Human Subjects Research

Institutional Responsibility

CSUMB assumes responsibility for the protection of the rights and welfare of human subjects in compliance with federal regulations as documented within CSUMB's Assurance issued by the U.S. Department of Health and Human Services Office of Human Research Protections. CSUMB's assurance states requirements and procedures for human subjects protections to ensure that all research conducted within its jurisdiction complies with the Code of Federal Regulations pertaining to human subjects (DHHS - 45 CFR 46 and FDA - 21 CFR 50 and 56). 

California State University, Monterey Bay has obtained a Federalwide Assurance for the Protection of Human Subjects from the US Department of Health and Human Services (HHS) by agreeing to follow the Code of Federal Regulations. CSUMB acknowledges that it bears full responsibility for the performance of all research involving human subjects covered by its Assurance (i.e., policies and procedures), including complying with federal, state or local laws as they may relate to such research. Further, in accordance with the compositional requirements of 45 CFR 46.107, CSUMB has established the Committee for the Protection of Human Subjects (CPHS) as its Institutional Review Board (IRB). CSUMB will provide both meeting space and sufficient staff to support the review and record-keeping duties of the CPHS.

Should the need arise, CSUMB will be responsible for acquiring appropriate Assurances or Amendments, when requested, and certifications of CPHS review and approval for federally sponsored research from all standing affiliates and Assurances or Agreements for all others, domestic or foreign, which may otherwise become affiliated on a limited basis in such research.

CSUMB is responsible for ensuring that no affiliate cooperating in the conduct of federally sponsored research for which this Assurance applies does so without an appropriate assurance of compliance and satisfaction of CPHS certification requirements. 

Sponsored Programs Office Responsibility

Administrative support for CSUMB’s CPHS is provided through the Sponsored Programs Office. Designated by the Provost, the Sponsored Programs Office:

• Negotiates the Assurance of Compliance with the Department of Health and Human Services (DHHS)

• Prepares the Assurance of Compliance for approval of the Institutional Official and DHHS in consultation with the CPHS Chair

• Prepares and updates university policy for research with human subjects

• Implements CSUMB’s Project Assurance

• Provides administrative and clerical support to the CPHS

• Coordinates and convenes CPHS meetings

• Appoints members to the CPHS

• Receives all research protocols that involve human subjects 

• Processes protocols, amendments, continuation and final project reports

• Disseminates the HS applications to members of the CPHS for review on a weekly basis

• Keeps researchers informed of decisions and administrative processing and returns all disapproved protocols to them 

• Provides training, with the CPHS Chair, to new reviewers, researchers, and student classes 

• Forwards certification of CPHS approval of proposed research to the appropriate Federal department or agency only after all CPHS-required modifications have been incorporated to the satisfaction of the CPHS

Further, the Sponsored Programs Office:

• Ensures (a) solicitation, receipt and management of all assurances of compliance (whatever the appropriate format), and certifications of CPHS review (where appropriate) for all affiliates to this institution, and (b) subsequent submission of these documents to the proper authorities as a condition for involvement in human subjects research activities sponsored by DHHS or any other Federal department or agency for which this Assurance applies

• Ensures that all affiliated performance sites that are not otherwise required to submit assurances of compliance with Federal regulations for the protection of research subjects at least document mechanisms to implement the equivalent of ethical principles to which this institution is committed

• Assumes responsibility for ensuring conformance with special reporting requirements for any Cooperative Protocol Research Programs in which the signatory institution(s) participate(s)

• Is responsible for procedural and record-keeping audits not less than once every year for the purpose of detecting, correcting, and reporting (as required) administrative and/or material breaches in uniformly protecting the rights and welfare of human subjects as required at least by the regulations and as may otherwise be additionally required by CSUMB and the University Corporation at Monterey Bay

The researcher will be notified in writing of the committee's decision to approve, disapprove or revise the protocol, application, or other relevant documents associated with the research. Researchers may not engage in research activities until receiving written approval from the CPHS Administrator.

If the committee disapproves a project, a statement of the reasons for its decision will be given to the researcher and he/she will have an opportunity to respond in person or in writing. 

Neither the Sponsored Programs Office nor any other office of the institution may approve a research activity that has been disapproved by the appropriate CPHS member. Notice of CPHS action will promptly be conveyed to the researcher. 

CPHS Responsibility

The Committee for the Protection of Human Subjects (CPHS) at CSUMB implements a review process established within the Code of Federal Regulations (45 CFR 46) to ensure that human subjects research complies with federal regulations, institutional policies and ethical standards. The CPHS serves to protect the rights and ensure the safety of people involved as participants in research. The CPHS also provides assistance to the researcher in complying with federal and state regulations and institutional standards for human subjects research. The CPHS is guided by the ethical principles as set forth in the Ethical Principles and Guidelines for the Protection of Human Subjects of Research also known as the Belmont Report. 

