Variation across research ethics boards (REBs) in conditions placed on access to medical records for research purposes raises concerns around negative impacts on research quality and on human subject protection, including privacy.
To study variation in REB consent requirements for retrospective chart review and who may have access to the medical record for data abstraction.
Thirty 90-min face-to-face interviews were conducted with REB chairs and administrators affiliated with faculties of medicine in Canadian universities, using structured questions around a case study with open-ended responses. Interviews were recorded, transcribed and coded manually.
Fourteen sites (47%) required individual patient consent for the study to proceed as proposed. Three (10%) indicated that their response would depend on how potentially identifying variables would be managed. Eleven sites (38%) did not require consent. Two (7%) suggested a notification and opt-out process. Most stated that consent would be required if identifiable information was being abstracted from the record. Among those not requiring consent, there was substantial variation in recognising that the abstracted information could potentially indirectly re-identify individuals. Concern over access to medical records by an outside individual was also associated with requirement for consent. Eighteen sites (60%) required full committee review. Sixteen (53%) allowed an external research assistant to abstract information from the health record.
Large variation was found across sites in the requirement for consent for research involving access to medical records. REBs need training in best practices for protecting privacy and confidentiality in health research. A forum for REB chairs to confidentially share concerns and decisions about specific studies could also reduce variation in decisions.
Since Sweden abolished anonymity in connection with sperm donation in 1985, a number of other countries have followed suit. A legal provision still exists in Denmark to the effect that the donor must be anonymous. Arguments given in a Danish context against retaining the present scheme involving anonymous sperm donation will be discussed. The biggest problem with sperm donation seems to be non-disclosure. Current and important arguments in favour ofabolishing anonymity are that it sends out a clear signal that non-disclosure is unacceptable and that, in principle, all citizens should have access to the information available about themselves. However, the arguments can be criticised both from theoretical (legal) and several practical (medical) points of view. A substantive alternative to abolishing anonymity might be to inform parents about avoiding non-disclosure--and to design information material for the children, to support the parents.
About nine in 10 Canadians support legislation that would protect patient confidentiality. However, the Canadian public is not consistent in its views regarding privacy. Data suggest that the public's attitudes to privacy, and particularly access to medical records, are heavily influenced by the context in which the situation is presented and potential benefits to the individual or to the public.
In living kidney donation, transplant professionals consider the rights of a living kidney donor and recipient to keep their personal health information confidential and the need to disclose this information to the other for informed consent. In incompatible kidney exchange, personal health information from multiple living donors and recipients may affect decision making and outcomes.
We conducted a survey to understand and compare the preferences of potential donors (n = 43), potential recipients (n = 73), and health professionals (n = 41) toward sharing personal health information (in total 157 individuals).
When considering traditional live-donor transplantation, donors and recipients generally agreed that a recipient's health information should be shared with the donor (86 and 80%, respectively) and that a donor's information should be shared with the recipient (97 and 89%, respectively). When considering incompatible kidney exchange, donors and recipients generally agreed that a recipient's information should be shared with all donors and recipients involved in the transplant (85 and 85%, respectively) and that a donor's information should also be shared with all involved (95 and 90%, respectively). These results were contrary to attitudes expressed by transplant professionals, who frequently disagreed about whether such information should be shared.
Future policies and practice could facilitate greater sharing of personal health information in living kidney donation. This requires a consideration of which information is relevant, how to put it in context, and a plan to obtain consent from all concerned.
Cites: Am J Transplant. 2003 Jul;3(7):830-412814474
Cites: Am J Transplant. 2009 Jul;9(7):1558-7319459792
Cites: Transplantation. 2004 Aug 27;78(4):491-215446304
Cites: Lancet. 1992 Oct 3;340(8823):807-101357243
Cites: Can J Surg. 2004 Dec;47(6):408-1315646438
Cites: Transplantation. 2005 Mar 27;79(6 Suppl):S53-6615785361
Cites: HIV Med. 2006 Apr;7(3):133-916494626
Cites: Ann Intern Med. 2006 Aug 1;145(3):185-9616880460