action:
X

Approved. Forwarded for administrative processing by OPS, Clinical Center.
Approved with stipulations pending re-review by SSIRB Chair. See review.
Deferred pending response to stipulations and re-review by the full SSIRB. See
review.
Disapproved. See review.

AMENDMENT REVIEW FORM
(TO ADD OR CHANGE PREVIOUSLY APPROVED RESEARCH)
All changes or new activities for previously approved studies require submission, review, and approval of
an Amendment Review Form. Please complete and submit this form to irb@westat.com and attach all necessary
materials to be reviewed. Once the request has been reviewed, you will be contacted. If this change or new activity
requires a full Board review, those meetings occur on the second Tuesday of every month. To check the date of
meetings, please see the meeting schedule under IRB in WesInfo. Thank you for your cooperation.
1. Today’s Date:

04 / 22 / 2014

Date of Original Approval:

03 / 28 / 2011

Project Name:

PLCO CDCC

Westat Project Number:

8906.00.00

Agency Grant or Contract Number:

HHSN261201100008C

Project Director:

Sunitha M. Mathew

Unit Ops Number/Study Area:

1121.74

Area IRB Representative:

Nancy Weinfield

Ext. 4472

Ext. 2480

2. Indicate the type of addition or change being requested to a previously approved study.
(SELECT ALL THAT APPLY.)
Name(s) of investigators
Review of final instrument such as interview
questions or data collection sites for a
Project number
previously approved study
Introduction of a new IRB or request for
Mode of administration of instruments in your
Westat to serve as the IRB
study (e.g., from mail or telephone to web or
Study design, survey questionnaire, or
Internet access)
procedure(s)
Data access rights
Informed consent process, consent form(s),
Any other change in protocol that affects
parent permission(s), or assent form(s)
treatment of human subjects:
Recruitment materials or strategies
(PLEASE SPECIFY)
Incentives
Survey instruments
Number or type of populations studied

AMENDMENT REVIEW FORM
January 2010 version

Page 1 of 2

Amendment Review Form

Submit materials by email: IRB@westat.com

3. Please provide a brief summary of your change or addition to previously approved research.

4.

We are adding approximately 54,000 people to the Continued Follow-up of PLCO participants cohort
for the purpose of passive follow-up only. These people were participants in the National Lung
Screening Trial (NLST), a sister study of the PLCO Cancer Screening Trial, designed to determine
the effectiveness of screening with chest X-ray as compared to screening with low dose CT scans
on lung cancer mortality. Approximately 35,000 participants were recruited from the same screening
centers
aseach
the PLCO
The remaining
20,000
recruited from
23 screening
centers
across
How
does
changeTrial.
or addition
affect the
riskswere
to participants
in your
study? (SELECT
ONLY ONE.)
the United States coordinated by the American College of Radiology Imaging Network (ACRIN). All
a.participants
No change
have consented to having their data collected from state cancer registries. Passive
follow-up
will
b.
N/A – consist
no risksof data linkage to state cancer registries and NDI searches. Future linkages
including these 54.000 participants will involve the same variables that were used in previous data
c.linkages
Decreases
riskcohort.
(SPECIFY):
with the the
PLCO

d.

Increases the risk (SPECIFY):

e.

Adds a new risk (SPECIFY):

FOR HARD-COPY SUBMISSION, PLEASE SIGN HERE:
A signature is not required when you return this form electronically; however, please fill in the date of
completion.
The information provided in this request form is complete and correct.
Project Director/
Principal Investigator:

Date: 04 / 22/ 2014

Please attach:
 One document that clearly identifies (through track changes, highlights, or italics) the revision in the
previously approved submission.
 Another document labeled “corrected version.”
If you have any questions, feel free to contact Sharon Zack, the IRB Administrator, at x8828.
IRB Administration Use Only
Expedited review and approval for the modification(s) on this form:

5/5/2014
IRB Chair / Associate Chair / Designee
IRB Office Only
APPROVED – NEXT CONTINUING REVIEW DATE: 03 / 28/ 2015
CONDITIONAL APPROVAL (PLEASE SEE ATTACHED LETTER)
DID NOT QUALIFY FOR EXPEDITED REVIEW
AMENDMENT REVIEW FORM
January 2010 version

Page 2 of 2

Colorado Multiple Institutional Review Board, CB F490
University of Colorado, Anschutz Medical Campus
13001 E. 17th Place, Building 500, Room N3214
Aurora, Colorado 80045

303.724.1055
303.724.0990
COMIRB Home Page
comirb@ucdenver.edu
FWA00005070

[Phone]
[Fax]
[Web]
[E-Mail]
[FWA]

University of Colorado Hospital
Denver Health Medical Center
Veteran's Administration Medical Center
The Children's Hospital
University of Colorado Denver
Colorado Prevention Center

