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THE COMMITTEE ON HUMAN RESEARCH
Responsibilities in Research Involving Human Subjects
Responsibilities of:
Committee on Human Research (CHR) |
Principal Investigators/Staff |
University Administration | Study Sponsors
Safeguarding the rights and welfare of human research participants is a collective responsibility. The Principal Investigators and their research staff, the Committee on Human Research, University Administration and the Study Sponsors all bear responsibility for this important endeavor. General responsibilities for each of these groups are outlined below.
Committee on Human Research (CHR)
It is the responsibility of the CHR to safeguard the rights and welfare of human subjects. To this end, the Committee is obligated and authorized to systematically evaluate each research study to ensure the protection of participants, including but not limited to the following:
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Identify and analyze potential sources of risk and measures to minimize risk, including physical, psychological, social, legal, or economic
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Determine that the risks to participants are reasonable in relation to potential benefits to participants and to society
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Review plans for data and safety monitoring in research protocols and, when applicable, determine that the plan provides adequate protection for the participants
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Determine risks for vulnerable populations as defined in federal regulations and determine the specific risk categories in protocols involving children and prisoners
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Establish and follow written procedures for suspending or terminating previously approved research if warranted by findings in the continuing review or monitoring process
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Evaluate the equitable selection of participants
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Review and permit when appropriate proposed participant recruitment methods, advertising materials, and participant payment arrangements
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Evaluate the protection of privacy interests of research participants and confidentiality of data in proposed research
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Evaluate compliance with policies and procedures for seeking informed consent from participants or their legally authorized representatives, and assent from participants when appropriate
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Require that prospective participants whose decision-making capacity is in question be appropriately protected
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Review the consent process and the consent documents, focusing on measures to improve participant understanding and voluntary decision making
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Require that the investigator has and follows a procedure for properly documenting informed consent
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Review and approve the waiver or alteration of the consent process and the waive of consent documentation when appropriate
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Review protocols that request exceptions to the informed consent requirements for emergency situations and approve as appropriate
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Have procedures for observation of the informed consent process
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Have procedures for the review and oversight of research conducted at multiple sites
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Maintain documentation of its activities
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Make the applications, forms, guidelines and policies necessary for the proper conduct of human research publicly available to the research community on the HRPP website
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Serve as the IRB of record for UCSF, San Francisco General Hospital, the San Francisco Veterans Affairs Medical Center, the Ernest Gallo Clinical Research Center, the J. David Gladstone Foundation, and the Northern California's Institute for Research and Education (NICRE) |
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Principal Investigators/Staff
It is the responsibility of Principal Investigators and their research staff to protect the rights and welfare of human research participants. To that end, they are required to:
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Consider conflicts of interest that might affect the relationship with the research participant or the outcome of the research and, with the help of the Conflict of Interest Committee as needed, identify and manage these conflicts
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Employ sound study design in accordance with the standards of the discipline
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Design and carry out research studies with adequate data and safety monitoring during the research, when appropriate
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Implement reporting mechanisms that provide information to monitor the rights and welfare of participants enrolled in research
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In research involving greater than minimal risk to participants, provide the CHR with plans for promptly detecting harm and mitigating potential injuries
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Recruit participants in a fair and equitable manner, weighing the potential benefits of the research to the participants against their vulnerability and the risks to them
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Determine the resources necessary to protect participants and ensure that they are present before and during the conduct of the research study
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Maintain appropriate oversight of the research protocols and research staff and delegate appropriately
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Develop an informed consent process and method of documentation appropriate to the type of research and the study population, emphasizing the importance of participant comprehension and voluntary participation
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Respond to participants’ complaints or requests for information
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Be qualified by training an experience for their research roles, including knowledge of applicable federal, state, and UC regulations
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Understand the definition of human research and seek guidance when appropriate
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Assess and report unanticipated problems occurring during a research study in accordance with UCSF policies and procedures and sponsor requirements
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Before initiating, modifying, or extending any research project involving human subjects, submit without exception an application to the Committee on Human Research for review and approval.
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Prepare applications and consent documents according to UCSF's standards as described and available on this website |
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University Administration
University Administration is responsible for the rights and welfare of human research participants. UCSF through the Office of the Executive Vice Chancellor assures
the federal government that the campus is in compliance with federal
regulations regarding the protection of human subjects in research
and that no research involving human subjects is conducted without
prior review and approval.
UCSF grants the Committee on Human Research the authority to function independently of other organizational entities in its role in protecting research participants.
UCSF provides adequate resources to support the activities of the Human Research Protection Program, which includes the Committee on Human Research, the Quality Improvement Unit, and an Education and Assessment Unit.
UCSF
may provide treatment and compensation for injured research subjects.
The University provides legal protection for members of the Committee
on Human Research and to principal investigators granted approval
to conduct such research who have met their obligations in good
faith.
University Administration is responsible for assuring that investigations occur for individual incidents or allegations of misconduct pertaining to the use of humans in research. To report incidents of non-compliance or unauthorized research, call the Committee on Human Research at 415-476-1814 or the Vice Chancellor for Research at 415-476-5869. For a more detailed description of this process, please link to Reporting Research-Related Concerns and Complaints.
The University provides whistle-blowing protection for anyone who reports an activity that violates any regulations and policies on the use of human subjects.
Under the provisions of the federal Freedom of Information Act
and California's Public Records Act, the University is required,
upon request, to release to the public documentation on any active
or retired protocol. Top of Page
Study Sponsors
In order to protect the rights and welfare of human research participants, both the Sponsor and Institution agree to comply with the ethical standards used in human research.
In studies where sponsors bear the responsibility for the monitoring of research, the Sponsor agrees to promptly report to the University findings that could affect the safety of participants or their willingness to continue participation, influence the conduct of the study, or alter the CHR’s approval to continue the study. Top of Page |
