Assessing the Decision-Making Capabilities of Artificial Intelligence Platforms as Institutional Review Board Members

Abstract

Background: Institutional review boards (IRBs) face delays in reviewing research proposals, underscoring the need for optimized standard operating procedures (SOPs). This study assesses the abilities of three artificial intelligence (AI) platforms to address IRB challenges and draft essential SOPs. Methods: An observational study was conducted using three AI platforms in 10 case studies reflecting IRB functions, focusing on creating SOPs. The accuracy of the AI outputs was assessed against good clinical practice (GCP) guidelines. Results: The AI tools identified GCP issues, offered guidance on GCP violations, detected conflicts of interest and SOP deficiencies, recognized vulnerable populations, and suggested expedited review criteria. They also drafted SOPs with some differences. Conclusion: AI platforms could aid IRB decision-making and improve review efficiency. However, human oversight remains critical for ensuring the accuracy of AI-generated solutions.

Keywords

life sciences research AI ChatGPT IRB‌communication in research data safety monitoring decision making capacity ethics education

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References

Al Tajir

(2018). Ethical treatment of participants in public health research. J Public Health Emerg, 2(2). https://doi.org/10.21037/jphe.2017.12.04

Dyrbye

L. N.

Thomas

M. R.

Mechaber

A. J.

Eacker

Harper

Massie

F. S.

Jr. Power

D. V.

Shanafelt

T. D.

(2007). Medical education research and IRB review: An analysis and comparison of the IRB review process at six institutions. Academic Medicine: Journal of the Association of American Medical Colleges, 82(7), 654–660. https://doi.org/10.1097/ACM.0b013e318065be1e

Dyrbye

L. N.

Thomas

M. R.

Papp

K. K.

Durning

S. J.

(2008). Clinician educators’ experiences with institutional review boards: Results of a national survey. Academic Medicine: Journal of the Association of American Medical Colleges, 83(6), 590–595. https://doi.org/10.1097/ACM.0b013e318172347a

Elliott

(2024). AI-driven misinformation ‘biggest short-term threat to global economy’. https://www.theguardian.com/business/2024/jan/10/ai-driven-misinformation-biggest-short-term-threat-to-global-economy (Accessed on March 5, 2024)

FERCAP/SIDCER handbook of case studies on ethical issues in health research. (2012). Forum for ethics review committees in the Asian and Western Pacific Region and strategic initiative for developing capacity in ethical review (1st ed.). FERCAP & SIDCER.

Fiske

S. T.

(2009). Institutional review boards: From bane to benefit. Perspectives on Psychological Science: A Journal of the Association for Psychological Science, 4(1), 30–31. https://doi.org/10.1111/j.1745-6924.2009.01085.x

Ford

D. E.

Johnson

Nichols

J. J.

Rothwell

Dubinett

Naeim

(2021). Challenges and lessons learned for institutional review board procedures during the COVID-19 pandemic. Journal of Clinical and Translational Science, 5(1), e107. https://doi.org/10.1017/cts.2021.27

Gogtay

N. J.

Doshi

B. M.

Kannan

Thatte

(2011). A study of warning letters issued to clinical investigators and institutional review boards by the United States food and drug administration. Indian Journal of Medical Ethics, 8(4), 211–214. https://doi.org/10.20529/IJME.2011.082

Grady

(2015). Institutional review boards: Purpose and challenges. Chest, 148(5), 1148–1155. https://doi.org/10.1378/chest.15-0706

10.

Harvard Longwood Medical Area standard operating procedures. (2023). https://hms.harvard.edu/sites/default/files/assets/Sites/OHRA/files/Binder1.pdf (Accessed on 14th October 2023).

11.

ICH E6 (R3) Guideline on good clinical practice (GCP). (2023). https://www.ema.europa.eu/en/documents/scientific-guideline/draft-ich-e6-r3-guideline-good-clinical-practice-gcp-step-2b_en.pdf (Accessed on 10th October 2023).

12.

Infectious Diseases Society of America (2009). Grinding to a halt: The effects of the increasing regulatory burden on research and quality improvement efforts. Clinical Infectious Diseases: An Official Publication of the Infectious Diseases Society of America, 49(3), 328–335. https://doi.org/10.1086/605454

13.

IRB Mayo Clinic. (2023). https://www.mayo.edu/research/institutional-review-board/irb-policy-manual (Accessed on 14th October 2023).

