AGE;
ARTICLE;
BIOMEDICAL AND BEHAVIORAL RESEARCH;
DRUG INDUSTRY;
ETHICS;
FEMALE;
FINANCIAL MANAGEMENT;
FOOD AND DRUG ADMINISTRATION;
GOVERNMENT;
GOVERNMENT REGULATION;
HEALTH CARE ORGANIZATION;
HUMAN;
HUMAN EXPERIMENT;
METHODOLOGY;
MINORITY GROUP;
MISCELLANEOUS NAMED GROUPS;
NATIONAL INSTITUTES OF HEALTH;
NIH GUIDELINES;
PATIENT SELECTION;
PRACTICE GUIDELINE;
PROFESSIONAL STANDARD;
RESEARCH;
RESEARCH SUBJECT;
RISK;
RISK ASSESSMENT;
SOCIAL CONTROL;
UNITED STATES;
VULNERABLE POPULATION;
BIOMEDICAL AND BEHAVIORAL RESEARCH;
NATIONAL INSTITUTES OF HEALTH;
NIH GUIDELINES;
AGE FACTORS;
DRUG INDUSTRY;
DRUGS, INVESTIGATIONAL;
ETHICAL REVIEW;
ETHICS;
ETHICS COMMITTEES;
ETHICS COMMITTEES, RESEARCH;
FEDERAL GOVERNMENT;
FEMALE;
FINANCIAL SUPPORT;
FINANCING, GOVERNMENT;
GOVERNMENT;
GOVERNMENT REGULATION;
GUIDELINES;
HUMAN EXPERIMENTATION;
HUMANS;
MINORITY GROUPS;
NATIONAL INSTITUTES OF HEALTH (U.S.);
NONTHERAPEUTIC HUMAN EXPERIMENTATION;
PATIENT SELECTION;
PERSONS;
RESEARCH;
RESEARCH DESIGN;
RESEARCH SUBJECTS;
RISK;
RISK ASSESSMENT;
SOCIAL CONTROL, FORMAL;
THERAPEUTIC HUMAN EXPERIMENTATION;
UNITED STATES;
UNITED STATES FOOD AND DRUG ADMINISTRATION;
VULNERABLE POPULATIONS;
WOMEN;
NIH guidelines on the inclusion of women and minorities as subjects in clinical research
Department of Health and Human Services, and National Institutes of Health: NIH guidelines on the inclusion of women and minorities as subjects in clinical research. Federal Register 1994; 59:14508-13.
Clinically significant adverse effects in a phase one testing program
Zarafonetis CJD, Riley PA, Willis PW, et al.: Clinically significant adverse effects in a phase one testing program. Clinical Pharmacology and Therapeutics 1978; 24:127-32.
A report on adverse effects insurance for human subjects
President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research. (Appendices). Washington, D.C.: Government Printing Office
McCann DJ, Pettit JR: A report on adverse effects insurance for human subjects. In: President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research. Compensating for Research Injuries: the Ethical and Legal Implications of Programs to Redress Injuries Caused By Biomedical and Behavioral Research (Appendices). Washington, D.C.: Government Printing Office, 1982.
Incidence of injury during clinical pharmacology research and indemnification of injured research subjects at the Quincy Research Center
President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research.
Arnold JD: Incidence of injury during clinical pharmacology research and indemnification of injured research subjects at the Quincy Research Center. In: President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research. Compensating for Research Injuries.
The exclusion of pregnant, pregnable, and once pregnable people (aka women) from biomedical research
Merton V: The exclusion of pregnant, pregnable, and once pregnable people (aka women) from biomedical research. American Journal of Law and Medicine 1994; 19: 369-450.
Mastroianni AC, Faden R, Federman D: Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Research (vol. 1). Washington, D.C.: National Academy Press, 1994:36-74.
Guidelines for the Study and evaluation of gender differences in the clinical evaluation of drugs
Food and Drug Administration: Guidelines for the Study and evaluation of gender differences in the clinical evaluation of drugs. Federal Register 1993; 58:39406-16.
These are outlined in a letter to IRBs by Gary Ellis, Director of the Office for Protection from Research Risk, 25 April 1994
These are outlined in a letter to IRBs by Gary Ellis, Director of the Office for Protection from Research Risk, 25 April 1994.
12
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45 CFR 46; Revised 18 June 1991
45 CFR 46; Revised 18 June 1991.
13
0003392968
Washington, D.C.: U.S. Government Printing Office
Office for the Protection from Research Risk: Protecting Human Research Subjects: Institutional Review Board Guidebook. Washington, D.C.: U.S. Government Printing Office, 1993.
Analysis and interpretation of treatment effects in subgroups of patients in randomized clinical trials
Yusuf S, Wittes J, Probstfield J, Tyroler HA: Analysis and interpretation of treatment effects in subgroups of patients in randomized clinical trials. JAMA 1991; 266:93-8.
Ethics and statistics in clinical research: Towards a more comprehensive examination
Freedman B, Shapiro S: Ethics and statistics in clinical research: towards a more comprehensive examination. Journal of Statistical Planning and Inference 1994; 42:223-40.
Demarcating research and treatment: A systematic approach for the analysis of the ethics of clinical research
Freedman B, Fuks A, Weijer C: Demarcating research and treatment: a systematic approach for the analysis of the ethics of clinical research. Clinical Research 1992; 40:653-60.