What is IRB?
The Institutional Review Board (IRB) is the committee charged with the responsibility of approving federal-funded studies involving human subjects. The institution was created as a solution for the rising cases involving the violation of participants’ rights by various research teams in the course of conducting biomedical studies (Amdur & Bankert, 2010).
The Three Types of IRB Review
Exempt Review
This review involves approval by a single member of the board. It applies to studies considered to pose negligible risk to human participants engaged in biomedical research works. Low-risk studies are listed in the 45 CFR 46.101(b), and any research that falls in this purview does not require approval by all members of the board (White, 2007). Some of the studies that belong to this category include
- Studies carried out in line with the standard learning practices
- Studies utilizing no-risk tests such as surveys, interviews, and observations
- Studies involving pubic officers
- Studies involving the collection of publicly available data
- Taste and food preference by individuals
Expedited Level of Review
Research works that fall under this category are considered to pose minimal risks to the subjects. The board’s chair and at least one experienced researcher execute the approval (Amdur & Bankert, 2010).
Full Board Review
This category of the review includes research works that are considered to pose a high risk to participants, and it requires approval by all board members (Greene & Geiger, 2006). Studies that fall under this category take long to be approved due to the protocols involved.
The Level of IRB Review for my Project
My research plan would focus on abuse cases on minors by seeking to establish the effects of abuse on children aged between five and ten years with learning difficulties. The research would require full board approval since it involves minority groups.
Ethical Challenges
My research plan would center on children with learning disabilities who are categorized as members of the special population. In conducting such research work, the controversy would be evident due to the ethical requirements involved. Firstly, there is an ethical requirement by IRB that the privacy of data acquired from such research be guaranteed. Storage of such data may be compromised since it may only be stored in computers, which unauthorized individuals can access. The courts may also compel a researcher to disclose certain information, thus compromising data confidentiality provision (Rowan-Legg, Weijer, Gao, & Fernandez, 2009).
Secondly, the collection of data from human subjects requires informed consent from the participants. Minors may not enter binding contracts, and thus such consent can only be obtained from their parents or guardians (White, 2007). Parents might be reluctant to give such consent since child abuse is a sensitive issue that may result in legal actions if detected.
Weighing out the Risks and the Benefits
The findings from the research would be used to increase the current knowledge about child abuse and recommend strategies to mitigate the vice. Additionally, this study would be used as the framework for future research works on the topic, and thus it would result intangible benefits to the target population. In light of the listed benefits, I would undertake the study since it is evident that the gains outweigh the risks.
The Possible Ramifications for not using IRB Review
Failure to obtain IRB approval may result in several negative consequences. Some of the consequences of non-compliance with IRB approval requirements include premature termination of the research, obliteration of the wrongfully obtained data, the suspension of the researchers’ eligibility to conduct such studies, and denial of funds (Greene & Geiger, 2006). Moreover, legal action can be instituted against the noncompliant researcher for obtaining data from human subjects without the IRB’s approval.
References
Amdur, J., & Bankert, E. (2010). Institutional review board: Member handbook. Burlington, MA: Jones & Bartlett Publishers.
Greene, M., & Geiger, A. (2006). A review finds that multicenter studies face substantial challenges but strategies exist to achieve Institutional Review Board approval. Journal of Clinical Epidemiology, 59(8), 784-790.
Rowan-Legg, A., Weijer, C., Gao, J., & Fernandez, C. (2009). A comparison of journal instructions regarding institutional review board approval and conflict-of-interest disclosure between 1995 and 2005. Journal of Medical Ethics, 35(1), 74-78.
White, R. (2007). Institutional review board mission creep. Independent Review-Oakland, 11(4), 547.