CPHS and Institutional Authority

The CPHS may approve research reviewed or may require that modifications to the protocol be made to secure approval to conduct the research. The CPHS may also disapprove research. Decisions made by the CPHS are communicated in writing to the researcher (45 CFR 46.109). The CPHS may also suspend or terminate approval of research that is not conducted in accordance with the approved protocol or that has been associated with unexpected serious harm to subjects (45 CFR 46.113). Actions taken by the CPHS to suspend or terminate approval will be documented in writing and reported to the researcher and institutional officials. 

Research that is approved by the CPHS may be subject to further review by the officials of the institution. Authorized institutional officials may approve or disapprove research planned by an employee, student or agent of the University. The institutional officials may not approve research involving human subjects that has not been approved by the CPHS (45 CFR 46.112). 

Researcher Responsibility

Protecting the rights and welfare of the research subject is a shared responsibility of the CPHS and the researcher. Ultimately, the researcher is responsible for the conduct of the study. This includes the application and monitoring of ethical practices, compliance with all applicable foreign, federal, state and institutional regulations and policies, institutional practices, and supervision of research staff. 

The Lead Researcher will document other applicable laws, policies, regulations and "standards of professional conduct and practice" in the  CPHS application. 

CPHS Jurisdiction

The CPHS reviews research when procedures are proposed to obtain information about a living individual through the use of a survey, interview, observation, experimentation, or the analysis of human tissues, records, samples or other data previously collected from human subjects. All research involving human subjects must be reviewed and approved by the CPHS in advance of study initiation (45 CFR 46.109). 

A CPHS review must occur when CSUMB is engaged in human subjects research (per http://www.hhs.gov/ohrp/policy/engage08.html). For example: 

• CSUMB or University Corporation at Monterey Bay employees or agents, in connection with his/her institutional responsibilities, intervene or interact with human subjects for purposes of research or obtain individually identifiable private information about human subjects for purposes of research; 

• CSUMB or CSUMB University Corporation at Monterey Bay receives a direct federal award to conduct human subject research, even where all activities involving human subjects are carried out by a subcontractor or collaborator. 

• Research that involves the use of CSUMB’s non-public information to identify or contact human research subjects or prospective subjects or utilizes any CSUMB property or facilities in connection with human subjects research. 

CPHS Membership

Federal regulations require a breadth of expertise on university institutional review boards. The membership of the CSUMB CPHS shall therefore consist of a minimum of seven (7) members. One or more representatives from a non-degree-granting department within Academic Affairs, one or more faculty representatives from each of the academic colleges, one or more representatives from the Student Affairs division, one or more student representatives designated by Associated Students, and one or more members of the community at large. The CPHS may also bring in additional subject matter experts as it deems necessary on an ad hoc basis. Such experts may advise the CPHS, but shall not take part in the Committee’s decision on the pending application.

Selection and Appointments

The CPHS members and reviewers are experienced researchers who are highly qualified to determine the level of research risk. Their selection is based upon the referral of a committee member and approval of the Provost. The committee is composed of both men and women of various ethnic backgrounds. A current curriculum vita of each member is kept on file in the Sponsored Programs Office.

Members of the CPHS serve a four-year term and can be reappointed. Attendance is required at all meetings. The CPHS Administrator must be notified if a member is going to be absent. If a member has more than three unexcused absences, he/she will be removed as a full member and placed on alternate status for a period of one year, after which he/she will be dropped from the committee roster. 

Members are expected to have knowledge of current regulations, policies and procedures regarding the protection of humans used as subjects in research projects. CPHS members are also knowledgeable about subject populations, institutional constraints, differing legal requirements, and other factors that may contribute to a determination of risks and benefits to subjects and subjects' informed consent and can properly judge the adequacy of information to be presented to subjects. 

In addition, the CPHS reviewer is expected to assist the researcher in meeting the requirements for approval as well as maintaining professional ethics for research. The reviewers' primary obligation is to ensure that the subjects' rights and welfare are protected and that risks are minimized and reasonable in relation to anticipated gains. Reviewers must be able to serve as resource persons for their department or school. A committee member cannot review a research project in which he/she is involved as a researcher or subject. 

The committee may invite individuals with special competencies to assist in the review if the proposed research requires expertise beyond or in addition to that available on the committee. These individuals may not vote with the committee. A licensed and certified mid-level medical practitioner or higher must attend committee meetings for projects that involve drugs or medical protocols. 

Alternate Member

The committee may invite former CPHS members or members of the university community who have fulfilled training requirements to serve as alternate members. 

CPHS Member Responsibilities

Member Training

Active members are required to have current training certification in the protections of human subjects during their tenure on the CPHS. Administered by the Sponsored Programs Office, the on-line training program offered by the CITI Program consists of training modules in social and behavioral research and provides a comprehensive selection of educational modules that can be used to satisfy institutional instructional mandates in the protection of human research subjects.

In addition to the on-line training program, CPHS members are familiar with the following:

• Institutional Review Board (IRB) Guidebook (http://www.hhs.gov/ohrp/archive/irb/irb_guidebook.htm);

• Code of Federal Regulations (45 CFR 46) (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html);

• The Belmont Report Ethical Principles and Guidelines for the Protection of Human Subjects of Research (http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html);

• Office for Human Research Protections - Policy and Guidance (http://www.hhs.gov/ohrp/policy/index.html); and 

• The U.S. Food and Drug Administration (FDA) INFORMATION SHEETS Guidance for Institutional Review Boards and Clinical Investigators, 1998 Update (http://www.fda.gov/oc/ohrt/CPHSs/default.htm). 

