For an irb review to be required, clinical research must be:

An IRB is a committee within a university or other organization receiving federal funds to conduct research that reviews research proposals. The IRB reviews the proposals before a project is submitted to a funding agency to determine if the research project follows the ethical principles and federal regulations for the protection of human subjects. The IRB has the authority to approve, disapprove or require modifications of these projects.

An IRB consists of at least five members of varying backgrounds. IRB members should have the professional experience to provide appropriate scientific and ethical review. An IRB must have at least one scientist member and at least one member whose primary concerns are nonscientific. Additionally, there must be one member who is not otherwise affiliated with the institution (a community representative). The IRB should strive for appropriate representation in gender and racial and cultural heritage as well.

In 1974, the Department of Health Education and Welfare promulgated the regulations on the Protection of Human Subjects that established the IRB. IRBs are administered on a federal level by the Office for Human Research Protections (OHRP), an office within the Department of Health and Human Services. OHRP assists IRBs in their work and receives and investigates claims of inappropriate research practices.

The institution that the IRB serves provides administrative support for its activities including designation of an individual within the institution to oversee research and IRB functions. The institution also files an "Assurance" with the federal government that describes the procedures and guidelines that the IRB must follow.

IRBs are charged with reviewing all federally funded research projects involving human subjects with a few exceptions (e.g., reviews of records or surveys in which subjects cannot be individually identified or when disclosure of subjects' responses could not place them at risk of criminal or civil liability and is not damaging to subjects financially, vocationally or socially). However, based on the procedures set forth in the Institutional Assurance, the IRB may review all research projects, regardless of the source of funding.

Before an investigator can receive federal funds to conduct a research project, the protocol (research procedures) is reviewed by the IRB. The researcher provides the IRB with all the necessary materials to conduct their review including a full description of the proposed project, materials the subjects will use (surveys, questionnaires, tests, etc.), a description of the manner in which subjects will be recruited and provide consent to participate in the project (including a consent form), and how the subjects' confidentiality will be maintained.

The IRB examines all these materials to determine if the research participants are adequately protected. The IRB's consideration is based primarily on weighing the risks and benefits of the research. Risks may be physical, psychological, social or economic. Benefits include both those to the individual research participant and to society as a whole. The IRB also considers the population being studied — Does it require additional protections? Would this population assess the risks and benefits differently?

After examining the materials the researcher provides to the IRB, they must decide if the benefits of the research have been maximized and the risks minimized, and make a final determination whether the benefits justify the risks to the subjects. If the IRB finds that this is the case, they may approve the protocol. Alternatively, the IRB may request that the researcher make specific changes to the procedures and approve the protocol contingent on these changes or ask that the protocol be revised and resubmitted. Finally, the IRB may decide to disapprove of the project. Institutional officials may disapprove research protocols that have IRB approval, but they may not grant approval of research projects that have been disapproved by the IRB.

In addition to reviewing new research protocols, IRBs also review continuing projects or those that have changes in their procedures. Continuing projects are reviewed yearly (or more often if the IRB feels it is necessary).

The Code of Federal Regulations requires that IRBs give special consideration to some classes of subjects: children, prisoners, pregnant women, mentally disabled persons, and economically or educationally disadvantaged persons. The IRB carries out this charge in a number of ways. In many cases, the IRB may approve of research with these subjects only when it involves minimal risk or when the benefits apply to the subject directly. Additionally, if the IRB frequently reviews protocols involving one of the special groups, they may have a community member whose primary interests are with one of these groups.

The institution and the IRB maintain records of IRB activities including copies of the research protocols reviewed, minutes from meetings and correspondence. All records must be made available for review by OHRP.

The content I just read:

APA strongly encourages the use of psychological science in policy-making decisions and vigorously defends the field from partisan attacks.

Institutional review boards (IRBs) are an important part of regulatory efforts. An IRB is an ethics review committee that is in place to ensure human research subjects’ rights are protected, as well as the rights of the patients who ultimately benefit from the research.

Operating under US federal regulations, state laws, and institutional policies, the IRB has the authority to approve, require modification to, and disapprove research. IRB approval is required for all human research.

