Is IRB review required for a research study conducted by a high school student?

July 3, 2019 Yvonne Higgins

Question:

I am a high school student seeking to create a speech database on vocal impairments. The study will involve human subjects, and the data collected would be audio recordings of each subject speaking from a generic list of words and phrases. If I am conducting this human subjects study independently, am I still required to submit it for an IRB review?
- High school student

Answer:

IRB review of the research you describe is not required by the U.S. federal regulations on human subjects protections unless the research is funded or supported by a federal agency (such as the National Institutes of Health or the Department of Education) or the research is regulated by the Food and Drug Administration.  It is important to note, however, that most universities and scientific journals extend the requirement for IRB review to human research even when the activity is not covered by the federal regulations. 

As a first step, check with your advisor to see if your school has any requirements for review or oversight of human research studies.  If you are planning to share your results at a science fair, check in with the sponsoring organization to make sure you are following their policies.

If you plan to publish your results in a journal, we recommend that you submit your study plan to an IRB (or an individual or to an entity that is knowledgeable about the regulations) to make a determination that the research does not require further review by the IRB.

Although IRB review may not be required by policy or regulation, you may still wish to consider applying certain ethical principles to your research.  For example, you could provide an information sheet to prospective participants that describes the research project and lets them know that their participation is voluntary and how personally identifiable information will be safeguarded to ensure confidentiality.

About the Author

Yvonne Higgins

Yvonne has contributed to the cause of ethics and responsibility in human research for more than 20 years. During that time, she has served as Vice President of Quality Management for Copernicus Group IRB, Executive Director of the human research protections program (HRPP) and Institutional Review Boards (IRBs) at the University of Pennsylvania, Co-Chair of the workshop and didactic planning committee for PRIM&R’s Advancing Ethical Research annual conference, and Public Health Analyst within the US Department of Health and Human Services Office for Human Research Protections (OHRP).

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