Certificate of Approval
17-Oct-2014
Not Approved to Enroll Subjects! Recruiting of new subjects will require new COMIRB approval
Investigator:

E Crawford

Sponsor(s):

National Cancer Institute/NIH/DHHS~

Subject:

COMIRB Protocol 93-377 Continuing Review

Effective Date:

14-Oct-2014

Expiration Date:

13-Oct-2015

Expedited Category:

8

Title:

NATIONAL CANCER INSTITUTE PROSTATE, LUNG, COLORECTAL AND OVARIAN (PLCO) CANCER
SCREENING TRIAL

Submission ID: CRV016-2
Description:
CRV016-1: Enrollment complete; research activities limited to Long-term Follow-up.
___________________________________________________________________
CRV016-2: Response to Minor Modifications.

All COMIRB Approved Investigators must comply with the following:
l

For the duration of your protocol, any change in the experimental design/consent and/or assent form must be approved by the COMIRB
before implementation of the changes.

l

Use only a copy of the COMIRB-approved, stamped Consent and/or Assent Form. The investigator bears the responsibility for obtaining
from all subjects "Informed Consent" as approved by the COMIRB. The COMIRB REQUIRES that the subject be given a copy of the
consent and/or assent form after it is signed. Consent and/or assent forms must include the name and telephone number of the
investigator.
Provide non-English speaking subjects with a certified translation of the approved Consent and/or Assent Form in the subject's
first language.
The investigator also bears the responsibility for informing the COMIRB immediately of any Unanticipated Problems that are
unexpected and related to the study in accordance with COMIRB Policy and Procedures.
Obtain COMIRB approval for all advertisements, questionnaires and surveys before use.

l

l

l
l

Federal regulations require a Continuing Review to renew approval of this project within a 12-month period from the last approval
date unless otherwise indicated in the review cycle listed below. If you have a restricted/high risk protocol, specific details will be
outlined
in this letter. Non-compliance with Continuing Review will result in the termination of this study.

You will be sent a Continuing Review reminder 75 days prior to the expiration date. Any questions regarding this COMIRB action can be
referred to the Coordinator at 303-724-1055 or UCHSC Box F-490.

Review Comments:

APPROVED: Approved with recent clarification of subject numbers and corrected tables.

......

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MedSlar Health

(jBOR(]E"'J'OfV:J'(. UNIVERSI1'Y Research Ins t Hut e

MedStar Health Research Institute-Georgetown University

Oncology Institutional Review Board

Date:

8/18/2014

To:

Claudine Isaacs

From:

Harley Gould
Institutional Review Board

IRB#

1993-276

Title:

Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial

Annual
Approval
Date:

7/23/2014

Expiration 7/22/2015
Date:
Action

Continuing Review - Expedited

Your above referenced continuing review was approved through expedited review by Dr.
George K. Philips, IRB Chair or designee, 8/18/2014.
This is to inform you that you may continue your project.
Please note that this approval is granted until 7/22/2015. The IRB requires that you submit
an application for annual renewal at the end of the approval period and/or at study
completion. Please note that this office will automatically terminate the project on the date
stated above, unless reviewed and re-approved by the IRB. It is the PI's responsibility to
submit the application for annual renewal and the appropriate IRS forms at least
one month before the expiration date.
Please remember to:
1. Seek and obtain prior approval for any modifications to the approved protocol.
2. Promptly report any unexpected or otherwise significant adverse effects encountered in the
course of this study to the Institutional Review Board within 7 calendar days. This includes
information obtained from sources outside MedStar Health Research Institute and
Georgetown University that reveals previously unknown risks from the procedures, drugs or
devices used in this study.

HENRY FORD HEALTH SYSTEM INSTITUTIONAL REVIEW BOARD
Continuation/Final report form
The IRB is responsible for the continuing review of research to ensure that the rights and welfare of human
participants are being protected. This application for renewal of approval or final report must be submitted to the
Research Administration (IRB) Office by the published deadline date at least one month prior to the expiration date
to guard against lapse in IRB approval.
EXPIRED RESEARCH: If you have not responded in time to renew the protocol before it lapses, the protocol
is considered expired. Any research activity conducted under an expired protocol is in violation of federal
regulations, and could jeopardize the Health System’s privilege to conduct human research. The federal
regulations allow no “window” after the expiration of the approval period. It is important that your protocol
be renewed on time. If your approval expires and you wish to continue your research, the protocol may
have to undergo IRB review again as a new protocol. Timely renewal avoids approval lapses.
The IRB must determine from the information provided on this form whether or not this study should be approved to
continue. Per Federal regulations, “continuing review of research must be substantive and meaningful.” Insufficient
information may result in a delay in approving continuation of your project. If this study is part of a multi-center
project, provide data on HFHS subjects separately from national data but include both when available.

