These considerations are in place to set realistic expectations and maintain clear communication throughout the review process.
The primary researcher or principle investigator will submit a detailed proposal, which includes the research design, methodology, informed consent forms, and other relevant documents (such as recruitment materials or surveys) through Sitero Mentor.
The submission also includes a risk assessment, outlining potential risks to participants and how they will be mitigated.
Have you completed the intake form? In order to begin submitting your research you will first need to fill out the form here.
The IRB staff or chairperson conducts an initial review to ensure that all required documentation is complete and that the study adheres to ethical guidelines. They check if the study qualifies for exempt, expedited, or full review based on its risk level:
Exempt Review:
Low-risk studies that meet certain criteria (e.g., anonymous surveys or educational tests).
Expedited Review:
Moderate-risk studies that involve minimal risk, such as research on existing data or certain types of non-invasive procedures.
Full Review:
High-risk studies involving more sensitive or invasive procedures.
For studies that require full review, the proposal is examined by the full IRB committee, which typically consists of experts in research ethics, law, science, and sometimes community representatives.
Committee members evaluate:
Risk-Benefit Ratio:
Is the risk to participants minimized and justified by the potential benefits of the research?
Informed Consent:
Are the participants adequately informed about the nature of the study, risks, and their right to withdraw at any time?
Privacy and Confidentiality:
Are participant data protected, and is the level of confidentiality appropriate for the study?
Vulnerable Populations:
If the study involves vulnerable groups (e.g., minors, pregnant women, prisoners), additional safeguards must be in place.
The IRB may approve the study as is, approve it with conditions (requiring modifications before final approval), or reject the study if it does not meet ethical standards.
If modifications are needed, the PI is informed of the required changes, and the study is re-evaluated once these are implemented.
Once the IRB is satisfied with the study’s ethical standing and compliance with guidelines, it grants approval to proceed.
The study can now begin, but the IRB will typically require periodic continuing review (e.g., annually) to monitor the study’s progress and ensure ongoing compliance with ethical standards.
The IRB may require periodic reports, amendments for any changes in the study, and notifications if unanticipated problems or adverse events occur.
If any significant changes are made to the study (e.g., recruitment methods, procedures), the PI must submit an amendment for IRB approval.
Get Started Today
Submit your information through the intake form. Don't worry, this is just the first step to get you started!
