Human Subjects Approval

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All projects, master’s theses and doctoral dissertations research involving human subjects must be reviewed and approved by a UNC Chapel Hill Institutional Review Board (IRB, also called Human Subjects Committee) or by an IRB with which the UNC-Chapel Hill IRB can negotiate an IRB Authorization Agreement. The UNC-Chapel Hill IRB has negotiated these agreements with many institutions including Duke University, Bowman Gray School of Medicine and Wake Medical Center. Research involving human subjects and submitted for external or internal funding, including NRSAs and minority supplements, also typically needs IRB approval, although whether that approval must be received before submission or after funding varies among funding agencies. Research is generally considered to involve human subjects if the investigator has direct or indirect contact with individuals or identifiable data or pathological specimens about living persons. Research using only data from publicly available and deidentified databases or from published sources may not be considered human subjects research if no one on the study team has a way to link to the identity of the original subjects; this determination is best made by the IRB. It is important to note that databases without name or social security number are not necessarily deidentified, as there are many other demographics considered as “identifiers.” Determination of whether or not data is sufficiently deidentified is best made by the IRB.

A number of studies submitted to the UNC-Chapel Hill IRB are deemed “not human subjects” research which means, once reviewed and so designated, no further involvement with the IRB is needed unless a change in the study might alter that decision. This designation can be given to studies that involve human beings but are not considered to be research in the federal regulations (e.g., not systematic, as in single subject case studies and/or are not designed to contribute to generalizeable knowledge, as in program evaluation or quality improvement projects) or when information is collected from humans but is not about them (e.g, a survey of public health department directors about the content of programs offered).  When a student has a study that might qualify for a “not human subjects research” designation from the IRB, the online IRB application will be shortened considerably.  Once submitted, the IRB will review the application and let the student know if it agrees with the “not human subjects research” determination. If it does not agree, then a longer IRB application will be necessary.

IRB applications are submitted online and students can be “PI” (Principal Investigator) for the IRB submission. However, the faculty member guiding the research, typically the research advisory committee chair, must be listed as the faculty advisor on the IRB submission. While the student is responsible for the conduct of the research, including adhering to laws, regulations and University policies pertaining to human subjects research, the faculty advisor has the ultimate responsibility for ensuring the student’s compliance. 

The IRB application is a “smart application” in that it builds the latter parts of the application based on answers to earlier questions. Two students submitting IRB applications may answer quite different questions, depending on the nature of their respective proposed studies; the greater the complexity of the study or the potential for risks to subjects, the longer the application will be. However, most student research does not trigger an extensive number of questions, so that application is straight forward.

Rarely does an application get approved when initially submitted, although it does happen. Feedback from the IRB can be expected within a week for most studies. If you pay close attention to the issues raised by the IRB, a resubmission should be approved within a few days after being returned to the IRB. While applications can be submitted at any time, studies that require review by the entire IRB committee (referred to as a “full board review”) must be submitted at least 10 business days prior to a scheduled meeting. Meeting dates for the Non-Biomedical IRB, the Committee most commonly involved in reviewing applications from the School of Nursing, can be found on the IRB website. Rarely do School of Nursing faculty- or student-led studies necessitate full committee review, so these deadlines should not be a concern for most students.

It is School of Nursing policy that thesis, research project or dissertation studies may not be submitted to an IRB until the research advisory committee has approved the proposal for the study. In rare instances (for example, studies that require pilot work prior to the final development of the proposal), exceptions may be made to this policy with the consent of the committee chair.  However, exceptions will not be made purely to decrease the time spent in the research process.

Graduate students who are working on their dissertation, research project or thesis with a faculty member’s data from a study with current IRB approval may not need to have their own IRB approval if the proposed study is wholly subsumed under the existing IRB approval. Guidance for this can be found on the IRB Website in the FAQ section (download the document under the FAQ question “What about student research or other class projects?”).  If the student’s intended research activity is not addressed in the faculty member’s current IRB approval, there are two options — either the student will need to submit an independent IRB application for their research activity or the faculty advisor can submit an addendum to their original IRB protocol including the student’s research activities.

