Attach_09_Assurances of Compliance

Attachment 9: Assurances of Compliance: Certification of IRB Review

Date:

March 28, 2011

To:

Barbara O’Brien, Project Director

From:

Kerry Levin, Chair Westat IRB

Subject:

Initial Approval of PLCO CDCC, Project 8906
FWA 05551

As Chair of the Westat Institutional Review Board (IRB), I reviewed the materials submitted for the
following: PLCO CDCC, Project 8906. The Westat IRB reviews all studies involving research on
human subjects. This project is sponsored by National Cancer Institute. This study received full
review and approval by the NCI SSIRB on November 16, 2009.
Westat will serve as the Central Data Collection Center (CDCC) for the 18 year old Prostate, Lung,
Colorectal, and Ovarian (PLCO) cancer screening trial. Their responsibilities will include all active
data collections with participants, physicians, and medical records and pathology departments for
those PLCO participants who agree to be followed by Westat for five additional years.
All previously enrolled PLCO participants who agree to continued follow-up by the CDCC will
participate in the study. As part of the planned phase-out of the ten PLCO screening centers (SCs),
and following their own IRB’s review and approval, SCs will notify or re-consent their PLCO study
participants to allow for their data to be transferred to Westat for continued active follow-up.
IRB regulations permit expedited review of certain activities involving minimal risk [45 CFR pt.
46.110 (b) (1)]. This study can be considered minimal risk and is approved under expedited
authority.
As the Project Director you are responsible for the following:
You are required to submit this study for a continuing review on or before March 28, 2012.
In the interim, notify the IRB Office as soon as possible if there are any injuries to subjects
as well as problems or changes with the study that relate to human subjects.
cc:

Institutional Review Board
Nancy Weinfield

Colorado Multiple Instititutional 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
uchsc.edu/comirb
[email protected]
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

Protocol Amendment Approval
19-Apr-2011
Investigator:

E Crawford

Sponsor(s):

National Cancer Institute/NIH/DHHS~

Subject:

COMIRB Protocol 93-377 Amendment

Effective Date:

15-Apr-2011

Title:

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

Amendment Description:
PAM007-2
1. Notification letter was revised to be one page with an additional page for participants to note their choice of follow-up option.
2. The plan for follow-up of Spanish-speaking participants was revised to include mailing a letter to participants notifying them of the change to
the study and giving them 2 options: (1) passive follow-up by UCD PLCO or (2) withdrawal from the study.
3. waiver of consent is not required, so attachment M is not included.
4. The Protocol Summary was amended to add a statement regarding participants who will be followed passively by default. Because adequate
consent has been obtained for continued long-term follow-up, no waiver of consent is required.
Attachments:
1. COMIRB Feedback letter
2. Change Form (as originally submitted)
3. revised letter to participants
4. Letter to Spanish-speaking participants
5. Revised Protocol Summary

Review Comments:

PAM007-2
Minor modifications completed and requested PAM007 is approved.
Note: The Spanish consent can now be translated from English to Spanish. Please submit this on a change form along with the
translator's credentials prior to use.
Sincerely,
UCD Panel A

REQUEST FOR PLANNED CHANGE(S)
Changes may not be implemented until IRB written approval is received.
Investigators are responsible for utilizing the most current versions of IRB
forms and the IRB has the authority to refuse out of date forms.

This form can now be submitted electronically! See general directions at end of form!
Principal Investigator (PI): Paul A. Kvale, MD
Department (select from the drop downs): BRE

Division:

Entire Project Title (no acronyms): Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial (PLCO Study)
IRB #.: 112 Current IRB Approval Period: 4/21/2010 – 4/20/2011 Location to send correspondence (required): OFP 3C75
Contact Person: Karen Broski Contact phone #: 874-7053 Contact e-mail: [email protected]
Reason for IRB review (check all that apply):
Protocol Amendment:NCI transition of PLCO
1.
Study from HFH to a central data coordinating center
CDCC
Investigator Brochure Update/Package insert:
2.
3.
Response to IRB Concerns from:
Initial Submission
Previous Planned Change Form
Adverse Event Form
Continuation/final report un-approved
Other:

Revised Consent Form:
Advertisement
PI Change (will require revised consent form)
Title Change (will require revised consent form)
Database Declaration
DSMB Reports (attach report)
Protocol Deviation:
Request to Re-open a closed study
Study closed to accrual:
Other:

4.
5.
6.
7.
8.
9.
10.
11.
12.
13.

