Yes. The IRB may audit research to assure that investigators are fulfilling the agreed upon assurance for participant protection and that changes have not been made that alter the Exempt status.
Yes. The investigator must notify the IRB when the research project is closed. An investigator should close the project when:
- The project no longer meets the definition of “human subject”, e.g. data are de-identified and the researcher does not have the ability to personally identify any data; and data collection and analysis are complete; or
- The PI no longer has privileges or is no longer on staff at any of the MHC subsidiary hospitals and an alternate investigator has not been designated as the PI.M
Revisions in projects that would change the Exempt category include, but are not limited to:
- New knowledge that increases the risk level;
- Use of any methods described in the Expedited Review categories that do not meet exempt criteria (e.g. blood draws);
- Surveying or interviewing children (under 18) or observing public behavior of children and participating in the activities being observed;
- Change in the way identifiers are recorded (directly or indirectly) from existing data, documents, records, pathological specimens, or diagnostic specimens so that subjects can be identified;
- Addition of an instrument, survey questions, etc. that would pose more than minimal risk to subjects;
- Addition of an instrument, survey, etc. from which information is obtained:
- is recorded in a way that subjects can be identified (directly or through identifiers)
- any disclosure of the information outside the research could reasonably place the subjects at risk (i.e. criminal or civil liability) or be damaging to the subjects’ financial standing, employability, or reputation;
- Addition of prisoners as research subjects
- Addition of other vulnerable populations that may pose more than minimal risk
An Amendment Application with appropriate attachments (e.g. new or revised instruments, consent forms, etc.) must be submitted to the IRB for review and approval prior to initiation of such changes.
IMPORTANT – Contact the IRB prior to implementing any of the above changes or if you have questions about whether a change alters the Exempt status.
Approved Without Stipulations
“Approved Without Stipulations” means the study is approved as submitted. The PI is not required to change any aspect of the protocol or informed consent document. The approval date is the date of the IRB meeting. The approval is valid for one year unless the IRB Committee, IRB Chair or designee designates a shorter period due to the risk in the study.
Approved With Contingencies
“Approved With Contingencies” means that a study is approved, provide some minor stipulations (e.g. require simple concurrence from the PI and do not require substantive judgment by the IRB) are met by the PI.
- The IRB may vote to authorize the IRB Chair or designee to approve the response submitted by the PI unless the investigator does not provide the minor revisions requested.
- Should the IRB Chair or designee feel that the response is not adequate or requires review by the fully convened IRB, the study would be added to the next available agenda for the committee that originally reviewed the application.
- The PI may not make additional changes until full IRB approval is granted.from consideration.
“Moved” means the IRB analyst has determined that further information regarding the protocol is needed in order for the IRB to make a determination.
- Moved studies will be transferred to the next convened IRB meeting.
“Not Approved” means the IRB has determined that the research cannot be conducted at MHC and its subsidiary hospital or by employees or agents of MHC and its subsidiary hospitals or otherwise under the auspices of MHC.
Suspension of IRB Approval
- Once a study has been disapproved, it can be resubmitted as a new application to the IRB for further consideration.
- All resubmissions of disapproved protocols must be reviewed by the fully convened IRB.
- Resubmission of applications must be substantially modified to address all previous concerns outlined by the IRB prior to being reconsidered by the fully convened board.
“Suspension of IRB Approval” is an action of the IRB or Organizational Official to temporarily or permanently withdraw IRB approval of some or all research procedures.
- Suspended studies remain open and are subject to continuing review
“Tabled” means that the study might be tabled for discussion at a later time when the quorum was lost during the convened IRB meeting.
“Termination” is a directive of the convened IRB to permanently cease all activities in a previously IRB-approved research protocol.
- Terminated protocols are considered closed and no longer require continuing review.
- Terminations of protocols approved under expedited review must be made by the convened IRB.
“Withdrawn” means the IRB Analysts remove a study from eProtocol when the PI requests to retract a submission
- Withdrawn studies will be removed from the eProtocol system at the request of the PI.
- No further action will be taken unless the PI resubmits the protocol