ERIC Number: EJ1194107
Record Type: Journal
Publication Date: 2018-Jul
Pages: 12
Abstractor: As Provided
ISBN: N/A
ISSN: ISSN-1747-0161
EISSN: N/A
Research Governance Review of a Negligible-Risk Research Project: Too Much of a Good Thing?
Rush, Amanda; Ling, Rod; Carpenter, Jane E.; Carter, Candace; Searles, Andrew; Byrne, Jennifer A.
Research Ethics, v14 n3 Jul 2018
There are increasing concerns that research regulatory requirements exceed those required to manage risks, particularly for low- and negligible-risk research projects. In particular, inconsistent documentation requirements across research sites can delay the conduct of multi-site projects. For a one-year, negligible-risk project examining biobank operations conducted at three separate Australian institutions, we found that the researcher time required to meet regulatory requirements was eight times greater than that required for the approved research activity (60 hours versus 7.5 hours respectively). In total, 76 business days (almost four months) were required to obtain the necessary approvals, and site-specific processes required twice as long (52 business days/approximately 10 weeks) as primary Human Research Ethics Committee and Research Governance Office processes (24 business days/approximately five weeks). We describe the impact of this administrative load on the conduct of a one-year, externally-funded research project, and identify a shared set of application requirements that could be used to streamline and harmonise research governance review of low- and negligible-risk research projects.
Descriptors: Research, Risk Management, Research Projects, Time, Governance, Foreign Countries, Cancer
SAGE Publications. 2455 Teller Road, Thousand Oaks, CA 91320. Tel: 800-818-7243; Tel: 805-499-9774; Fax: 800-583-2665; e-mail: journals@sagepub.com; Web site: http://sagepub.com
Publication Type: Journal Articles; Reports - Evaluative
Education Level: N/A
Audience: N/A
Language: English
Sponsor: N/A
Authoring Institution: N/A
Identifiers - Location: Australia
Grant or Contract Numbers: N/A