An IRB review includes information about the physicians, scientists, and community members involved in the research.

Here’s a quick overview of IRBs and the expectations for working with them.

Who serves on an IRB?

A typical IRB is composed of physicians, a scientist, a non-scientist, and a representative from the community from which the human subjects are drawn.

Research trials sometimes involve the participation of human subjects who belong to what are considered “vulnerable populations”; i.e., children or incarcerated individuals who cannot adequately communicate their own interests with regard to informed consent. In such cases, federal regulations require that the IRB include a representative to protect the interests of those individuals.

Federal regulations (21 CFR 56,107e) prohibit the participation in an IRB of clinical investigators or others who may have conflicting interests.

Specific study responsibilities

Informed consent is a critical consideration for IRBs in their mission to insure protection of the rights and interests of the human subjects of research trials. The IRB is responsible for determining that informed consent forms provided to research subjects include all required information about the nature and extent of the activities involved in the research, and that the forms were reviewed and signed by the trial subjects.

The IRB further protects the interests of human subjects by reviewing the research trial in order to insure an appropriate balance of risks and benefits. Risk minimization efforts can include the use of already available data or processes. “There are safety provisions along the way,” explains Dr. Wanda Snead, research educator in the Global Quality and Education Department at Sarah Cannon Research Institute. “There’s monitoring of all of the aspects of the trial.” The IRB also is responsible for insuring that each step in the research trial process is properly documented and reported.

Equitable subject selection is also a critical IRB consideration. What is the rationale for the inclusion and exclusion criteria applied in subject selection? If vulnerable populations are to be involved, what is the justification? What measures are in place to protect the privacy and confidentiality of research subjects?

“The IRB will review all of this criteria,” says Dr. Snead, “and if they find any of it lacking, they can refuse the start of the trial until all of these matters are cleared.”

Does your research require IRB review?

Is it research? U.S. Department of Health and Human Service Office for Human Research Protections (45 CFR 46) defines research as “a systematic investigation, including research development, testing and evaluation, [that] is designed to develop or contribute to the generalizable knowledge.” Based on this definition, case studies do not qualify as research because they are not systematic. Similarly, internal quality improvement activities do not qualify as research because they’re not designed to produce generalizable knowledge. In either case, IRB review is unnecessary.
Does it involve human subjects? The involvement of human subjects in research is not limited to the use of the human body. Access to private information about the subject and the use of data or specimens also constitutes human involvement, as does interaction or intervention with the patient. Research “may not just be injecting the body with some new vaccine,” says Dr. Snead. “It could be just reviewing records or using data from the medical chart, and there may be blood samples or tissues samples that have been taken for perpetuity that can be linked back to an individual. Or it could be questionnaires or surveys and procedures.” Each of these examples involves a human subject, and as such is considered human research.

What an IRB wants to know

In fulfilling its oversight mission, an IRB seeks answers to certain key questions. Those answers provide the IRB with proof that the investigators and medical and scientific professionals involved in a study fully understand the ethical and technical requirements and standards that must be met in conducting the research.

The information the IRB is looking for includes:

A clear definition and explanation of the activities, procedures, and protocols involved in the research;
Specific information on the composition of the subject population and the inclusion/exclusion criteria used in the selection of human subjects;
Proof of informed consent — the voluntary participation of human subjects; and
Documentation of the risks and benefits of the proposed research.

“Investigators can’t just decide that they’re going to run a clinical trial,” explains Dr. Snead. “They’ve got to go through training in the rules and regulations, making sure that they can conduct the trial from an ethical standpoint.”

The IRB’s role is that of a watchdog, guarding the interests of the human subjects of the trial.

NIH policy mandates use of a single IRB (sIRB). And in January of this year, OHRP “Common Rule” regulations expanded the requirement to all federal research.

As a result, research sites will increasingly need to work with multiple IRBs, not just the local IRB. This impacts many aspects of how research sites conduct research and interact with the IRB, especially for sites previously accustomed to working with only a local IRB.

You may also like: What Goes Into An Instigator Site Fie

The Complion platform provides easy-to-use tools to file, control, share and central access all regulatory documents. Schedule a demo to learn more today.