Human Subjects in Research

Recommended By
Academic Affairs
Ming-Tung "Mike" Lee, President
Issue Date
Wednesday, January 2, 2002
Current Issue Date
Friday, October 14, 2022
Effective Date
Friday, October 14, 2022
Contact Office
Research and Sponsored Programs
Policy number
  1. Purpose
    The purpose of this document is to provide information and set forth policies to ensure that human subjects participating in research activities conducted at and/or sponsored by the University or its auxiliaries are protected from undue risks and deprivation of personal rights and dignity.
  2. Authority
    Title 45: Public Welfare section of the Electronic Code of Federal Regulations (45 CFR 46 2018 Requirements – Revised Common Rule) calls for all institutions applying for federal funding to have on‐site permanent review boards that review biomedical and behavioral research involving human subjects in order to protect the rights of human subjects.
  3. Institutional Responsibilities
    At Sonoma State University (SSU), the administrative authority for the protection of human subjects has been delegated to the Provost and Vice President for Academic Affairs. The Provost or designee appoints the members of the Institutional Review Board for the Rights of Human Subjects, who work under the sponsorship of the Office of Research and Sponsored Programs (ORSP) to ensure the protection of the human subjects’ rights for purposes of local, state, and federal requirements. Membership on the board is for a three‐year, renewable term unless the member requests to terminate their membership on the board before their term ends. The IRB Chairperson is appointed by the Provost or designee to guide IRB activities and to ensure compliance with all relevant policies, procedures, and government regulations. After a three year term, the chair can be reappointed. The Associate Vice‐President of ORSP serves as the University’s Institutional Signatory Official for federal regulation purposes.

    The IRB is responsible for the ethical oversight of human subjects research conducted by members of the SSU community, and ensuring compliance with federal regulations, state laws, and CSU/SSU policies.
  4. Structure of the IRB
    In compliance with the federal regulations cited above, the IRB:
    • Must be comprised of at least five persons with varying backgrounds to assure complete and adequate review of research activities commonly conducted by the institution. For example, members should represent a variety of academic disciplines and methodological expertise with human subjects.
    • Must be sufficiently qualified based on members’ experience, expertise and background including consideration of race, gender, and cultural backgrounds and sensitivity to such issues as local community attitudes to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects. When a new board member is required, the chair will solicit nominations. Current board members will review proposed candidates’ background and experience. Invitations to serve on the board will require that a majority of the board members approve the nomination.
    • Must not consist entirely of men or women, nor can it consist entirely of members of one profession.
    • Must include at least one member whose primary concerns are in scientific/empirical areas including the sciences, social sciences, humanities disciplines in which empirical research is conducted and at least one member whose primary concerns are in nonscientific/community areas outside of Sonoma State University.
    • Must have at least one member who is not otherwise affiliated with the institution and who is not part of the immediate family of a person who is affiliated with the institution.
    • Must not have a member participate in its initial or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the IRB.
    • May, at its discretion, invite individuals with competence in specialized areas to assist in the review of issues that require expertise beyond or in addition to that available on the IRB. These individuals may not vote with the IRB.

    A quorum of the IRB is defined as a majority of the total members officially eligible to vote. In order for official committee business to be conducted, a quorum must be present. To complete a full board review of proposed research, the quorum must include at least one member whose principal concerns are in non‐scientific areas. Research submitted for full board review must be approved by a majority of IRB members.

    ORSP representatives shall be ex‐officio members who do not vote.

  5. Research Ethics Education
    The IRB Chairperson, members, staff, and human subject research researchers must complete appropriate education related to the protection of human subjects before reviewing or conducting human subject research. The IRB Chairperson will ensure the existence of adequate education and oversight mechanisms (appropriate to the nature and volume of the research being conducted) to verify that IRB members, staff, researchers, and key personnel maintain continuing knowledge of, and comply with, relevant federal regulations, Office for Human Research Protections (OHRP) guidance, other applicable guidance, state and local law, and IRB determinations and policies for protection of human subjects. Board members, staff, and research personnel involved in data collection or analysis will provide the IRB with appropriate documentation of any required training.
  6. Human Subjects Review Requirements
    The IRB reviews research conducted with human subjects. Original research is defined as a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Original research includes collecting and analyzing data from questionnaires, observing subjects, and manipulating experimental conditions. Research using human subjects, even if it is done simply to verify existing hypotheses, theories, or ideas, is considered original research.

    For the purposes of this policy, the following are not considered “original research” and therefore, do not require IRB review:
    • works that deal entirely with secondary sources (public data sets like the U.S. census are considered secondary sources)
    • activities that human subjects perform exclusively for instructional purposes (note: the intent or effort to disseminate the data from such activities to an audience beyond the immediate class or program at any time‐converts these activities to original research involving human subjects)
    • data gathering for the purposes of fundraising by public affairs and alumni offices; market research for the purposes of admissions recruiting; recruiting efforts for faculty or staff; statistical data collected for the management of institutional affairs; and basic feedback surveys for program evaluation purposes. If these data are disseminated to professional or public audiences as evidence for broader generalizations, they could qualify as original research.
    • journalism
    • information collected for entertainment purposes
    • oral history

    Human subject refers to any specific living person about whom a researcher obtains (1) data through interaction with the individual, or (2) private information that can be traced back to a specific person. Interaction includes contact (including observational studies) or communication with the individual, manipulation of the subject, or manipulation of the subject’s environment). Private information includes information that can be identified with an individual and that is obtained in a context in which an individual can reasonably expect that no observation or recording is taking place, or information that has been recorded for specific purposes and which the individual can reasonably expect will not be made public (e.g., medical records). For the purposes of this policy, experts sharing facts or professional opinions in the area of their expertise are not considered human subjects.

