The Institutional Review Board (IRB) at any given institution (higher education or other) is responsible for determining the acceptability of proposed research in terms of institutional regulations, applicable laws, and standards of professional/ethical/societal conduct and practice. The Board evaluates the potential risks and benefits to participants outlined in each proposal. The IRB also examines subject recruitment procedures, proposed compensation, and the informed consent process. In addition, when the IRB reviews research involving a category of vulnerable subjects (e.g., prisoners, children, or individuals institutionalized as mentally disabled), the Board will include in its reviewing body at least one individual who has expertise regarding the welfare of those subjects. IRB reviews can be long, tedious, stressful, even confusing for anyone submitting a request to their institution. So, here is a general overview of how the process works.
In light of the information provided in the proposed research plan, the IRB determines whether protection of human research subjects is adequate and in accordance with the following criteria:
The IRB will determine that the choice of subjects is justifiable by considering the purposes of the research, the setting in which the research will be conducted, and the population from which subjects will be recruited. Where some or all of the subjects are likely to be vulnerable to coercion or some sort of influence, the IRB will determine that appropriate safeguards have been included to protect the rights and welfare of all subjects.
Incentives for participation
The IRB will review any proposed reimbursement that the subject will receive as a result of participating in the research. Although this practice in order to solicit enough participation in research has long been an integral part of the recruitment process, the Board must determine that such incentives are ethical and do not encourage any undue participation leading to an excessive increase in voluntariness or a decrease in understanding of the process subjects agreed to participate in.
Qualifications of Research Personnel
Procedures requiring special skills on the part of the investigators, licensure, and/or accreditation for the performance of the proposed research are reviewed by the IRB. The Board will also take into consideration the facilities and equipment used to conduct the research and maintain the rights and welfare of the subjects.
The IRB will identify the risks associated with the research and will determine whether risks, if any, to a subject are reasonable in relation to the anticipated benefits and the importance of the knowledge that is to be expected as a result. Where appropriate, the IRB will determine whether the research plan makes adequate provision for monitoring the data collected to assure the safety of the subject, and that there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.
The IRB is also required to ensure that potential subjects will be provided with an accurate and fair description of the risks or discomforts and the anticipated benefits, and to determine intervals of periodic review (i.e., informed consent).
The Informed Consent Process
The Board will evaluate the informed consent process: when, where, and how consent is obtained and any provisions for the ongoing consent of subjects. The IRB will verify that the basic elements of consent have been incorporated into the consent document that is presented to the prospective subject in as clear and easily readable a manner as possible.
Basic elements of consent
The IRB will determine that informed consent will be obtained in a manner and method that meets the requirements of 45 CFR 46.116. Such requirements include, but are not limited to:
· obtainment of consent from the subject or the subject’s legally authorized representative;
· all information written in language understandable to the subject or the representative;
· data is obtained under circumstances that offer the subject or the representative sufficient opportunity to consider whether the subject should or should not participate;
· and does not include language through which the subject or the representative is made to waive or appear to waive any of the subject’s legal rights or releases (or appears to) the research investigator, sponsor, institution, or its agents from liability for negligence.
FDA requirements for informed consent
For research involving FDA-regulated products, a statement that the FDA is authorized to inspect all records associated with the research must be included on the consent form. For more information, visit the Food and Drug Administration’s web page on Regulations.
Levels of IRB Reviews
The review of applications to involve human subjects in research is a multi-step process. The process begins with the submission of an application to the IRB Office who screens the initial application packet and corresponds with the investigator if clarification is needed on any part of the application. Once the screening has been completed, the protocol is submitted to the Board for review.
New and continuing protocols may undergo one of two levels of Board review, full Board or expedited review. In some cases the IRB Office, in consultation with the IRB Chair, may determine that a protocol requires only administrative review by the IRB Office. Amendments or modifications to currently approved protocols must also be reviewed by the IRB.
During the review process, the Board examines the protocol and supporting documentation to ensure that the investigator has addressed all information regarding their proposed research. Any issues or concerns identified during the IRB review will be communicated to the investigator. Investigators should be aware that initial Board review most often results in a request for additional information, clarification, or revisions to the protocol prior to the Board giving final approval of the research protocol. Receiving correspondence from the IRB Office after a review by the IRB is typical and should not be viewed as a negative commentary as the Board is only asking for expansion or clarification in order to complete a thorough review.
Research Reviewed by the Convened Board (Full-Board Review)
Except for research qualifying for an expedited review, all protocols (including those considered classified or sensitive) must be reviewed during convened meetings at which a majority of the members of the IRB are present, including at least one member whose primary concerns are in nonscientific areas. In order for the research to be approved, it must receive approval from a majority of those members present at the meeting.
Reviews by the convened Board can take up to two months from the date of submission until the Board identifies necessary clarifications and modifications. In the event that no additional information or modification is required, the IRB may approve a study within this time period. The Board may come to one of the following four determinations:
Approved as submitted—an approval letter is sent to the investigator and supervisor within three to five working days.
Approved pending completion of minor modifications and/or clarifications—The IRB will correspond with investigators regarding clarification and/or modifications to the protocol or consent form. An investigator’s response to IRB correspondence may be approved without review by the full Board (a subcommittee or chairperson is sufficient).
Deferred—Studies are deferred when the IRB has substantive concerns or significant requests for clarification. Responses to IRB correspondence in this category will be resubmitted to the full Board for further consideration.
Disapproved—Investigators have the right to directly discuss with the Board requests for revision and decisions of disapproval. The IRB, however, retains the final authority.
Research Eligible for Expedited Review
Expedited review allows the IRB Chair, an individual Board member, or a designated subcommittee of the IRB, to evaluate and approve specific types of minimal risk research (the probability and magnitude of harm or discomfort anticipated in the research). Reviewers conducting an expedited review may exercise all of the authority of a convened Board meeting except that they may not disapprove a study. If the research cannot be approved under expedited review, the study will be referred to the full Board for review at the next scheduled meeting. Investigators should note that some of the expedited review categories may not apply to the previously listed vulnerable populations. Additionally, the involvement of human subjects must fall into one or more of the categories found at the Office for Human Research Protections website.
All protocols that have been approved by the IRB will be reviewed on a continuing basis at intervals appropriate to the degree of risk as determined by the IRB. The IRB will determine the frequency of continuing review when it grants final approval to a proposed study. This determination will be expressed in the approval letter used to notify the investigator of the Board’s decision and any additional information. The IRB may also be called into an interim review session at the request of an IRB member or investigator regarding any matter concerned with the rights and welfare of any subject.
Amendments and Modifications to Currently Approved Research
Substantive changes in research during the period for which IRB approval has already been given shall not be initiated by investigators without IRB review and approval. The only exception to this policy is if it becomes necessary to revise a protocol to eliminate apparent immediate hazards to the subject, and these changes must be reported immediately to the IRB.
Termination of IRB Approval
The IRB has the authority to suspend or terminate approval of research that is not being conducted in accordance with the IRB’s requirements or that has been associated with unexpected serious harm to subjects. Any suspension or termination of approval will include a statement of the reasons for the IRB’s action and will be reported promptly to the investigator, appropriate institutional officials, and the department or agency head.