Roles and Responsibilities

Assures compliance with the Federalwide Assurance (FWA)

Assures Vanderbilt University Medical Center’s policies and procedures are effectively applied in compliance with state and federal laws and regulations, the FWA, OHRP, FDA, NIH, OCR, and any other applicable federal agency.

Provides interpretation and application of federal regulations.

Develops, implements, and interprets HRPP policies and procedures.

Takes action on non-compliance according to HRPP policies and procedures, as necessary.

Ensures adequate resource allocation and annual review of resources.

Actively participates in the IRB Optimization Committee.

Supports and facilitates the IRB process.

Maintains ongoing educational programs (e.g., News You Can Use, Research Matters, IRB Essentials, etc.) for Investigators, key study personnel, IRB Committee members, and HRPP staff.

Participates in mandatory training, as well as other ongoing educational activities to keep abreast of current events.

Provides regular training and education to IRB Committee members and keeps the Committees abreast of current events.

Mentors and trains new staff as needed, including HRPP staff, Investigators, and key study personnel on human subject protections and the IRB process. 

Performs and documents quality assurance activities to assure compliance.

Provides internal and external monitoring, which is designed to assess compliance and safety in human subjects research.

Performs directed audits and random compliance reviews. Formulates and implements, as needed, recommendations for the Investigator and his/her staff.

Assures all investigators and key study personnel complete initial and continuing education in human research protections, to remain up-to-date on federal regulations, Vanderbilt policies and procedures, and compliance expectations.

Adheres to federal regulations, state and local laws, institutional policies, IRB policies and procedures regarding the safety and protection of human participants, and Good Clinical Practice (GCP) guidelines.

Reports adverse events and unexpected problems involving risk to participants and others to the IRB according to Institutional policy, IRB policies and procedures, DSMB/C, VUMC Risk Management, sponsors, and appropriate federal agencies as required.

Assures continuing review applications are submitted in a timely manner so that review occurs prior to the expiration date. The Investigator acknowledges that the federal regulations do not allow a grace period. The Investigator is responsible for being aware of the current literature in his/her field of study to assure participants are no longer placed at risk if additional risks have been identified or no benefit has been proven. The Investigator should build off previously conducted research to decrease the potential for participants to be needlessly placed at risk.

Acts as a liaison between the IRB and the sponsor.

Supervises the research process. Takes responsibility for assuring key study personnel are properly trained, qualified, and have appropriate facilities and resources to conduct the research. Assures adherence to the study protocol. Monitors the informed consent process. Communicates regularly and effectively with the research staff. Responsible for protection of the safety and welfare of research participants.

Oversees external performance sites, assuring adequate staff, resources, pharmacy practices, and Federal assurances with appropriate IRB approvals.

Assures the IRB protocol is reflected in the grant proposal for extramural or intramural support, informs the IRB of any updates or modifications to the protocol prior to their implementation and in compliance with federal and institutional regulations.

Assures proper performance of the informed consent process. Retains a copy of the signed and dated informed consent document in the study file and provides a copy to the research participant.

Promotes compliance and maintains documents in accordance with federal and state regulations, sponsor, and institutional policies and procedures regarding the safety and welfare of human participants.

Reviews and approves IRB applications, amendments, and adverse events prior to submission to the IRB, as documented by a signature on the IRB application.

Assures participant privacy and confidentiality according to HIPAA guidelines, institutional regulations, and IRB policies and procedures.

All key study personnel must complete initial and continuing education in human research protections to remain up-to-date on federal regulations, Vanderbilt policies and procedures, and compliance expectations.

Adheres to federal regulations, state and local laws, institutional policies, IRB policies and procedures regarding the safety and protection of human participants, and Good Clinical Practice (GCP).

Reports adverse events and unanticipated problems involving risks to the participants and others to the IRB according to Institutional policy, IRB policies and procedures, DSMB/C, VUMC Risk Management, sponsors, and appropriate Federal agencies as required.

Acts as a liaison between the IRB, the Investigator, and the sponsor.

Promotes compliance and maintains documents in accordance with federal and state regulations, sponsor, and institutional policies and procedures regarding the safety and welfare of human participants.

Assures participant privacy and confidentiality according to HIPAA guidelines, institutional regulations, and IRB policies and procedures.

Promotes compliance with Federal and State regulations, sponsor, and Institutional policies and procedures regarding the safety and welfare of human participants involved in research studies initiated within his/her department.

Reviews and approves IRB applications prior to submission, as documented by his/her signature on the IRB application, to assure the soundness of the research design, scientific and scholarly merit in relation to the departmental capacities and adequate staff and resources to conduct the study.

