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Data and/or Specimen Banking and Research Use of Banked Materials

This guidance is intended for investigators who currently have IRB approval or exemption to perform the following research activities:

  • Collect data and/or specimens for existing banks
  • Release data and/or specimens for research uses from existing banks
  • Complete ongoing analysis of data and/or specimens obtained from existing banks (i.e., secondary research with stored data and/or specimens).

Background

The volume of research with data and bio-specimens has grown exponentially over recent years, and the value of analyzing large cohorts of data and/or specimens is widely recognized. Current practices have evolved nationally to place greater emphasis on the ethical obligation to obtain prospective informed consent (and in some cases also HIPAA authorization) for collection and retention of data and/or specimens for future research uses (i.e., banking) and to reconsider research uses of data and specimens (particularly identifiable materials) for which consent was never obtained.

A multidisciplinary working group representing investigators, IRB leaders, and research administrators was convened to review The Ohio State University Human Research Protection Program (HRPP) policies and practices at Ohio State regarding data and bio-banking. The working group considered existing guidance, national and international standards, and other peer institutions’ policies and practices before forwarding its recommendations to the IRB Policy Committee for final consideration and possible implementation. As a result, the HRPP policy, Research Involving Data and/or Biological Specimens (originally approved 08/29/10), was recently updated by the IRB Policy Committee to include recommendations from this working group. In addition to the revised policy, guidance was developed to help investigators comply with the revised requirements for establishing data and/or specimen banks. See Guidelines for Writing a Banking/Repository Protocol for more information.

FAQs

  1. How do I know if my research involves a bank or repository? 
  2. Does this new guidance apply to me if my research involves an external bank/repository NOT controlled by Ohio State?
  3. I have an existing Ohio State bank/repository. What will I need to do? 
  4. I have more than one IRB approved protocol that includes banking data and/or specimens as part of the research. Can I combine these collections into one banking/repository protocol?
  5. I have a protocol that involves collecting data and/or specimens for a specific study and using some of these materials for ancillary studies or sub-studies. Do I need approval for a bank/repository? 
  6. My study includes a plan to hold data and/or specimens for specific testing or analysis that can only occur once all materials are collected. Does holding materials for this purpose constitute banking?
  7. What if my bank/repository has outstanding requests (e.g., contractual obligations), but release of the data and/or specimens no longer meets current policy requirements?
  8. I do not have a bank/repository, but I am obtaining data and/or specimens from one for my research – how do these new requirements affect me?
  9. When will I need to comply with this guidance?

 

1. How do I know if my research involves a bank or repository?

Ohio State HRPP policy defines a bank or repository as a collection of data and/or specimens obtained and stored for future research uses and/or distribution, including a collection not originally or primarily obtained for research purposes.

In addition to active collection and storage of materials for future research, retaining “excess” data and/or specimens (e.g., those not required for diagnosis, treatment, quality control, or education), whether originally obtained for research or non-research purposes, with the intent to use/distribute these materials for “future” research purposes (i.e., research not included in the protocol, if any, under which the data and/or specimens were originally collected) is also considered banking.

2. Does this new guidance apply to me if my research involves an external bank/repository NOT controlled by Ohio State?

This guidance applies only to current internal banks or repositories controlled by Ohio State researchers. A separate protocol for data and/or specimens collected and sent to external banks (e.g., other institutions, sponsors, NIH, NCI, cooperative groups, etc.) will not be required. However, there may be additional information requested for Ohio State protocols with ongoing data and/or specimen collection. Contact ORRP for more information.

3. I have an existing Ohio State bank/repository. What will I need to do?

  • My bank/repository is currently approved as a stand-alone protocol: If your bank is currently approved as a stand-along protocol (i.e., not included in an existing clinical/research project and not combined with analysis projects), see Chart A below.
  • My bank/repository is currently described in a protocol including other research activities (e.g., a clinical trial) and/or I have approval to conduct analyses with the data and/or specimens in the same protocol: If your data and/or specimens are currently banked as part of another project (i.e., a separate, specific study), or you bank the materials and conduct analyses under the same protocol, see Chart B below.

4. I have more than one IRB approved protocol that includes banking data and/or specimens as part of the research. Can I combine these collections into one banking/repository protocol?

Yes, the sources can be combined into a single repository protocol. See Chart B for guidance below.

5. I have a protocol that involves collecting data and/or specimens for a specific study and using some of these materials for ancillary studies or sub-studies. Do I need approval for a bank/repository? 