THE REST OF THIS PAGE IS FOR IRB USE ONLY
Type of IRB Review:
Expedited
Full Board (reviewed at a Full Board Meeting on:
Risk to subjects increased:
Consent form satisfactorily revised:

Yes
Yes

No
No

)

N/A

APPROVAL STAMP

If yes, does this require re-consenting currently active subjects in treatment
Yes
No
phase:
Yes
No
If yes, does this require re-consenting all subjects:
Result of IRB Review:
Approve
Withheld pending response ( Member review
Approval denied (requires full board review)
IRB notified: Approval not required

APPROVED
Mar 24, 2011
INSTITUTIONAL REVIEW BOARD

Administrative review)

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

_______________________________________________
Chairperson or designee - Henry Ford Health System IRB

Date: 3-24-11

Comments from Chairperson or designee:
Action required:

IRB PCF: Revised 02/2009

COMPLETE THE FOLLOWING QUESTIONS AS DIRECTED
(if your item number is not noted, you only need to complete numbers 1-5 on this page)
1. Provide a description/explanation of this submission. (“See attached” format is not acceptable) The National Cancer
Institute (NCI) plans to continue the Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial (PLCO Study)
beyond the end of our contract which expires in September 29, 2011 at several centers (doc 1- Letter of Direction
and Notification from Dr Berg and doc 2- NCI SSIRB approval of Centralized Follow up). The continuation plan
will follow up these study participants through a contract with one central administration rather than the current
multi-site administration (doc 3 Rational for Continued Follow up of PLCO participants). The new contract for
continued follow up was awarded to establish and maintain a centralized data collection center (CDCC). This
CDCC contract was awarded to Westat Inc. on March 1, 2011. Westat has served as the coordinating center for
the PLCO Study from the beginning of the trial and will continue to serve in this role for an additional 5 years.
Westat has extensive knowledge of the PLCO Trial and is familiar with the data security and confidentiality
requirements for PHI (doc 4- Data Security Procedures). In addition to continuing to administer the Annual Study
Update (ASU) mailings, the CDCC (WESTAT) will perform other tasks formerly carried out by the Screening
Centers. The continuing tasks include: the administration of the Health Status Questionnaire (HSQ), a brief risk
factor questionnaire, participant retention and tracing activities, the collection of medical records to confirm
reported cancers and cause of death, periodic linkages to the National Death Index (NDI), collection of pathology
tumor tissue specimens, periodic linkages to state cancer registries. Once IRB Approval is obtained at the
original screening centers (SC), the SC's will send a letter to inform study participants that the study will
continue and they will be followed by a centralized data coordinating center (WESTAT) if they are willing to
participate in continued active follow up (doc 5- Draft Centralized Follow Up Cover Letter and doc 6- Draft
Continued Follow Up Notice). Participants will have the option to decline active follow up in favor of being
followed up passively by the screening centers through linkages to the state cancer registries and National
Death Index search. Participants will also have the option to withdraw completely (doc 7- Notification
Procedures) Participants have previously signed consent forms regarding participation in the PLCO Study and
the use of their biological specimens for research. It is anticipated that the screening centers will continue to
perform a limited number of tasks as part of the continued follow up effort. This continued participation would
be supported through a subcontract with Westat Inc. (CDCC). These tasks would include: organized
submissions to the local IRB, assisting with data submissions to the NDI and state cancer registries, liason with
the local medical community as needed to facilitate collection of medical records. Each screening center will
continue to have a Principal Investigator who will remain scientifically involved in the continued follow up of this
trial and will attend an Annual Steering Committee Meeting.

