Table 1 Overview of ethical concerns in GDR and assessment whether current recommendations suffice for a broader use of GDR
From: Genotype-driven recruitment: a strategy whose time has come?
Ethical concerns in GDR | Published recommendations | Do the recommendations suffice under a broader use of GDR? |
|---|---|---|
Risk of violating the individual’s privacy and right not to know if genetic information is implicitly unveiled during re-contact [1, 3, 4] | Inform about potential re-contact and future disclosure in the informed consent of original study [2, 6, 7, 12] | No: informed consent process may not have taken place before genotyping |
Offer the individual the possibility to choose whether she wants to be involved in future GDR studies [2–4, 6, 7] | No: choice to participate in future GDR studies may not have been given | |
Design re-contact process in consultation with the Institutional Review Board (IRB) of the original study [6, 7] | No: contact with/identification of the IRB of the original study may not be possible | |
Risk that the individual enrolled does not understand why she is eligible for the GDR study [9, 14] | Take into consideration the context into which the individual is invited to participate in GDR (e.g. previous participation in research, previous research focusing on similar condition) [6, 7, 14] | No: the research background of the individual may be unknown to the researcher inviting to join a GDR study |
Risk of creating unnecessary anxiety and distress for the individual re-contacted [1] | Contact by known and/or trusted health professional [3, 4, 7] | No: the individual may receive an invitation to participate in an original GDR study from unknown researchers |
Risk of deceiving the individual if he is not informed about the reasons for enrolment [1] | Return genetic results to the individual more systematically than in other research designs [1, 3, 6, 7, 9, 15, 17] | No: the individual may not have been prepared to receive genetic results |
Risk of group/individual discrimination and/or stigmatisation if re-identification is possible through the analysis of the study’s pedigree description [1] | Add randomly selected sub-groups in case-only studies [1] | Yes: randomly selected sub-groups could also be added in original GDR case-only studies |
Risk of provoking emotional distress for the individual if the results disclosed are uncertified, have low clinical utility [1, 3, 5] or if they indicate the presence of a rare variant of significance for the health of the individual [1, 4, 9] | Return only results which are clear, concise, and accurate and explain the meaning and utility of the results [1, 7, 9, 15, 17, 18] | No: individuals may not have been prepared to receive genetic results |
Use consistent disclosure criteria as agreed beforehand with individuals [8, 15] | No: process to reach agreement beforehand on which results to return may not have taken place | |
Design the return of results process in consultation with the IRB of the original study [7] | No: contact with the IRB of the original study may not be possible | |
Take into consideration the context of the research, the relationship between research and research participant, and the degree of vulnerability and dependence of the research participant [5, 7, 9] | No: the personal/research background of the individual may be unknown to the researcher inviting to join a GDR study | |
Risk of making the individual re-contacted the carrier of bad news for non-contacted family members [1, 4, 9] | Include recruitment of family members as part of the research protocol [4] | No: individuals may not have had the opportunity to consent to the invitation of their relatives into the GDR study |
Risk of harassing the individual if multiple re-contact for inclusion in GDR studies takes place [1] | Make use of independent governance bodies (e.g. centralised ethics committee or data access committee) which can determine which individuals to re-contact [2, 10] | No: governance bodies may not be co-ordinated across publicly funded and privately funded projects |
Inform the individual about the role of governance bodies in the consent of the original study [10] | No: informed consent process may not have taken place before genotyping | |
Make use of flexible and less intrusive electronic information exchange systems for communication with research participants [2] | No: communication systems may not be established between the researchers inviting to participate in a GDR study and the individuals receiving the invitation |