DIRECTIONS FOR FORM COMPLETION:
1. Use this form for all continuation or final reports. Tab through the form, entering your information in the
spaces provided.
2. E-mail this completed form and consent form/s (if still recruiting subjects) to: research_admin@hfhs.org
You must follow these directions:
•

•
•

The e-mail subject line must be in the following format (with underscore):
a. Indicate ‘IRB continuation’ or ‘IRB final’
b. PI last name
c. HFHS IRB #
d. Indicate ‘expedited’ or ‘full’
e. Example: ‘IRB continuation_Jones_123_full’ or ‘IRB final _Jones_123_expedited’
Attach the continuation/final report form saved with a title of: PI last name and IRB number (i.e.
‘jones_123’). Note use an underscore between the items.
If applicable: attach the consent saved with PI last name, IRB number and ‘ICF’ (i.e. ‘jones_123_ICF)
as the title. If there is more than one consent form, differentiate them by number (ICF_1, ICF_2,
ICF_3, etc.) or other obvious way (ICF_main study, ICF_genetic_substudy) (use an underscore
between the items).

3. Your forms will be returned to you by e-mail. You may print them for your records as you will not be
receiving copies through interdepartmental mail. As always, should you need a copy, the IRB maintains
paper files for every study.

All IRB forms are available on our website (http://henry.hfhs.org/body.cfm?id=7764 ).

continuation/final 02/2012

Continuation/Final Report
All submissions must be sent electronically to: research_admin@hfhs.org
Investigators are responsible for utilizing the most current versions of IRB
forms and the IRB has the authority to refuse out of date forms.

Institutional Review Board

Please Indicate:
SECTION 1

Continuation

Final Report

INVESTIGATOR INFORMATION

Principal Investigator (PI): Lois Lamerato, PhD
Department (select from the drop downs):

Public Health Sciences Division:

Entire Project Title (no acronyms): Prostate Lung Colorectal and Ovarian Cancer Screening Trial (PLCO Study)
IRB #.: 112 Current IRB Approval Period: 1/7/2014 – 1/5/2015
Location to send correspondence (required): OFP 3E97
Contact Person: Karen Broski

Contact phone #: 874-7053

Contact e-mail: kbroski1@hfhs.org

Current source of funding: none Is this study currently NIH funded?
If yes, was it originally submitted as such?

No

No (if no, submit copy of grant)

Current budget period (if federally funded):

–

Yes (grant #

)

Yes

Title of NIH grant (if different):

THE REST OF THIS PAGE IS FOR IRB USE ONLY
Type of IRB Review:
Full Board
Expedited (all expedited continuation & final reports are reviewed
as informational items at fully convened IRB meetings)
Result of IRB Review:
Continuation Approved
Approval Withheld (see reason below)
Final Report Approved (Closure #

APPROVAL STAMP

APPROVAL PERIOD
Nov 26, 2014 – Nov 25, 2015
INSTITUTIONAL REVIEW BOARD

)

The HFHS IRB has read & reviewed this protocol & finds this research is appropriate in design and meets the
requirements of the Federal Guidelines, 45 CFR Part 46 and 21 CFR Part 50.

_______________________________________________
Chairperson or designee - Henry Ford Health System IRB

Date: 11/26/2014

Abstentions:
Comments:
Action required:

continuation/final 02/2012

University of Pittsburgh
Institutional Review Board

3500 Fifth Avenue
Ground Level
Pittsburgh, PA 15213
(412) 383-1480
(412) 383-1508 (fax)

MEMORANDUM
TO:

Joel Weissfeld, MD, MPH

FROM:

Christopher R. Ryan, PhD

DATE:

June 26, 2014

SUBJECT:

IRB #9602115: Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial
(UPCI 93-03)

The renewal of the above-referenced proposal has received expedited review and approval by the
Institutional Review Board under 45 CFR 46.110 (8). This protocol is closed to accrual and all
protocol interventions are complete.
Approval Date:

June 26, 2014

Renewal Date:

June 26, 2015

Please note that it is the investigator’s responsibility to report to the IRB any unanticipated
problems involving risks to subjects or others [see 45 CFR 46.103(b)(5) and 21 CFR 56.108(b)].
The IRB Reference Manual (Chapter 3, Section 3.3) describes the reporting requirements for
unanticipated problems which include, but are not limited to, adverse events. If you have any
questions about this process, please contact the Adverse Event Coordinator at 412-383-1144
The protocol and consent forms, along with a brief progress report must be resubmitted at least
one month prior to the renewal date noted above as required by FWA00006790 (University of
Pittsburgh), FWA00006735 (University of Pittsburgh Medical Center), FWA00000600 (Children’s
Hospital of Pittsburgh), FWA00003567 (Magee-Womens Health Corporation), FWA00003338
(University of Pittsburgh Medical Center Cancer Institute).
Please be advised that your research study may be audited periodically by the University of
Pittsburgh Research Conduct and Compliance Office.
CR:kh