ADVANCING COLLABORATIVE GENETIC RESEARCH:
ETHICAL AND POLICY CHALLENGES
Ohio State University
1/18/12 – updated 1/30/12
Aim 1 A: Assess and contrast the written policies of CTSC institutions’ IRBs
1. Does the academic health center’s (AHC) IRB permit investigators to ask participants for consent for unspecified future research with their biospecimens?
Coding preliminary answer / SilentNote that page 7 ( section 8A) and beyond address future research but does not talk about “unspecified” future research
Policy cited and location of relevant text / Doc #1 “Research Involving Data and/or Biological Specimens
Response by CTSC re: answer above
Additional information identified by CTSC
Final resolution on answer
2. Does the AHC’s IRB permit OR require investigators to use tiered consent when prospectively collecting biospecimens?
Coding preliminary answer / silentPolicy cited and location of relevant text
Response by CTSC re: answer above
Additional information identified by CTSC
Final resolution on answer
3. Does the AHC’s IRB permit investigators to ask for consent to retain biospecimens with identifiers for future research?
Coding preliminary answer / SilentBut page 6 implies that it is ok to store identified specimens (does not address consent form)
Policy cited and location of relevant text / Doc #1 “Research Involving Data and/or Biological Specimens—note page 6 4th bullet
Response by CTSC re: answer above
Additional information identified by CTSC
Final resolution on answer
4. 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?
Coding preliminary answer / YesPolicy cited and location of relevant text / Doc #1 “Research Involving Data and/or Biological Specimens – page 5, E
And Page 9 - E
Response by CTSC re: answer above
Additional information identified by CTSC
Final resolution on answer
5. Does the AHC’s IRB permit investigators access to clinical data at the time of the consent to contribute biospecimens ?
Coding preliminary answer / silentPolicy cited and location of relevant text
Response by CTSC re: answer above
Additional information identified by CTSC
Final resolution on answer
6. Does the AHC’s IRB permit investigators access to clinical data subsequent to time of the consent to contribute biospecimens?
Coding preliminary answer / silentPolicy cited and location of relevant text
Response by CTSC re: answer above
Additional information identified by CTSC
Final resolution on answer
7. Does the AHC’s IRB have a standard (i.e. applicable to all patients) written disclosure to patients entering the hospital or undergoing a clinical procedure regarding the use of clinically acquired biospecimens for research?
Coding preliminary answer / silentPolicy cited and location of relevant text
Response by CTSC re: answer above
Additional information identified by CTSC
Final resolution on answer
8. Are the following types of disclosures permitted for patients entering the hospital or undergoing a clinical procedure regarding the use of clinically acquired biospecimens for research?
8a. 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
8b. 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
8c. 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
8d. Other types of disclosures permitted (specify ______)
Coding preliminary answer / silentPolicy cited and location of relevant text
Response by CTSC re: answer above
Additional information identified by CTSC
Final resolution on answer
9. Are new uses of identifiable biospecimens or related data from repositories required to undergo IRB review at the AHC?
Coding preliminary answer / Yes (for all pages of Doc #1)Policy cited and location of relevant text / Doc #1 “Research Involving Data and/or Biological Specimens – page 1, 2nd parag.
Doc #1 page 2, 3C
Doc #1 page 4, 6A
Response by CTSC re: answer above
Additional information identified by CTSC
Final resolution on answer
10. If yes to q9 (i.e. IRB review of new uses is required), is an IRB review of the original consent required?
If yes (IRB review of original consent is required) and the scope of the original consent is not consistent with the new research, does the IRB:
10a. Permit re-contact to obtain consent?
10b. Permit or require anonymization/de-identification before the biospecimens/data can be used in new research?
10c. Waive consent requirement?
10d. Not allow biospecimens and/or associated data to be used in the new research
10e. Other (Specify ______)
Coding preliminary answer / We think the answer to 10a is “yes” if there was an original consent10b-10e are silent
Policy cited and location of relevant text / Doc #1 “Research Involving Data and/or Biological Specimens – page 5, D
Response by CTSC re: answer above
Additional information identified by CTSC
Final resolution on answer
11. 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?
