Guidelines on research ethics review vary significantly between countries, according to study data published in Health Research Policy and Systems. Investigators assessed review guidelines from ethics committees in Australia, the Netherlands, the United States, and the United Kingdom. In each country, at least 1 form of human subject research was exempted ethics review. However, exemptions differed broadly by country and type of research.
Investigators examined national guidance documents authored by research ethics committees in each country. Included in the study was guidance from the National Health and Medical Research Council of Australia, the Central Committee on Research Involving Humans (Netherlands), the National Health Service (UK), and the Office for Human Research Protections (US). The countries included in the study were chosen based on the projected breadth of available research categories. One investigator read all documents and identified all categories of human subject research. Exemptions were identified and sorted by research category. Any uncertainties regarding terminology or methodology were resolved across 3 authors.
Investigators defined 9 research categories that were deemed exempt in some capacity: (1) existing deidentified data/specimen; (2) questionnaire or survey; (3) interviews; (4) postmarketing studies; (5) evaluation of public benefit or service program; (5) randomized clinical trials; (6) research with staff in their professional role; (7) audit and service evaluation; and (8) other or miscellaneous exemptions. Research involving existing data/specimens was exempt in all 4 countries. Research evaluating a public benefit or service program was exempt only in the United States; research involving staff in their professional role and audit research were exempt only in the United Kingdom. Randomized clinical trials were exempt from ethics review in the Netherlands if patients were not exposed to treatment or behavioral modification. The remaining 4 categories of research were exempt in 2 or 3 countries each. Overall, the Netherlands had the greatest number of exemptions, whereas Australia had the fewest.
According to study authors, a clearer delineation of exemptions can streamline the review process and reduce research waste. This may be more easily achieved, they wrote, with standardization of research exemptions across countries, particularly where international collaboration is concerned. “Given the considerable costs and burdens on researchers and ethics committees, it would be worthwhile to develop…clearer guidance on exemptions…with transparent underpinning rationales,” the investigators wrote.
Scott AM, Kolstoe S, Ploem MCC, Hammatt Z, Glasziou P. Exempting low-risk health and medical research from ethics reviews: comparing Australia, the United Kingdom, the United States and the Netherlands. Health Res Policy Syst. 2020;18(1):11.