The Importance of the Internal Review Board for Approving Proposed Research

Abstract

Sonography, or the use of ultrasound, has become readily available in nearly every health care service line, giving sonographers countless opportunities to take an active role in research. Effective research is not limited to clinical investigations but can also include other important aspects of sonography such as education, new technologies, or departmental and administrative matters. It is important to remember that with these research opportunities comes responsibility. The first step in responsible research is learning the role and process of the hospital review board and/or an internal review board (IRB).

What Is an IRB?

The IRB is a review board that evaluates research that involves human or animal participants. Federal regulations require institutions receiving federal funding to review and approve the research.¹ As a result, research institutions require IRB approval for all research involving human and animal participants, regardless of the funding source. The process of each IRB varies by institution, but there are typically three levels of IRB review: exempt, expedited, and full review. Most institutions do not allow researchers to “self-exempt.” Determining whether the proposed research qualifies for exemption is the responsibility of the IRB. The best course of action for the researcher is to submit an application and allow the IRB to determine if the research status is exempt.

Why Have an IRB?

The main goal of implementing an IRB is to protect the rights and welfare of human and animal participants. Special consideration is given to vulnerable populations such as pregnant women and fetuses, individuals involuntarily confined, or students. This is not a foreign concept in the health care setting where a primary goal is to protect the patients and their data. The importance of this process is rooted in The Belmont Report of 1979, which outlines three main principles in conducting ethical research with human participants.² These principles are respect for persons, beneficence, and justice. The report stemmed from concerns regarding questionable ethical practices used by researchers during the early 1900s through the 1960s.

When the IRB is discussed, many questions may arise:

Is all research subject to the same standard as experimental research? Yes!

Do I always have to have IRB approval for survey research involving human participants? Yes!

Are students under the same IRB standard when working on research? Yes!

What if a student is not the primary investigator? Does the student still need to be “IRB approved”? Yes!

What if I or a student is added to a project after it is IRB approved? Must the IRB be notified? Yes!

What if My Institution Does Not Have an IRB?

Although institutions that engage in research involving human or animal participants usually have an IRB to oversee research conducted within the institution, federal regulations permit a non-IRB institution to arrange for an IRB institution to be responsible for reviewing research conducted at the non-IRB institution. Such arrangements for review of proposed research should be documented with a written agreement.

What Does an IRB Application Require?

Institutions will first require researchers to complete a training course that reviews the ethical principles of research. Then an application can be submitted to the IRB that outlines the research purpose, the research methods, the research subjects with process for anonymity, the risks and benefits to the subjects, and the forms that will be used during the research project.

When Can Data Be Collected?

Participant recruitment, participant consent, and data collection can begin after written approval from the IRB has been received. No provision is noted in the federal regulations to allow IRB approval for research that has already been conducted.¹ The IRB can approve analysis of data initially collected for nonresearch purposes.

Guiding Principles

Be diligent: While the IRB process seems arduous, breaking the task into smaller steps allows the submission process to be managed easier. Create a task list and work through it.

Use the IRB website: The institutional IRB website will have needed information related to the application process but will also have helpful information like board review timelines, required paperwork, and so on.

Consult the IRB and use them as a resource: If an ethical concern within the research arises, the IRB chairperson or consultant is there to offer guidance and recommendations about how to address those concerns.

Appreciate the review and the approval process: Remember that the IRB review process is in place to protect the rights of the participants. The board will focus its review on the risk to the participants. The IRB is not there to critique the value of the research.

In summary, opportunities for sonography research are more abundant than ever. It is important to underscore that conducting research must be done ethically and responsibly. Start all research projects with an IRB review and approval process. While the IRB process may seem daunting, obtaining IRB approval ensures that investigators critically think about the research goals that make the project stronger while safeguarding participants from unnecessary risk.

Dora DiGiacinto, MEd, RDMS, RDCS, FSDMS

References

Office of the Federal Register and Government Publishing Office: Code of Federal Regulation; Title 45 Public Welfare; Part 46 Protection of Human Subjects. https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html#46.103. Accessed November 1, 2018.

National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, Office for Human Research Protections: The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/index.html. Accessed November 1, 2018.