MUSC Student Handbook
Guidelines for Student Research Involving Human Subjects
Research can be defined as a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. This includes the development of research repositories and databases for research.
A human subject can be defined as a living individual about whom an investigator (whether professional or student) conducting research obtains:
1) Data through intervention or interaction with the individual; or
2) Identifiable private information.
Student research involving human subjects usually meets one of the following categories:
1) Research practica; or
2) Directed or independent research projects.
Research practica is a class project designed to provide students an opportunity to practice various research methods such as interview, observation and survey techniques, measurements of behavior and data analysis. Such projects are limited in scope and should not lead to any generalizable knowledge. These projects shall not involve the collection or use of any sensitive or personal information. In addition, there is no intent to present the results at a professional meeting or to publish the results.
Research practica do not require IRB review. However, if the practica involves the use of vulnerable subjects or poses a potential risk to subjects, the practica should be approved by the IRB. Generally, if the research practica falls into one of the below listed categories, the practica should be approved by the IRB:
1) The practica involves any sensitive or personal information;
2) The practica involves the use of vulnerable subjects (i.e. children, prisoners, etc.);
3) The practica involves asking subjects about illegal activities, such as underage drinking or the use of drugs;
4) The practica involves placing the subjects at risk due to a breach of confidentiality, such as asking about socially stigmatized behaviors and attitudes;
5) The practica places the subjects at risk due to emotionally charged subject matter;
6) The practica involves physically or psychologically invasive, intrusive, or stressful procedures;
7) Data collected is identifiable to the individual; or
8) The practica has the potential to place the individual at more than minimal risk.
Minimal risk can be defined as the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
Research practica must be conducted according to the ethical standards of the relevant discipline. In addition, data collected from research practica activities cannot be used at a later date for presentations at professional meetings, for publications or for dissertations.
Directed or Independent Research Projects
Research activities conducted by students, graduate or undergraduate, which uses human subjects and are intended to contribute to generalizable knowledge must be submitted to and approved by the IRB prior to conducting the research. This includes, but not limited to, independent research projects, honor and masters’ theses and dissertations.
Instructions on the process to submit a project to the IRB can be found at the following location: http://research.musc.edu/ori/irb/home.htm
A listing of research support resources can be found at the following location:
Information concerning the MUSC Human Research Protection Program can be found at the following location: http://academicdepartments.musc.edu/hrpp
The MUSC Human Research Protection Program Guide can be found at the following location: http://research.musc.edu/HRPP/MUSC%20HRPP%20Guide.pdf
All individuals involved in research involving human subjects must complete applicable human subjects research training. MUSC is registered for this training through the University of Miami Collaborative Institutional Training Initiative (CITI). A link to the education and training requirements for individuals involved in human subjects research can be found at the following location:
A CITI user guide can be found at the following location:
The South Carolina Clinical and Translational Research (SCTR) Institute is a catalyst for changing the culture of biomedical research, facilitating sharing of resources and expertise and streamlining research-related processes to bring about large-scale change in the clinical and translational research efforts in South Carolina. The SCTR Support Center for Clinical and Translational Science (Success Center) is the entry portal for the SCTR Institute programs and services. The Success Center can provide investigators and research team members numerous research services including research navigation, regulatory consultation, recruitment consultation, grant forms assistance, budget development, etc. Additional information concerning the SCTR Success Center can be found at the following location:
Questions or concerns regarding these guidelines, the MUSC Human Research Protection Program, required human subjects research training, etc. can be addressed to the University Compliance Office or the Office of Research Integrity. Contact information for these offices can be found at the following locations:
University Compliance Office: http://academicdepartments.musc.edu/uco
Office of Research Integrity: http://research.musc.edu/ori/index.html