Investigator Communications

Initial Comments from the IRB – General Information

The principal investigator will be notified, in writing, of the IRB’s decision to approve, reconsider, or disapprove the proposed research, or of the modifications required to secure IRB approval of the research study. Comments will be issued to investigators once either the minutes from the full board meeting have been accepted by the IRB Vice Chair, or the comments have been finalized for expedited or exempt submissions. Correspondence will contain, at a minimum:

  • the name of the principal investigator;
  • the title of the project;
  • the IRB number assigned to the submission;
  • the decision of the IRB.

Full Board Decisions

The IRB full board decisions will be outlined in the investigator communications as follows:

  • Full Approval - If a convened IRB determines that the study can be approved as submitted, the investigator will be issued a full approval letter.
  • Approved subject to minor modifications (comments must be directive)- If the IRB decides to approve a research study subject to modifications, the written notification will include the specific revisions stipulated by the IRB in order to obtain full approval to conduct the research.
    • The written notification provides instruction to the investigators to revise the research and informed consent document(s) in accordance with the specific revisions stipulated by the IRB and to resubmit for final IRB approval.
  • Reconsideration - If a convened IRB decides to reconsider a research activity, the written notification to the investigator will include:
    • a statement of the primary reason(s) for the IRB’s decision to reconsider the research;
    • a listing of additional problems and/or deficiencies identified by the IRB;
    • instructions relating to resubmission of the research for full-board IRB review, including statements that the principal investigator should address in writing the comments and concerns of the first IRB review and that s/he may appear in person to address additional questions or concerns related to full-board IRB review of the resubmitted protocol.
  • Disapproval – If a convened IRB decides to disapprove a research activity, the written notification to the investigator will include:
    • a statement of the primary reason(s) for the IRB’s decision to reconsider the research;
    • a listing of additional problems and/or deficiencies identified by the IRB;
    • instructions relating to resubmission of the research for full-board IRB review, including statements that the principal investigator should address in writing the comments and concerns of the first IRB review and that s/he may appear in person to address additional questions or concerns related to full-board IRB review of the resubmitted protocol.

Exempt/Expedited Submissions

Submissions that are reviewed by the Exempt/Expedited Team can either receive full approval or approval subject to minor modifications. In the event that directive comments cannot be provided or if the study does not meet a regulatory category which would permit an expedited review, the investigator will be notified that the study will be reviewed by the convened IRB.

Investigator Responses

Responses of the principal investigator are returned to the IRB reviewer who conducted the initial review (i.e., or to another IRB reviewer if the initial reviewer will be unavailable for an extended period) for final approval.

In the event of a failure to resolve problems or concerns related to the investigator’s response(s), the IRB submission (to include prior correspondence between the IRB reviewer and investigator) will be reviewed at a convened meeting of an IRB committee (i.e., full-board IRB review).

Response Deadline

The communication to the principal investigator specifies that s/he must respond to the comments or concerns of the IRB reviewer within 6 weeks of the date of the communication, and that failure to respond within this 6-week period may result in withdrawal of the project by the IRB.

Content of IRB Concurrence/Approval

The principal investigator is notified of IRB concurrence/approval through written correspondence prepared and discharged by the HRPO staff. All correspondence contains:

  • the name of the principal investigator;
  • the title of the project;
  • the IRB number assigned to the submission;
  • the date of IRB approval/concurrence;
  • the date of IRB expiration (for expedited and full board studies only) the date of IRB modifications (for modification requests only);
  • a statement that modifications to the IRB approved research study will require either notification to the IRB (for no human subjects research or exempt determinations) or approval by the IRB (for expedited or full board studies).

For studies that are designated as “not human subject research” the correspondence will indicate a concurrence that the project does not meet either the definition of "research" at 45 CFR 46.102(d) or "clinical investigation" at 21 CFR 56.102(c), or the definition of "human subject" at 45 CFR 46.102(f) or 21 CFR 56.102(e).

For activities determined by the IRB Reviewer to meet either the DHHS or FDA definition of “human subject research,” the principal investigator will be advised to resubmit the project for exempt, expedited or full-board IRB review as appropriate.

For studies that are designated as "exempt" the correspondence includes the basis for granting exempt status (i.e., 45 CFR 46.101(b)(1-6) and/or 21 CFR 56.104(d)). For research activities that involve human subjects but are determined to not qualify for exempt status, the principal investigator will be advised to resubmit the research for expedited or full-board IRB review as appropriate.

For studies that are approved as "expedited" the correspondence includes the basis for granting expedited approval of the research. This would not only include the minimal risk status of the research, but the applicable category or categories of research activities listed in the OHRP and FDA document, "Categories of Research That May Be Reviewed by the Institutional Review Board through an Expedited Review Procedure". That information is documented, with justification, within the IRB Research Protocol and/or review materials. For research activities that are determined to not qualify for expedited review status, the principal investigator will be advised to resubmit the research for full-board IRB review.

Renewal Reminder Notices

For renewals that have been approved in a paper format, the IRB Office will send a reminder notice to the principal investigator and, if applicable, the study coordinator, 60 days and 30 days in advance of the expiration date of IRB approved research studies.

For renewals that have been approved in the OSIRIS system, the system automatically generates an e-mail notification to the principal investigator and, if applicable, the study coordinator, 90, 60 and 30 days in advance of the expiration date of the IRB.

Study Expiration

If the study is not reviewed and approved by the IRB prior to the expiration date of the previous IRB approval, the principal investigator will be required to cease all research activities described in the IRB protocol (including data analysis) until notification of final IRB approval for continuation of the research has been issued. The approval period expires at 11:59 p.m. on the date set forth in the IRB approval letter. The notification sent to the investigator will indicate that: 1) enrollment of new participants must stop; 2) all research activities must stop; and 3) any continuation of research activity is a violation of Federal regulations. The letter also indicates that the investigator may petition the IRB Chair for permission to continue certain research activities if there is an overriding safety concern or ethical issue.  However, under no circumstances can new subjects be enrolled into a research study after expiration of IRB approval. In order to preserve the historical integrity of a research study, investigators who want to continue research activities must submit a renewal to the IRB. Research activities may not resume until a new IRB approval has been issued.

version 12.10.2015