Introduction: The quality of ethics review is often a bone of contention with trialists. Accredit... more Introduction: The quality of ethics review is often a bone of contention with trialists. Accreditation typically focuses on administrative requirements rather than assessing the quality of decisions. To date there are no established metrics of quality for research ethics review.
Aim: As a first stage we reviewed the empirical research regarding ethics review. We examined the range and nature of research activity in order to identify key themes, research foci, and research gaps to aid in the planning and commissioning of future research.
Methods: A scoping review of published studies. A study was eligible if it was empirical, considered the ethics review process, was focused on human subjects, and was published in English. Manuscript content was coded by two reviewers.
Results: 197 papers were included for data extraction. Few studies were from outside North America, Europe or Australasia. The most common research methodologies were surveys (N=93) and review of administrative data (N=79). Only two longitudinal studies and one systematic review were identified. The most common subject of study was the review process (N=148) and IRB member views (N=101). Only 7 studies included research participants and only one research sponsors. Main outcomes were: IRB structures (N=105), variation in decisions (N=62), IRB membership (N=61), delays in approvals (N=54). Least studied were participant views (N=4), IRB member knowledge (N=9), and post-approval outcomes (N=23).
Conclusion: To date studies have tended to focus on structure and timeliness of ethics review and there has been a lack of research around participant experiences, particularly in less developed countries or settings. A major limitation to date is the lack of longitudinal research which precludes any analyses of change or assessment of quality improvement in ethics review.
Introduction: The quality of ethics review is often a bone of contention with trialists. Accredit... more Introduction: The quality of ethics review is often a bone of contention with trialists. Accreditation typically focuses on administrative requirements rather than assessing the quality of decisions. To date there are no established metrics of quality for research ethics review.
Aim: As a first stage we reviewed the empirical research regarding ethics review. We examined the range and nature of research activity in order to identify key themes, research foci, and research gaps to aid in the planning and commissioning of future research.
Methods: A scoping review of published studies. A study was eligible if it was empirical, considered the ethics review process, was focused on human subjects, and was published in English. Manuscript content was coded by two reviewers.
Results: 197 papers were included for data extraction. Few studies were from outside North America, Europe or Australasia. The most common research methodologies were surveys (N=93) and review of administrative data (N=79). Only two longitudinal studies and one systematic review were identified. The most common subject of study was the review process (N=148) and IRB member views (N=101). Only 7 studies included research participants and only one research sponsors. Main outcomes were: IRB structures (N=105), variation in decisions (N=62), IRB membership (N=61), delays in approvals (N=54). Least studied were participant views (N=4), IRB member knowledge (N=9), and post-approval outcomes (N=23).
Conclusion: To date studies have tended to focus on structure and timeliness of ethics review and there has been a lack of research around participant experiences, particularly in less developed countries or settings. A major limitation to date is the lack of longitudinal research which precludes any analyses of change or assessment of quality improvement in ethics review.
Uploads
Aim: As a first stage we reviewed the empirical research regarding ethics review. We examined the range and nature of research activity in order to identify key themes, research foci, and research gaps to aid in the planning and commissioning of future research.
Methods: A scoping review of published studies. A study was eligible if it was empirical, considered the ethics review process, was focused on human subjects, and was published in English. Manuscript content was coded by two reviewers.
Results: 197 papers were included for data extraction. Few studies were from outside North America, Europe or Australasia. The most common research methodologies were surveys (N=93) and review of administrative data (N=79). Only two longitudinal studies and one systematic review were identified. The most common subject of study was the review process (N=148) and IRB member views (N=101). Only 7 studies included research participants and only one research sponsors. Main outcomes were: IRB structures (N=105), variation in decisions (N=62), IRB membership (N=61), delays in approvals (N=54). Least studied were participant views (N=4), IRB member knowledge (N=9), and post-approval outcomes (N=23).
Conclusion: To date studies have tended to focus on structure and timeliness of ethics review and there has been a lack of research around participant experiences, particularly in less developed countries or settings. A major limitation to date is the lack of longitudinal research which precludes any analyses of change or assessment of quality improvement in ethics review.
Aim: As a first stage we reviewed the empirical research regarding ethics review. We examined the range and nature of research activity in order to identify key themes, research foci, and research gaps to aid in the planning and commissioning of future research.
Methods: A scoping review of published studies. A study was eligible if it was empirical, considered the ethics review process, was focused on human subjects, and was published in English. Manuscript content was coded by two reviewers.
Results: 197 papers were included for data extraction. Few studies were from outside North America, Europe or Australasia. The most common research methodologies were surveys (N=93) and review of administrative data (N=79). Only two longitudinal studies and one systematic review were identified. The most common subject of study was the review process (N=148) and IRB member views (N=101). Only 7 studies included research participants and only one research sponsors. Main outcomes were: IRB structures (N=105), variation in decisions (N=62), IRB membership (N=61), delays in approvals (N=54). Least studied were participant views (N=4), IRB member knowledge (N=9), and post-approval outcomes (N=23).
Conclusion: To date studies have tended to focus on structure and timeliness of ethics review and there has been a lack of research around participant experiences, particularly in less developed countries or settings. A major limitation to date is the lack of longitudinal research which precludes any analyses of change or assessment of quality improvement in ethics review.