Secondary analysis of completely deidentified data is often not considered to be human subjects research. One exception to this, as noted earlier, is when someone on the research advisory committee has access to the “link” between the subject codes and the identity of the subject. In these cases the IRB cannot determine the research to be “not human subjects research.” As noted earlier this is best decided by the IRB after submitting an IRB application.

After passing the thesis, research project or dissertation proposal defense, the student submits the Research Proposal IRB Tracking Form to the Office of Academic Affairs. On this form, the student and committee chair indicate which IRB the study will be submitted to and the approximate date of this submission. The Office of Academic Affairs (OAA) Secretary will stamp and copy the IRB tracking form and return the stamped form to the student. OAA will retain a copy of the form. Note that a copy of the project, thesis or dissertation proposal is to be submitted along with the IRB application. As noted earlier, the IRB used must be a UNC-Chapel Hill IRB or an IRB with which the UNC-Chapel Hill is willing to enter into an IRB Authorization Agreement.

Students who intend to include patients (or their families) or nurses at University of North Carolina Hospitals in their research activities must have their studies reviewed by the Nursing Research Council (NRC) at UNCH. It is important to check with that committee chair to determine if that review occurs before, after or simultaneously with the IRB submission. Once a study is approved by the NRC and the IRB, additional permission may be needed for access to the patients and nurses. Check with the direct administrator (such as nurse manager on a clinical unit) to obtain more details on how to proceed with research. Similar permission is generally needed at other institutions, although there may or may be a review committee.  Remember: IRB approval does not guarantee access to potential subjects

All SON students and faculty conducting or participating in research must have recent education specific to human subjects in research. Before any IRB application is approved, the student and faculty advisor must have completed this education and be included in the UNC-Chapel Hill Ethics Training database. This database typically is updated two or three times a week. Additionally, anyone on the study tram or advisory committee with access to identifiable data is also required to complete the same human subjects ethics education. Completion of the required education is automatically checked when the IRB application is received. Also, students working on faculty research involving human subjects, whether as an RA, volunteer or as part of a course assignment, are required to complete human subjects education training. Doctoral students are informed about the need for human subjects ethics training during orientation and Master’s students should hear about it during their research course. To check whether the education has been completed and recorded, go to the OHRE website.

The Health Insurance and Portability and Accountability Act (HIPAA) may be an issue for studies involving Protected Health Information (PHI). HIPAA reviews are conducted along with the IRB protocol review if the study has HIPAA implications. For more information about HIPAA, see the University’s HIPAA website. Because a study involves what HIPAA defines as PHI does not necessarily mean that there must be specific review for HIPAA when the IRB application is reviewed; PHI is only PHI if a health care provider, plan or clearinghouse is involved.

Submission of IRB applications

IRB applications are submitted online.  Once the application is complete and the “submit” button selected, the student and faculty advisor must certify the application in an electronic routing process. The faculty advisors division chair will also have to certify it before it actually reaches the IRB. Until these and any additional certifications occur, the application will not be released to the IRB for review.  When incomplete or incorrectly developed applications are submitted to the IRB, the time needed for approval lengthens since no review will occur if the application is missing essential components.

All of the IRBs noted earlier have the same three levels of review: exempt, expedited and full board. The exact type of review that a study requires can be determined by referring to the OHRE website and consultation with the research advisory committee, an IRB Coordinator or an IRB committee chair. All studies involving human subjects must be reviewed by an IRB even if they are thought to be exempt. Exempt status is a determination made by the IRB after it has been initially reviewed to assure the level of risk is no more than minimal and other criteria are met. Expedited and full board review studies are monitored by the IRB, and renewals must be filed at least annually. The actual renewal date will be established by the IRB at the time of approval/subsequent renewals. Studies that have expedited or full board approvals must be closed when the study is completed and before the student graduates. Closing an IRB approved study involves completing the closure component of the online application.

UNC-Chapel Hill requires that any signed consent forms and a copy of the original data (paper-based or digital) must be retained for at least three years after the end of the project. It is often best to entrust these to the faculty advisor as they need to be retained on campus.