Reviewer Expertise (Research Involving Children, Prisoners, etc.)

The CPHS membership includes those familiar with the type of research routinely conducted in the social and behavioral sciences. The CPHS recognizes that additional expertise may be necessary when reviewing a protocol (45 CFR 46.107). The CPHS may request consultation from an individual with competence in a specific area when issues relevant to a protocol require expertise above or beyond that available on the CPHS. Individuals invited to comment due to their expertise may not vote on a motion. 

Primary Reviewer Process

The primary reviewer is responsible for presenting an in-depth review of all protocol documents submitted to the CPHS members and identifies areas of the research that require elaboration prior to securing approval. A committee member is identified as a primary reviewer based on his or her expertise in the discipline in which the research is taking place as long as he or she does not have a conflicting interest with the study. This process is used for initial and continuing review as well as proposed protocol modifications not eligible for Expedited (Level II) review. 

Documents Reviewed by the CPHS

The primary reviewer reviews the entire application packet including the protocol, consent documents, grant application (if funded by the Department of Health and Human Services), recruitment materials and other supporting documents. Exempt (Level I) applications require approval by one CPHS reviewer. Expedited (Level II) applications require approval by two CPHS reviewers. Full Board or Convened Meeting Review (Level III) applications require approval from the full CPHS.

Each CPHS reviewer may access the entire initial review application packet including the protocol, consent documents, recruitment materials and other supporting documents. In addition, each reviewer completes a review sheet to document comments specific to a protocol and each reviewer documents any conflict of interest related to a specific research protocol. 

Subcommittee Procedures

A subcommittee of the CPHS is defined as one or more experienced CPHS members designated by the CPHS Chair or CPHS Administrator to act on behalf of the committee when action by the full board is not required (45 CFR 46.110). 

Review of Significant Adverse Events (SAE)

It is the responsibility of the researcher to immediately report to the CPHS any unanticipated and/or adverse problems involving risks to the subjects or others involved in the research. Researchers reporting adverse effects of their research must submit a CPHS Adverse Event Report within five days of the event. 

Additionally, if a subject suffers an injury during research, the researcher must take immediate action to assist the subject, and notify the CPHS in writing of the injury within 48 hours. 

The CPHS reviews individual adverse event reports and, if necessary, conveys individual or adverse event report data to the Provost or CSUMB Risk Management as appropriate.

Quorum and Voting Requirements (46.107 and 46.108)

Initial and continuing convened CPHS reviews and approvals occur in compliance with 45 CFR 46 and provisions of this Assurance for each project. Continuing reviews will include appropriate project review reports from the researcher, including available study-wide findings. 

Scheduled meetings of the CPHS occur once a month during the academic fall and spring semesters and as needed during the summer. The CPHS may be called into an interim review session by the CPHS Chair at the request of any CPHS member or institutional official to consider any matter concerned with the rights and welfare of any subject.

Members will be contacted about their availability for meetings before the beginning of each semester. A reminder will be sent to members one week before each meeting. CPHS members will contact the Sponsored Programs Office, CPHS Recorder, if they are unable to attend a meeting. 

It is agreed that a quorum consists of one-half of the voting CPHS membership. A majority of votes is required to pass a motion. In the event of a tied vote, the CPHS Chair will cast the additional deciding vote. If the CPHS Chair is not present, the action will be tabled for a future meeting.

The CPHS Recorder will document and record all action items requiring a vote. 

In the case of Full Board or Convened Meeting Review (Level III) reviews, a member may not vote on any project in which he/she is involved as a researcher, co-researcher, assistant, or subject. 

For Full Board or Convened Meeting Review (Level III) reviews, the committee will vote to: 

• Approve

• Research proposal is approved as submitted

• Approve Contingent: Research proposal is approved contingent upon changes being made in the consent form, questionnaires, or other documents. These revised documents must be submitted and approved before the project can begin. Questions on research procedures or design may need to be answered satisfactorily before the project can begin.

• Table a Project: The committee has questions that must be answered or detects a problem with the research design that would pose problems with the protection of humans used as subjects in research. The project will be reconsidered when questions are answered or problem areas are cleared up. 

• Disapprove: Research cannot begin because the committee determines that the project as presented posed significant risk to the participant(s). 

CPHS Member Conflict of Interest

Regulations stipulate that a CPHS member may not participate in the initial or continuing review of a project in which the member has a conflicting interest except in response to information requested by the committee (45 CFR 46.107.e). If a member has a conflict of interest (personal, professional, or financial), he/she will leave the meeting room while discussion and voting occurs. This will be documented on the review documents as well as the meeting minutes. If the quorum should fail due to the absence of the member in conflict, the CPHS chair will determine whether the member may remain present and abstain from the vote in order to retain the quorum.