Institutional Review Boards in Saudi Arabia: The First Survey- Based report on Their Functions and Operations

Author:

AlFattani Areej1,AlBedah Norah1,AlShahrani Asma1,Alkawi Ammar1,AlMeharish Amani1,Altwaijri Yasmin1,Omar Abeer1,AlKawi M. Zuheir2,Khogeer Asim3

Affiliation:

1. King Faisal Specialist Hospital and Research Center

2. King Abdulaziz City for Science and Technology

3. The Strategic Planning Administration, Ministry of Health

Abstract

Abstract Background Institutional review boards (IRBs) are formally designated to review, approve, and monitor biomedical research. They are responsible for ensuring that researchers are compliant with the ethical guidelines concerning human research participants. IRBs might face different obstacles that cause delay in their processes or conflicts with investigators. This study aims to report the functions, roles, resources, and review process of the IRBs in Saudi Arabia. Method This was a cross-sectional self-reported survey conducted from March 2021 until March 2022. The survey was sent to the IRB chairperson and the administration director (or secretary) through email after receiving verbal consent. The validated survey consisted of eight aspects: (a) organizational aspects, (b) membership and educational training, (c) submission arrangements and materials, (d) minutes, (e) review procedures, (f) communicating a decision, (g) continuing review, and (h) research ethics committee (REC) resources. A total of 200 points indicates optimal IRB functions. Results Twenty-six IRBs across Saudi Arabia responded to the survey. Relatively newer IRBs that were established less than ten years ago, conducted meetings at least once in a month, had annual funding, and more balanced gender representation tended to score higher than older IRBs. The organizational aspect score was the lowest among all items in the survey (14.3 score difference, p-value < 0.01). The average turnaround time for expedited research from proposal submission to final decision was 7 days, while it was 20.5 days for the full committee review. Conclusion Saudi IRBs performed well generally. However, there is room for focused improvement with respect to extra resources and organizational issues that require closer evaluation and guidance from the regulatory bodies.

Publisher

Research Square Platform LLC

Reference22 articles.

1. The IRB structure and medical research reform;Babyar J;Clin Transl Med,2018

2. IRB problems and solutions in health communication research;King CS;Health Commun,2018

3. Certificates of confidentiality and informed consent: perspectives of IRB chairs and institutional legal counsel;Check DK;IRB,2014

4. Results of a self-assessment tool to assess the operational characteristics of research ethics committees in low-and middle-income countries;Silverman H;J Med Ethics,2015

5. Human Research Ethics Committees: Examining Their Roles and Practices;Guillemin M;J Empir Res Hum Res Ethics,2012

同舟云学术

1.学者识别学者识别

2.学术分析学术分析

3.人才评估人才评估

"同舟云学术"是以全球学者为主线,采集、加工和组织学术论文而形成的新型学术文献查询和分析系统,可以对全球学者进行文献检索和人才价值评估。用户可以通过关注某些学科领域的顶尖人物而持续追踪该领域的学科进展和研究前沿。经过近期的数据扩容,当前同舟云学术共收录了国内外主流学术期刊6万余种,收集的期刊论文及会议论文总量共计约1.5亿篇,并以每天添加12000余篇中外论文的速度递增。我们也可以为用户提供个性化、定制化的学者数据。欢迎来电咨询!咨询电话:010-8811{复制后删除}0370

www.globalauthorid.com

TOP

Copyright © 2019-2024 北京同舟云网络信息技术有限公司
京公网安备11010802033243号  京ICP备18003416号-3