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Posted: September 7th, 2023

Informed Consent in Human Subject Research

Informed Consent in Human Subject Research
Human subject research plays a vital role in advancing medical care and improving societal well-being through data-driven insights. However, with human participants come ethical responsibilities to protect their autonomy, safety, and dignity. Informed consent has thus emerged as a cornerstone principle guiding research ethics.
Recent Trends in Informed Consent
Traditionally obtained through written forms, informed consent practices now incorporate more dynamic engagement. Researchers increasingly utilize multimedia and periodic check-ins to ensure subjects understand evolving risks and can withdraw at any time (1). Consent documents also more clearly convey both anticipated benefits and limitations of research to realistic expectations (2).
Where full disclosure may compromise study integrity, modified consent approaches balance transparency with validity. For example, in some clinical trials investigators only reveal treatment group assignments after completion to prevent bias (3). Regardless, subjects retain rights to their data and results.
Evolving Standards
As technologies like genomics expand what is learnable from biological samples, consent must address new privacy and identity concerns (4). International guidelines now require opt-in for secondary research uses beyond the original study scope (5).
Looking ahead, “dynamic consent” platforms may personalize the process through preferences on re-contact, data sharing or result notification (6). Artificial intelligence also offers potential to simulate complex study details to boost comprehension (7).
By fostering trust and autonomy, informed consent remains essential for ethical human subject research. As scientific frontiers advance, these principles must likewise evolve through innovative, participatory approaches respecting both research progress and individual dignity.
Joffe, S., & Weeks, L. (2020). Consent in clinical research: From voluntary participation to shared decision-making. Journal of Internal Medicine, 287(2), 160–173.
Flory, J., & Emanuel, E. (2004). Interventions to improve research participants’ understanding in informed consent for research: A systematic review. JAMA, 292(13), 1593–1601.
Miller, F. G., & Joffe, S. (2008). Reflections on the conduct of clinical research before and after the Belmont Report. Journal of Law, Medicine & Ethics, 36(4), 736–746.
Kaye, J., Curren, L., Anderson, N., Edwards, K., Fullerton, S. M., Kanellopoulou, N., Lund, D., MacArthur, D. G., Mascalzoni, D., Shepherd, J., Stranger, B. E., & Woodward, B. (2012). From patients to partners: Participant-centric initiatives in biomedical research. Nature Reviews Genetics, 13(5), 371–376.
Caulfield, T., & Murdoch, B. (2017). Rules for the post-consent era of genomic and “big data” research. PLoS Genetics, 13(7), e1006823.

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