Attachment S

Request for Data/Specimen Banking for Future Research

COMIRB #:Approval Stamphere:

Principal Investigator:

Protocol Title:

Version date:

The Office of Human Research Protections (OHRP) intends that the operation of any HHS-supported human tissue or data repository and its management center should be subject to oversight by the IRB. The COMIRB applies the same oversight regardless of the source of financial support. The following questions and request for information are related to this oversight function.

Use this form if you are storing (banking) data or samples for future unspecified research use

1) This protocol will bank the following for future unspecified use (check one or both):

Data

Biological specimens

A. DATA ( N/A; skip to section B)

2)If storage of data is the sole objective of the study, and data fields stored, database security, and database access/control are all described in the protocol, skip to Section B and check here Otherwise, answer the following questions

3)List thedata fields that will be banked:

4)Where will banked data be stored?

5)How will database security be protected?

6)How are the data backed up?

7)Who will have access to the database?

B. BIOLOGICAL SPECIMENS ( N/A; skip to Section C)

8)What specimens will be banked?

9)Will storedbiological specimens be:

leftover/discarded materials from clinical or research procedures already performed

taken/removed specifically for banking

a. Will the subject experience any increased risk as a result of the collection of the specimen?

Yes No

i. If yes, provide a justification:

10)Where will banked specimensbe stored?

11)Will genomic DNA (including SNPs) be collected, or be produced from banked specimens?

Yes No

If yes, please complete Attachment Q

12)Will immortalized cell lines be developed? Yes No

If yes, this must be disclosed in the consent form

13)[Optional] If the flow of specimens is through multiple sites, or is otherwise complicated, COMIRB recommends you submit a flow chart detailing collection of specimens to facilitate the review.

C. COMPLETE THE FOLLOWING QUESTIONS FOR BOTH DATA AND SPECIMENS

14)How are stored data/specimens labeled?

  1. No Identifier(unlinked code / anonymous / unlabeled)

Data Specimens

  1. Indirect Identifier (code which links to subject identity)

Data Specimens

  1. Direct Identifier (e.g., subject name, medical record number, DOB, etc.)

Data Specimens

15)Breach of subject confidentiality is the most likely risk experienced by subjects participating in the repository. It is the recommendation of the COMIRB that all data and specimens be anonymous, or coded withthe key to the code kept only by the PI.

If data or samples are labeled with direct identifiers, provide a justification:

16)Can the subject withdraw their data/specimen at a later date via a written request to the PI?

Yes No

If yes, this must be stated in the consent.

a. If no, justify why not:

17)Will data/specimens be distributed to investigators outside of the primary research team?

Yes No

  1. If yes, will any recipient-investigator who receives the data/specimens have access to the identity of any donor? Yes No

i. Detail your plan for protecting the subjects from loss of confidentiality risks:

ii. If yes, how will HIPAA authorization be obtained from subjects?

18)How long will data/specimens be stored?

  1. Data:
  2. Specimens:

19)Will you obtain a Certificate of Confidentiality to protect the data/samples in this bank?

Yes No

a. If no, provide a justification (e.g., no genetic or potentially sensitive/stigmatizing information will be stored):

20)COMIRB has developed a consent addendum template, Optional Consent for Data and Specimen Banking for Future Research. Investigators are strongly encouraged to use this addendum in the consent form for any study that will bank data or biological specimens for future research. This addendum can be edited to be specific only for data, only for biological specimens, or for both.

Addendum will be used in the consent form for this study

Additional Points:

1. A specimen, tissue or data collection protocol to be followed by all collector-investigators and a sample written informed consent document must be supplied to all collaborating institutions and their IRBs. The research at these satellite institutions may not proceed until the COMIRB has received notification of successful review and approval by the satellite institution and their properly constituted local IRB. Attach the specimen, tissue or data collection protocol.

2. Collector-investigators are prohibited from providing recipient-investigators access to the identities of donor-subjects or other information that could lead to the identity of donor-subjects, unless HIPAA authorization is obtained for this release. This should be stated in a written agreement between collector-investigators and recipient investigators. This agreement should also indicate that the collector-investigator will provide and execute a valid informed consent to all donor-subjects as required. Please attach a copy of the collector-investigator agreement.

3. A written usage agreement for recipient-investigators will include the following:

“Recipient acknowledges that the conditions for use of this research material are governed by the Institutional Review Board with purview over sample or data repository, in accordance with federal regulations contained in 45 CFR 46. Recipient agrees to comply fully with all such conditions and to report promptly to the tissue or data repository any proposed changes in the research project and any unanticipated problems involving risks to subjects or others. Recipient remains subject to applicable State or local laws or regulations and institutional policies that provide additional protections for human subjects.

This research material may only be utilized in accordance with the conditions stipulated by the IRB approving the tissue or data repository. Any additional use of this material requires prior review and approval by the COMIRB and, where appropriate, by an IRB at the recipient site, which must be convened under an applicable OHRP-approved Assurance.”

Attachment S: Request for Data/Specimen Banking for Future Research

CF-108, Effective 8/22/11

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