14.

Kästner

Behre

Lutz

Bürger

Luntz

Hinderhofer

Bendszus

Hoffmann

G. F.

Ries

(2015). Clinical research in vulnerable populations: Variability and focus of institutional review boards’ responses. PloS one, 10(8), e0135997. https://doi.org/10.1371/journal.pone.0135997

15.

Klitzman

(2011). How local IRBs view central IRBs in the US. BMC Medical Ethics, 12, 13. https://doi.org/10.1186/1472-6939-12-13

16.

Mariani

Garau

M. L.

Roitman

A. J.

Vukotich

Perelis

Ferrero

Domínguez

A. G.

Campos

Serrano

Villa Monte

G. G.

(2023). Variability in ethics review for multicenter protocols in Buenos Aires, Argentina. An observational study. Journal of Empirical Research on Human Research Ethics: JERHRE, 18(1-2), 69–77. https://doi.org/10.1177/15562646221134620

17.

Mrisho

Essack

(2021). Understanding constraints and enablers of turnaround time for ethics review: The case of institutional review boards in Tanzania. Journal of Empirical Research on Human Research Ethics: JERHRE, 16(5), 514–524. https://doi.org/10.1177/15562646211026855

18.

Nadig

Joshi

Uthappa

(2011). Competence of ethics committees in patient protection in clinical research. Indian Journal of Medical Ethics, 8(3), 151–154. https://doi.org/10.20529/IJME.2011.061

19.

Committee on Revisions to the Common Rule for the Protection of Human Subjects in Research in the Behavioral and Social Sciences, Board on Behavioral, Cognitive, and Sensory Sciences , Committee on National Statistics , Committee on Population , Division of Behavioral and Social Sciences and Education , & National Research Council . (2014). Proposed revisions to the common rule for the protection of human subjects in the behavioral and social sciences. National Academies Press (US). 6, Improving the IRB Process. https://www.ncbi.nlm.nih.gov/books/NBK217974/

20.

Pandiya

(2011). Quality of independent review board/ethics committee oversight in clinical trials in India. Perspectives in Clinical Research, 2(2), 45–47. https://doi.org/10.4103/2229-3485.80364

21.

The Pieces Team. (2023). Best LLM for Coding: Cloud vs Local. https://code.pieces.app/blog/best-llm-for-coding-cloud-vs-local (Accessed on March 5, 2024).

22.

Schutte

Scheele

van Luijk

(2021). Roses and balances: A paradigm for constructive ethical review of health professions education research. Advances in Medical Education and Practice, 12, 529–535. https://doi.org/10.2147/AMEP.S305094

23.

Silberman

Kahn

K. L.

(2011). Burdens on research imposed by institutional review boards: The state of the evidence and its implications for regulatory reform. The Milbank Quarterly, 89(4), 599–627. https://doi.org/10.1111/j.1468-0009.2011.00644.x

24.

Singh

Mishra

Pattanayak

Priyadarshini

Das

(2023). Artificial intelligence and the institutional ethics committee: A balanced insight into pros and cons, challenges, and future directions in ethical review of clinical research. J Integr. Med. Res., 1, 164–168. https://doi.org/10.4103/jimr.jimr_30_23

25.

Spellecy

Eve

A. M.

Connors

E. R.

Shaker

Clark

D. C.

(2018). The real-time IRB: A collaborative innovation to decrease IRB review time. Journal of Empirical Research on Human Research Ethics: JERHRE, 13(4), 432–437. https://doi.org/10.1177/1556264618780803

26.

Sridharan

Sivaramakrishnan

(2024). Leveraging artificial intelligence to detect ethical concerns in medical research: A case study. Journal of Medical Ethics, jme-2023-109767. Advance online publication. https://doi.org/10.1136/jme-2023-109767

27.

Straight

T. M.

(2009). Clinical research regulation: Challenges to the institutional review board system. Clinics in Dermatology, 27(4), 375–383. https://doi.org/10.1016/j.clindermatol.2009.02.012

28.

Varley

P. R.

Feske

Gao

Stone

R. A.

Zhang

Monte

Arnold

R. M.

Hall

D. E.

(2016). Time required to review research protocols at 10 veterans affairs institutional review boards. The Journal of Surgical Research, 204(2), 481–489. https://doi.org/10.1016/j.jss.2016.06.004

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