| Clemson University | Research | Office of Research Compliance | IRB | > | Regulations |
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Regulations, Policy & Procedures
Guidance on the Use of Students as Research Participants:
Universities provide investigators with a ready pool of research participants,
namely students. The IRB pays special attention to the potential for undue
influence, power disparities, and whether or not the process for selecting
student participants is fair. An underlying principle of the federal regulations
governing the use of human subjects in research is that the subject’s
participation is voluntary and based upon full and accurate information.
Click
here for a list of guidelines that apply.
Guidance on the Use of Audio or Video Tapes (Revised 10/15/07):
Audio and video recording of human subjects is a form of research where it is often impossible / difficult to maintain the anonymity of the subject. Therefore, certain precautions must be taken, whether the project is reviewed through Exempt, Expedited or Full committee procedures. Click
here for a list of guidelines that apply to research projects involving
audio or video taping.
Guidelines for Advertising for Research Participants:
If written advertisements are used to recruit research participants, a
copy of advertisement(s) should be included, along with its mode
of communication at the time of protocol submission. If advertising is
developed / planned for at a later time and was not submitted with an
original protocol / application, an amendment form should be completed.
Click here for guidelines on advertising
for research participants.
Students As Principal Investigators:
The IRB does not accept submissions that list a student as a Principal
Investigator (PI). The PI listed must be a faculty or staff member of
the University. However, students may be listed as Co-Investigators on
the forms.
Use of Human Cell Lines Obtained from Commercial Sources (Revised 04/14/08)
Research Involving Deception or Concealment (Revised 07/27/07)
Link to Federal Regulations Governing Human Subjects
Research:
The principal investigator should be familiar with the Code of Federal
Regulations pertaining to human participants research. You may access
this information through http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm.
You may also access the Office for Human Research Protections’ (OHRP’s)
Policy Guidance at http://www.hhs.gov/ohrp/policy/index.html.
Federal Regulations Regarding Research Involving
Minors, Pregnant Women and Prisoners:
Minors
(Subpart D, 45 CFR 46.401-409)
Prisoners
(Subpart C, 45 CFR 46.301-306)
Pregnant
Women, Human Fetuses and Neonates (Subpart B, 45 CFR 46.201-207)
Federal Assurance:
On behalf of Clemson University, the Office of the Vice President for
Research and Economic Development (OVPRED) has entered into a Federal
Wide Assurance (FWA00004497; expiration 4/10/2009) with the Department
of Health and Human Services committing CU to abide by Federal regulations
applicable to human research subjects protection. This assurance is provided
to all research funded by Federal agencies that have adopted Title 45
CFR 46 U.S. Department of Health and Human Services (DHHS) / Office for
Human Research Protections (OHRP) Regulations, including the “Common
Rule” regulations and Subparts B, C, and D of the U.S. Code of Federal
Regulations (CFR). Research that is not funded by these Federal agencies
is covered by policies and procedures of the Clemson University OVPRED,
the Office of Research Compliance (ORC) and the IRB. These policies and
procedures provide equivalent review and human research subjects protections.
Random Audits:
To help insure that research is being conducted within institutional guidelines,
the IRB will be conducting periodic, random audits through the Office
of Research Compliance. If your study is selected for audit, you will
be contacted and asked to provide requested information. The Office of
Research Compliance will select records or data to be audited and contact
you for a time and place convenient for the audit.
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