Principal Investigator: Leona Cuttler, M.D.
ADVANCING COLLABORATIVE GENETIC RESEARCH:
ETHICAL AND POLICY CHALLENGES
ORIGINAL AND REVISED QUESTIONS
Rev. 1/30/12
Aim 1 A: Assess and contrast the written policies of CTSC institutions’ IRBs regarding human subjects protections for the collection, storage, use, and sharing of biospecimens and associated data for collaborative genetic research, with emphasis on informed consent and sharing biospecimens and/or associated data across institutions.
Informed consent
(A) Scope of consent:
1. ORIGINAL: Does the academic health center’s (AHC) IRB permit investigators to ask participants for consent for unspecified future research with their biospecimens?
REVISED: No changes.
2. ORIGINAL: Does the AHC’s IRB permit OR require investigators to use tiered consent when prospectively collecting biospecimens?
REVISED: No changes.
3. ORIGINAL: Does the AHC’s IRB permit investigators to ask for consent to retain biospecimens with identifiers for future research?
REVISED: No changes.
4. ORIGINAL: Does the AHC’s IRB permit genetic research using stored biospecimens and/or related data to be considered minimal risk?
REVISED: Does the AHC’s IRB permit genetic research using stored biospecimens and/or related data to be considered minimal risk and therefore eligible for a waiver of consent?
5/6. ORIGINAL: Does the AHC’s IRB permit investigators access to clinical data at the time of consent to contribute biospecimen or subsequently?
REVISED: Does the AHC’s IRB permit investigators access to clinical data at the time of consent to contribute biospecimen? AND Does the AHC’s IRB permit investigators access to clinical data subsequent to the time of consent to contribute biospecimen?
(B) Nature of consent for specimens acquired in clinical care and translated to research applications:
7. ORIGINAL: Does the AHC’s IRB have a routine written disclosure to patients entering hospital regarding the use of clinically acquired biospecimens for research?
REVISED: Does the AHC or its IRB have a standard (i.e., applicable to all patients) written disclosure procedure for patients entering the hospital or undergoing a clinical procedure regarding the use of clinically acquired biospecimens for research?
8. ORIGINAL: Are the following types of disclosures permitted to patients entering hospital regarding the use of clinically acquired biospecimens for research?
REVISED: Are the following types of disclosures permitted to patients entering hospital or undergoing a clinical procedure regarding the use of clinically acquired biospecimens for research?
a. ORIGINAL: Individuals who do not opt out of research (as part of their consent for hospital admission or clinical procedure) will have their clinically obtained biospecimens considered available for research use
REVISED: No changes.
b. ORIGINAL: Individuals must opt-in (as part of their consent for hospital admission or clinical procedure) if their clinically obtained biospecimens are to be used in research
REVISED: No changes.
c. ORIGINAL: Individuals must sign a specific consent (i.e., separate from their consent for hospital admission or clinical procedure) if their clinically obtained biospecimens are to be used in research
REVISED: No changes.
d. ORIGINAL: Other types of disclosures permitted (specify ______)
REVISED: No changes.
(C) Use of stored biospecimens and/or associated data for new research:
9. ORIGINAL: Are new uses of identifiable biospecimens or related data from repositories required to undergo IRB review at the AHC?
REVISED: No changes.
10. ORIGINAL: If yes (i.e., IRB review of new uses is required), is an IRB review of the original consent required?
REVISED: No changes.
ORIGINAL: If yes (IRB review of original consent is required), if the scope of the original consent is not consistent with the new research, does the IRB:
REVISED: If the scope of the original consent is not consistent with the new research, does the IRB:
ORIGINAL:
(a) Require re-contact of subject to obtain consent?
(b) Permit re-contact to obtain consent?
(c) Require anonymization/de-identification before the biospecimens/data can be used in new research?
(d) Permit anonymization/de-identification before the biospecimens/data can be used in new research?
(e) Waive consent requirement?
(f) Not allow biospecimens and/or associated data to be used in the new research?
(g) Other (specify)
REVISED:
(a) Permit re-contact to obtain consent?
(b) Permit or require anonymization/de-identification before the biospecimens/data can be used in new research?
(c) Waive consent requirement?
(d) Not allow biospecimens and/or associated data to be used in the new research
(e) Other (Specify ______)
11. ORIGINAL: In using stored biospecimens (and/or associated data) for new research, does the AHC’s IRB require re-consent of adults who had given assent for biospecimen storage while still children?
REVISED: No changes.
Sharing biospecimens and/or associated data across institutions
(D) Role of consent and IRB review in determining sharing of biospecimens/data:
12. ORIGINAL: Under what conditions does the AHC permit sharing biospecimens or genetic data with other institutions?
REVISED: Under what consent conditions does the AHC permit sharing biospecimens or genetic data with other institutions?