Reviews all proposed human subject research to determine that:

• Risks to participants are minimized by (a) using procedures which are consistent with sound research design and which do not unnecessarily expose participants to risk; and (b) when appropriate, by using procedures already being performed on participants for diagnostic or treatment purposes;

• Risks to participants are reasonable in relation to anticipated benefits, if any, and the importance of the knowledge that may reasonably be expected to result from participation in a study. In evaluating risks and benefits, the IRB Committee should consider only those risks and benefits that result from the research (as distinguished from risks and benefits of therapies participants would receive if not participating in the research). The IRB Committee should not consider possible long-range effects of applying knowledge gained in the research (e.g., the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility;

• Selection of participants is equitable considering the purposes of the research and the setting in which the research will be conducted and should be particularly cognizant of the special problems of research involving vulnerable populations and potential need for additional protections, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons;

• Informed consent will be appropriately documented, in accordance with, and to the extent required by Federal and State regulations and Institutional policies and procedures including the IRB;

• When appropriate, the research plan makes adequate provisions for monitoring data collected to assure the safety of participants;

• When appropriate, there are adequate provisions to protect privacy of participants and to maintain the confidentiality of data;

• There are adequate provisions to protect the rights and welfare of vulnerable populations from coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons. The IRB Committee must determine if additional safeguards need to be included in the study to protect the rights and welfare of these participants;

• When appropriate, the need for ancillary care, additional monitoring, counseling, and social support are provided; and

• When appropriate, the informed consent document includes the additional elements of informed consent.

Conducts timely continuing reviews of approved research, as appropriate.

Reviews all proposed human subject research in accordance with the basic ethical principles (Respect for Persons, Beneficence, Justice) of The Belmont Report.

Reviews, and has the authority to approve, require modification in, or disapprove all research activities that fall within its jurisdiction.

Evaluates research applications involving the use of radiological procedures (e.g., x-rays, radionuclides, etc.), which the participant would otherwise not receive as part of his/her medical care.

Participates in mandatory annual training, including the required CITI training modules, and keeps abreast of current events.

Evaluates research applications involving the use of radioactive drugs intended to obtain basic information regarding the metabolism of a radioactively labeled drug or regarding human physiology, pathophysiology, or biochemistry, but not intended for immediate therapeutic, diagnostic, or similar purposes or to determine the safety and effectiveness of the drug in humans for such purposes as defined by the FDA.

Reviews, and has the authority to approve, require modification in, or disapprove all research activities that fall within its jurisdiction.

Evaluates research applications for review of the use of gene transfer or therapy in human subjects research, the use of investigational, live, recombinant and/or attenuated microorganism for vaccination or infection, or select agent or toxin research or similar purposes.

Reviews, and has the authority to approve, require modification in, or disapprove all research activities that fall within its jurisdiction.

Meets with the student investigator on a regular basis to monitor study progress;

Should problems arise during the course of the study, the Faculty Advisor agrees to be available, personally, to supervise the student investigator in solving them;

Ensures that all investigators and key study personnel have completed the VU human subjects training program;

Ensures that the project is performed only by qualified personnel according to the approved IRB application;

Ensures that the student investigator does not implement any changes to the approved IRB application or informed consent document without prior IRB approval in accordance with VU IRB policy (except in an emergency, if necessary to safeguard the well-being of human participants, and will report to the IRB within 5 days of such change);

If children are included in research activities, ensures that the student investigator follows the Vanderbilt University and Vanderbilt University Medical Center Protection of Minors policy, as applicable, which includes appropriate provisions for background clearance checks, training and education, Codes of Conduct, external and mandatory reporting.

Ensures that the student investigator only obtains legally effective informed consent from human participants or their legally responsible representative, only the currently approved date stamped informed consent documents for human participants are used; and a copy of the informed consent is provided to the participant.

Ensures that the study investigator promptly reports any unanticipated problems involving risks to participants or others, or any serious adverse events (whether anticipated or not) to the IRB in accordance with Vanderbilt University IRB Policies and Procedures;

Assumes responsibility for the accurate documentation, investigation and follow‑up of all possible study‑related adverse events and unanticipated problems involving risks to participants.

If unavailable to supervise this research personally, as when on sabbatical leave or vacation, the Faculty Advisor arranges for an alternate Faculty Advisor to assume direct responsibility in his or her absence and advises the IRB by letter in advance of such arrangements;

Ensures that the student investigator promptly provides the IRB with any information requested relative to the project;

Ensures that the student investigator promptly and completely complies with an IRB Decision to suspend or withdraw approval for the project; and

Ensures that the student investigator obtains continuing review approval prior to the date approval for the study expires. Further, the Faculty Advisor understands that if the student investigator fails to apply for continuing review, approval for the study will automatically expire and the Faculty Advisor must ensure that all study activity ceases until IRB approval is obtained.