What Does My MDHHS IRB Determination Notice Mean?

The MDHHS IRB uses form DCH-1280, the "MDHHS IRB Determination Notice" to communicate the results of formal IRB review to Responsible MDHHS Employees. Receiving one of these forms does not mean that a research proposal has been approved by the IRB. Responsible MDHHS Employees should take care to understand the type of determination that was made by the IRB, and what that determination means for the research proposal.

 

The various actions or recommendations the IRB can make are listed in the center portion of the DCH-1280.  These determinations include:

 

Tabled - Tabled research was considered at a convened IRB meeting, but the board determined additional information was needed to meet the federal regulations or to otherwise allow the board to make a determination about the proposal. Investigators should review the comments section of this letter to determine what additional information is needed to allow the board to make a determination. A tabled determination does not constitute IRB approval and research should not begin if tabled by the MDHHS IRB.

 

Not human subjects research - Activities determined by the IRB to either not involve humans as subjects, or to not include research are approved by the IRB as activities that are not subject to federal regulations governing human research protections. This type of approval does not include an expiration date. Researchers are only required to contact the IRB regarding this type of research if a change is proposed that may result in human subjects being involved, or if the scope of the activity changes to include research.

 

Exempt - Research determined to be exempt is minimal risk research that falls into one of the allowable categories for approval under 45 CFR 46.101(b). Approval under an exemption indicates that not all of the provisions of the federal regulations governing human research protections apply to this research. That being said, it is the researchers responsibility to ensure that the ethical principles of respect for person's autonomy, beneficence, and justice are upheld in the conduct of this research. Annual reporting on exempt research is required under MDHHS policies and procedures. Researchers should immediately notify the MDHHS IRB if any changes are considered that may impact the exempt status of a project.

 

Approved by expedited review without modifications - Minimal risk research can occasionally be reviewed by individuals or small groups of members from the IRB and approved outside of a convened IRB meeting. This mechanism of review is expedited review. Approval of research on an expedited basis without modification allows for the research to be started immediately and as proposed. The IRB will require a report on the status of this research no more than 1 year after the date the project receives approval.

 

Approved by expedited review with modifications - Approval on an expedited basis with modification indicates that the individual IRB reviewer or small group of reviewers approves of most aspects of a research proposal but will require very specific changes before allowing the research to begin. The required changes will be specified in the comments section of the DCH-1280. Once a Responsible MDHHS Employee documents that the required changes have been made, the IRB will re-issue an approval notice without modification indicating the condition on approval has been met and research can begin. The IRB will require a report on the status of this research no more than 1 year after the date the project receives approval.

 

Approved by full committee review without modifications - This type of approval indicates that research was approved at a meeting of the convened IRB and may begin immediately. The IRB will require a report on the status of this research no more than 1 year after the date the project receives approval. Additionally, research approved by full committee review will generally require full committee review every time the current approval expires.

 

Approved by full committee review with modifications - Approval by the full committee with modification indicates that most aspects of a research proposal were approved at a convened meeting of the IRB, but specific changes are required before allowing the research to begin. The required changes will be specified in the comments section of the DCH-1280. Once a Responsible MDHHS Employee documents that the required changes have been made, the IRB will re-issue an approval notice without modification indicating the condition on approval has been met and research can begin. The documentation that conditions have been met does not require re-approval by the board at a convened meeting. The IRB will require a report on the status of this research no more than 1 year after the date the project receives approval. Additionally, research approved by full committee review will generally require full committee review every time the current approval expires.

 

Disapproved - Research that is found by the full committee at a convened IRB meeting to not meet the regulatory requirements for IRB approval cannot be approved and must not be conducted at MDHHS. A disapproved determination notice will document the regulatory requirements that were not met in the research proposal.

 

MDHHS IRB Determination Notices are sent to the Responsible MDHHS Employee and the Bureau or Office Director of the Responsible MDHHS Employee for their records. Should the primary investigator not be the Responsible MDHHS Employee, it is the expectation of the MDHHS IRB that the Responsible MDHHS Employee will provide the determination notice (or a copy) to the primary investigator. Don't hesitate to contact the MDHHS IRB should you have questions on an MDHHS IRB Determination Notice.