Some research projects will require a special compliance review. If your proposal involves the use of human subjects, tissue, or data; vertebrate animals; or select agents and biohazardous materials, it must be reviewed and approved by the appropriate office within the university. Below we provide a brief summary of each type of special compliance review, the office that reviews each type of research and what is required at the proposal stage.
Please also note that many of these areas of special review, and others not listed here, require certificaton via training courses to be completed, and in some cases re-certifictaions to be completed every four years. The Office of Research Protections maintains this table that details what trainings and certifications are required for each type of research.
Human Subjects Research
The U.S. Department of Health and Human Services defines a “human subject” as “A living individual about whom an investigator (whether professional or student) conducting research obtains (1) information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens, or (2) obtains, uses, studies, analyzes, or generates private identifiable information or identifiable biospecimens.”
In other words, a project may be classified as human subjects research even if it does not involve living research subjects. Researchers are encouraged to consult with Pitt’s for guidance on any issues and questions relating to human subjects research.
While most sponsors do not require Institutional Review Board (IRB) approval at the time of proposal submission for projects involving human subjects, an approval is required at the award stage before you can begin any human subjects research. If your project involves human subjects, we recommend you begin the IRB review and approval process either at the time of proposal submission or as soon as possible afterward.
If you are submitting a proposal involving human subjects to the NIH, you must include the PHS Human Subjects and Clinical Trials Information Form. This form contains all relevant information for each human subjects research study involved in the proposal. NIH defines a “Study” as “a research protocol or set of experiments designed to investigate a scientific question.” So, a PI may have one study for each protocol, or protocols may be grouped together into a single study if they share the same human subjects populations. Detailed guidance on this form can be found in the NIH SF424 Application Guide.
Because other sponsors vary in their guidelines on how to address human subjects research activities, you can consult with your pre-award administrator for guidance on a specific sponsor or specific proposal. NSF, for example, does not require a separate section addressing human subjects like NIH does, but other sponsors do. We will be happy to help you determine the appropriate approach.
Vertebrate Animals Research
All research involving vertebrate animals must be reviewed and approved by Pitt’s Institutional Animal Care and Use Committee (IACUC). Similar to human subjects research, most sponsors do not require an approved IACUC protocol to be in hand at the time of proposal submission, but approval is required at the award stage before any animal work can be done.
Pitt’s IACUC has an online portal for submission and management of protocols, called ARO Online.
As with human subjects research, NIH has a specific section of the proposal where vertebrate animals are addressed, touching on issues such as handling procedures, minimizing pain and distress, and, when applicable, euthanasia. The NIH SF424 Application Guide contains detailed guidance on what to include in this document.
Other sponsors vary in their proposal requirements for addressing vertebrate animal research. Your pre-award administrator can help guide you through the requirements for individual sponsors.
Institutional Biosafety Committee & Select Agent Research
All research involving recombinant or synthetic nucleic acid molecules must be reviewed and approved by Pitt’s Institutional Biosafety Committee. As with the other compliance reviews, an approved protocol is generally not required at the proposal stage, but approval is needed in order for work to begin at the award stage.
While sponsor requirements vary widely on required proposed content addressing the use of these materials, NIH proposals do require a separate proposal attachment addressing Select Agents. The SF424 Application Guide offers detailed guidance on what is required. For other sponsors, you can consult with your pre-award administrator for what is needed at the proposal stage.