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At least 37 records · Page 2Linked to original sources
PubMed1999

Office of Recombinant DNA Activities; recombinant DNA research: action under the guidelines. National Institutes of Health (NIH), PHS, DHHS. Notice of action under the NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines).

This notice sets forth an action to be taken by the Director, National Institutes of Health (NIH), under the NIH Guidelines for Research Involving Recombinant DNA Molecules (59 FR 34496, amended 59 FR 40170, 60 FR 20762, 61 FR 1482, 61 FR 10004, 62 FR 4782, 62 FR 53335, 62 FR 56196, 62 FR 59032, 63 FR 8052, 63 FR 26018).

DNA, Recombinant↗
PubMed1995

U.S. prisoners' access to experimental HIV therapies.

PURPOSE: To examine Department of Corrections (DOC) policies prohibiting prisoner participation in research studies and to assess the variables associated with state policies and practices relating to access by inmates in U.S. prisons to HIV-related clinical studies and experimental therapies. METHODS: A telephone survey conducted in 1994-95 of DOC medical directors from 32 states throughout the United States to obtain information about state DOC policies and practices relating to HIV clinical studies. RESULTS: State policies governing prisoner participation in clinical trials and access to new therapies vary widely. States with high AIDS incidence rates, a large number of AIDS-related deaths in prison, and high concentrations of minorities in the correctional system were more likely to allow prisoners to enroll in clinical studies and to receive experimental medications. Overall, a relatively small number of prisoners in state prisons have enrolled in clinical studies. Participation of a prison representative on the board reviewing a clinical study was identified as an important factor in allowing prisoner participation in studies. CONCLUSIONS: Barriers to prisoner participation in clinical studies are numerous but not insurmountable. Results from this study have led to efforts in Minnesota to revise current policy in order to permit prisoner participation in studies if appropriate guidelines are followed.

Antiviral Agents↗
PubMed1989

Informed consent in emergency research. Prehospital thrombolytic therapy for acute myocardial infarction.

Can the conscious patient in the midst of a medical emergency provide adequate informed consent for a clinical research protocol? Adequate consent is crucial to the ethical conduct of clinical trials, including those performed in emergency settings. We examine the problem of emergency informed consent. As an illustrative case, we discuss a pilot trial of prehospital thrombolytic therapy for myocardial infarction. Federal regulations for clinical research do not provide clear guidelines on emergency research in the conscious patient. Clinical investigators currently approach emergency consent in four ways: (1) avoid such research, (2) omit the consent process, (3) obtain deferred consent, or (4) obtain customary consent. We suggest a fifth alternative, two-step consent, which permits the conduct of emergency research while protecting the rights of the emergency research subjects. Such a process may serve as an alternative solution for future studies faced with the problem of informed consent in emergencies.

Emergencies↗
PubMed1989

Recombinant DNA research; proposed actions under guidelines. National Institutes of Health, PHS, DHHS.

This notice sets forth proposed actions to be taken under the National Institutes of Health (NIH) Guidelines for Research Involving Recombinant DNA Molecules. Interested parties are invited to submit comments concerning these proposals. These proposals will be considered by the Recombinant DNA Advisory Committee (RAC) at its meeting on October 6, 1989. After consideration of these proposals and comments by the RAC, the Acting Director of the National Institutes of Health will issue decisions in accordance with the NIH Guidelines.

DNA, Recombinant↗
PubMed1986

Deferred consent. A new approach for resuscitation research on comatose patients.

Methodological constraints inherent in the rapidly growing field of resuscitation research have created an apparent conflict with newly promulgated federal regulations, especially those concerning informed consent requirements. We propose that two new concepts be applied to resuscitation research to satisfy the current federal regulations governing biomedical research. The first of these concepts is "minimal differential risk," ie, in resuscitation medicine, the difference between the risk of an undesirable outcome when standard, commonly accepted therapy may be used and the risk of an undesirable outcome with experimental therapy is minimal. The second concept is "deferred consent," ie, obtaining consent to continue with an experimental therapy after administration of that therapy has already begun. We believe that the emergency exception to informed consent applies to resuscitation research. Recognition of the applicability of these concepts to resuscitation research should allow compliance with federal and state regulations that otherwise might inhibit or preclude such research endeavors.

Brain Diseases↗
PubMed1995

Genetic research, adolescents, and informed consent.

The participation of adolescents in genetic research engenders unusual problems concerning the nature of their informed consent. In this study we analyze 70 consent documents collected from genetics investigators in the United States who conduct research with children and adolescents. We find that many consent documents do not reflect either the current or the developing ethical and legal standards for research with adolescents and that in many cases the documents are simply confusing or unclear. We make recommendations for change to reflect more adequately the changing perspective concerning the autonomous decision-making capacity of adolescents.

Adolescent↗
PubMed1988

Children as participants in medical research.

The use of children in research raises the questions about proper justification, assessment of benefit in relation to risk, ability to consent, compensation, and the just selection of subjects. Although substantive and procedural standards have evolved, subpopulations of vulnerable children created new challenges and concerns.

Beneficence↗