Introduction: 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.
Aim: To study variation in REB consent requirements for retrospective chart review and who may have access to the medical record for data abstraction.
Methods: 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.
Results: 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.
Conclusions: 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.
Statistics from Altmetric.com
If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.
Funding: This research was funded by a grant from the Canadian Institutes of Health Research (grant number MOP-577484).
Competing interests: At the time of the study, KMW and MDC served on research ethics boards that participated in the study. In neither of these two cases did they attend the interview or attempt to coach or influence the response of the interviewee(s).
Read the full text or download the PDF:
Other content recommended for you
- Variations in institutional review board processes and consent requirements for trauma research: an EAST multicenter survey
- Written informed consent and selection bias in observational studies using medical records: systematic review
- Informing research participants of research results: analysis of Canadian university based research ethics board policies
- Patients' consent preferences for research uses of information in electronic medical records: interview and survey data
- Reconsenting paediatric research participants for use of identifying data
- Using human tissue: when do we need consent?
- Assessment of children's capacity to consent for research: a descriptive qualitative study of researchers' practices
- Exploring the experiences of substitute decision-makers with an exception to consent in a paediatric resuscitation randomised controlled trial: study protocol for a qualitative research study
- Holding personal information in a disease-specific register: the perspectives of people with multiple sclerosis and professionals on consent and access
- Public good, personal privacy: a citizens' deliberation about using medical information for pharmacoepidemiological research