Probably not. Such work does not usually constitute banking, as long as the ancillary/sub studies are specified in (and part of) the main project; there is no intent to use the data and/or specimens beyond the described work for future, unspecified research; and the materials will not be distributed to investigators for their own work separate from the main study or ancillary/sub studies.

6. My study includes a plan to hold data and/or specimens for specific testing or analysis that can only occur once all materials are collected. Does holding materials for this purpose constitute banking?

No. Only the storage of materials for future unspecified research uses constitutes banking. If you are only storing and using data and/or specimens for purposes specifically described in the protocol for which they were collected, you are not creating a repository.

7. What if my bank/repository has outstanding requests (e.g., contractual obligations), but release of the data and/or specimens no longer meets current policy requirements?

The IRB understands that there may be current commitments for which all promised materials have not been provided and will work with you to determine how it may be possible to fulfill outstanding requests. Contact ORRP for assistance.

8. I do not have a bank/repository, but I am obtaining data and/or specimens from one for my research – how do these new requirements affect me?

In addition to updating the guidelines for establishing banks to collect, store, and distribute data and/or specimens for research purposes, the working group also made recommendations that have been adopted by the IRB Policy Committee regarding requirements for “secondary research” activities, which use materials obtained from established banks. Depending on the source of your data and/or specimens, there may be changes to the way the bank/repository operates and the types of materials that can be released (e.g., identifiable v. de-identified materials).

9. When will I need to comply with this guidance?

The revised standards will be applied to approved studies at continuing review during 2015.

 

Chart A – Transitioning an Existing Internal (Ohio State) Stand-Alone Banking Protocol

Considerations and possible changes:
Collection of data and/or specimens is ongoing Collection of data and/or specimens is complete
Does the protocol meet the current standards for banking protocols?  
  • Yes
 No changes necessary. No changes necessary.
  • No
 You will need to update the protocol to meet current requirements (see Guidelines for Writing a Banking Protocol). You will need to update the protocol to meet current requirements (see Guidelines for Writing a Banking Protocol).
Was/is informed consent (and HIPAA Authorization) for banking obtained?  
  • Yes
 You may need to revise the consent process/form to conform to current standards (see HRPP policy Research Involving Data and/or Specimens).The IRB will review the consent process for existing materials to determine if adequate information describing future research uses was included to permit continued release. Note: There may be limits on how existing materials can be used/distributed. You will not need to revise the consent process/form.
The IRB will review the consent process for existing materials to determine if adequate information describing future research uses was included to permit continued release. Note: There may be limits on how existing materials can be used/distributed.
  •  No
 You will need to develop a consent process/form that conforms to current standards (see HRPP policy Research Involving Data and/or Specimens). Note: Additional collection cannot occur without informed consent.The IRB will consider appropriate release of existing materials for future research uses. Note: There may be limits on how existing materials can be used/distributed. The IRB will consider appropriate release of existing materials for future research uses. Note: There may be limits on how existing materials can be used/distributed.

 

 

Chart B – Transitioning an Existing Protocol Including Both Banking and Other Research Activities (where a separate stand-alone protocol for the internal bank does not exist)

Considerations and possible changes:
Collection of data and/or specimens is ongoing Collection of data and/or specimens is complete
Will I need to submit a separate protocol for the Ohio State bank/repository? Yes, you will need to submit a separate protocol for the bank/repository (see Guidelines for Writing a Banking Protocol). In general, a new protocol for the bank will be required if data and/or specimens will continue to be released. Contact ORRP for guidance.
Was/is informed consent (and HIPAA Authorization) for banking obtained?
  • Yes
 You may need to revise the consent process/form to conform to current standards (see HRPP policy Research Involving Data and/or Specimens).The IRB will review the consent process for existing materials to determine if adequate information describing future research uses was included to permit continued release. Note: There may be limits on how existing materials can be used/distributed. You will not need to revise the consent process/form.The IRB will review the consent process for existing materials to determine if adequate information describing future research uses was included to permit continued release. Note: There may be limits on how existing materials can be used/distributed.
  •  No
 You will need to develop a consent process/form that conforms to current standards (see HRPP policy Research Involving Data and/or Specimens). Note: Additional collection cannot occur without informed consent.The IRB will consider appropriate release of existing materials for future research uses. Note: There may be limits on how existing materials can be used/distributed. The IRB will consider appropriate release of existing materials for future research uses. Note: There may be limits on how existing materials can be used/distributed.

 

Questions or Assistance

Ellen Patricia, Quality Improvement Program Director
Office of Responsible Research Practices
300 Research Administration Building
1960 Kenny Road
Columbus, OH 43210
Phone: 614-688-5556
Fax: 614-688-0366
Email: patricia.1@osu.edu