Retention of Research Data/Biospecimens

Per the basic elements of the Revised Common Rule 45 CFR 46.116(b)(9), the informed consent document should include “One of the following statements about any research that involves the collection of identifiable private information or identifiable biospecimens:

1. A statement that identifiers might be removed from the identifiable private information or identifiable biospecimens and that, after such removal, the information or biospecimens could be used for future research studies or distributed to another investigator for future research studies without additional informed consent from the subject or the legally authorized representative, if this might be a possibility; or
2. A statement that the subject's information or biospecimens collected as part of the research, even if identifiers are removed, will not be used or distributed for future research studies.”

Statements precluding any and all future research (per .116(b)(9)(ii)) are generally not accepted by IRBMED. Due to the type of research conducted at Michigan Medicine and elsewhere at the U-M Medical School, it is IRBMED’s position that it is not feasible to ensure compliance with .116(b)(9)(ii). The research data collected as part of a clinical research study are often entered into medical records or maintained in other research data warehouses for future research studies. This could be applicable to biospecimens too. Therefore, there is always a possibility that data and/or biospecimens collected as part of a research study might be utilized for future research.

In addition to ensuring compliance with .116(b)(9)(i), IRBMED follows principles regarding informed consent considerations consistent with NIH guidance (regardless of study funding). Per NIH Guidance:

“In general, participants should be given the choice about whether or not they wish to have their data and biospecimens stored and shared for future use. Providing options for participants to agree to data and biospecimen storage and sharing is particularly important in studies that offer the prospect of direct benefit to the participant. Requiring storage and sharing may be considered undue influence if the participant does not want to agree to sharing of data and biospecimens but feels compelled to agree anyway to join a possibly beneficial research study.  If the primary research study offers no prospect of direct benefit, it may be reasonable to consider requiring storage and sharing in the primary protocol (e.g., if the primary protocol is a repository protocol with the sole purpose being to collect data and/or biospecimens for future use). In this case, there is no reason to participate if the participant does not want to provide consent for storage and sharing.”

Therefore, if the research offers the potential for direct benefit that is only available in the context of a research study, the direct benefit of the primary intervention has the potential to unduly influence subjects into agreement. To prevent this, subjects should opt-in to future unspecified research, and also have the opportunity to withdraw consent for future unspecified research at a later date. Section #III below for additional details.

When completing the IRB application, the study teams should follow the following instructions:

Section 10-1

1. The informed consent document(s) uploaded in 10-1.1 should always include the IRBMED Standard Informed Consent Template (ICT) language in section 4.4. This is applicable even if a study does not have specific plans to retain and utilize data and/or bio-specimens for future use. This fulfills the .116(b)(9)(i) requirement regarding retention of de-identified data/biospecimens for future use. Exceptions are rarely allowed.
2. For retention of identifiable or coded data/biospecimens for future use: IRBMED’s standard ICT also provides suggested language and instructions:
   1. Section 4.1: bluebox C for a sub-study with specific use & bluebox D for unspecified future use
   2. Section 12: additional signature fields

   NOTE: Check with the particular repository to which data/biospecimens will be submitted (if known) to make sure consent is appropriate to their policies. Some repositories require a separate consent form (e.g. UMMS Central Biorepository (CBR)), or specialized language in the main consent form.

3. 10-1.6 should be “Yes” (At the conclusion of this study, will specimens and/or data be retained for future research use?)
   1. If retaining data/biospecimens only for maintenance for current research, answer “No” (see Sections A and B above).
4. 10-1.7 should be “Yes” (Does the informed consent document explicitly notify subjects that their data and/or specimens will be stored for future research?). This question only displays when 10-1.6 is “Yes”
   1. See “informed consent” heading above (#1) for additional information.
5. 10-1.8 should be “No” for most scenarios (Are subjects required to agree to retention of their data and/or specimens as a condition of participating in the research?). This question only displays when 10-1.6 is “Yes”
   1. IRBMED’s standard ICT 4.4 language regarding retention of de-identified data and/or biospecimens does NOT trigger ‘Yes’ to this question. IRBMED interpretation of this question is “Are subjects required to agree to retention of their identifiable data and/or specimens as a condition of participating in the research….”. This question will be corrected/updated in the eResearch updates in the future.
   2. If retention of identifiable data/biospecimens is NOT mandatory (most often): 
      1. 10-1.8: “No”
      2. IRBMED’s standard ICT includes appropriate language related to retention and allows subjects to opt-out. See point #2. above.
   3. If retention of identifiable data/biospecimens is justifiable as mandatory for participating in the main research study:
      1. 10-1.8: “Yes”
      2. 10-1.8.1 provides appropriate justification. E.g. “The repository/registry aspect is one of the aims/objectives of the study, and there is no prospect of direct benefit for the subjects for the main research study.”
      3. Protocol includes a specific objective/aim for the repository/registry
      4. Study should NOT present a prospect of direct benefit available only in the context of a research study.
         • If there is a prospect of direct benefit and also a repository for future research is a specific objective/aim of the study, there should be separate informed consents and/or checkboxes. In this scenario, even if it is an objective in the protocol, it is separable from the direct benefit aspect.
      5. IRBMED’s standard ICT includes appropriate language related to retention. There should not be an opt in/out when this part is mandatory. See point #2. above. 

Section 11

1. 11.6: “Retain for future research use” (along with others if applicable)
2. Section 11-4 captures information regarding where data/biospecimens will be stored, what type of data/biospecimens, etc. This may refer to a stand-alone eResearch repository application (REP) managed by the study team or others (e.g. CBR).