Independent Research and IRB Reviews

by Solutions IRB Board Member, Ron Wallace, PhD

Many Methodspace researchers conduct independent research, or are in situations where they do not have access to an Institutional Review Board or other ethics review options. Working with a private agency is an option, as described in this guest post.

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The first thing that often comes to mind when thinking about research is studies associated with clinical research. For purposes of this article, clinical research is defined as studies that involve some type of intervention that results in a direct interaction with the subject’s body and/or biospecimens.

However, social, behavioral, and educational (SBE) research also comprises a significant portion of the research world. These types of studies are often conducted by independent researchers that may not be affiliated with an academic institution that has an established institutional review board (IRB). Organizations involved in research might also find it beneficial to outsource study reviews to independent IRBs. In these situations, the independent researcher and organizations without an internal IRB will need to rely upon a private IRB to obtain the necessary ethical review prescribed by the Code of Federal Regulations Title 21 to ensure human subjects are protected. An IRB is responsible for confirming that studies are conducted in a way that minimizes risks to participants and meets federal guidelines.

It should be noted that just because human subjects and/or their personal data is required for the study does not automatically mean the study requires a formal IRB review. The researcher has a responsibility to determine whether or not IRB review and approval are required. Independent researchers can ask themselves a few simple questions as a first step towards determining whether or not the study requires an IRB review. Taking the time to verify whether or not a research study requires IRB review and approval provides the researcher with the confidence of knowing their study complies with federal guidelines designed to protect human subjects in research.

Some studies may require an IRB review and approval for reasons that are not directly related to the federal code definitions of human subjects in research. For example, the funding source may require IRB review and approval as a condition of a grant or award. Another potential reason the researcher might want to obtain an IRB review and approval is to ensure the study design has the rigor and credibility required for publishing findings in scholarly peer-reviewed journals.

Risk Levels

Typically, the first step when working with a private IRB is a determination of initial risk and classification level. It is important to stress ‘initial’ levels here because as new information about the study emerges during the review, the risk and classification level are subject to change.

There are two risk levels that can be assigned to a study; ‘no greater than minimal risk’ and ‘greater than minimal risk’. The main difference between the two risk levels is whether or not the study could pose a risk to the welfare of study participants. Most ‘greater than minimal risk’ studies tend to be clinical in nature since a medical intervention could have an unwanted physical consequence to the study participant, thereby increasing the potential for harm. The majority of non-clinical (SBE) studies tend to fall within the ‘no greater than minimal risk’ level.

Classification Levels

Classification levels are broken into three levels; ‘exempt’, ‘expedited’, and ‘full board’. Simple studies often qualify for an ‘exempt’ or ‘expedited’ classification review status. More complex studies will require a ‘full board’ review. If a study is being conducted outside of the U.S., it will be designated as an ‘international’ study and then assigned to either the ‘expedited’ or ‘full board’ classification level. ‘Exempt’ and ‘expedited’ studies also have subcategories that describe the type of study being conducted. There are currently eight subcategories for ‘exempt’ status studies and nine subcategories of ‘expedited’ status studies.

‘Full board’ classification level studies typically involve one of the officially designated vulnerable populations per federal code (i.e., children, prisoners, and pregnant women), other study participants that might require an additional level of special protection (e.g., mentally impaired, elderly, end-of-life, etc.), or some other attribute that requires special IRB review. These ‘full board’ studies undergo a review by two IRB reviewers and then are presented to the full board at convened meetings. The members of the full board will discuss each study presented and then vote to establish risk level and whether to approve, approve with conditions, defer, or deny a study. Unless specifically designated otherwise by the full board, all studies are reviewed again on an annual basis for continued compliance.

Informed Consent

A key aspect of all studies regardless of risk or classification level is the requirement for informed consent by study participants. In some special situations, the IRB may allow for an alteration of consent, waiver of consent, or waiver of consent documentation. Criteria exists for determining whether a study qualifies for either of these deviations from the normal informed consent process.

Help is available!

Feeling overwhelmed by the process after reading this article? When an independent researcher does not have access to an institutional or organizational IRB, a private IRB such as Solutions IRB could be the right answer. A private IRB has the resources available to assist any researcher in navigating the sometimes challenging process of obtaining formal IRB approval for a study.

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