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Human Research Protection Policy

Policy Administrator: Academic Affairs

Authority: Provost and Vice President for Academic Affairs

Effective Date: 11/26/19

Updated: October 17, 2019

Index Cross-References: FS 19/20-20/FPC/EX

Policy File Number: ACA-158

HUMAN RESEARCH PROTECTON POLICY


Policy Statement:

The Policy of California State University, Sacramento (University) is to adhere to the U.S. Department of Health and Human Services Policy for the Protection of Human Research Subjects as codified at 45 CFR 46. All research involving human subjects that is the responsibility of the University is reviewed by the Institutional Review Board (IRB) to ensure compliance with the highest ethical standards of research

Who the Policy applies to:

This policy applies to Sacramento State employees, students, and other affiliates who engage the institution in human subjects research

Why the Policy is necessary:

The University is committed to the ethical conduct of research involving human subjects, regardless of funding. In addition, the federal policy at 45 CFR 46 has been widely adopted by federal, state, and non-governmental funding agencies that require institutions to have and uphold written procedures through which the institution carries out its mandate to protect human research participants. Locally, the Integrative CSU Administrative Manual (ICSUAM) Section 11002.01, Article 3.1.2. states appropriate approval procedures for human subjects research must be in place prior to grant or contract acceptance.

Responsibilities:

The University, including investigators and research staff, accepts responsibility for assuring that research involving the use of human subjects is conducted in accordance with this policy. The Associate Vice President for Research, Innovation, and Economic Development is appointed as the Institutional Official (IO) by the Provost and Vice President for Academic Affairs and is responsible for ensuring the adherence to the University’s Federal-wide Assurance with the Office of Human Research Protections. The IRB is responsible for upholding the federal policy through human subjects research review. Procedures for the IRB are the responsibility of the IO, IRB Chair, and IRB collectively.

Procedure:

Procedures for IRB Members, Administrators, and Investigators can be found on the Resources webpage: https://www.csus.edu/research/irb/resources.html

Approved by:   Robert S. Nelsen, President    Date: 11/26/19

Human Research Protection Policy

The Policy of California State University, Sacramento (University) is to adhere to the U.S. Department of Health and Human Services Policy for the Protection of Human Research Subjects as codified at 45 CFR 46 regardless of funding or funding source. All research involving human subjects that is the responsibility of the University is reviewed by the Institutional Review Board (IRB) to ensure compliance with the highest ethical standards of research.

The University is committed to the ethical conduct of research involving human subjects, regardless of funding.

The federal policy at 45 CFR 46 has been widely adopted by federal, state, and non-governmental funding agencies that require institutions to have and uphold written procedures through which the institution carries out its mandate to protect human research participants. Locally, the Integrative CSU Administrative Manual (ICSUAM) Section 11002.01, Article 3.1.2. states appropriate approval procedures for human subjects research must be in place prior to grant or contract acceptance.

I. Responsibilities

The University, including investigators and research staff, accepts responsibility for assuring that research involving the use of human subjects is conducted in accordance with this policy and the Belmont Principles of autonomy, beneficence, and justice.

A. Education Requirement 

CSUS requires that all investigators, faculty advisors of students conducting human subject research, and any other CSUS or auxiliary employees engaged in or reviewing human subjects research, successfully complete the appropriate training for their status. This will be the Collaborative Institutional Training Initiative (CITI) Human Subjects course.

B. IRB Review of Research

All human subjects research must be reviewed by the Institutional Review Board (IRB) in advance of study initiation. The IRB has the authority to suspend or terminate approval of research that is not being conducted in accordance with this policy or federal regulations. In some circumstances, IRB review will be a collaborative process if more than one institution is engaged in research.

C. Shared Authority of the IRB and Institution

The Associate Vice President for Research, Innovation, and Economic Development is appointed as the Institutional Official (IO) by the Provost and Vice President for Academic Affairs and acts on behalf of the University for ensuring the adherence to the University’s Federal-wide Assurance with the Office of Human Research Protections. The IRB Chair acts on behalf of the IRB and reports directly to the Institutional Official.

Research covered by this policy that has been approved by the IRB may be subject to further appropriate review and approval or disapproval by officials of the institution. The institutional officials may not approve research involving human subjects that has not been approved by the IRB (§46.112).

II. Institutional Review Board Membership

A. Composition

Per §46.107(a)-(e):

1. The IRB shall have at least five members, with varying backgrounds to promote complete and adequate review of research activities commonly conducted by the University. The IRB shall be sufficiently qualified through the experience and expertise of its members (professional competence), and the diversity of its members, including race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects. The IRB shall be able to ascertain the acceptability of proposed research in terms of institutional commitments (including policies and resources) and regulations, applicable law, and standards of professional conduct and practice. The IRB shall therefore include persons knowledgeable in these areas. If an IRB regularly reviews research that involves a category of subjects that is vulnerable to coercion or undue influence, such as children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons, consideration shall be given to the inclusion of one or more individuals who are knowledgeable about and experienced in working with these categories of subjects.

2. The IRB shall include at least one member whose primary concerns are in scientific areas and at least one member whose primary concerns are in nonscientific areas.

3. The IRB shall include 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.

4. No IRB may have a member participate in the IRB’s initial or continuing review of any project in which the member has conflicting interest, except to provide information requested by the IRB.

5. The IRB may, in its discretion, invite individuals with competence in special 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. An individual who meets the requirements of more than one of the categories may fulfill more than one requirement. However, the committee may not consist of fewer than five members.

B. Selection/Appointments

a. Members

The Institutional Official appoints IRB faculty members through the following:

1. A call for nominations is announced through Faculty Senate,

2. Self-nominees submit their CV and other required information to the Faculty Senate,

3. The Faculty Senate confirms the list of nominees, and sends it to the Office of Research, Innovation, and Economic Development,

4.The IRB Chair, Vice-Chair, Institutional Official, and appropriate IRB staff will review and appoint members from the confirmed nominees. The Institutional Official has the authority to keep the call for nominations open until a qualified candidate, as determined by 45 CFR 46, is confirmed.

IRB members are appointed for a three-year term. Reappointment may occur, provided the member is in good standing. Staff and community members are appointed by the Institutional Official for a three-year term or as needed. Reappointment occurs as needed.

b. Alternate Member

The appointment of alternate members will follow the Member process. Alternate members are appointed to the IRB to serve in the absence of a member in an equivalent discipline. In an emergency, an alternate member may be appointed by the Institutional Official for the duration of one semester. After the alternate term, they may apply for full membership via the Member process if a position is open.

c. Membership in Good Standing

A member in good standing demonstrates research integrity, regular meeting attendance, completion of CITI training appropriate for researchers and IRB members, and timely reviews.

III. Procedures for the IRB, Administrators, and Investigators

Procedures for the IRB are the responsibility of the Institutional Official, Administrator, IRB Chair, and IRB collectively. Changes to the procedures will be communicated to the campus by the Institutional Official. Procedures can be found on the Resources webpage: https://www.csus.edu/compliance/research-integrity-compliance/

IV. References

Federal Code of Regulations 45 Public Welfare Department of Health and Human Services, Part 46, Protection of Human Subjects: https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/

The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research: https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/index.html

ICSUAM Section 11000 (2016) Sponsored Programs Administration: http://www.calstate.edu/icsuam/documents/Section11000.pdf

Engagement of Institutions in Human Subjects Research (2008): https://www.hhs.gov/ohrp/regulations-and-policy/guidance/guidance-on-engagement-of-institutions/index.html