Human Research Participants Resources

The following resources are available for human research participants. For questions, concerns or suggestions about research, a research-related injury, or questions about your rights as someone taking part in research, call the ECU UMCIRB Monday through Friday at 252-744-2914. If you would like to report complaint or concern about a specific research study, you may call the UMCIRB director at 252-744-2914.

Who is considered a human research subject?

An individual is considered a human subject when they meet the following definition:

“… is a living individual about whom an investigator (whether professional or student) conducting research:

Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies or analyzes the information or biospecimens; or
Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.
- Intervention includes both physical procedures by which information or bio-specimens are gathered (i.e. venipuncture) and manipulations of the subject or subject’s environment that are performed for research purposes.
- Interaction includes communication or interpersonal contact between investigator and subject.
- Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public.
- Identifiable private information is private information for which the identity of the subject is or may readily be ascertained by the investigator or associated with the information.
- An identifiable biospecimen is a biospecimen for which the identity of the subject is or may readily be ascertained by the investigator or associated with the bio-specimen.”

Should research participants receive payment for participation?

Investigators or research sponsors sometimes pay participants. The payment should be based on the time that the individual gives to taking part in the study. Payment based on effort or discomfort associated with participation is subjective and can differ greatly across individuals. Payment for time can be equitably divided should a participant be withdrawn or choose to drop out of the study. If you are conducting research and payment is offered to participants, you need to inform the IRB on how payment will be prorated and when payment will be provided (by visit, at the end of the study, etc.). Payment cannot be of such an amount that it creates coercion or undue influence.

Federal regulations require that participants who receive greater than $600 for participating in a research study must file an IRS Form 1099 as earned income. The informed consent document should include a statement to this effect as well as a description of the process about how the IRS Form 1099 will be generated.

Brochures and Information Sheets

About Research Participation

The Office of Human Research Protection’s About Research Participation offers resources designed to help potential volunteers better understand research and find the information they need to decide whether to participate in research. Trial coordinators and research staff also could use these materials to facilitate and improve the informed consent process. These resources include a series of short videos about participating in research, a printable list of questions that potential volunteers can ask researchers, and links to additional resources.

Participation in Research Links