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All non‐exempt human subjects research must be reviewed by the IRB. The first step in determining whether research must be reviewed is to determine whether it meets the regulatory definition of human subject research.

This SOP discusses rules governing investigator self-experimentation and experimentation on family members of investigators.

Regulations require an organization to have written procedures for ensuring prompt reporting of changes in research activity; unanticipated problems involving risk to subjects or others; and any instances of serious or continuing non-compliance to the IRB, organizational officials, and applicable federal agencies.

There is the inherent risk that incidental findings (IF) may be discovered on research- directed imaging procedures. These IFs may or may not be of clinical significance. The incidence of detected abnormalities when imaging varies depending on a number of factors including age of subjects, health status, the technology used and the expertise of the individual reviewing the image.

The UNC IRB has developed this SOP to describe a series of consistent, deliberate steps to mitigate fetal exposure to risk in clinical research studies among women of child-bearing potential (CBP).

The IRB will review all transnational research involving human participants to assure adequate provisions are in place to protect the rights and welfare of the participants. Approval of research is permitted if “the procedures prescribed by the foreign institution afford protections that are at least equivalent to those provided in 45 CFR 46.”

Learning how to conduct ethical human subject research is an important part of a student’s educational experience. Research activities that are designed as part of a course requirement for purposes of learning experience only and are not “designed to develop or contribute to generalizable knowledge” may not require IRB review and approval if all of the following conditions are true...

Generally, researchers at UNC-Chapel Hill may not solicit by direct appeal to students, employees or trainees in that researcher’s department or class in an effort to recruit subjects for a study. Such direct and targeted solicitation (which should be distinguished from the dissemination of information such as is done in mass distribution emails) takes place within a power dynamic that could be construed as coercive by the potential subjects being solicited.

The IRB should pay particular attention to the following issues in survey research: Possibility of undue influence in administration of the survey; Possibility of deductive disclosure based on demographic information garnered from subjects (subject confidentiality and privacy must be protected); The setting of the survey and the issues raised by such a setting; and The mode of obtaining consent, especially when implied consent is to be used.

If researchers wish to utilize data from voice, video, digital or image recordings, they must take a variety of special precautions. First, the researcher must obtain appropriate permissions from subjects who will not have their anonymity protected due to the very nature of the data being collected.

Each separate human subjects research study requires IRB review and approval of the specific proposed study, regardless of whether the data set or research materials have been previously compiled.

Studies involving the use of radiation, such as those requiring patients to be X-rayed, are not eligible for expedited review, even if all of the other procedures in the study have been deemed to pose no more than minimal risk.

With respect to cigarettes and alcoholic beverages, IRBs and researchers should be aware that under North Carolina state law these substances may not be distributed to or used by minors.

Some research designs may require the withholding of information from human subjects. Research involving deception or withholding of information must be reviewed by the IRB with common sense and sensitivity. The withholding of information by researchers is different from the practice of deception, in which researchers provide false or misleading information to subjects.

All activities involving the collection of human biological specimens for research purposes, as well as the research use of specimens collected for clinical care, must be conducted under the terms of an IRB approved research protocol. The collection and use of human biological specimens (either identifiable or de-identified) must comply with all applicable laws and regulations for research involving human biological specimens or superseding requirements.