CITI Training is a web-based program designed to educate researchers about the ethical principles for working with human research subjects and the regulatory requirements for conducting research. Topics include concepts specific to types of research, roles in the protection of human subjects, informed consent, vulnerable populations, and data safety monitoring.
IRB, or Institutional Review Board, approval is necessary for research that involves human subjects to ensure the safety and agency of those being studied.
The Institutional Review Board safeguards the rights of all subjects of research carried out under the auspices of Mississippi University for Women. The IRB establishes guidelines for the use of human subjects in research; reviews appropriate research proposals to ensure that the proposed research meets the established guidelines; and recommends approval or disapproval of the research.
CITI Training
The first step in the IRB process is to complete CITI Training, which is required for all researchers. To register, go to citiprogram.org to create an account and affiliate with MUW. Complete the modules required prior to IRB approval.
Upon successful completion of the training, print and save the certificate for your records.
IRB Packet
Investigators will download a Review Packet and submit the documents electronically to the chair of the IRB. All proposals must be approved by the research advisor prior to submission to the IRB. The investigator will submit necessary materials for the review committee. The committee prefers that submissions be made within the first six weeks of the Fall and Spring semesters and the first three weeks of the First Summer term. Exceptions may be made where appropriate. Requests for such action should be directed to the committee chair.
Forms:
These definitions are adapted from Texas Tech Health's IRB Glossary, Utah State's IRB Glossary, and Oregon State University's Glossary
Anonymous: Subjects’ identities are unknown to the investigator, not requested, and not given. Data collected do not contain any information that would permit identification of the individual subjects. Subjects cannot be described as anonymous if the research involves audio/video recordings or in-person interviews.
Confidentiality: Pertains to the treatment of information that an individual has disclosed in a relationship of trust and with the expectation that it will not be divulged to others without permission in ways that are inconsistent with the understanding of the original disclosure.
Deception: Deception is the intentional misleading of subjects or the withholding of full information about the nature of a research experiment or procedure. Misleading or omitted information might include the purpose of the research, the role of the researcher, or what procedures in the study are actually experimental.
Drug: Any chemical compound that may be used on or administered to humans as an aid in the diagnosis, treatment, cure, mitigation, or prevention of disease or other abnormal conditions.
External funding: Applies to research done under externally funded programs, such as local, state, or federal grants. Examples could include private grants (e.g. Weyerhauser Foundation) or publicly funded grants (e.g. Mississippi Humanities Council, National Institutes of Health, etc.)
Human Participants: A living individual about whom an investigator (whether professional or student) conducting research obtains data through intervention or interaction with the individual, or obtains identifiable private information (no intervention or interaction required).
Informed Consent: A person's voluntary agreement, based upon adequate knowledge and understanding of relevant information, to participate in research or to undergo a diagnostic, therapeutic, or preventive procedure. In giving informed consent, subjects may not waive or appear to waive any of their legal rights, or release or appear to release the investigator, the sponsor, the entity or agents thereof from liability for negligence.
Inclusion/Exclusion criteria: List of criteria guiding enrollment of participants into a study. The criteria describe both inclusionary and exclusionary factors, (e.g. inclusion criterion - participants must be college students; exclusion criterion – must not be student athletes).
Incentives: A stated reward given to (or offered to) participants in a study. Incentives are usually financial (e.g. a gift card or a raffle ticket), but can take other forms (e.g. free food or a course-related incentive).
Principal Investigator: The person with ultimate responsibility for the design and conduct of a research project, i.e. the student, grant supervisor, etc. The principal investigator's partners can be listed as co-investigators.
Potential Benefits: any valued or desired outcomes or advantages to participating in or conducting the study, e.g. gaining insight about a topic, providing therapeutic practices, etc.
Recruitment: Methods of finding participants for the study, e.g. email invitations, social media posts, referral, etc. This method should demonstrate how the participants from potentially relevant groups are not accidentally excluded.
Retrospective Study: Research conducted by reviewing records from the past (e.g., birth and death certificates, medical records, school records, or employment records) or by obtaining information about past events elicited through interviews or surveys. Case control studies are an example of this type of research.
Risk: The probability of harm or injury (physical, psychological, social, or economic) occurring due to participation in a research study.
Surveys: Studies designed to obtain information from a large number of respondents through written questionnaires, telephone interviews, door-to-door canvassing, or similar procedures.
Safeguards: Measured used in the study to mitigate risk (i.e. protecting privacy, preventing harm, backing up data, etc.)