Obviously some kinds of data are felt by data-subjects or the public in general to be especially sensitive. A commonly cited example is that HIV–AIDS data are much more sensitive than, say, data about wrist fracture. Whether sensitivity is somehow justified will always be debatable within the context. But for purposes of ethical practices, polic
This study takes it as given that because members of society benefit greatly from health research, research— if it is for justifiable purposes, and is conducted with proper protection of subjects —must continue to be allowed controlled access to individuals' health data.
Wrongful disclosure of confidential health data may occur either through carelessness— through gossip in a clinic, for instance, or lazy discarding of clinical records—or through deliberate transgression, either by someone associated with the data-holder or by an outsider.
The ethos surrounding research on humans was recast and codified after World War II, as the world coped with the revelation of the medical atrocities perpetrated by the Nazis. The resulting "Nuremberg Code"—the opening sentence of which was, "The voluntary consent of the human subject is absolutely essential"—established principles having to d
Privacy is a deeply felt but elusive concept. Everyone is sensitive to having his privacy violated. The concepts of "personal matters" and "intimate knowledge" are familiar, as is the notion that individuals live in a "private sphere" over which they are to be granted autonomy. The right to private life was proclaimed in the Universal Declaration
At issue right now—as health care is rapidly becoming industrialized, collectivized, and computerized—is to what extent society will preserve the cherished tradition of patient–healthcare provider confidentiality with its many implications, and the related relationships of trust with those who perform health research. Also at issue is whet
The Report identifies many problem areas. The following are four large groups of issues that, while not entirely new, are growing rapidly in scale and complexity, and must urgently be attended to: Secondary uses of data, and data linking Research on private-sector health data Cybersecurity Genetic privacy. Issue cluster: Secondary res
The following principles are recommended for organizations that conduct, sponsor, or regulate health research involving personally identifiable data. They can be transposed into professional guidelines, standard operating principles, regulations, or laws. Criteria and procedures should be established that are specific to the context.
The Federal Common Rule and other laws and regulations require many protections for human subjects of research. The main social instruments are informed consent of the data- subject, and Institutional Review Board (IRB) supervision. Both of these mechanisms have served society well. But both now need to be renewed.
Health data of concern for ethics and policy, and for this Report, include not only primary medical and hospital records, but also pharmacy and laboratory data; vital records; administrative and financial data; data from surveys, clinical trials, adverse-drug-event reports, and outcomes and health-economics studies; registries organized by disease
In September 1996 the U.S. Secretary of Health and Human Services, Dr. Donna E. Shalala, requested this study as background for policy decisions that her Department and American society, along with their counterparts in other countries, urgently must confront. The study was conducted by Dr. William W. Lowrance, an external consultant, who for ad
[Click here to download a zipped WordPerfect 5.1 version of this report] A Report to the U.S. Secretary of Health and Human Services OFFICE OF THE ASSISTANT SECRETARY FOR PLANNING AND EVALUATION
Market Barriers to the Development of Pharmacotherapies for the Treatment of Cocaine Abuse and Addiction: Final Report. Case Studies: LAAM, Naltrexone, Clozapine, and Nicorette
The purpose of the case studies is to gain insight into the experiences of companies that are relevant to developing and marketing medications for drug abuse and addiction. Presented below are two in-depth case studies of LAAM (Roxanne), for heroin addiction, and naltrexone (DuPont Merck), for heroin (as Trexan) and alcohol (as ReVia) addiction. I
Market Barriers to the Development of Pharmacotherapies for the Treatment of Cocaine Abuse and Addiction: Final Report. Scenario 2: Biotech Gets Help
In this scenario, a small biotechnology firm, Company B, takes on the full product development cycle with a new class of compounds based on a recent scientific breakthrough that is highly specific to cocaine receptor neuropharmacology. The company anticipates that a new Product B from this class of compounds will have excellent compliance in the u
Market Barriers to the Development of Pharmacotherapies for the Treatment of Cocaine Abuse and Addiction: Final Report. Scenarios of Company Decision Making
This report presents several scenarios of pharmaceutical company decision making regarding undertaking projects to develop pharmacotherapies for substance abuse (e.g., cocaine) under various sets of market conditions. Using a quantitative model developed by The Lewin Group, the market conditions are translated into financial and other parameters t
HHS Strategic Goals and Objectives - FY 2001 . Objective 6.7 - Strengthen Mechanisms for Ensuring the Protection of Human Subjects in Research and the Integrity of the Research Process.
We will strengthen mechanisms for ensuring protection of human subjects by: increasing and enhancing the educational opportunities for clinical investigators and Institutional Review Board (IRB) members and staff to facilitate their understanding and application of federal requirements for the protection of human subjects.