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.
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.
MSDH IRB application, research proposal and all other required documents shall be submitted to the chair of the IRB at email@example.com 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
|Document type||Level of Review|
|Protection of human subjects training certificate(s)||X||X||X|
|MSDH IRB application form, including:||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|
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.
Please complete the application form below and return by e-mail to firstname.lastname@example.org. 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.
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 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.
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.
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.
The Institutional Review Board meets regularly to consider requests in a timely manner.
|IRB Meeting Date||Submission Deadline|
|Jan 15, 2020||December 24, 2019|
|March 28, 2020||Feb 26, 2020|
|May 20, 2020||April 29, 2020|
|July 15, 2020||June 24, 2020|
|Sept 16, 2020||August 26, 2020|
|Nov 14, 2020||Oct 28, 2020|
|Self-Certification Form for Determining Whether a Proposed Activity is Research Involving Human Subjects||http://msdh.ms.gov/msdhsite/_static/resources/6648.pdf|
|Title 45 CFR 46 federal rules and regulations||http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html|
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