Standard Operating Procedures (SOPs)

Table of Contents

• Standard Operating Procedures (SOPs)
• List of Abbreviations
• Statement of Authority & Purpose

Standard Operating Procedures (SOPs)

Regulations require that Institutional Review Boards (IRBs) have written policies and procedures, and that activities at the institution are carried out as described in the written policies and procedures document. These Standard Operating Policies and Procedures (SOP) are written to enable IRBs to maintain a system of compliance. The SOPs of an IRB reflect not only the laws and regulations, but also the underlying ethical principles that are the basis of the IRB's mandate. Finally, these policies also reflect the overarching commitment of Brigham Young University to provide protection for all human subjects involved in research conducted under the direction of its faculty, staff and students.

These SOPs apply to all operations of the IRB. The SOPs apply to all persons employed by the IRB, all members who serve on it as part of their overall institutional responsibilities, and all others who must subscribe to its decisions and its requirements.

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List of Abbreviations

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Statement of Authority & Purpose

1. Governing Principles

Brigham Young University’s Human Research Protection Program (HRPP) and Institutional Review Boards (IRBs) are guided by the ethical principles applied to all research involving humans as subjects, as set forth in the Belmont Report (Appendix A). These principles are defined in the Belmont Report as follows:

• Beneficence -- The sum of the benefits to the subject and the importance of the knowledge to be gained so outweigh the risks to the subjects as to warrant a decision to allow the subject to accept these risks.
• Autonomy -- Legally effective informed consent is obtained, unless the requirements for waiver of informed consent are met by adequate and appropriate methods in accordance with the provisions of applicable regulations.
• Justice -- The selection of subjects is equitable and is representative of the group that will benefit from the research.

2. Authority

An Institution's HRPP/IRB is established and empowered under the Institution’s executive authorities, and by the Institution’s assurance with the Federal Office for Human Research Protections (OHRP). This Institution requires that all research projects involving humans as subjects or human material be reviewed and approved by the IRB prior to initiation of any research related activities, including recruitment and screening activities.

The HRPP/IRB is established to review all BYU human subjects research regardless of the source of funding, if any, and location of the study. All research involving human subjects, and all other activities which even in part involve such research, regardless of sponsorship, are subject to these policies and procedures if one or more of the following apply:

• The research is sponsored by institutional authorities; and/or
• The research is conducted by or under the direction of any employee, faculty, staff, student or agent of the Institution in connection with his or her institutional responsibilities.

The IRB has the authority to ensure that research is designed and conducted in such a manner that protects the rights and welfare of participating subjects.

Specifically:

• The IRB may disapprove, modify or approve studies based upon consideration of human subject protection aspects;
• The IRB reviews, and has the authority to approve, require modification in, or disapprove, all research activities that fall within its jurisdiction;
• The IRB has the authority to conduct continuing review as it deems necessary to protect the rights and welfare of research subjects, including requiring progress reports from the Investigators and auditing the conduct of the study, and observing the informed consent process and/or auditing the progress of any study under its jurisdiction as it deems necessary to protect the rights and welfare of human subjects;
• The IRB may suspend or terminate approval of a study; and
• The IRB may place restrictions on a study and the role any investigator in such study.

Regarding externally funded research, if a human subjects research project is part of an application to a sponsoring agency, it must be reviewed and approved prior to the initiation of any human subjects research and/or expenditure of any grant/contract funds.

The IRB also has a relationship to other institutional research review committees. The IRB functions independently of, but in coordination with those other committees. Research that has been reviewed and approved by the IRB may be subject to review and disapproval by institutional officials or other committees. However, those officials or committees may not approve research if it has been disapproved by an IRB.

3. Responsibility

A. IRB Review of Research

All research involving human subjects (as defined below), and all other activities, which even in part involve such research, regardless of sponsorship, must be reviewed and approved by the Institution's IRB(s). No intervention or interaction with human subjects in research, including recruitment, may begin until the IRB has reviewed and approved the research protocol. Specific determinations as to the definition of “research” or “human subjects,” and their implications for the jurisdiction of the IRB under Institutional policy are determined by the IRB (Appendix C).

The IRB's purpose and responsibility is to protect the rights and welfare of human subjects. The IRB reviews and oversees such research to ensure that it meets well established ethical principles and that it complies with federal regulations at 45 CFR 46 and 21 CFR 50 and 56, that pertain to human subject protection.

The activities that require HRPP/IRB review include any activities involving the collection of data through intervention or interaction with a living individual, or involving identifiable private information regarding a living individual.

B. Failure to Submit a Project for IRB Review

The implications of engaging in human subject research without obtaining HRPP/IRB review/approval are significant. Without such review, no approval will be granted to publish results of such activity, it is also against Institutional policy to use those data to satisfy thesis or dissertation requirements. If the IRB does not approve the research, data collected cannot be used as part of a thesis or dissertation, and/or the results of the research cannot be approved to be published.

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