Coding preliminary answer / silentPolicy cited and location of relevant text
Response by CTSC re: answer above
Additional information identified by CTSC
Final resolution on answer
12. Under what conditions does the AHC permit sharing biospecimens or genetic data with other institutions?
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)
Coding preliminary answer / 12d: Both statements (G and H) apply to “other consent issues related to sharing” such that IRB approval is required for sharing; And, researchers are told to contact OSU office of technology licensing and commercialization for further information12a-c are silent
Policy cited and location of relevant text / Doc #1 “Research Involving Data and/or Biological Specimens – page 5, G and H
Response by CTSC re: answer above
Additional information identified by CTSC
Final resolution on answer
13. 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 (ie receiving biospecimens from another institution), must its IRB review the consent form used when the biospecimens were collected?
Coding preliminary answer / 13a and 13b Yes13c silent
Policy cited and location of relevant text / Doc #1 “Research Involving Data and/or Biological Specimens – page 5 G
Response by CTSC re: answer above
Additional information identified by CTSC
Final resolution on answer
14. 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?
Coding preliminary answer / Silent for allPolicy cited and location of relevant text
Response by CTSC re: answer above
Additional information identified by CTSC
Final resolution on answer
15. Does the AHC’s IRB oversee the de-identification process for biospecimens (i.e. require investigators to explain in detail in the protocol how de-identification will occur)?
Coding preliminary answer / silentPolicy cited and location of relevant text
Response by CTSC re: answer above
Additional information identified by CTSC
Final resolution on answer
16. 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)
Coding preliminary answer / Silent for allPolicy cited and location of relevant text
Response by CTSC re: answer above
Additional information identified by CTSC
Final resolution on answer
17. Does the AHC’s IRB permit sharing of identifiable biospecimens (and/or associated data) with other AHCs?
Coding preliminary answer / silentPolicy cited and location of relevant text
Response by CTSC re: answer above
Additional information identified by CTSC
Final resolution on answer
18. If someone who provided a biospecimen withdraws from research, which of the following options are acceptable to the AHC’s IRB?:
a. 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?
Coding preliminary answer / Silent for allPolicy cited and location of relevant text
Response by CTSC re: answer above
Additional information identified by CTSC
Final resolution on answer
19. 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?
19a. Who has responsibility for the action toward the biospecimen- the giving institution, the receiving institution, or both institutions?
19b. Who has responsibility for the action toward the data derived from the biospecimen – the giving institution, the receiving institution, or both institutions?
Coding preliminary answer / Silent for allPolicy cited and location of relevant text
Response by CTSC re: answer above
Additional information identified by CTSC
Final resolution on answer
20. Does the AHC or its biobank have a method of tracking distribution of each biospecimen (including other institutions) in case donor withdraws from research?
Coding preliminary answer / SilentPolicy cited and location of relevant text
Response by CTSC re: answer above
Additional information identified by CTSC
Final resolution on answer
21. Does the AHC’s IRB have policies on disclosure of genetic results?
Coding preliminary answer / SilentPolicy cited and location of relevant text
Response by CTSC re: answer above
Additional information identified by CTSC
Final resolution on answer
22. If yes to 21, under what conditions does the policy call for disclosure of genetic results?
22a. Consent must state explicitly that individual results will be disclosed
22b. Results are disclosed only if they indicate high risk for a condition that can be effectively treated, regardless of consent?
22c. There must be a specific request by the investigator to the IRB and IRB approves?
22d. There must be specific request by the subject to the IRB and IRB approves?
22e. AHC does not permit disclosure of results to individual subjects?
22f. Other (specify____)
Coding preliminary answer / Silent for allPolicy cited and location of relevant text
Response by CTSC re: answer above
Additional information identified by CTSC
Final resolution on answer
23. If yes to 21, 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___)
e. Unspecified
Coding preliminary answer / Silent for allPolicy cited and location of relevant text
Response by CTSC re: answer above
Additional information identified by CTSC
Final resolution on answer
Non-Content Analysis Measures:
24. Are you considering changes to policies as a result of proposed rule changes?
a. If yes, how have you done so?
b. Have you done that yet?
c. Can we see a copy of the changes made?
25. How often do you review your policies?
26. Are there any relevant policies that are presently under review?
27. How does your institution approach outdated policies (i.e., are they removed from the web or are they archived on the web?