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- What is a human subjects review?
- Does my research require review?
- How do I begin the review process?
- What will happen to my application?
- What issues does the Committee consider?
- Is approval ever denied?
- Does all research go through the same review process?
- How long does this process take?
- How do I change my research after it has been approved?
- How long is approval valid?
- Suppose I have more questions?
What is a human subjects review?
Federal, state and university regulations require that the use of human subjects in research be reviewed and approved by a Human Subjects Review Board (HSRB). At the Metropolitan State University, the Human Subjects Review Committee carries out this function. The Provost and Vice President for Academic Affairs office provides administrative support for the Committee
The Human Subjects Review Board also:
- reviews proposals and providing certifications of review to funding agencies,
- reviews modifications to existing approvals,
- receives reports of adverse effects resulting from research with human subjects,
- monitors complaints from human subjects,
- advises researchers and departments on human subjects review.
Does my research require review?
If you are a faculty or staff member, or a student at the Metropolitan State University and your research involves the use of human subjects (either directly or through records or other data), your research requires human subjects review.
- complete a Human Subjects Review application form and submit it to the Human Subjects Review Board via IRBNet.org.
- include all relevant information (grant proposals, consent forms, questionnaires, test instruments, advertisements, debriefing statements, contact letters, etc.).
Training for submitting applications via IRBNet.org is available in Brightspace under *Departments, Organizations, and Misc. - Center for Online Training (Human Subject Review Board Training Site).
What will happen to my application?
When the Human Subjects Review Board receives your application, our staff will check it to make sure it is complete. After the Committee has reviewed your application, you will receive notification either the application marked "Approved," or a letter requesting additional information and revisions. After you respond to the letter, your application will be re-reviewed and returned to you after final approval.
What issues does the Committee consider?
The Committee reviews the proposed purpose, procedures, and subject populations to be used and determine if the benefits of the activity outweigh the risks to subjects. Issues considered in this analysis include:
- how subjects are approached to participate,
- what measures are used to protect subjects' privacy,
- what physical and psycho-social risks, stresses, and discomforts subjects will be asked to endure.
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 Committee also evaluates advertisements, approach letters, consent/assent forms or information statements, telephone scripts, and debriefing statements to determine if they are accurate, explanatory, and written in simple, lay language appropriate for the intended subjects.
Is approval ever denied?
Sometimes, the Committee decides there is insufficient information to approve or disapprove an application. In such a case, the Committee defers consideration and asks the researcher to provide additional information. When the Committee receives the information, the application is reconsidered.
Very rarely, a Committee will determine that the risks of a proposed activity outweigh the benefits and will withhold approval. Usually, the researcher and the Committee can work out a compromise to reduce the risks and gain permission to carry out the research. If a researcher disagrees with a Committee's disapproval, the decision may be appealed.
Does all research go through the same review process?
No. Research falling into minimal risk categories is reviewed by a subcommittee of the HSRB, usually consisting of the chair of the committee and one or two other committee members. Research falling into categories considered to be of more than minimal risk requires review by the full Committee.
How long does this process take?
The Human Subjects Review Board staff screens a new application for completeness after receiving it. If the application is complete, it will be assigned to the review Committee. The agenda is sent to members one week before the meeting. If your research is scheduled for a full review, you may be asked to attend the meeting. You can expect to receive a letter from the Committee after the meeting requesting any additional information and consent form revisions necessary before full approval. After you respond to the Committee's requests, you can expect approval unless there are further questions.
How do I change my research after it has been approved?
You must notify the Committee if you wish to change your research. You can make minor and administrative changes by submitting a Research Modification form describing the changes to the Committee. Substantial changes in the focus, procedures, or subject population of the research may require submission of a new application. Call the Human Subjects Review Board Chair if you have questions about what kinds of changes require new applications.
How long is approval valid?
Approval is good for one year. One month before expiration the Human Subjects Review Board will send an e-mail alerting you to the need to submit a Continuing Review Form if the research is to continue. If you want to make substantial changes that affect human subjects, you must submit a complete application. If you don't want to renew your application, submit the Research Status form as a final report. Certificates of Exemption are valid for five years, and may not be modified.
Suppose I have more questions?
Ensure that you have completely reviewed this website for information. If you still have questions and are a student, contact your advisor; if you are a faculty or staff member, contact the office of the Provost and Vice President for Academic Affairs 651-793-1921.