Mississippi State Department of Health

Institutional Review Board


The purpose of the MSDH Institutional Review Board (IRB) is to conduct an ethical review of human subjects research activities (including those research activities attached to agency grants) to determine whether the potential benefits of the research to subjects outweigh the risk that may be associated with the research.

Research is defined as a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalized knowledge, or a clinical investigation.

Human participants are defined as living individuals 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.

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Required Reviews

IRB review is required for all initial or continuing research projects in which activities extend beyond standard public health surveillance and program improvement/evaluation projects. Examples include:

The below form provides guidance if you are unsure if your project is research and whether or not you need to submit your project to the MSDH IRB.

Self-Certification Form for Determining Whether a Proposed Activity is Research Involving Human Subjects

Submission of Requests

MSDH IRB application, research proposal and all other required documents shall be submitted to the chair of the IRB at irb@msdh.ms.gov 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.

Responsibilities of the MSDH co-investigator, as with the principal investigator, are to ensure

Documents required to submit to the MSDH IRB by level of review

Document typeLevel of Review
Protection of human subjects training certificate(s)XXX
MSDH IRB application form, including:XXX
Research protocolXXX
All recruitment letters, advertisements, questionnaires, survey instruments, interview questions, discussion guides and/or data collection instrumentsXXX
Consent document(s) or Waiver of Consent document XX
For research involving children, assent document and parental permission document XX
Copy of approval(s) by other IRB(s), if applicable XX

Protection of Human Subjects Training Certificate(s)

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.

MSDH IRB Application Form

Please complete the application form below and return by e-mail to irb@msdh.ms.gov. Provide a copy of your research protocol; all recruitment letters, advertisements, questionnaires, survey instruments, interview questions, discussion guides, and/or data collection instruments; and consent document(s) with your application. Approval is not given retroactively for any research.

Consent documents have certain required language that must be included (see elements within a consent document). The University of Minnesota provides a useful on-line course in preparing informed consent documents.

For survey documents, the key elements of consent can be provided to respondents in a concise way at the beginning of the survey, in the brief introductory statements of a telephone interview, in a cover letter for a self-administered survey, or in the introductory screen in a web survey (www.aapor.org). Survey documents must include the consent language when a separate consent document is not submitted.

Protected health information (PHI) refers to individually identifiable health information, meaning health information which can be linked to a particular person. Common identifiers of health information include names, social security numbers, addresses, and birth dates. To use protected health information (PHI) in a study protocol, you must have authorization (consent) from the research participant which meets HIPAA requirements or a 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.

Reviews & Exemptions

IRB Review Exemption

The following public health activities may be considered exempt from IRB review:

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.

Requests for Protocol Modifications and Continuing Reviews

Continued approval of any study is contingent on informing the IRB of any changes in the research protocol. Prior to implementation of any changes in the protocol, the Research Investigator must submit a request for protocol modification for IRB review.

Documents to submit to the MSDH IRB for Request for Protocol Modification

  1. Cover letter requesting review of modification(s) which includes the MSDH IRB protocol number and gist of changes
  2. Track changes AND clean copy of any modifications to existing approved documents (for very large documents you may be able to submit the applicable section only)
  3. Any new documents, recruitment letters, advertisements, questionnaires, survey instruments, interview questions, discussion guides and/or data collection instruments resulting from the modification
  4. Certificate(s) of protection of human subjects training, as appropriate, for any new staff involved in the study

Research approved under Expedited or Full IRB Review must undergo Continuing Review by the IRB at least annually. A request for continuation must be submitted at least 60 days in advance of end of the approval period.

Documents required to submit to the MSDH IRB for Continuing Review

  1. Cover letter requesting continuing review which includes the MSDH IRB protocol number
  2. Statements, documents or information addressing:
    • Stage of activity of the research (e.g., still enrolling, doing follow-up, data analysis, etc.)
    • Number of subjects enrolled to date
    • Copy of all documents currently in use (e.g., informed consent, surveys, etc.)
    • Any protocol revisions (new or already reviewed modifications) since last IRB review
    • Report of any unexpected events or statement of no unexpected events
  3. Any changes in staff conducting the research, and if so, submit certificates of human subject training
  4. Copies of current approvals of other IRB(s), if applicable

Meetings and Deadlines

The Institutional Review Board meets regularly to consider requests in a timely manner.

IRB Meeting DateSubmission Deadline
March 15, 2023February 22, 2023
May 17, 2023April 26, 2023
July 19, 2023June 28, 2023
September 20, 2023August 30, 2023
November 15, 2023October 25, 2023

Institutional Review Board Members

Links referenced on this page
Self-Certification Form for Determining Whether a Proposed Activity is Research Involving Human Subjects    http://msdh.ms.gov/msdhsite/_static/resources/6648.pdf
irb@msdh.ms.gov    mailto:irb@msdh.ms.gov
NIH online course: Protecting Human Research Participants    http://phrp.nihtraining.com/users/login.php
irb@msdh.ms.gov    mailto:irb@msdh.ms.gov
consent document(s)    http://msdh.ms.gov/msdhsite/index.cfm/19,0,335,324,html ok
Application Form    http://msdh.ms.gov/msdhsite/index.cfm/19,3268,335,pdf/IRBSubmissionForm.pdf
Sample Research Protocol Template    http://msdh.ms.gov/msdhsite/index.cfm/19,6080,335,pdf/Research_Protocol_Template.pdf
Sample Language for Informed Consent Documents    http://msdh.ms.gov/msdhsite/index.cfm/19,3814,335,pdf/MSDH_informed_consent.pdf
Elements within a Consent Document    http://msdh.ms.gov/msdhsite/index.cfm/19,6081,335,pdf/Research_Consent_Information.pdf
Informed Consent Course    https://acrpnet.org/courses/ethics-human-subject-protection/
www.aapor.org    http://www.aapor.org/
Waiver of the HIPAA authorization requirement from the IRB    http://msdh.ms.gov/msdhsite/index.cfm/19,6083,335,pdf/IRB_Waiver_request.pdf
Title 45 CFR 46 federal rules and regulations    http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html

Resources referenced
Self-Certification Form for Determining Whether a Proposed Activity is Research Involving Human Subjects    https://msdh.ms.gov/msdhsite/_static/resources/6648.pdf ok
Application Form    https://msdh.ms.gov/msdhsite/index.cfm/19,3268,335,pdf/IRBSubmissionForm.pdf ok
Sample Research Protocol Template    https://msdh.ms.gov/msdhsite/index.cfm/19,6080,335,pdf/Research_Protocol_Template.pdf ok
Sample Language for Informed Consent Documents    https://msdh.ms.gov/msdhsite/index.cfm/19,3814,335,pdf/MSDH_informed_consent.pdf ok
Elements within a Consent Document    https://msdh.ms.gov/msdhsite/index.cfm/19,6081,335,pdf/Research_Consent_Information.pdf ok
Waiver of the HIPAA authorization requirement from the IRB    https://msdh.ms.gov/msdhsite/index.cfm/19,6083,335,pdf/IRB_Waiver_request.pdf ok

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