”Theirs was not to make reply, Theirs was not to reason why.”

المؤلفون

  • Margaret Hoogland

DOI:

https://doi.org/10.18060/26492

الكلمات المفتاحية:

Institutional Review Board، Research Approval Process

الملخص

Background: In 1974, the United States passed the Research Act, which required creating and implementing guidelines for conducting research on humans and animals. In 1978, universities and hospitals created Institutional Review Boards for reviewing and approving research protocols in the United States.

 

Objectives: This article will define and explain the components of a research protocol, research team member roles and responsibilities, pre-protocol submission training requirements, and provide suggestions for improving how researchers obtain research approval.

 

Lessons Learned: The author failed to provide all the required information before collecting Informed Consent to prospective participants for four different study protocols.

 

Conclusions: Obtaining research approval is necessary for most study designs. It is a complex and frequently tedious process, but obtaining approval gives research studies greater credibility.

المراجع

References

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Ethical Principles For Medical Research Involving Human Subjects. World Medical Association; 1964 [updated September 6, 2022]; [cited 2022 November 9]. Available from: https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/.

Gelling L. Why do I have to apply for ethical approval before I can begin my research? Nursing times. 2011;107(30-31):23. https://search.ebscohost.com/login.aspx?direct=true&AuthType=shib&db=mnh&AN=21957523&site=eds-live&authtype=ip,shib&custid=s8899245.

Code of Federal Regulations Washington, DC: National Archives; 2022 [updated 2022]. Available from: https://www.ecfr.gov/.

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Nagai H, Nakazawa E, Akabayashi A. The creation of the Belmont Report and its effect on ethical principles: a historical study. Monash Bioeth Rev. 2022;40(2):157-70. doi:10.1007/s40592-022-00165-5

Barnard M. How to apply for research ethics committee approval. Nurs Child Young People. 2016;28(6):16. doi:10.7748/ncyp.28.6.16.s20

735. Protocol Deviations. Reno, Nevada: University of Nevada at Reno - Institutional Review Board; 2021 [updated July 14, 2021]; [cited 2022 October 18]. Available from: https://www.unr.edu/research-integrity/human-research/human-research-protection-policy-manual/735-protocol-deviations#:~:text=irb%20review%20of%20protocol%20deviation%20reports&text=each%20protocol%20deviation%20reported%20to,or%20the%20resultant%20scientific%20data.

Protocol Violation or Incident. San Francisco, California: University of San Francisco - Institutional Review Board; [updated August 2, 2022]; [cited 2022 October 18]. Available from: https://irb.ucsf.edu/protocol-violation-or-incident#:~:text=You%20must%20report%20all%20major,or%20continuing%20noncompliance%20(SCNC).

IRB Manager: Tech Software [updated 2022]; [cited 2022 November 9]. Available from: https://www.techsoftware.com/.

Eldermire E, Alpi K, Fricke S, Kepsel A, Kerby EE, Page JR, Norton HF. Expanding a single-institution survey to multiple institutions: Lessons learned in research design and deployment. Hypothesis [Internet]. 2021 Feb. 25 [cited 2023 Feb. 13];32(1). Available from: https://journals.iupui.edu/index.php/hypothesis/article/view/23945

Hoogland MA. Options for Accessing Online Electronic Resources in Difficult Fiscal Times. Journal of Electronic Resources in Medical Libraries. 2021;18(1):1-19. doi:10.1080/15424065.2021.1875944

التنزيلات

منشور

2023-03-30

كيفية الاقتباس

Hoogland, M. (2023). ”Theirs was not to make reply, Theirs was not to reason why.”. Hypothesis: Research Journal for Health Information Professionals, 35(1). https://doi.org/10.18060/26492

إصدار

القسم

Hypothesis: Failure

الفئات

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