BARNETT INTERNATIONAL RELEASES DEFINITIVE QUESTION AND ANSWER REFERENCE GUIDE FOR HIPAA AND HUMAN SUBJECTS RESEARCH
MEDIA, PA, March 4, 2003 — Barnett International, a division of a wholly owned subsidiary of PAREXEL International Corporation (NASDAQ: PRXL), announced the release of HIPAA and Human Subjects Research: A Question-and-Answer Reference Guide, designed specifically for clinical trial sponsors, trial monitors, investigators, clinical site staff and others directly involved in the clinical research process.
Developed by a team of leading legal and research experts, the new reference guide provides detailed answers to how the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule will affect aspects of the clinical research process, including patient recruitment, informed consent, Institutional Review Board (IRB) reviews, clinical data handling, and the responsibilities of industry sponsors, monitors, investigators, and IRBs.
By supplying answers to over 100 of the most complex HIPAA-related questions, the all-new reference guide provides readers with access to the perspectives and insights of a team of leading legal and research experts. Heading this team and providing commentary on how the HIPAA Privacy Rule should be applied in the real world of human subject research is Mark Barnes, J.D., LL.M., and Jennifer Kulynych, J.D. Ph.D, both from the law firm of Ropes & Gray. Barnes is a leading consultant in the field of research compliance and HIPAA regulations, and a member of the Department of Health and Human Services (HHS) Secretary’s Advisory Committee on Human Research Protections. Kulynych, a former regulatory counsel at the Association of American Medical Colleges (AAMC) has authored several articles on HIPAA in the New England Journal of Medicine and is a noted expert on the Privacy Rule and medical privacy issues.
HIPAA and Human Subjects Research: A Question-and-Answer Reference Guide also provides a collection of the essential HIPAA-related documents, including the research-related provisions of the Privacy Rule (45 CFR Parts 160 and 164), relevant excerpts from the HHS Office of Civil Rights’ December 2002 guidance on HIPAA, and key preamble commentary from the August 2002 Final Privacy Rule, March 2002 Proposed Rule, and December 2000 Final Rule.
Mark Barnes will be presenting at Barnett’s upcoming conference Understanding the Impact of HIPAA on Research, March 17-19, 2003, in Tyson’s Corner, Virginia. The conference features Office of Human Research Protections (OHRP) representation, multiple industry HIPAA
implementation case studies, as well as sessions featuring strategies for IRB compliance, developing authorizations and data de-identification strategies. For further information, visit our website at www.barnettinternational.com.
Founded in 1979, Barnett International helps pharmaceutical, biotechnology and medical device companies optimize the drug development process through comprehensive consulting services and clinical education programs. Barnett International is a division of a subsidiary of PAREXEL International Corporation, one of the largest biopharmaceutical outsourcing organizations in the world, providing a broad range of knowledge-based contract research, medical marketing and consulting services to the worldwide pharmaceutical, biotechnology and medical device industries. With a commitment to providing solutions that expedite time-to-market and peak market penetration, PAREXEL has developed significant expertise in clinical trials management, data management, biostatistical analysis, medical marketing, clinical pharmacology, regulatory and medical consulting, industry training and publishing and other drug development consulting services. Its information technology subsidiary, Perceptive Informatics, Inc., provides a variety of technology products and services, including web-based portal solutions and voice and data systems, and the use and interpretation of medical images as clinical trial endpoints, which are designed to accelerate and enhance the clinical development and launch processes. The Company’s integrated services, therapeutic area depth and sophisticated information technology, along with its experience in global drug development and product launch services, represent key competitive strengths. Headquartered near Boston, MA, PAREXEL operates in 58 locations throughout 35 countries around the world, and has approximately 4,970 employees.
This release contains "forward-looking" statements regarding future results and events, including statements regarding the Company’s existing capital resources and future cash flows from operations, and statements regarding expected financial results, future growth and customer demand that involve a number of risks and uncertainties. For this purpose, any statements contained herein that are not statements of historical fact may be deemed forward-looking statements. Without limiting the foregoing, the words "believes", "anticipates", "plans", "expects", "intends", "appears", “estimates”, “projects” and similar expressions are intended to identify forward-looking statements. The Company's actual future results may differ significantly from the results discussed in the forward-looking statements contained in this release. Important factors that might cause such a difference include, but are not limited to, risks associated with: actual operating performance; actual expense savings and other operating improvements resulting from recent restructurings; the cancellation, revision, or delay of contracts, including those contracts in backlog; the Company's dependence on certain industries and clients; the Company's ability to win new business, manage growth, and attract and retain employees; the Company's ability to complete additional acquisitions and to integrate newly acquired businesses or enter into new lines of business; government regulation of certain industries and clients; competition and consolidation within the pharmaceutical industry; the potential for significant liability to clients and third parties; the potential adverse impact of health care reform; and the effects of exchange rate fluctuations and other international economic and political risks. Such factors and others are discussed more fully in the section entitled "Risk Factors" of the Company's Form 10-Q for the quarter ended December 31, 2002, as filed with the Securities and Exchange Commission, which “Risk Factors” discussion is incorporated by reference in this press release. The forward-looking statements included in this press release represent the Company’s estimates as of the date of this release. The Company specifically disclaims any obligation to update these forward-looking statements in the future. These forward-looking statements should not be relied upon as representing the Company’s estimates or views as of any date subsequent to the date of this press release.