For all projects, an application with relevant attachments must be submitted to the HSRB for review. The application asks for information about the investigator(s), the nature of the research, the funding source, targeted subject groups, how subjects will be recruited, how informed consent will be obtained, how confidentiality will be protected, and the risks and benefits of the proposed research. We encourage all researchers to take advantage of Metropolitan State's membership in CITI and to complete the free training. Click on Register, then choose Metropolitan State University from the All Others dropdown menu.
All forms that an investigator must file are available at the bottom of this page, or from the HSRB office.
HSRB members can help researchers determine which level of review is appropriate for a project, which form to use, and provide guidance in preparing the application.
To submit a research project for HSRB review, an investigator must complete the appropriate application form and attach supporting material (i.e., measurement instruments, survey and cover letter, interview protocol, consent forms and script, recruitment letters or script, etc.). A full completed application will include:
- A hardcopy signature/cover page with original signatures of the investigators, including responsible project investigators. Original signatures are required to certify that the investigator(s) will be actively involved in the research project and has made a commitment to protect subjects according to federal and university guidelines. Faculty advisors or instructors must sign all student research proposals as the Responsible Project Investigator (RPI);
- An up-to-date version of the appropriate Application Form;
- Answer every question on the form, and provide requested documentation.
The application form will be used as background information for all future reviews of the study; therefore, "see protocol" is not an adequate response to any application question.
Before submitting the application to the HSRB office, investigators must make a copy of the application for their own records. Submit a hardcopy signature page; the rest of the documents should be in one electronic file.
After submission of the proposal to the HSRB, the Committee Chair will make a determination of an expedited or full review. If the proposal is designated for expedited review, at least one member of the committee will review it for meeting the requirements as outlined in federal and university policy. If a full review is necessary, the materials will be sent to all committee members for review at the next scheduled meeting.
In the case of a full review, committee members give their feedback to the Chair who will summarize the committee members' responses and contact the responsible investigator regarding the outcome of the review. The committee member(s) who review an expedited proposal will contact the investigator directly with their decision. All correspondence is copied to the committee's support staff and formal approval will be mailed from the HSRB office to the responsible project investigator (RPI).
If revisions to the proposed research protocol are requested, the investigator should communicate directly with the reviewer(s) and submit the changes directly to the reviewer(s) for final approval. All of the documentation is filed in the HSRB office upon completion of the review.
Faculty should expect the process to take at least 2 weeks depending on the nature of the review required. Full review and any reviews during the summer months may take longer.
Approvals are good for one year from the date of approval.
When materials (whether approach, recruitment or consent forms or procedures, or questionnaires, surveys or other study procedures or materials) are to be administered in a language other than English, the materials should ideally be submitted in the target language(s), accompanied by English translation(s) that accurately represent the materials one actually intends to use. The following points should be considered.
- Approach, recruitment and consent materials are often revised as a result of review. It is often better to submit English versions for initial review, and explain that translations will be submitted after English versions have been approved. However, because translation sometimes requires re-thinking and revision, it may be that the approved English versions no longer correspond to the actual materials. If this occurs, it is important to submit new English versions for review and approval.
- Similarly, questionnaires and interview material to be used in several languages may require adapatations that make each translation a separate version. In such cases, it may be necessary to submit an English translation of each version.
Issues arising from use of materials in several languages can become complex, and must often be handled on a case-by-case basis. When submitting an application involving use of translated materials, it is generally helpful to address the issues preemptively, in the application itself. Addressing the issues at the time of application can help reduce delays in screening and review.