Vulnerable populations are defined by ethical frameworks as persons whose ability to make independent decisions about trial participation free from undue influence or coercion is either not possible or may be compromised, and therefore, who need special protection. Normal healthy volunteers (NHVs) are used in the conduct of many Phase I studies. However, since they will not benefit from exposure to the test article and because most of these studies require patients to stay in Phase I units for up to 28 days at a time, it is common to pay these subjects for their participation. The issue of vulnerability in this population needs special consideration.
In the panel discussion "Normal Healthy Volunteers as a Vulnerable Population: Implications for Researchers" (SP115), Dr. Geoffroy and the other panelists will discuss the ethical principles related to vulnerability, the vulnerability of NHVs, and safety considerations to reduce risk in this population. Also covered will be strategies that institutional review boards and research staff can implement to reduce the vulnerability of this population. This session is part of the Ethics & Human Subject Protection track, which will be held on April 16 from 8 to 10:15 a.m.
INC Research's early phase specialists are among the most highly respected experts in their fields. Through the Company's center of research in Toronto, Canada, the early phase team can develop an optimal early phase plan from initial protocol design through to regulatory submission, providing support at agency meetings and assistance to help present and explain complex data. Whether it is a small biotechnology company requiring additional specialist input into early phase program, or a large pharmaceutical company looking for nimble problem-solving capabilities and personal interaction on a scientific and operational level, INC Research has the flexibility to rapidly address a wide range of needs. To meet with INC Research at ACRP or for more information on our early phase or other clinical development capabilities, please visit the website.
About INC Research
INC Research is a therapeutically focused clinical research organization with a high-performance reputation for conducting global clinical development programs of the highest integrity. Pharmaceutical and biotechnology companies look to INC Research for a complete range of customized Phase I through Phase IV programs in all therapeutic areas and innovative pediatric and women's health trials. The Company's Trusted Process® methodology and therapeutic foresight lead customers to more confident, better-informed drug and device development decisions. INC Research is headquartered in Raleigh, NC. For more information, please visit www.incresearch.com or follow us at @inc_research.
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