For Students: Research Involving Human Subjects
Navigating the IRB Process: Steps for Students
UNC-Chapel Hill is committed to upholding the highest standards in research involving human subjects. This requires knowledge of the ethical and regulatory obligations and applies to all faculty, staff, and students who are engaged in the design and conduct of human subjects research that is conducted under the aegis of UNC-Chapel Hill.
As a student conducting human subjects research, you are responsible for ensuring that you are conducting research in an appropriate manner and in concordance with federal requirements and UNC-CH policies. You should begin thinking about the IRB process at the same time you are discussing your research plans with a faculty member. Note the following:
- Begin discussing your research with a faculty member. Ask about the IRB at the onset!
- Your research cannot be initiated until you have IRB approval. The IRB cannot grant retroactive approval after research has been initiated or completed.
- You should allow a couple of weeks for review of your IRB application. Refer to the OHRE website for important dates and deadlines if the research will require Full IRB review: http://research.unc.edu/offices/human-research-ethics/researchers/dates-deadlines/index.htm.
- Contact your department and ask about IRB procedures and ask if they have examples of completed applications.
- Check out the UNC-CH Office of Human Research Ethics (IRB) website for useful information, Frequently Asked Questions, and links to additional resources: http://research.unc.edu/offices/human-research-ethics/index.htm.
- Review the IRB Guidance for Student Research and Class Projects.
- If human subjects research will take place outside of the United States, there are additional requirements, so the IRB process should be started as soon as possible.
It is essential that researchers have sufficient knowledge of the local research context to be able to design and conduct research in a way that protects the rights and welfare of the subjects.
To gain a better appreciation for what the IRB has to consider when reviewing human subjects research being conducted outside the US, consider reviewing the OHRE SOP on International Research. This will assist you with providing the IRB with all the required information: http://research.unc.edu/offices/human-research-ethics/regulatory-documents/sop/31/index.htm.
Ensure you are familiar with the federal guidance from the Office of Human Research Protections (OHRP) on conducting human subjects research outside the United States: http://www.hhs.gov/ohrp/international/index.html.
Ensure you are familiar with the UNC-CH policy on Study, Travel, and Research in Countries Under State Department Warnings: http://provost.unc.edu/policies/travel_warning.
- Review the OHRE website to determine if your IRB application will be submitted on-line or by paper: http://research.unc.edu/offices/human-research-ethics/online-submission/applications/index.htm.
- If submitting your application on-line, complete the Screening questions to determine if your project requires IRB approval. If submitting your application on paper, complete the Determination Whether Research or Similar Activities Require IRB Approval.
- Complete your on-line human subjects protection (ethics) training and be sure your faculty advisor has completed the training too: http://research.unc.edu/offices/human-research-ethics/researchers/training/index.htm.
If you have questions about training, contact the IRB Training Coordinator by email (email@example.com) or by phone:
Training Coordinator / Office of Human Research Ethics
- Ensure that your faculty advisor is aware of the IRB and their responsibilities (Navigating the IRB Process: Steps for Faculty Advisors). Get your advisor's input throughout the IRB application process.
- Complete the IRB application being sure to follow all instructions: http://research.unc.edu/offices/human-research-ethics/about/contact-map/index.htm.
If you have questions about the application, the forms, or general questions, contact the IRB by email: firstname.lastname@example.org or by phone: 919-966-3113.
It is better to get questions clarified before the IRB application is submitted. Once the application is submitted, any changes will require a Modification.
- Refer to the OHRE website for on-line submission training materials: http://research.unc.edu/offices/human-research-ethics/online-submission/training/index.htm
- If you are submitting your application on-line, be sure to get your faculty advisor to certify the application before you hit “SUBMIT.” If you are submitting your application on paper, be sure to get your faculty advisor's signature before you submit your application.
- A note about Informed Consent. Obtaining informed consent is a PROCESS in which the investigator discloses all relevant information; the potential subject has the opportunity to ask questions; the investigator answers the questions; and if the subject is willing to participate, the subject signs a consent form. The consent form is a permanent record of information conveyed and the subject's willingness to participate.
The IRB may waive certain elements of the consent form or the requirement for the investigator to obtain a signed consent form under certain circumstances.
If you are submitting your application on paper, OHRE has consent form templates that include all the required elements as defined by federal regulations. If you are submitting your application on-line, as you complete your application, consent forms are “built” by the on-line system depending on your application responses.