    If it is not clear whether a project qualifies as research with human subjects, the project should be submitted for review.

  7. Ethical Principles for the Use Of Human Subjects in Research
    It is the responsibility of the individual researcher to ensure that appropriate ethical principles are adhered to in the conduct of research involving human subjects. The researcher also is responsible for the ethical treatment, and prevention of negligent treatment, of human subjects by collaborators, assistants, students, or employees who assist the research.

    The University is guided by the ethical principles regarding human subjects research as set forth in the report of The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research entitled “Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research.” SSU also follows the Common Rule revised in 2019, The Common Rule is a federal policy covering research on human subjects that applies across federal agencies. It includes requirements for compliance with human subject protections by research institutions and lays out requirements for Institutional Review Board operations, how researchers should obtain and document informed consent of research subjects, and additional protections for vulnerable populations.

    The primary ethical principles that must be considered in all research involving human subjects include:

    1. Ensuring the participation of human subjects is voluntary, occurring as a result of free choice, without compulsion or obligation, based upon disclosure of relevant information in a clear, concise, understandable way with sufficient opportunity to discuss and in language understandable to the subject or the legally authorized representative.
    2. Protecting the subjects from physical and mental discomfort, harm, or danger.
    3. Designing projects with the intent that the knowledge gained will benefit the subjects and/or a larger community and outweigh any risks to the subjects.
    4. Conducting research in a fair and equitable manner so that selection of subjects does not overburden, over‐utilize, unfairly favor or discriminate against any subject population.
    5. Honoring commitments made to subjects, contributors, or collaborators in a research project relative to its design, confidentiality and the anonymity of any information about subjects gathered during the investigation.
  8. Investigator Responsibilities and Requirements
    An IRB review is required when human subjects research is conducted and/or sponsored by University employees, auxiliary employees, and/or students (including student/faculty collaborative research). When the research is sponsored by an outside agency that utilizes the time, facilities, resources of SSU faculty, staff or students, approval must be obtained from the IRB of both SSU and the outside agency. The ORSP website includes guidelines and checklists for informed consent forms, required ethics training and the IRB Human Subjects application. The investigator should provide the IRB with the information and materials necessary for the board to determine risks to participants, acceptability of proposed research in terms of institutional commitments (including policies and results) and regulations, applicable law, and the standards of professional conduct and practice.
    1. Review Process
      All research involving human subjects that is designed, in whole or in part, to develop or contribute to generalized knowledge through publication or presentation in any medium must receive IRB approval prior to initiation whether it is conducted by faculty, students, or staff. The type of review required depends upon the nature of the research, the subjects, and the risk imposed on the subjects. Research intended solely for classroom use (with no possibility of further disclosure or publication) and conference/workshop evaluation surveys do not require IRB review.
      1. Review Categories
        Research involving the use of human subjects falls into three review categories: (1) research that qualifies for exemption from federal regulations; (2) research that qualifies for expedited IRB review; and (3) research that requires full IRB review. Information on the circumstances that qualify a research study for a particular review category is listed in the Code of Federal Regulations, Title 45, Part 46.104 and 46.110, and provided as an Appendix to the IRB approval application form that may be downloaded from the ORSP website. Researchers must submit a Human Subjects application and receive approval, even if the proposed research is perceived by the researcher to be exempt from federal regulations. The IRB chairperson conducts exempt and expedited reviews, consulting with IRB members and experts when necessary. Board members receive summaries of IRB applications and status each academic semester.
      2. Informed Consent
        Except as provided elsewhere in this policy, no researcher may involve a human being as a subject in research unless the researcher has obtained legally effective informed consent of the subject. Informed consent means the knowing consent of an individual or his/her legally authorized representative so situated as to be able to exercise free power of choice without undue inducement or any element of force, fraud, deceit, duress, or other form of constraint or coercion.

