IRB Policies and Resources

IBC and IRB Protocols

A protocol will need to be submitted to both committees when:

it involves the transfer of recombinant DNA or DNA/RNA derived from recombinant DNA (human gene transfer). Recombinant and synthetic nucleic acids are defined as:
- molecules that are constructed by joining nucleic acid molecules and that can replicate in a living cell, i.e. recombinant nucleic acids,
- molecules that are chemically or by other means synthesized or amplified, including those that are chemically or otherwise modified but can base pair with naturally occurring nucleic acid molecules, i.e. synthetic nucleic acids,
- molecules that result from the replication of those described in (i) or (ii) above.
using infectious agents with research participants
the IBC protocol involves the use of human research participants or identifiable human biospecimens

An IRB protocol submission is not required to the IBC If the researcher is only collecting, storing, or shipping specimens.

Either IRB approval or IBC approval can be sought first. However, once approval is obtained, the approval notice must be appended to the protocol submitted to the other committee via a modification or amendment.

W&M Policy for Paying Human Participants

Accounts Payable lists policies related to paying human participants. Please follow the links below for more information.

Financial Operations Procedure for Paying Human participants
- Click "Direct Payments" and scroll to "Human Subjects Payments"
Payment Log for Payments $50 or less
Payment Log for Payments from $51 to $100
Payment Log for Payments $101 or greater

If you experience difficulties accessing the documents, please contact Accounts Payable for assistance.

Federal Regulations and Procedures

The U.S. Department of Health and Human Services (HHS), Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA) oversee operations of the IRB.

Federal Regulation 45 CFR 46 Protection of Human Participants: applies to all research involving human participants conducted, supported, or otherwise subject to regulation by any Federal department or agency that takes appropriate administrative action to make the policy applicable to such research. Protection of Human Participants mandates research that involves human participants must be approved by an Institutional Review Board (IRB) to ensure the safety and the appropriate use of humans as participants in research studies.

Resources:

Policy Resources from OHRP

The Office for Human Research Protections (OHRP) works to protect the rights, welfare, and well being of volunteers who participate in research. These resources are only references are not used in lieu of required CITI training.