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.
The acquired immunodeficiency syndrome (AIDS) pandemic has raised difficult ethical issues in public policy formulation and in the care of patients infected with the human immunodeficiency virus (HIV). Many issues relate to measures proposed for the protection of the public from HIV infection. This article presents an analytic framework from which these measures can be rationally evaluated. Specific measures are assessed on the basis of their likelihood of success, in relation to their justification for infringement on individual rights, and with reference to other less intrusive measures that could accomplish the same objective. Case histories are discussed which raise ethical dilemmas in the care of HIV infected and high-risk patients. The application of this framework could assist physicians in analysing public health policy and making judgements in individual clinical situations.
Cites: JAMA. 1987 Oct 23-30;258(16):2298-30011652513
Cites: JAMA. 1987 Mar 13;257(10):1357-663546744
Cites: JAMA. 1987 Oct 9;258(14):19403656608
Cites: JAMA. 1987 Oct 9;258(14):1939-403656607
Cites: JAMA. 1987 Oct 9;258(14):1924-83309386
Cites: Lancet. 1987 Sep 12;2(8559):589-932887886
Cites: N Engl J Med. 1987 Oct 29;317(18):1125-353309656
Cites: JAMA. 1988 Mar 4;259(9):1353-62963151
Cites: JAMA. 1988 Mar 4;259(9):1357-93276950
Cites: N Engl J Med. 1988 Feb 18;318(7):444-73340123
Cites: JAMA. 1988 Jun 24;259(24):3609-103131557
Cites: Lancet. 1988 May 14;1(8594):11182896956
Cites: JAMA. 1988 May 20;259(19):2898-93367458
Cites: N Engl J Med. 1988 Feb 25;318(8):473-83422337
This paper begins with a discussion of the value of privacy, especially for medical records in an age of advancing technology. I then examine three alternative approaches to protection of medical records: reliance on governmental guidelines, the use of corporate self-regulation, and my own third hybrid view on how to maintain a presumption in favor of privacy with respect to medical information, safeguarding privacy as vigorously and comprehensively as possible, without sacrificing the benefits of new information technology in medicine. None of the three models I examine are unproblematic, yet it is crucial to weigh the strengths and weaknesses of these alternative approaches.
BACKGROUND: Sweden prohibited anonymous sperm donation in 1985 and Norway in 2005. In recent years the question of continued use of sperm from anonymous sperm donors for insemination in couples and the question of insemination of single and lesbian women have been vividly debated in Denmark. This survey examines the sperm donors' attitude towards these questions and describes any changes in attitude between 1992 and 2002. The objective is to investigate the likely consequences of abolishing anonymous sperm donation in Denmark. METHODS: A questionnaire survey carried out among donors at a private Danish sperm bank, Cryos-International Sperm Bank Ltd. Over a period of 9 weeks in 2002 an anonymous questionnaire was handed out to all donors who were in contact with the sperm bank. The results were compared to a questionnaire survey carried out in 1992 at the same sperm bank. RESULTS: In 2002, 25% (19% approved; 35% non-approved) of the donors stated that they would continue as donors if anonymity was abolished, whereas in 1992 the number was 32%. But when donors were asked whether they would accept that the children could contact them, only 22% agreed in 1992 and 13% (15% approved; 10% non-approved) in 2002. Altruistic as well as financial motives were the main factors for becoming a donor in both 1992 and 2002. Approximately 50% would accept sperm donation to lesbians in both surveys. In 2002 approximately one third was positive towards donation to single women. CONCLUSION: Maintaining anonymity is still important for the vast majority of the donors.
What are the attitudes towards different aspects of embryo donation among Swedish infertile couples who have surplus cryopreserved embryos?
Nearly three-quarters of infertile couples with surplus embryos were in favour of embryo donation. A majority of respondents were also in favour of embryos being donated for research.
Currently, embryo donation to other infertile couples is prohibited by law in Sweden. Encouraging results have been published from countries allowing embryo donation, although it is a complex procedure associated with many emotional, ethical, legal and psychosocial aspects.
This cross-sectional study included 471 infertile couples (942 patients) treated during the period March 2006 to March 2009.
Infertile couples who had been treated at a Swedish university-based hospital and private IVF clinic and who had cryopreserved embryos were sent questionnaires with questions regarding socio-demographic data and their attitudes towards embryo donation.
The response rate to the questionnaire was 58%. Of the respondents, 76% supported the donation of surplus embryos to other infertile couples, but there were divided opinions regarding the disclosure of the genetic parents' identities. Close to 60% of the participants indicated that donations of embryos should be allowed for research and about 45% of the participants approved donations of embryos to single women.
The relatively low response rate and the hypothetical nature of the questions may limit the validity of the results.
The results from the study indicate that cryopreserved embryos may be available for donation to other infertile couples, particularly where restrictions can be set on recipient characteristics.