2. Does this change increase the risk significantly?

No

Yes (consent changes may be required)

3. How many HFHS subjects are currently enrolled? 24,676 Is the study still enrolling subjects at HFHS?
•
No
•

•
•

Are there subjects still in the active treatment phase of the study?
Are there subjects still in the long term follow-up phase of the study?
Yes

4. Does the benefit still outweigh the risk for this study?

No

No
No

Yes
Yes

Yes

5. Does the new information require a revised informed consent?
•

•

No
o If no, why not?
No
Yes
o Was consent for this study waived originally?
Yes - submit 2 copies of the consent form with one yellow highlighted to show the changes

6. If you checked numbers 1 - 2 on page one, answer the following. If not, proceed to the next question.
•

Is the study sponsored?

No

Yes

Name of Sponsor (if applicable): National Cancer Institute (NCI)

If yes, check the appropriate box and provide the information requested:
A copy of the sponsor’s amendment, if sponsor initiated the change.
A copy of your notice to the sponsor, if you initiated the change.
Other:

7. If you checked number 3 on page one, attach the copy of the IRB letter you received, your response, and the revised
consent form (attach 2 copies of the revised consent, all consent changes must be marked with a yellow highlighting on
one copy) if applicable. If not, proceed to the next question.
IRB PCF: Revised 02/2009

8. If you checked number 5 on page one, complete the following. If not, proceed to the next question.
•

•
•

Advertisements must be submitted for review before being published. Please include the reasons for the
advertisement, and where it will be placed.
If you are submitting an advertisement for television or radio, please attach a copy of the script along with a video or
audiotape if available.
If you are submitting an advertisement for the HFHS external Internet, please complete the following and attach the
sponsor’s approval of the text of the advertisement as a supporting document.
• Date you want trial on web site:
• Date you want trial off web site:
• Choose your clinical area:
If ‘other’, please specify:
• In lay terms, please indicate the eligibility criteria for subjects:
• How do you want patients to contact you to get into the trial (ie. name & phone #)?
• In lay terms, describe the purpose of the study (you can use the sentence from your consent form:
• If the study is sponsored, please indicate the sponsor name:
• If you know the grant number, please provide:

9. If you checked number 6 on page one, attach letter from the new PI indicating they will assume the responsibility for the
study and the signatures of both the current & new investigator. You must also change the PI in the consent form (if
applicable), and submit. If not, proceed to the next question.

10. If you checked number 7 on page one, type the old & new title in the title section of page 1, & highlight the new title, you
must also change the title on the consent form (if applicable), & submit it for review. If not, proceed to the next question.

11. If you checked number 10 on page one, submit only significant deviations as deemed by the investigator. If not, proceed
to the next question.

12. If you checked number 11 on page one, please indicate the reason below. If not, proceed to the next question.
Audit Site Visit
Query for data clarification/data existing at the time of study closure
Query for new data related to events occurring since study closure
To Notify Subjects of their Randomization and the Study Results (attach the letter)
Protocol lapsed and was administratively closed (provide reason for lapse, any study-related unanticipated
problems that occurred since the study closed, and plan to prevent a lapse from occurring in the future).

General Information for completing this form
1. This form must be typed with all blank shaded spaces completed. You can tab through the form, entering your
information in the spaces provided. Please use attachment pages when requested, providing all the required and
necessary information.
2. You may submit this request either paper or electronically (but not a combination of both). If you submit electronically, all
supporting documents must also be submitted electronically and be saved in word or adobe.
To submit by paper
Submit this original signed form and any attachments, along
with 1 extra copy (of this form and any attachments) to the
Research Administration (IRB) Office (CFP Basement room
46). Please copy the packet either all front side only or all
both sides (not a combination).

To submit Electronically
E-mail this completed form and supporting documents to:
[email protected] You must follow these
directions:
• The e-mail subject line must be in the following format
(with underscore):
a. Indicate ‘IRB PCF’
b. PI last name
c. HFHS IRB #
d. Example: ‘IRB PCF_Jones_123’
• Attach the Planned Change Form saved with a title of:
PCF and PI last name and IRB number (i.e.
‘PCF_jones_123’). Note use an underscore between
the items.
• If applicable: attach supporting documents saved with
PCF, PI last name, IRB number and ‘supportingdoc’ as
the title. If there is more than one supporting document,
differentiate them by number (supportingdoc_1,
supportingdoc 2, ICF_3, etc.). example:
IRB PCF: Revised 02/2009

PCF_Jones_123_supportingdoc_1
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 through the Research Administration website (http://henry.hfhs.org/body.cfm?id=166).

