Institutional Review Board (IRB)
Review of Research
All research conducted by any individual (faculty, staff, or student) under the auspices of LSUHSC-S, irrespective of the risks, scope, funding, or location of the research, must comply with federal regulations and LSUHSC-S policies for the protection of human subjects. It is the shared responsibility of this institution, the Human Research Protections Program, Institutional Review Board, Departmental Chairs, investigators and all others engaged in research to ensure that all LSUHSC-S research activities meet these requirements.
Jurisdiction of the IRB
Federal policy establishes the IRB as the administrative body responsible for oversight functions that protect the rights and welfare of human research subjects recruited to participate in research activities. The IRB has the authority to approve, require modifications in, or disapprove all research activities that fall within its jurisdiction as specified by both the federal regulations and LSUHSC-S policy. Research that has been reviewed and approved by the IRB may be subject to review and disapproval by officials of LSUHSC-S. However, those officials may not approve research if it has been disapproved by the IRB (45cfr46.112).
Review of Research
All research projects must be submitted to the IRB along with the initial application, and relevant attachments. Please see the Initial Application Form for a complete list of required attachments and information to be submitted.
The IRB asks for information about the investigators, the nature of the research, the funding source, contracts, targeted subject groups, how subjects will be recruited, advertisements, how informed consent will be obtained, how confidentiality will be protected, and the risks and benefits of the proposed research.
Human Subjects Determination
Is this Research?
The IRB should be involved with any activity that meets the definition of research. An activity is considered research if it meets both of the following criteria:
- The activity is a systematic investigation, inquiry or analysis. This means the activity involves a prospective plan which incorporates data collection, either quantitative or qualitative, and data analysis to answer a question, test a hypothesis, discover or collate facts, principles or effects, reach new conclusions, or reexamine existing information.
- The activity is designed to develop or contribute to generalizable knowledge. This means the activity is designed to draw general conclusions, inform policy or generalize findings that are disseminated, published, presented, or shared outside this institution.
Does this Research Involve Human Subjects?
Research is considered human subjects research if it meets both of the following criteria:
- The research involves living individuals.
- An investigator (professional or student) will obtain data through:
- Intervention with the subject; This includes both physical procedures from which data is gathered (example: venipunture) and manipulations of the subject or the subject’s environment that are performed for research purposes; or
Interaction with the subject; This includes all forms of communication (verbal, written, electronic, visual, body language) or interpersonal contact between investigators and subjects; or
- Collection of identifiable private information or identifiable specimens. This includes information about a subject or behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information that has been provided by an individual and which the individual can reasonably expect that it will not be made public (example: medical record).
Note: Information is individually identifiable if the identity of the subject is or may be readily ascertained by the investigator or associated with the information. In general, OHRP considers private information or specimens to be individually identifiable as defined at 45cfr46.102(f) when they can be linked to specific individuals by the investigator(s) either directly or indirectly through coding systems.
Obtaining identifiable private information or identifiable specimens includes, but is not limited to:
1) using, studying, or analyzing for research purposes identifiable private information or identifiable specimens that have been provided to investigators from any source; and
2) using, studying, or analyzing for research purposes identifiable private information or identifiable specimens that were already in the possession of the investigator.
Activities meeting the definition described in the above section: “Does this Research Involve Human Subjects?” constitutes research for purposes of LSUHSC-S HRPP policies, whether or not they are considered research for other purposes.
Examples of human subjects research include
- studies in which a substance or stimulus is administered to a subject,
- studies in which a subject’s response, condition or state is measured;
- studies that involve changes in the subject's physical or psychological state or environment, or changes in diet;
- interviews, surveys, tests, inquiries, and observations designed to elicit or obtain nonpublic information; and
- studies of existing records where the identity of the subjects is known or could be readily determined by the investigator or any member of the research team.
For additional help please see the Human Subject Research Determination Form/Checklist.