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Animal Care and Use Policies and Procedures Guidelines on Duplicate Review of Protocols [1] There are many circumstances that involve partnerships between collaborating institutions or relationships between institutional animal care programs. OLAW and the United States Department of Agriculture's (USDA's) Animal and Plant Health Inspection Service (APHIS) agree that review of a research project or evaluation of a program or facility by more than one recognized institutional animal care and use committee (IACUC) is not a federal requirement. It is imperative that institutions define their respective responsibilities. Public Health Service (PHS) Policy requires that all awardees and performance sites hold an approved Animal Welfare Assurance. OLAW negotiates Inter-institutional Agreement Assurances of Compliance when an awardee institution without an animal care and use program or IACUC will rely on the program of an Assured institution. Assured institutions also have the option to amend their Assurance to cover non-assured performance sites, which effectively subjugates the performance site to the Assured institution and makes the Assured institution responsible for the performance site. If both institutions have full PHS Assurances, they may exercise discretion in determining which IACUC reviews research protocols and under which institutional program the research will be performed. It is recommended that if an IACUC defers protocol review to another IACUC, then documentation of the review should be maintained by both committees. Similarly, an IACUC needs to know about any significant questions or issues raised during a semi-annual program inspection by another IACUC of a facility housing a research activity for which that IACUC bears some responsibility or exposure. Procedure for Domestic Institutions 1. When no animal activity occurs at Johns Hopkins University (JHU):
2. When some animal activity occurs at JHU:
Procedure for Foreign Institutions 1. When JHU investigators collaborate with scientists in other countries or go abroad to collect samples from animals, duplicate review of protocols by JHU and a foreign performance site may be necessary. 2. If the research activities are supported to any extent by PHS funds administered through JHU, the protocol must be reviewed by the JHU IACUC regardless of whether a protocol also is reviewed by a foreign institution. This rule applies even when samples are obtained by citizens of a foreign country for subsequent shipment. Furthermore any foreign institution that serves as a performance site must have Assurances on file with OLAW. 3. If the research activities are not supported by PHS funds, but some animal activity occurs at JHU, then the degree of review of the component that involves activity in the foreign country will be considered on a case-by-case basis. Submit a letter summarizing the study and the role of any JHU faculty, trainees, or staff that will participate. 4. Where no animal activity occurs at JHU, and no PHS funds are involved, but samples are collected at a foreign site for use by investigators at JHU, the investigator should submit a letter to the IACUC office describing the study and the circumstances under which the samples will be collected. Include species, nature of the specimen, degree of invasiveness of the procedure, and information on planned use of anesthetics and analgesics. 5. Before sample collection and regardless of whether specimens are obtained by a JHU investigator or by persons in a foreign country, the investigator should consult with appropriate agencies of the U.S. Government about importation requirements. Depending on the species involved and the nature of the specimen, the following may be of assistance:
1. Approved by the Animal Care and Use Committee on: October 16, 2003. |