IRB PCF: Revised 02/2009

-------- Original Message -------Subject:9302M06411 - PI Church - IRB - APVD Continuing Review
Date:Thu, 29 Jul 2010 23:19:40 -0500 (CDT)
From:[email protected]
To:[email protected]
TO : [email protected], [email protected], [email protected], [email protected],
[email protected], [email protected],
The IRB: Human Subjects Committee renewed its approval of the referenced
study listed below:
Study Number: 9302M06411
Principal Investigator: Timothy Church
Expiration Date: 07/27/2011
Approval Date: 07/28/2010
Title(s):
Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial Screening Centers
________________________________________________________
This e-mail confirmation is your official University of Minnesota HRPP
notification of continuing review approval. You will not receive a hard copy
or letter. This secure electronic notification between password protected
authentications has been deemed by the University of Minnesota to constitute
a legal signature.
You may go to the View Completed section of http://eresearch.umn.edu/ to view
or print your continuing review submission.
For grant certification purposes you will need this date and the Assurance of
Compliance number, which is FWA00000312 (Fairview Health Systems Research
FWA00000325, Gillette Childrens Specialty Healthcare FWA00004003). Approval
will expire one year from that date. You will receive a report form two
months before the expiration date.
In the event that you submitted a consent document with the continuing review
form, it has also been reviewed and approved. If you provided a summary of
subjects' experience to include non-UPIRTSO events, these are hereby
acknowledged.
As Principal Investigator of this project, you are required by federal
regulations to inform the IRB of any proposed changes in your research that
will affect human subjects. Changes should not be initiated until written IRB
approval is received. Unanticipated problems and adverse events should be
reported to the IRB as they occur. Research projects are subject to
continuing review.
If you have any questions, please call the IRB office at (612) 626-5654.
The IRB wishes you continuing success with your research.

University of Pittsburgh
Institutional Review Board

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

MEMORANDUM
TO:

Joel L. Weissfeld, MD, MPH

FROM:

Christopher Ryan, PhD, Vice Chair

DATE:

March 31, 2011

SUBJECT:

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

The Institutional Review Board reviewed the recent modifications to your protocol and consent form(s)
and find them acceptable for expedited review. These changes, noted in your submission of March 28,
2011, are approved.
Please include the following information in the upper right-hand corner of all pages of the consent
form(s), if modifications were made to the consent form(s):
Modification Approval Date: March 30, 2011
Renewal Date: August 2, 2011
University of Pittsburgh
Institutional Review Board
IRB # 9602115
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).
If this research study is subject to FDA regulation, please forward to the IRB all correspondence from
the FDA regarding the conduct of this study.
Please be advised that your research study may be audited periodically by the University of
Pittsburgh Research Conduct and Compliance Office.
CR:kh

https://erica.research.utah.edu/erica/Doc/0/I6GRUD326JAKP0V5SBITG9913D/fromString.html

5/17/11 1:59 PM

IRB_00004389
Principal Investigator: Saundra Buys
Title: Prostate, Lung, Colorectal, & Ovarian Cancer Screening Trial - Screening Centers
This Amendment Application (CDCC notification) has been reviewed and approved by a University of Utah IRB
convened board. The convened board approved your amendment request for this study on 5/11/2011. The
approval of this amendment request does NOT change the expiration date of this research study as noted
below.
Your study will expire on 10/5/2011 11:59 PM.
Any future changes to this study must be submitted to the IRB prior to initiation via an amendment form.
APPROVED DOCUMENTS
Other Documents
PLCO Centralized Follow-up Cover Letter_FINAL.doc
PLCO Centralized Follow-up Notification_FINAL.doc
Rationale for Continued Follow-up
CDCC Data Security Procedures
NCI IRB Approval for CDCC
Westat IRB Approval for CDCC
Click AM_00009958 to view the application and access the approved documents.
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