RESPONSIBILITIES WHEN USING HUMAN SUBJECTS IN RESEARCH

Medical University of South Carolina

The use of human subjects in research at MUSC falls under the jurisdiction of federal regulations (45 CFR 46 and 21 CFR 50 and 56). MUSC investigators are granted the privilege of using human subjects under normal assurance to the government that research conducted at MUSC complies with these regulations protecting human subjects. Research involving human subjects must be reviewed by the MUSC IRB where one or more of the following apply:

Review by IRB

1. The research is sponsored by this institution, or
2. The research is conducted by or under the direction of an individual in connection with his/her institutional responsiblities, or
3. The research is conducted by or under the directionof an individual who is receiving remuneration from the institution, or
4. The research is conducted by or under the direction of an individual using any property or facility of this institution, or
5. The research involves the use of this institution's non-public information to identify or contact human research subjects for prospective subjects, or
6. The institution's name is used in any way in connection with the study including procurement of sponsorship, announcement or advertisement or other recruitment of subjects.

Principal Investigator and Mentors

1. Full time faculty can serve as principal investigators and mentors.
2. Faculty, who do not meet the qualifications stated above, can serve as co-investigators but not as principal investigators. In unique situations, the Provost, may waive this constraint provided a mentor is added to the study.
3. MUSC trainees in good academic standing can function as principal investigators with the inclusion of a faculty mentor.
4. MUSC employees can function as principal investigators with the inclusion of a faculty mentor.
5. A principal investigator and the mentor are both responsible for the conduct of the human research. These responsibilities are outlined in the MUSC Federal Wide Assurance and the IRB documents signed by the principal investigator and mentor.

Employees as research subjects:
Employees (normal volunteers) may not participate in immediate supervisor’s studies if the study poses greater than minimal risk. Exceptions are allowed for those who may derive direct health benefits (e.g. cancer protocol).

Students as research subjects:
Students cannot participate as subjects in their mentor’s clinical research if the study poses greater than minimal risk. Exceptions are allowed for those who may derive direct health benefits (e.g. cancer protocol). These will be determined on a case-by-case basis.
Student studies can be performed at the VA provided that:

If the primary mentor does not have VA privileges, another qualified person with VA privileges can be the PI of record at the VA provided that they serve as a secondary mentor to the student. As a secondary mentor, the VA PI will have responsibility over the VA section of the study. The primary mentor will still have ultimate responsibility over the whole study, including the VA and MUSC. The VA R&D Committee determines the PI for VA studies.

Principal Investigator and Staff
Before initiating, modifying, or extending any research project that uses human subjects, Principal Investigators must submit an application including an informed consent form to the Institutional Review Board for Human Research (IRB) for review and approval.

In both the design and conduct of their studies, investigators are obligated to consider racial, cultural, and gender diversity among the subject populations and be sensitive to community attitudes.

Any serious or recurring problem, unanticipated side effect, or adverse reaction experienced by a subject must be reported to the IRB. Problems related to the conduct of a study or patient participation (including those in the recruitment or consent process) must also be reported.

The violation of an experimental protocol or any use of subjects not approved by the IRB must be reported immediately to the IRB.

Any investigator who uses human subjects without IRB approval or who willfully violates the scope of his or her approval may lose legal protection provided by the University and may be held liable for any litigation costs and the costs of any medical care provided to subjects who suffer injury under such circumstances.

Institutional Review Board for Human Research (IRB)
It is the responsibility of the IRB to safeguard the rights and welfare of human subjects. To this end the Board is obligated and authorized to:

Ensure that subjects are adequately informed of the nature of the study;

Ensure that subjects' participation is voluntary;

Ensure that the benefits of a study outweigh its risks;

Ensure that the risks and benefits of the study are evenly distributed among the possible subject population ; and,

Suspend human subjects activity that violates regulations, policies, procedures, or an

approved protocol, and report such violation and suspension to the Institutional Official.

University Administration
MUSC assures the federal government that the university is in compliance with federal regulations on the use of human subjects in research (45 CFR 46), and that no research involving human subjects is conducted without prior review and approval.

MUSC provides resources to support the activities of the IRB, maintain necessary records, and report as required to federal agencies.

MUSC may provide treatment (subject to the State Budget and Control Board) for injured research subjects.

The University provides legal protection for members of the IRB and to principal investigators granted approval to conduct research, provided they have met their obligations in good faith.

MUSC is responsible for investigating incidents or allegations of misconduct pertaining to the use of human subjects in research.

The University provides whistle-blowing protection to anyone who reports an activity that violates any regulations or policies on the use of human subjects.

Under the provisions of the Federal Freedom of Information Act, the University is required, upon request, to release to the public documentation on any active or retired research protocol.

For assistance in the preparation of applications to the IRB for Human Research call the Board's office at 792-4148.

To report incidents of non-compliance or unauthorized research, call the Office of Research Integrity at 792-4148.