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Standard Operating Procedures
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Introduction

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.

The ethically responsible investigator is expected to carry the dual burden to advance knowledge that can improve the human condition or generate new knowledge and, at the same time, to recognize the absolute imperative to treat human research subjects with the utmost care and respect.

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.

These policies are based on current regulations, ethical principles, and guidelines for the protection of the human subjects of biomedical and behavioral research. The policies and procedures are not an end unto themselves. They are the framework upon which research activities in these facilities are conducted.

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    List of Abbrev

    AE Adverse Event
    CFR Code of Federal Regulations
    DHHS Department of Health and Human Services (or HHS)
    FDA Food and Drug Administration
    IBC Institutional Biosafety Committee
    IND Investigational New Drug
    IRB Institutional Review Board
    NIH National Institutes of Health
    OHRP Office for Human Research Protections (former OPRR)
    PI Principal Investigator
    QA Quality Assurance
    QC Quality Control
    SOP Standard Operating Procedure

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    Glossary

    1.

    1. CERTIFICATION Certification means the official notification by the institution to the supporting Federal department or agency component, in accordance with the requirements of this policy, that a research project or activity involving human subjects has been reviewed and approved by an IRB in accordance with an approved assurance.
    2. CONFLICT OF INTEREST A “Conflict of Interest” means a Significant Financial Interest that could directly and significantly affect the design, conduct, or reporting of Research or a Sponsored Program
    3. DEPARTMENT OR AGENCY HEAD Department or agency head means the head of any Federal department or agency and any other officer or employee of any Federal department or agency to whom authority has been delegated.
    4. DEPENDENT Dependent is defined as any person who receives more than one-half of his or her annual support from an Investigator, whether or not related to that Investigator.
    5. FAMILY MEMBERS Family Members are defined as the Investigator’s spouse and Dependents.
    6. FINANCIAL INTEREST

    “Financial Interest” is defined as anything of monetary value, whether or not the value is readily ascertainable, including, but not limited to, salary, commissions, consulting fees, honoraria, equity interests, interests in real or personal property, dividends, royalties, rent, capital gains, intellectual property rights, and forgiveness of debt, other than:

    1. compensation from BYU;

    2. income from seminars, lectures, or other educational activities sponsored by a federal, state, or local government agency, an Institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education;

    3. income from service on advisory committees, or review panels for a public federal, state, or local government agency, an Institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education; or

    4. an interest arising solely by means of investment in a mutual, pension, or other institutional investment fund where the Investigator does not exercise control over the management and investments of such fund.

    7. HUMAN SUBJECT

    “Human subject” means a living individual about whom an investigator (whether professional or student) conducting research obtains:

    (i) data through intervention or interaction with the individual; or

    (ii) identifiable private information.

    “Intervention” includes both physical procedures by which

    data are gathered (e.g., venipuncture) and manipulations of

    the subject or the subject's environment that are performed for research purposes.

    “Interaction” includes communication or interpersonal contact between investigator and subject.

    “Private information” includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (e.g., a medical record).

    “Identifiable private information” is private information for which the identity of the subject is or may readily be ascertained by the investigator or associated with the information.

    8. INSTITUTION Institution means any public or private entity or agency (including federal, state, and other agencies).
    9. IRB IRB means an institutional review board established in accord with and for the purposes expressed in this policy.
    10. IRB APPROVAL IRB approval means the determination of the IRB that the research has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and by other institutional and federal requirements.
    11. LEGALLY AUTHORIZED REPRESENTATIVE Legally authorized representative means an individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject's participation in the procedure(s) involved in the research.
    12. MINIMAL RISK Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
    13. RESEARCH

    Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program that is considered research for other purposes. For example, some demonstration and service programs may include research activities. For purposes of this part, the following activities are deemed not to be research:

    Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected. Public health surveillance activities, including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority. Such activities are limited to those necessary to allow a public health authority to identify, monitor, assess, or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance (including trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products). Such activities include those associated with providing timely situational awareness and priority setting during the course of an event or crisis that threatens public health (including natural or man-made disasters). Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes. Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions.

    14. SIGNIFICANT FINANCIAL INTEREST

    Significant Financial Interest means one or more of the following Financial Interests of the Investigator (and those of the Investigator’s Family Members) that reasonably appear to be related to the Investigator’s University Responsibilities:

    (1) With regard to any publicly traded entity, it is the value of any remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure, when aggregated, the value of which exceeds $5,000 from one enterprise or entity;

    (2) With regard to any non-publicly traded entity, it is the value of remuneration received from the entity in the twelve months preceding the disclosure, when aggregated, exceeds $5,000, or when the Investigator holds any equity interest;

    (3) Intellectual property rights and interests, upon receipt of income related to such rights and interests subject to the de minimis thresholds set forth by the federal regulations and guidance;

    (4) Salary, remuneration, or similar payments which exceed, or are expected to exceed, $5,000 within any one-year period, when aggregated for the member and his or her Family Members; or,

    (5) Any reimbursed or sponsored travel, related to an Investigator’s University Responsibilities subject to the de minimis thresholds set by the federal regulations and guidance; provided, however, that Investigators need not disclose travel that is reimbursed or sponsored by a federal, state, or local government agency, an Institution of higher education as defined at 20 U.S.C 1001(a), an academic teaching hospital, a medical center, or a research institution that is affiliated with an Institution of higher education.

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    Statement of Authority and 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.