HVO Policy on Volunteers & Clinical Research

HVO's mission is to improve the availability and quality of health care in developing countries through the training and education of local health care providers. Volunteers, on occasion, may see an opportunity to participate in or to initiate a research project at a site. The purpose of this policy is to assure that any clinical research* undertaken by an HVO volunteer is conducted in a manner that is both ethical and transparent. Sites have the right to know about any planned clinical research initiatives, as well as the right to determine if the research is inappropriate or otherwise unwelcome. If a site does not approve a research request, the volunteer must comply with this decision.

HVO volunteers who intend to conduct clinical research while on assignment must do the following:

1. Prior to their assignment, notify HVO in writing of their intent to conduct research by providing an abstract that:
1. Includes the hypothesis or study question and a description of the methods.
2. Discusses the process for assuring human subject protection.
2. Obtain proper IRB approval from their home institution.
3. Notify the proper authorities at the site of their intentions and provide information on the nature and scope of the study, IRB status, and other relevant information.
4. Obtain permission from site as required by the institution's committee on human research or equivalent body.
5. Confirm with HVO that these requirement have been successfully completed and receive final approval from HVO.

Permission from the host site should include approval through appropriate authorities and take into account local culture, the need for informed consent in local languages, and ethical standards consistent with conducting research in the United States. Publication of any material should acknowledge the local host site professional input and facilitation.

* The following categories comprise clinical research per the NIH:

1. Patient-oriented research conducted with human subjects or on material of human origin such as tissues, specimens, and cognitive phenomena for which an investigator directly interacts with human subjects. It includes mechanisms of human disease, therapeutic interventions, clinical trials, and development of new technologies. Patient-oriented research excludes in vitro studies that utilize human tissues that cannot be linked to a living individual.
2. Epidemiologic and behavioral studies
3. Outcomes research and health services research

December 2010

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