The document discusses the roles of central institutional review boards (central IRBs) and local institutional review boards (local IRBs) in protecting human subjects. It takes the position that central and local IRBs are not equivalent in their roles. Central IRBs represent the interests of a broader population in multisite research studies, while local IRBs represent more limited, local populations. Central IRBs also have greater resources and efficiency in reviewing protocols compared to local IRBs. However, the document also discusses opposing arguments, noting that both central and local IRBs aim to ensure ethical standards like informed consent and assessing risks and benefits. Ultimately, both play important roles in research oversight and human subject protection.

1. Dr. Obumneke Amadi-Onuoha_scripts_ 6
Crit Analysis in Clin Research
No, Central vs. local IRBs equivalent
The purpose of this discussion post assignment is to post a position statement and a rationalized
argument on : Are central institutional review boards (central IRBs) and local institutional
review boards (local IRBs) equivalent in their roles in the protection of human subjects?
1. Formulate a definitive position (yes/no).
 No, central and local IRBs are not equivalent in their roles in the protection of
human subjects.
2. In the body of your thread, present your position. Include the following:
 Brief introduction :
 The IRBs are referred to as a properly constituted group that has been
officially nominated to provide ethical and regulatory oversight (review
and monitor) biomedical research to assure the protection of the rights and
welfare of human subjects participating in clinical research/trail, there are
3 different types of IRBs, however, they have common goal of protecting
the rights of human subjects involving in clinical research/trail (Bronte-
Tinkew, Allen, & Joyner, p.3). For this discussion, the emphasis is on
central and local IRBs, the local IRBs, are affiliated with the institution or
organization conducting the research and are within the location of study
site (i.e. research occurs in one site) and the central IRBs, are affiliated
with large and multi-site clinical research / trials e.g. cancer research.
Research are conducted and involved multidisciplinary team efforts in the
community (Bronte-Tinkew, Allen, & Joyner, p.3).
 Thesis statement:
 There is not equivalence in the roles of central and local IRBs in the
protection of their human subjects.
 Arguments to support my thesis:
1. I argue to support my thesis statement that with contrast in research
efficiency & coordination, the local IRBs, represents the interest of local

2. communities- limited population, whereas, the central IRBs represents the
public, broader population in research (Wechsler, 2007, p.1). Local IRBs
have less efficiency and coordination of regulatory actions to review
compared to central IRBs, because central IRBs are enhanced by factors
that include frequent meetings, better technologic resources and
management and others (Mascette, 2012, p. 3-4).
2. I argue to support my thesis statement that, the central IRBs operations are
commercial, conducts high stake smart studies and involves multi expert
collaborations, whereas, the local IRBs is the opposite(Wechsler, 2007,
p.1). In justifying ethical values in terms of scientific validity of the
research, local IRBs have lesser roles in assessing the feasibility of the
scientific principles and methods in compliance with all ethical rules
outlined in Belmont report (Respect for Persons, Beneficence, Justice)for
human research protection (NIEHS/NIH, 2019).
3. I argue to support my thesis statement that, in comparison to local IRBs, a
central IRB have much workload (reviewing multisite protocols) than the
local IRBs that may make it very challenging to conduct a thorough and
consistent, informed review of research to enhance the protection of
research participants(Stephanie, 2013, p.11-12) e.g. research involving
central IRBS are conducted at different places, whereas, those involving
local IRBs are conducted in the site (Bronte-Tinkew, Allen & Joyner,
2008, p.3),this augments the nature of workload and duties performed by
the different IRBs, showing they cannot be equivalent in their roles.
 Opposing arguments to my thesis:
1. I oppose my argument 1above, that, because both central and local IRBs
comprise & effect authorization of IRB protocols, and assess the
investigators credentials, also, both can either evaluate the local context of
the research and can also provide waiver of consent for the study, these are
the basics and fundamental ethical requirement assessment towards
conducting research for the protection of human subject research, also,
according to National Academy of Sciences (2019), the local and central

3. IRBs reviews research that requires ethical and legal responsibilities for
the protection of human participants enrolled into such research(p.251).
Based on this, both IRBs are equivalent in roles for their duties towards
determining and justifying the ethical research requirements of research
participants (Flynn et al, 2013, p.3).
2. The function of IRBs, both central and local is fundamentally to resolve
questions about ethics, the moral obligation towards conducting a clinical
research involving human subjects with respect to their autonomy and
protection as volunteer subjects, there is no expert skill requirement for
members of IRBs (Moon, 2009, p. 314), therefore, I oppose my argument
2 above, that, the central and local IRBs are not equivalent in roles in
assignment, because their role is to evaluate and justify ethical values
requirements such as respect for potential and enrolled subjects in research
e.g. protecting privacy and confidentiality, inform subjects of risk and
benefits in research for participants protection(Emanuel, Wendler &
Grady, 2000, p. 2703).
3. I oppose argument 3 above, that, neither IRBs structure is free from
potential conflict resolution(Moon,2009, p.312), because both IRBs
structure roles performs independent review of the research design, that
entails justifying the ethical values of public accountability, and reducing
of potential conflict of interest that promotes e.g. a favorable risk benefit
ratio to protect research participants(Emanuel, Wendler & Grady, 2000, p.
2703), also, they provide information’s such as the purpose of the research
to research participants and obtain informed consent for their enrollment
into the research. According to Klitzman (2011), IRBs play important
roles in observing, monitoring, and responding, to research integrity, such
that they develop research initiatives that monitors the misconduct and
conflict of interest issues among researchers as measures to oversee and
protect research participant from injury (p. 1).

4. Reference
Bronte-Tinkew, J., Allen, T., & Joyner, K. (2008). Institutional Review Boards
(IRBs): What Are They, And Why Are They Important? Atlantic Philanthropies.
Emanuel, E. J., Wendler, D., & Grady, C. (2000). What makes clinical research ethical? Jama,
283(20), 2701-2711
Flynn, K. E., Hahn, C. L., Kramer, J. M., Check, D. K., Dombeck, C. B., Bang, S., & Weinfurt,
K. P. (2013). Using central IRBs for multicenter clinical trials in the United States. PloS
one, 8(1), e54999.
Klitzman R. (2011). Views and experiences of IRBs concerning research integrity. The Journal
of law, medicine & ethics: a journal of the American Society of Law, Medicine &
Ethics, 39(3), 513-28.
Moon, M. R. (2009). The History and Role of Institutional Review Boards: A Useful Tension.
AMA Journal of Ethics, 11(4), 311-316.
Mascette, A. M., Bernard, G. R., Dimichele, D., Goldner, J. A., Harrington, R., Harris, P. A.,
Leeds, H. S., Pearson, T. A., Ramsey, B., Wagner, T. H. (2012). Are central institutional
review boards the solution? The National Heart, Lung, and Blood Institute Working
Group's report on optimizing the IRB process. Academic medicine: journal of the
Association of American Medical Colleges, 87(12), 1710-4.
National Academy of Sciences (2019). Ethical Conduct of Clinical Research Involving Children
(2004).Chapter:8 Responsible Research Involving Children. Retrieved from
https://www.nap.edu/read/10958/chapter/10
NIEHS/NIH, 2019). Institutional Review Board. Retrieved from
https://www.niehs.nih.gov/about/boards/irb/index.cfm
Stephanie, P. (2013). Benefits of Working with a Central IRB: Improved Efficiencies and
Enhanced Human Subject Protections. Retrieved from
http://www.sairb.com/IRBForms/Benefits_of_Working_with_a_Central_IRB.pdf
Wechsler, J. (2007). Central vs. local: rethinking IRBs. Applied Clinical Trials, 16(2), 24.