The study must be conducted in strict accordance with the protocol approved by the Committee. Changes to the protocol or its related consent documents must be approved by the Committee before implementation. Adverse events or unanticipated problems must be reported promptly to the Committee. Participants must receive a copy of the consent document, if appropriate. The principal investigator is responsible for the ongoing conduct of the study. Any future correspondence must include the protocol reference number, the study title and its most recent version. In order to comply with the Federal Wide Assurance, the Human Research Ethics Committee approval letters for federally-funded research must also include the following: A valid Federalwide Assurance (FWA) number. A valid IRB number. The actual IRB meeting date and the protocol approval date. The complete protocol title, and approved version date. List of all reviewed and approved additional materials, e.g. consent forms, brochures, pamphlets. (Version dates must be included.) Name of Principal Investigator. Cooperative Agreement number or funding tracking number. Principal investigators are responsible for notifying Departmental Research Committees of the Committee’s findings and actions relating to their protocols. References Amdur RJ. Institutional Review Board Subcommittees. In: Bankert EA and Amdur RJ editors. Institutional Review Board, Second Edition. Jones and Publishers, , 2006. Department of Health and Human Services. Final Guidance Document. Financial Relationships and Interests in Research Involving Human Subjects: Guidance for Human Subject Protection. May 2004.
The study must be conducted in strict accordance with the protocol approved by the Committee. Changes to the protocol or its related consent documents must be approved by the Committee before implementation. Adverse events or unanticipated problems must be reported promptly to the Committee. Participants must receive a copy of the consent document, if appropriate. The principal investigator is responsible for the ongoing conduct of the study. Any future correspondence must include the protocol reference number, the study title and its most recent version. In order to comply with the Federal Wide Assurance, the Human Research Ethics Committee approval letters for federally-funded research must also include the following: A valid Federalwide Assurance (FWA) number. A valid IRB number. The actual IRB meeting date and the protocol approval date. The complete protocol title, and approved version date. List of all reviewed and approved additional materials, e.g. consent forms, brochures, pamphlets. (Version dates must be included.) Name of Principal Investigator. Cooperative Agreement number or funding tracking number. Principal investigators are responsible for notifying Departmental Research Committees of the Committee’s findings and actions relating to their protocols. References Amdur RJ. Institutional Review Board Subcommittees. In: Bankert EA and Amdur RJ editors. Institutional Review Board, Second Edition. Jones and Publishers, , 2006. Department of Health and Human Services. Final Guidance Document. Financial Relationships and Interests in Research Involving Human Subjects: Guidance for Human Subject Protection. May 2004.