Written Procedures
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IRBs must comply with HHS and FDA regulations in 45 CFR part 46 and 21 CFR parts 50 and 56, respectively, when reviewing research subject to those regulations. Both the HHS regulations at 45 CFR 46.103(b)(4) and (5) and the FDA regulations at 21 CFR 56.108(a) and (b) state that IRBs must follow written procedures for the following functions and operations:
- Conducting initial and continuing review of research and reporting findings and actions to the investigator and the institution;
- Determining which projects require review more often than annually and determining which projects need verification from sources other than the investigator that no material changes have occurred since previous IRB review;
- Ensuring prompt reporting to the IRB of proposed changes in a research activity and ensuring that changes in approved research, during the period for which IRB approval has already been given, may not be initiated without IRB review and approval except where necessary to eliminate apparent immediate hazards to the human subjects;
- Ensuring prompt reporting to the IRB, appropriate institutional officials, and the department or agency head (i.e., OHRP) for research conducted or supported by HHS, and FDA for FDA-regulated research of any:
- Unanticipated problems involving risks to human subjects or others;
- Instance of serious or continuing noncompliance with the applicable HHS and FDA regulations or the requirements or determinations of the IRB;
- Suspension or termination of IRB approval.
Institutional and CPHS 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).
Institutional Responsibilities
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.
Administrative Support Responsibilities
Administrative support for CSUMB’s CPHS is provided through the Sponsored Programs Office. Designated by the Provost, the Sponsored Programs Office:
- 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
- Provides training, with the CPHS Chair, to new reviewers, researchers, and student classes
- Keeps researchers informed of decisions and administrative processing and returns all disapproved protocols to them
- Disseminates the HS applications to members of the CPHS for review on a weekly basis
- Processes protocols, amendments, continuation and final project reports
- Receives all research protocols that involve human subjects
- Appoints members to the CPHS
- Coordinates and convenes CPHS meetings
- Provides administrative and clerical support to the CPHS
- Implements CSUMB’s Assurance
- Prepares and updates university policy for research with human subjects
- Prepares the Assurance of Compliance for approval of the Institutional Official and DHHS in consultation with the CPHS Chair
- 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
- Assumes responsibility for ensuring conformance with special reporting requirements for any Cooperative Protocol Research Programs in which the signatory institution(s) participate(s)
- 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
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 Responsibilities
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.
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:
- 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.
- 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.
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 11 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:
- 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).
- Office for Human Research Protections - Policy and Guidance (http://www.hhs.gov/ohrp/policy/index.html); and
- The Belmont Report Ethical Principles and Guidelines for the Protection of Human Subjects of Research (http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html);
- Code of Federal Regulations (45 CFR 46) (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html);
Researcher's Responsibilities
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 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 APPOINTMENT
- The departmental 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 MEMBERS & CONSULTANTS
The committee may invite former CPHS members or members of the university community who have fulfilled training requirements to serve as alternate members.
The committee may invite specialists with domain expertise to consult with the CPHS on protocols under review.