Human Subjects Policies & Procedures

Medical Campus IRB

For the Medical Campus, please see BU Medical Campus IRB Guidance.

Charles River Campus IRB

The Institutional Review Board (IRB) is a committee of scientists/doctors and non-scientists whose charge is to oversee the safety and protection of human subjects in research based on those regulations and guidelines as they apply to individual research studies. Governmental regulations and institutional policies exist to protect the rights and welfare, including privacy/confidentiality rights, of all human research subjects.

The purpose of this policy is to describe the additional requirements for human subjects research funded by federal agencies other than the Department of Health and Human Services (DHHS) or the Food and Drug Administration (FDA).

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The purpose of this policy is to outline the procedure for review and approval of amendments/modifications to previously approved research.

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Certificates of Confidentiality (COCs) are issued by the National Institutes of Health (NIH) to protect identifiable research information from forced disclosure. They allow the investigator and others who have access to research records to refuse to disclose identifying information on research participants in any civil, criminal, administrative, legislative, or other proceeding, whether at the federal, state, or local level.

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The purpose of this policy is to describe the additional responsibilities and procedures involved when reviewing research that involves children as subjects.

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The purpose of this policy is to outline the process for maintaining community outreach activities and to provide information on the resources available to research subjects.

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The purpose of this policy is to describe the process for reviewing researcher or research staff financial conflicts of interest that are related to human subjects research.

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The purpose of this policy is to outline the procedure for conducting reviews of human subjects research at a convened meeting (initial reviews, continuing reviews, and amendments).

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The purpose of this policy is to outline the procedure for conducting continuing reviews of human subjects research.

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The purpose of this policy is to outline the requirements for research with human subjects involving investigational devices, including Institutional Review Board (IRB) review and investigator responsibilities.

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The purpose of this policy is to outline the requirements for documenting informed consent for non-exempt research.

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The purpose of this policy is to outline the requirements for research with human subjects involving investigational drugs, including Institutional Review Board (IRB) review and investigator responsibilities.

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The purpose of this policy is to outline the procedure for reporting and reviewing exceptions and deviations.

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The purpose of this policy is to provide a description of the quality improvement and assessment activities of the Human Research Protection Program (HRPP).

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The purpose of this policy is to outline the authority and responsibilities of the Boston University (BU) Charles River Campus (CRC) Institutional Official.

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The purpose of this policy is to outline the policies and procedures for drafting, reviewing, distributing, and revising IRB policies and procedures.

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The purpose of this policy is to describe the process for reviewing research that is conducted outside of the United States.

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The purpose of this policy is to outline the composition of the IRB and to describe the roles and responsibilities of IRB members.

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TThe purpose of this policy is to outline the process for identifying and managing conflicts of interest for Institutional Review Board (IRB) members. This policy applies to any type of review (e.g. initial, continuing review, amendments, events, non-compliance, unanticipated problems, expedited, exempt determination, etc.)

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The purpose of this policy is to outline the policies and procedures for recordkeeping in the Charles River Campus (CRC) IRB.

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The purpose of this policy is to outline the procedure for conducting reviews of expedited human subjects research.

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The purpose of this policy is to outline the procedure for conducting reviews of exempt human subjects research.

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The purposes of this policy are to: 1) define noncompliance, 2) outline the procedure for reporting noncompliance to the IRB, and 3) describe the IRB actions.

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The purpose of this policy is to outline the process for protecting the privacy of subjects and the confidentiality of study data.

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The purpose of this policy is to outline the responsibilities of Principal Investigators (PIs) who conduct human subjects research on the Charles River Campus (CRC) at Boston University.

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The purpose of this policy is to describe the process for reviewing recruitment of research subjects (including advertisements) and to provide guidance on acceptable recruitment methods and advertisements.

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The purpose of this policy is to outline the procedure for reporting: 1) unanticipated problems involving risks to subjects or others, 2) any serious or continuing noncompliance, or 3) any suspension or termination of IRB-approved human subjects research.

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The purpose of this policy is to outline the additional protections that investigators and the IRB should consider when proposed research projects involve adults who are cognitively impaired.

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The purpose of this policy is define activities that are subject to review and approval by the Charles River Campus (CRC) IRB.

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The purpose of this policy is to describe the additional responsibilities and procedures involved when reviewing research that involves pregnant women as subjects.

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The purpose of this policy is to describe the additional responsibilities and procedures involved when reviewing research that involves prisoners as subjects.

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The purpose of this policy is to outline the procedure for assigning reviewers for studies that require review by the Institutional Review Board (IRB).

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The purpose of this policy is to outline the requirements and process for scientific or scholarly
review of human subjects research.

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The purpose of this policy is to describe the process for reviewing payments to research subjects and to provide guidance on acceptable payment practices.

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The purpose of this policy is to outline the procedure for suspending or terminating research approved by the IRB.

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The purpose of this policy is to outline the training requirements for individuals who are involved in either: 1) conducting human subjects research or 2) the oversight of human subjects research.

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The purpose of this policy is to outline the procedure for reporting and reviewing unanticipated problems involving risks to subjects or others and adverse events.

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The purpose of this policy is to outline the requirements for waiving or altering informed consent.

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Federal Regulations & Guidance

The Federal Regulations links include the regulations that govern human subjects research. There are two separate sets of regulations: one from Health and Human Services and one from the FDA (which govern any research under the purview of FDA).

HHS Regulations
FDA Regulations
HHS and FDA Regulations Compared
NIH’s Office of Behavioral and Social Sciences Research
Certificate of Confidentiality Background