Institutional Review Board - Mississippi State Department of Health

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:

research involving humans subjects and courses of treatment, medications, and vaccines;
research involving health information from medical records or data files with the intent of contributing new information about the disease or patient risk factors;
surveys and questionnaires which extend beyond program improvement and evaluation projects (often longitudinal with a before-after evaluation component);
research in which the agency's name will be used in the citation of the findings.

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

risks to participants have been minimized;
the MSDH IRB application has been submitted (research may not begin until MSDH IRB approval);
research is conducted in accordance with the MSDH IRB approved protocol;
any modifications to the protocol are submitted to the MSDH IRB (modifications may not be implemented until MSDH IRB approval); and,
submission of request for continuing review for protocols extending beyond the one-year approval period. If the research concludes prior to the end of the approval period, investigators and/or co-investigators may notify the MSDH IRB of conclusion of research.

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

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

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.

NIH online course: Protecting Human Research Participants

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.

Waiver of the HIPAA authorization requirement from the IRB

Reviews & Exemptions

IRB Review Exemption

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

Common educational practices in educational settings;
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;
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;
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.

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

Cover letter requesting review of modification(s) which includes the MSDH IRB protocol number and gist of changes
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)
Any new documents, recruitment letters, advertisements, questionnaires, survey instruments, interview questions, discussion guides and/or data collection instruments resulting from the modification
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

Cover letter requesting continuing review which includes the MSDH IRB protocol number
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
Any changes in staff conducting the research, and if so, submit certificates of human subject training
Copies of current approvals of other IRB(s), if applicable

Institutional Review Board Members

Davy Trewolla, Esq (Chair), Director, MSDH Data Governance
Meg Pearson, Pharm D. (Vice Chair), Director, MSDH State Public Health Pharmacy
Glenda Crump, MS, CPM, Chief Operations Officer, Mississippi Public Health Institute
Nikki Johnson, DrPH, MPH, Director, MSDH Office of Health Equity
Charles O. Lee, Esq, MSDH Privacy Officer and Civil Rights Coordinator
Paul Byers, MD (Alternate Member)