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Institutional Review Board Procedure - 61.17.01

College Policy Number/Title:

This procedure applies to employees and students at Howard Community College (HCC) as well as anyone outside of HCC who wants to conduct research using HCC’s employees or students.  Principal investigators conducting research involving living human subjects  must submit their research proposal to the college's Institutional Review Board (IRB). A principal investigator is any individual who assumes full responsibility for a research project, including the supervision of any co-investigators, research assistants, staff, and students.

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

  • IRB application, which includes a detailed description of the research protocol (e.g., the rationale for the study, research questions, hypotheses, research methods, selection of subjects including sampling methods, potential benefits/risks, managing confidentiality, compensation of subjects, etc.)
  • Copies of questionnaires/survey instruments, interview/focus group guides, or other materials that will be used with research participants over the course of the proposed study
  • Evidence of completion of the National Institutes of Health’s Office of Extramural Research’s seven-module training on Protecting Human Research Participants or equivalent training, like through the Cooperative Institutional Training Initiative (CITI)
  • Informed consent forms and related materials
  • Copy of home institution or other IRB approvals
  • Approval forms from applicable government agencies
  • Approvals from an HCC employee’s chain of command (supervisor/department chair, associate vice president/dean, and vice president/president).  All IRB applications are ultimately approved by the President’s Team.

All research proposals must be submitted to the chair of the IRB [the associate director of research and planning, in the office of planning, research, and organizational development (PROD)].           

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 the IRB chair, or by one or more IRB committee members 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 reviewer(s) 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.)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Once the application is reviewed by the IRB chair and/or committee, the IRB chair forwards a recommendation for approval/disapproval to the executive director of planning, research, and organizational development , who in turn sponsors the application on the President’s Team agenda for review and final approval.

All human subjects research activities that have been approved by the IRB through the exempt, expedited, or full review process are subject to continuing review. The continuing review will be performed at intervals appropriate to the degree of risk involved in the research.  

Investigators who have a project extending beyond one year must submit a request for renewal/continuation of research application, which can be found under the IRB section of PROD’s portal page.

A researcher cannot implement any changes to an IRB-approved protocol without prior IRB approval, except where necessary to eliminate apparent immediate hazards to subjects. If after a research proposal is approved and the researcher desires to modify the research process in a way that differs from the approved protocol, the investigator must obtain approval from the IRB by submitting an IRB change form,  found under the IRB section of PROD’s portal page. Researchers may not implement any changes until approval has been received.

It is the principal investigator’s responsibility  to inform the IRB chair  of any adverse events that occur during the course of the study that impact study participants.  Concerns related to research involving HCC faculty, students, or staff should be directed to  the IRB chair.  

Specific approval procedures and timelines are available on the HCC portal  under the research section of the planning, research, and organizational development’s portal page.

Effective Date:  12/11/20

President's Office Use:  EDPROD

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