Introduction to the HRPP and IRB
What is HRPP and the IRB?
The Human Research Protection Program (HRPP) and the Institutional Review Board (IRB) are closely related but serve distinct roles in the oversight of human subjects research:
Human Research Protection Program
- Broad oversight structure that encompasses all institutional responsibilities related to the protection of human research participants.
- Includes the IRB, but also involves other units and processes—such as research administration, conflict of interest, education/training, general counsel review, privacy oversight, data security, single IRB, radiation committee, MRI research facility, and contracts.
- Ensures the institution is compliant with federal, state, and institutional policies, and promotes a culture of compliance.
- Provides infrastructure, policies, education, and coordination across stakeholders.
- Led by the HRPP Associate Director.
Institutional Review Board for Human Subjects
- A committee within the HRPP responsible specifically for reviewing, approving, and monitoring individual research protocols involving human subjects.
- Charged with ensuring that research meets the ethical principles (Belmont Report) and regulatory requirements (e.g., 45 CFR 46).
- Reviews studies for risk, informed consent, participant protections, and regulatory compliance.
- The IRB is led by the IRB Chair and the IRB Administrator.
The HRPP is the institutional framework that supports and oversees all aspects of human research protections, while the IRB is the formal review committee that evaluates individual research studies to ensure the ethical and regulatory protection of participants.
Ethical Principles for the IRB
- Respect of Persons: Requires that research subjects are given the opportunity to choose what shall or shall not happen to them. Individuals should be treated as autonomous agents and persons with diminished autonomy are entitled to protection.
Application: IRB members review the informed consent procedures and informed consent materials. The IRB application, section 14 and the consent form under the said heading, should fully inform prospective subjects in a language that is easily understood by the population. There are regulatory requirements for informed consent [45 CFR 46.116(b)]
During the review of a study, IRB members should take into account the process of consent, being aware of any power differentials that could hinder the capacity to consent and to voluntarily participate in a study; particularly for vulnerable populations to participate without coercion.
- Beneficence: Persons are treated in an ethical manner by respecting their decisions, protecting them from harm, and securing their well-being. Do not harm and maximize benefits and minimize harms.
Application: Sections 11 and 12 of the application and the consent form under the “risks” and “benefits” sections, should provide information for members to conduct a risk-benefit assessment.
The IRB must evaluate the risks and the mitigation of potential risks to subjects.
- Justice: The selection of research subjects needs to be scrutinized in order to determine whether some classes are being systematically selected simply because of their easy availability, their compromised position, or their manipulability, rather than for reasons directly related to the research aims.
Application: Section 8, describes the target population. IRB members will review the protocol to ensure that research studies optimize the probability and magnitude of benefits to all subjects and the risks are likewise, equally distributed. Are the research recruitment procedures fair in the selection of research subjects? Is there exploitation of certain groups so that populations are not unfairly burdened?
Has the investigator identified all risks associated directly with the research activities? For the risks identified, has the investigator provided adequate and appropriate mitigation?
Regulatory Framework
As IRB members, you are charged with the responsibility to ensure that human research conducted on behalf of BYU is ethical and compliant with regulations, state and local laws, and institutional policies.
- Common Rule (45 CFR 46): The main thrust of the work an IRB will do is to ensure that the human research subjects are protected and the research complies with these regulations. The common rule provides important definitions for research and human subjects, and includes the criteria to approve studies, informed consent requirements, and additional protections for vulnerable populations.
- FERPA: Considerations for this regulation should be included in the review of studies which include students.
- BYU Human Research Protection Policy
- BYU Survey Policy
IRB Operations
This section will describe the roles and responsibilities of IRB members and the structure and processes to support human research protections at BYU.
Structure and Composition
- Regulations require at least 5 diverse member present. However, quorum is calculated by the total number of full members divided by 2, plus one. For example, we currently have 14 full members that are on the roster. To have a meeting, we must maintain a quorum of 8 members. If at any time during the meeting there are less than 8 members, we have to stop the meeting and potentially reschedule for a time when quorum is met.
- Alternate members serve a purpose to fill in for full members when they are not able to attend. Alternate members must have similar expertise with the member they are replacing.
- The committee is required to maintain a diversity of expertise, gender, and ethnicity, social and academic background as part of the roster.
- A non-scientist MUST be in attendance at every meeting. Even if there are 8 members present, if the non-scientist is not there, there will be no meeting. The non-scientist takes on the role of the human subject and advocates from that perspective.
- IRB staff, typically the IRB administrator currently fulfills the role of non-scientist.
IRB Meetings
- A poll is sent out a month in advance for members to indicate whether or not they will attend. The IRB is required to track compliance with regulations, and the poll helps staff to know if quorum will be met.
- If you have schedule conflicts, please let the IRB staff as soon as you know so we can ensure quorum is met. If we do not have quorum, the meeting cannot be held.
- Meetings are held every first Thursday of the month from 3 pm to 6 pm.
- BYU IRB uses the university Zoom account for privacy and security.
- We ask that you are in a private environment, free of distraction.
- IRB staff prescreens all studies and works with investigators to ensure all study components are ready for review.
- On the agenda are studies that are more than minimal risk or that are novel and would benefit from a collective discussion.
- The IRB chair or a designee presides over the meeting.
- Video cameras should remain active at all times in a place where it is free of distraction.
IRB Meeting Agenda and Materials
- The IRB administrator will organize the agenda each month and assign a primary and secondary reviewer.
- Primary and secondary reviewers, when applicable, should discuss the protocols together in preparation for the meeting.
- Primary and secondary reviewers should also consult with the principal investigator if there is a need to clarify information.
- If necessary, primary and secondary reviewers will be asked to serve on subcommittees to review the PI’s responses to stipulations after the meeting.
- All materials will be available on OneAegis.
- As member, even if you are not assigned as a primary or secondary reviewer, you are expected to review all items on the agenda and prepare to discuss the study from the perspective of your expertise.
- Please review all items 3 days before the meeting.
Criteria of Approval
Federal regulations list seven criterion to approve a study. The comprehensive list can be found in 45 CFR 46.111. On BYU’s IRB website, we have consolidated the regulations into five categories that is easier for readers to understand: Criteria of Approval; on this webpage, there is additional explanations and considerations when evaluating a study according to each criterion.
Review Types
All studies that meet the regulatory definition of research and human subject, are categorized into three categories:
At BYU, most studies are categorized as exempt and expedited.
Decision-Making Process
After you have completed the review of studies, there are categories of action that you will propose; please refer to the IRB standard operating procedures (SOPs) 405 if you need a reminder about the categories of action:
- Approve: The protocol submission is approved as submitted.
- Withheld approval: Minor changes of or in addition to, the submission is required.
- Tabled: Significant questions are raised by the proposal requiring its reconsideration after the PI adds more information. The IRB finds some academic benefit of the study but cannot ascertain the risks and benefits of the study.
- Disapproved: The protocol fails to meet one or more criteria of approval. Risks outweighs the benefits of the study. A disapproval determination can only be given by vote of majority in a fullboard meeting.