VT Agency of Humans Services Researcher Responsibilities and Procedures for the Proposal of Research involving Human Subjects
If a researcher is unsure whether or not an AHS IRB Research Proposal Form must be submitted for any given project, it is the researcher's responsibility to contact the IRB chairperson for further information and guidance.
Before actual investigation or recruitment of subjects begins
Researchers are to provide the Agency IRB with a brief written description of the study using the AHS IRB Research Proposal Form.
If research is to be considered by the full IRB or if the initial reviewer requests more information, the researcher may be asked to provide the IRB with a complete proposal text including the research design, methods to be used, etc. as specified by the IRB.
When submitting an AHS IRB Research Proposal Form, the researcher will attach:
- A copy of the lay summary and form that the researcher plans to use to obtain informed consent
- If applicable, HIPAA authorization form in order to use protected health information from participants
- If applicable, assent forms for teen-age minors (12-17 years of age).
- A copy of any survey instrument, interview or focus group protocol intended for use.
- The resume of the principal investigator and other key project staff
- Certificate of completion of the online tutorial for IRB researchers at http://phrp.nihtraining.com/users/login.php for all research staff involved in this project
- A statement that clearly indicates that the project leader/principal investigator understands their responsibilities and will assure IRB commitments are followed.
The researcher may be asked to attend the meeting of the IRB at which the proposal is reviewed.
Following IRB Approval
For pending or conditionally approved proposals, the researcher will notify the IRB in writing of his or her acceptance of the required changes and assure that changes are made prior to the initiation of the study.
Reporting issues of non-compliance and adverse events:
The researcher is responsible for notifying the IRB within ten working days of the following events:
- Any substantive changes in the research protocol
- Any substantial changes in the key project staff
- Any unexpected adverse events relating to the research
- Any issues of non-compliance or deviation from approved study protocols
- The completion of the research project within twenty working days of the completion date.
The researcher will assure that all Federal regulations and conditions of approval are followed and that participants are given all the protections from harm afforded them.
No less than annually, and unless otherwise specified, the researcher will supply to the IRB a status report on the progress of the research, including but not limited to:
- The number of participating subjects
- A summary of adverse events and any unanticipated problems involving risks to subjects or others and any relevant recent literature, interim findings and amendments or modifications to the research since the last review
- Any relevant multi-site trial reports
- Any other relevant information, especially information about risks associated with the research, and
- A copy of the current informed consent document and any newly proposed consent document.