        Waiver of signed informed consent will be considered for some or all subjects for situations if:
        1. The research involves no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context.
        2. The research could not practicably be carried out without the requested waiver or alteration, such as with anonymous telephone or internet‐ based surveys.
        3. The waiver or alteration will not adversely affect the rights and welfare of the subjects. Whenever appropriate, the subjects or legally authorized representatives will be provided with additional pertinent information after participation.
        4. The only record linking the subject and the research would be the informed consent form and the principal risk would be potential harm resulting from a breach of confidentiality.
        5. The subjects or legally authorized representatives are members of a distinct cultural group or community in which signing forms is not the norm.
        The IRB reviews each request individually, considering all aspects of the particular study. Requests for waiver must be in writing, providing a thorough explanation of the situation and a description of the proposed alternative method of obtaining informed consent. Researchers should provide a text of the consent statement that they plan to read and give to participants or legally authorized representatives. These statements must follow the same format as the Informed Consent Guidelines. An adequate standard of informed consent and confidentiality must be maintained for all research involving human subjects, even for projects that the IRB reviewed as exempt from federal regulations.
    2. IRB Review Criteria
      In order to approve a research project involving human subjects, the IRB must be assured of the following:
      • Risks to subjects are minimized by using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk.
      • Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may be reasonably expected to result from the research.
      • Selection of subjects and participants is equitable; based on evidence that no group of volunteers is unreasonably targeted for recruitment, and volunteer recruitment is as inclusive as possible.
      • Informed consent will be sought from each prospective subject and, if appropriate, the subject’s legally authorized representative.
      • Informed consent will be appropriately documented.
      • When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.
      • There are adequate provisions to protect the privacy of subjects and data confidentiality. Researchers should consider how data are protected when they are transferred from one place to another (e.g., from one computer to another) and where they are stored. For example, researchers must indicate how the computer being used for the research study is being protected, for how long they will archive paper and electronic documents, audio or video recordings, and whether versions of any recordings will be accessible to anyone other than the original researchers. Research participants should be informed what information will be included in the final documents and with whom it will be shared.
      • If researchers plan to collect identifiable private information from subjects, the IRB must confirm that the researchers tell subjects if these data will be used for future research studies or distributed to other researchers.
      • If researchers plan to include subjects who could be vulnerable to coercion or undue influence, such as children, prisoners, individuals with impaired decision‐ making capacity, or economically or educationally disadvantaged persons, the IRB must confirm that additional safeguards have been included in the study to protect the rights and welfare of these subjects.
      1. Notification of Approval or Disapproval
        Researchers will receive an email from the IRB chairperson that documents the review category of approval. If a project is not approved, the IRB will notify researchers of disapproval in writing, including a statement of the reasons for its decision. The researcher will be given an opportunity to respond in person or in writing.
      2. Suspension/termination of IRB approval
        The IRB has the authority to suspend or terminate approval of research that is not being conducted in accordance with its requirements or that has been associated with unexpected serious harm to subjects. Suspensions or terminations of approval will be made in writing, will include a statement of the reasons for the IRB’s actions, and will be reported to the researcher, the Institutional Signatory Official, and, in instances involving federal support, the department or agency head.
    3. Reporting Requirements
      1. Changes in Research Application Any change in Human Subjects application that affects the human subjects must be requested by the researcher in writing and approved by the IRB prior to implementation except where an immediate change is necessary to eliminate a hazard to subjects. The ORSP website includes a form to complete for Human Subjects application renewals or modifications. Any revised materials should be attached to the written request.
      2. Unanticipated Problems Involving Risks It is the responsibility of the researcher to immediately report to the IRB any unanticipated problems involving risks to subjects or others involved in the research.
      3. Submission of a Report of Injury If a subject suffers an injury during research, the researcher must take immediate action to assist the subject, and notify the IRB in writing of the injury within 24 hours.
      4. Reporting Non‐Compliance with IRB Policies and Procedures Any incident of non‐compliance with IRB policies and procedures must be reported immediately to the IRB.
      5. Continuing Review and Submission of Annual Update Except for studies determined to be exempt from IRB oversight, all human subjects studies are subject to continuing review. The IRB is required to review and approve all non‐exempt research projects at intervals appropriate to the degree of risk, but not less than once a year [45 CFR 46.109(e) (DHHS) and 21 CFR 56.109(f) (FDA)]. The continuing review for these studies is required to occur as long as the research remains active for long‐term follow‐up of the research subject, even when the research is permanently closed to the enrollment of new subjects and all subjects have completed all research‐ related interventions, as well as when the remaining research activities are limited to collection of private identifiable information. The IRB, IRB Chair, or Chair Designee reviews the continuing review application submission form as well as the research project and applicable attachments in its entirety.
    4. IRB Records
      1. Scope of Records
        The IRB will prepare and maintain adequate documentation of IRB activities, including the following: (i) copies of all Human Subjects applications and associated materials, progress reports submitted by researchers, and reports of injuries to subjects; (ii) minutes of IRB meetings, of sufficient detail to show attendance at the meetings, actions taken by the IRB, vote on these actions, basis for requiring changes or disapproving research, and a written summary of the discussion of controversial issues and their resolution; (iii) a list of IRB members identified by name, earned degrees, representative capacity, indications of experience such as board certifications, licenses, etc., sufficient to describe each member’s anticipated contributions to IRB deliberations, and any employment or other relationships between each member and SSU.
      2. Records Retention
        The university will keep electronic or written IRB files pertaining to approved applications for at least three years beyond the last approved end‐date and then destroyed. Files regarding denied applications will be kept for a period of three years following the date of application and then destroyed. Principal researchers are required to retain electronic or written IRB relevant records for at least three years after completion of the research.