informed consent research

• 21 CFR 50.24 - Exception from informed consent requirements for emergency research.

• Code of Federal Regulations - Title 21: Food and Drugs

• Regulating Clinical Research: Informed Consent, Privacy, and Irbs

Introduction. II. A Historical Overview of Research Abuses and the Development of Research Regulations. III. The Federal Regulations that Govern IRBs and Informed Consent. A. What Is Regulated?. B. IRBs. C. Informed Consent. D. Research Involving Only Existing Medical Records Or Tissue Samples. IV. Deficiencies in the Regulatory System. A. IRB Workloads. B. Flaws In The Informed Consent Process. C. Informed Consent Is Particularly Difficult To Obtain From Gravely Ill Patients. V. Recommendations. A. IRBs. B. Informed Consent Procedures. C. Storage Of Blood And Tissue Samples For Future Genetic Testing. VI. Conclusion.

• Capital University Law Review
• Nbr. 31-1, January 2003

• Protection of human subjects: Emergency research conducted without informed consent; hearing,

• FR, August 29, 2006
• Proposed rules
• Food and Drug Administration

• Researchers Test New Ways for People with Alzheimer's to Agree to Participate in Research; Symptoms Provide Informed Consent Challenge

MADRID, Spain, July 17 /U.S. Newswire/ -- Two researchers presented new methods for assessing the ability of people with Alzheimer's to give informed consent to participate in clinical trials, including the first study of this type done during an actual clinical trial, today in Madrid at the 10th International Conference on Alzheimer's Disease and Related Disorders, presented by the Alzheimer's Association. Informed consent is the process of ensuring that people understand all of the benefits and risks involved in a clinical trial before deciding whether or not to participate.

• U.S. Newswire
• July 17, 2006

• Adolescent Informed Consent: Ethics, Law, and Theory to Guide Policy and Nursing Research

The informed consent rights of adolescents present significant ethical and legal concerns and considerations for adolescents, parents of adolescents, nurses who treat adolescents, and legislators who formulate and implement minor informed consent policies. In all states adolescents can consent to various health care treatments without the required permission of the adolescent's parent or legal guardian. Yet, policies are implemented and amended without any empirical research support. This article examines the ethical and legal issues related to the consent rights of minors and provides a proposed theory to guide policy research, specifically related to psychiatric mental health treatment.

• Journal of Nursing Law
• Vol. 11 Nbr. 4, December 2007

• Protestant perspectives on informed consent (particularly in research involving human participants).

INTRODUCTION It is virtually impossible to state the Protestant position on any bioethical problem or issue. As a result, interpreters must focus on...

• Fordham Urban Law Journal
• Vol. 30 Nbr. 1, November 2002

• Reports and guidance documents; availability, etc.: Exception from informed consent requirements for emergency research; guidance for institutional review boards, clinical investigators, and sponsors,

• FR, August 29, 2006
• Notices
• Food and Drug Administration

• Emotional reactions to research participation and the relationship to understanding of informed consent disclosure.

Since 1995 when President Clinton issued Executive Order 12975 instructing the Office for the Protection from Research Risks (OPRR) to review its poli...

• Social Work Research
• Vol. 27 Nbr. 4, December 2003

• The psychology of competence and informed consent: understanding decision-making with regard to clinical research.

INTRODUCTION The role of psychology and related mental health disciplines in the informed consent process has gradually evolved from an essentially ...

• Fordham Urban Law Journal
• Vol. 30 Nbr. 1, November 2002

• Keeping managed care in balance.

Managed care promises to contain the cost of medical care while maintaining quality of care. Some studies have indicated that managed care can lead to improvements in utilization, costs and access. However, many sectors remain skeptical about managed care. For social workers and the people they serve, managed care raises several issues: confidentiality, duty to aid, self-determination, freedom of choice, access, quality of care, research protocols, informed consent, participation in treatment decisions and client rights.

• Health and Social Work
• Vol. 21 Nbr. 3, August 1996