Applying for review and providing notifications

Metropolitan State University is a member of the Collaborative Institutional Training Initiative (CITI). Researchers, including student researchers, are strongly encouraged to complete CITI training prior to submitting an application to the HSRB. To register, go to the CITI landing page click on Register and choose Metropolitan State University from the All Others dropdown menu. All projects requiring review, notification of exempt status or approval of classroom projects, are submitted to the HSRB via IRBNet. For information on how to submit a project, see the Human Subjects Review Board Training Site in D2L. Anyone at Metropolitan State with access to D2L will find the site among My Courses and may take the IRBNet Training for Researchers.

Application for research review

The research review application asks for information about the investigator(s), the nature of the research, the funding source, targeted participant group(s), how participants will be recruited, how informed consent will be obtained, how confidentiality will be protected, and the risks and benefits of the proposed research.

All forms that an investigator must file are available at IRBNet.org. The HSRB chair can help researchers determine which level of review is appropriate for a project and which forms to use. The chair can also provide guidance in preparing the application.

To submit a research project for HSRB review, an investigator must complete the appropriate application form and include supporting material (e.g., measurement instruments, survey and cover letter, interview protocol, consent forms and script, recruitment letters or script, etc.). A completed application includes:

  • Digital signatures of all investigators, including principal investigator (PI)/responsible project investigator (RPI). Signatures are required to certify that the listed investigator(s) will be actively involved in the research project and demonstrate(s) a commitment to protect subjects according to federal and university guidelines. Faculty advisors or instructors must sign all student research proposals as the PI/RPI.
  • The application form will all questions answered and all accompanying 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.

After submission of the application to the HSRB, the chair will make a determination of 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. At that meeting, at least one of the researchers is to be present to hear the board's concerns and answer questions.

It is the responsibility of the reviewer to complete the initial review and any subsequent reviews in a timely manner (typically within two weeks of receipt), to defer approval if modifications are required and to notify the researcher(s) of the final decision on whether or not the application is approved. It is the responsibility of the researcher(s) to respond to requests for modifications in a timely manner (typically within 30 days of request). Any application for which modifications are not received in a timely manner will be withdrawn from consideration. All correspondence, including requests for modifications and study approvals, is sent via IRBNet. All documentation of each study is retained in IRBNet.

The scientific merit of the activity is considered only if it has an impact on the risk-benefit analysis. For example, will the number of subjects proposed allow the results obtained to be statistically significant? Is there a less risky way to achieve the same results?

The standard requirements for informed consent (or its waiver, alteration or exception) apply regardless of whether the review is expedited or full. The criteria apply to both initial and continuing HSRB review.

Federal guidelines state that research records are to be stored securely (e.g., in a locked filing cabinet or password-protected computer) and retained for at least three years. All records of correspondence between the researcher(s) and the HSRB, including the original and modified application and supporting documentation, HSRB memos and any other HSRB correspondence, must also be retrained for at least three years.

Original signed consent forms must be kept in a secure location within Metropolitan State University property and separate from all other research and correspondence files. HSRB records are subject to inspection by federal authorities. Sanctions for incomplete or nonexistent records include suspension of funding, fines, and exclusion from future funding.

Adverse event reporting

Adverse events are unexpected problems whose nature, severity and/or frequency are not described in the information provided to the HSRB or to participants. Examples include unexpected complications for a participant, missteps in the consent documentation or breaches of confidentiality. Adverse events must be reported to the HSRB within 10 working days of the event. The principal investigator/responsible project investigator is charged with completing and submitting an adverse event report to the HSRB chair and the Office of the Provost and Executive Vice President. The report must discuss:

  • The facts of the case, including the date and a description of the participant involved,
  • Whether the event is related to the study's procedures or to the participant's situation (e.g., underlying disease or condition),
  • The steps that have been taken to address the problem,
  • Whether the event is likely to recur, and
  • Whether the event provides new information about the study's risks that should be conveyed to participants; if so, a revised consent form must be submitted.

Continuing review

Approvals are valid for one year from the date of approval. Notification of pending expiration of an approved study is provided by IRBNet via email. A research status form must be filed for any study that is continuing beyond the date of initial or most recent approval. If a study is not continuing, the research status form is filed indicating the completion of research activities.

Suspension or termination of approval

The HSRB has the authority to suspend or terminate approval of research that is not being conducted in accordance with the HSRB's requirements or that has been associated with unexpected serious harm to subjects. Any suspension or termination of approval shall include a statement of the reasons for the HSRB's action and shall be reported promptly to the investigator and the Provost and Vice President for Academic Affairs.

Exempt research notification

After submission of the exempt research form and accompanying consent form(s) to the HSRB, the chair will make a determination of whether or not the study matches the criteria for exemption from review. Unless a determination is made that the research is exempt, the chair will notify the researcher(s) of board agreement of the study's exempt status.

Classroom projects

After submission of the classroom project form and accompanying consent form(s) to the HSRB, the chair will make a determination of whether or not the study matches the criteria for a classroom project. Unless a determination is made that the research requires that a research review application be made, the chair will notify the researcher(s) of board agreement of the study's classroom project status.

Translations

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 the researcher(s) actually intend(s) to use. The following points should be considered.

  • Approach, recruitment and consent materials are often revised as a result of review. It may be 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 adaptations 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.

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.