IRB in Different Settings

IRB in Different Settings

Grantham University

CA408

IRB in Different Settings

Historically, some researchers had few (if any) scruples about the harm they inflicted on certain people or animals (Leedy, & Ormrod, 2016). For this reason, the federal government have created a system to review research that is being conducted on human research subjects. This is called the Institutional Review Board (IRB), which is a type of committee created by the federal government to protect human research subjects and their rights to ensure that the methods proposed are ethical. These boards are formally designated to approve or disapprove, monitor, and review research involving humans. The purpose of the IRB is to assure that appropriate steps are taken to protect the rights and welfare of human participating as subjects in a biomedical research study. Institutions can have their proposal review in one or two ways, through expedited review or IRB review.

Expedited review involves a review of a proposal by a subject of the IRB that include the Chair and at least one other board member. The expedited review is generally used for researchers in fields that have had many studies already done and data is already available. An expedited review maybe carried out if the research involves no more than minimal risk to participants and meets other standards, such as not including protection classes or vulnerable populations, and not using intentional deception. Expedited review can be used when minor changes are proposed to an approved research project during the period for which approval is authorized (University of North Carolina).

IRB review requires most IRB members to vote on the proposal. IRB usually involve projects that place human subjects at more than minimal risk, or that involves sensitive topics or vulnerable populations such as prisoners, terminally ill patients, children, veterans, or cognitively impaired persons. IRB review can approve, disapprove, or require modification for a proposal, conduct continuing reviews, suspend or terminate approval, observe or have a third party observe, the consent process, and the research procedures and their decision cannot be overturned by institutions (University of North Carolina).

Review procedures for expedited review and IRB review are similar in several ways: (1) the review criteria are the same, (2) reviewers using the expedited review procedures or the convened IRB can request modifications to research plans and approve the plans, and (3) expediting reviewers and the IRB must specify when a research plan must be reviewed again. By regulation it must be within twelve months of approval; but, the important difference between expedited review and IRB review is that expedited reviewers cannot disapprove a research plan; if an expediting review thinks a research plan is not approval, the plan must be submitted to the IRB to review (Hicks, 2015). However, the criteria and procedures of an IRB vary from one institution to another (Leedy & Ormrod, 2016)), because institutions have their own policies and procedures which they follow to meet the needs of an IRB review to ensure that their proposals are ethical.

Research activities that are eligible for expedited review, in additional to studies involving surveys, focus groups, interviews, and observation of behavior, includes studies involving the collections of biological samples and data by non-invasive. Biological samples include saliva and fingernail cuttings or measures of pesticide exposure using skin patches; and data collected by non-invasive includes galvanic skin response, heart rate and blood pressure. A category of research activity eligible for expedited review includes the collection of blood samples within well-defined parameters based, research involving identifiable data collected for non-research purposes and the collection of existing data from voice, digital, or image recordings made for research purposes; however, institutional policy, local conditions, and subject vulnerability require IRB review, even for a study with no more than minimal risk, such as a study of individuals with impaired decision making. IRB review involves consideration by a larger, more diverse group, and bring more perspectives and experience to the review (Hicks, 2015).

Each organization should place a large amount of importance in IRB, because it will help to ensure that the organization is not sued for liability, and have followed the ethical of conducting studies on human research subjects. The IRB serve as an objective third part to ensure that federal regulations are being followed for protecting and managing risk to human participants involved in research; this will help the organization to ensure that the safety and well-being of the person is secure, that they are adhering to the ethical values and principles when researching, and to help the organization to only conduct ethical and scientifically valid research.

References

Hicks, L. (2015). CITI Human Research Training Course: The Federal Regulations. CBE. Retrieved from, https://www.citiprogram.org/members/index.cfm?pageID=665&ce=1

Leedy, P. D., & Ormrod, J. E. (2016). Practical Research: Planning and Design

University of North Carolina. (n.d.). Institutional Review Board: Exempt, Expedited and Full Review. Retrieved from, https://irb.unca.edu/exempt-expedited-and-full-review