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1.    HCC employees, as well as investigators not associated with HCC who are conducting research involving HCC faculty, students, or staff, must submit their research proposal to the college's Institutional Review Board (IRB) if they are obtaining information about living humans, interacting or intervening with humans, or are supported by government funding.

2.    Investigators must submit the following documentation (not all may be applicable.)

  1. IRB application for exempt, expedited and full board review
  2. Description of research proposal
  3. Copies of questionnaires or survey instrument
  4. Evidence of completion of Office for Human Research Protections (OHRP) human subject assurance training modules for researchers
  5. Informed consent forms
  6. Copy of home institution or other IRB approval
  7. Approval forms from applicable government agencies

3.    All research proposals should be submitted to the chair of the IRB by the first Friday of the month. Submissions after the due date will be considered with the following month's group.           

4.    Once the proposal is received, it will be processed under the following schedule. Changes will extend the processing time.  To facilitate the review process, investigators are encouraged to use HCC’s IRB reviewer checklist to determine if the investigation requires an IRB application.

Type of Form

Description

Estimated Processing Time

Exempt

Research proposals with no risks to human subjects can qualify as exempt and will be reviewed by only the IRB chair.  The IRB chair reserves the right to determine the use of human subjects and the risk level of the human subjects based on the submitted documents.  Additionally, the IRB chair may request further documentation, recommend changes to the research, ask for clarification, or submit the proposal for review by additional board members.

4 weeks

(If complete and no revisions are required.)

Expedited

Research proposals that involve minimal risks to human subjects can qualify for expedited review.  The proposal will then be reviewed by two members of the IRB, one of which will be a member who best represents the area of study.  An expert may be consulted, if necessary.  The review team may request further documentation, recommend changes to the research, ask for clarification, or submit the proposal for review by the full IRB.

6 weeks

(If complete and no revisions are required.)

Full Board

Research proposals that involve more than minimal risks to human subjects, or if the expedited review team cannot reach agreement about the proposal, then a review by the full IRB will be required.  The IRB may request further documentation, recommend changes to the research, ask for clarification, or reject the proposal.

12 weeks

(If complete and no revisions are required.)































5.    No more than a 12-month period will be granted to complete approved research.  Research that will exceed 12 months may re-apply for IRB approval.  The IRB may revoke the investigator's privilege if the investigator violates or deviates from the approved methodology.  Any changes in research methodology must be submitted to the IRB for approval.

Specific approval procedures and timelines are available on the HCC website.

Policy Manual Review/Revision:  05/13/11