ORIGINAL:
a. If consent explicitly allows sharing
b. If consent does not explicitly prohibit sharing
c. If samples are de-identified regardless of whether sharing is specified in the consent
d. Other (specify)
REVISED:
a. If consent explicitly allows sharing
b. If consent does not explicitly prohibit sharing
c. If samples are de-identified regardless of whether sharing is specified in the consent
d. Other consent issues (specify)
13. ORIGINAL: Circumstances under which IRB review is needed for sharing biospecimens/data across institutions
a. If the AHC is sending identifiable biospecimens to another institution, and not otherwise involved in the research must its IRB review the protocol?
b. If the AHC is the sending institution with de-identified biospecimen data, must its IRB review the protocol?
c. If the AHC is the receiving institution (i.e., receiving biospecimens from another institution), must its IRB review the consent form used when the biospecimens were collected?
REVISED: No changes.
14. ORIGINAL: Approach of the AHC to sharing biospecimens/data if consent process for acquiring biospecimens at giving institution differs from receiving institution?
a. Does the AHC accept biospecimens and/or associated data if the consent process at the giving institution differs from its consent process?
b. Does the AHC give biospecimens and/or associated data if the consent process at the receiving institution differs from its consent process?
REVISED: No changes.
(E) Privacy and confidentiality:
15. ORIGINAL: Does the AHC’s IRB oversee the de-identification process for biospecimens (i.e., is there a requirement that investigators explain in detail in the protocol how de-identification will occur)?
REVISED: No changes.
16. ORIGINAL: Does the AHC’s IRB require specific information in the consent document about how privacy and confidentiality of genetic information will be protected when biospecimens are not anonymized?
a. Statement that privacy and confidentiality will be protected without describing the process for doing so?
b. Statement that privacy and confidentiality will be protected – including an explanation of the method for doing so (e.g., encryption)?
REVISED: No changes.
17. ORIGINAL: Does the AHC’s IRB permit sharing of identifiable biospecimens (and/or associated data) with other AHCs?
REVISED: No changes.
(F) Discontinuation of a subject’s consent for participation in research:
18. ORIGINAL: If someone who provided a biospecimen withdraws from research, which options are acceptable to the AHC’s IRB?:
a. The biospecimen is destroyed but data already derived from it can be used
b. The biospecimen is de-identified and then can continue to be used
c. The biospecimen and associated data are destroyed.
d. Other (specify)
e. Unspecified
REVISED: If someone who provided a biospecimen withdraws from research, which options are acceptable to the AHC’s IRB?:
a. What happens to the biospecimen when a subject withdraws from research? (Is the biospecimen to be destroyed? Or, can it be de-identified and used?)
b. Are the data derived from the biospecimen to be destroyed?
19. ORIGINAL: If someone who provided a biospecimen withdraws from research, but the biospecimens/data have already been sent from the AHC to another as part of collaborative research, what is the sending AHC’s policy about responsibility for taking actions as described in 18?
a. The giving institution has responsibility
b. The receiving institution has responsibility
c. Both institutions have responsibility
d. Other (specify)
e. Unspecified
REVISED: If someone who provided a biospecimen withdraws from research, but the biospecimens/data have already been sent from the AHC to another as part of collaborative research, what is the sending AHC’s policy about responsibility for taking actions as described in 18?
a. Who has responsibility for the action toward the biospecimen—the giving institution, the receiving institution, or both institutions?
b. Who has responsibility for the action toward the data derived from the biospecimen—the giving institution, the receiving institution, or both institutions?
20. ORIGINAL: Does the AHC or its biobank have a method of tracking distribution of each biospecimen (including other institutions) in case donor withdraws from research?
REVISED: No changes.
(G) Disclosure:
21. ORIGINAL: Does the AHC’s IRB have policies on disclosure of genetic results?
REVISED: No changes.
22. ORIGINAL: If yes to 21 (i.e., there is a policy on disclosure), under what conditions does the policy call for disclosure of genetic results?
a. Consent must state explicitly that individual results will be disclosed?
b. Results are disclosed only if they indicate high risk for a condition that can be effectively treated, regardless of consent?
c. There must be a specific request by investigator to the IRB and IRB approves?
d. There must be a specific request by the subject to the IRB and IRB approves?
e. AHC does not permit disclosure of results to individual subjects?
f. Other (specify____)
REVISED: No changes.
23. ORIGINAL: If yes to 21 (i.e., there is a policy on disclosure), and genetic results are derived from collaborative research involving sharing biospecimens with another AHC, which AHC has responsibility for disclosure?
a. The giving institution has responsibility
b. The receiving institution has responsibility
c. Both institutions have responsibility
d. Other (specify___)
REVISED: No changes.