Institutional Review Board

Proposals shall be submitted to the chair of the IRB at least 60 days prior to the initial time of subject enrollment in order for adequate consideration to be given to the request. The IRB shall review and have authority to approve, require modifications to secure approval, or disapprove all research activities. The IRB shall require the investigator to provide information that describes the research purpose and methodology and information given to subjects to obtain their informed consent. Research activities led by a non-MSDH employee must identify an MSDH employee who serves as a research co-investigator.

How to Apply

Knowledge certification: Individuals who will be involved in the design or conduct of human subjects research (key personnel such as the principal investigator) must demonstrate knowledge of human subject protection by providing a certificate of completion for human subjects research training. Investigators may complete an online training module and obtain a certificate below.

• NIH online course: Protecting Human Research Participants

Application form: Please complete the application form below and return by e-mail to irb@msdh.state.ms.us. Provide a copy of your research protocol and informed consent document(s) with your application. Approval is not given retroactively for any research.

• Application Form

Language: Informed consent documents have certain required language that must be included. You can find a sample below. The University of Minnesota also provides a useful on-line course in preparing informed consent documents.

• Sample Language for Informed Consent Documents
• Informed Consent Course
  from the University of Minnesota

Protected Health Information

To use protected health information (PHI) in a study protocol, you must have one of the following:

• Authorization (consent) from the research participant which meets HIPAA requirements.
• Waiver of the HIPAA authorization requirement from the IRB.

A waiver is a request to forgo the authorization requirement based on the fact that the disclosure of PHI involves minimal risk to the participant and the research cannot practically be done without access to/use of PHI. If the Research Investigator believes the study fulfills the waiver requirement, he/she may submit a request for waiver of HIPAA authorization. Please contact the IRB Chair to receive a Waiver Request Form at irb@msdh.state.ms.us.

IRB Review Exemption

The chair of the IRB may consider the following public health activities exempt from IRB review:

1. Common educational practices in educational settings;
2. Educational tests, surveys, or observations of public behavior that are not recorded in any identifiable format and could not place the subject at any risk for liability or damage;
3. Evaluations involving existing data, documents, records, or pathological specimens if these sources are publicly available or if the information is recorded by the investigator without identifiers that link to the participants;
4. Evaluations conducted by agency/department heads or their designees to measure the public's benefit from MSDH service programs, the methods for obtaining benefits/services, and the outcomes of these services.

Only the MSDH Institutional Review Board can determine whether research is exempt. Researchers must submit their protocol to the IRB even if the planned research may be exempt as defined by the Code of Federal Regulations. The IRB will make a determination in all cases.

Expedited IRB Review

Expedited review shall be used for research that presents no more than minimal risk to human subjects and involves only procedures authorized by Title 45 CFR 46 federal rules and regulations, and for minor changes in previously approved research during the period (of one year or less) for which approval is authorized. Additionally, some protocols may be eligible for expedited review if the protocol was previously approved by the IRB.

• Helen R. Turner, MD, PhD - Communicable Diseases Consultant
• Kathy Burk MSW, CPM - Director, MSDH Health Services
• Paul Byers, MD - MSDH Deputy State Epidemiologist
• David K. Scott - Special Assistant Attorney General, Mississippi Department of Corrections
• Juanita Graham, DNP, RN, FRSPH - Grants and Special Projects Nurse
• Samantha Heard - Health Systems Division Director, American Cancer Society
• Kay Henry, RN, MSN - Director of Nursing
• Leandro Mena, MD, MPH (Co-Chair) - Associate Professor, University of Mississippi Medical Center
• Nicholas Mosca, DDS (Chair) - Director, MSDH STD/HIV Office
• Meg Pearson, Pharm D. - Director, State Public Health Pharmacy
• Cassandra Walter, BPA, JD - Special Assistant Attorney General, MSDH Legal Services