Do Current Federal Regulations Adequately Protect People who Participate in Medical Research?: Hearing Before the Subcommittee on Criminal Justice, Drug Policy, and Human Resources of the Committee on Government Reform, House of Representatives, One Hundred Sixth Congress, First Session, December 9, 1999 |
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Page 10
... called an assurance of compliance . This is a written commitment to ethical principles , and institutional proce- dures that are adequate to safeguard the rights and welfare of human subjects . The assurance statement becomes a specific ...
... called an assurance of compliance . This is a written commitment to ethical principles , and institutional proce- dures that are adequate to safeguard the rights and welfare of human subjects . The assurance statement becomes a specific ...
Page 16
... called an " Assurance " of compliance . At OPRR's discretion , institutions with a large volume of research and demonstrated expertise in human subjects protection may be granted a Multiple Project Assurance . A Multiple Project ...
... called an " Assurance " of compliance . At OPRR's discretion , institutions with a large volume of research and demonstrated expertise in human subjects protection may be granted a Multiple Project Assurance . A Multiple Project ...
Page 26
... called for in the informed consent document , and the continuation of a research project for six weeks beyond when the IRB had suspended it . We were also aware of concerns about the IRB system raised by others — for instance , the ...
... called for in the informed consent document , and the continuation of a research project for six weeks beyond when the IRB had suspended it . We were also aware of concerns about the IRB system raised by others — for instance , the ...
Page 27
... called for changes in the protocol . A greater proportion of research is funded by commercial sponsors . Research is conducted Criminal Justice , Drug Policy , and Human Resources Subcommittee House Government Reform Committee December ...
... called for changes in the protocol . A greater proportion of research is funded by commercial sponsors . Research is conducted Criminal Justice , Drug Policy , and Human Resources Subcommittee House Government Reform Committee December ...
Page 31
... called for a greater emphasis on accountability , performance , and results . Our recommendations included a number of actions , many of which , in the near - term , could help to address the vulnerabilities in the system . Some of our ...
... called for a greater emphasis on accountability , performance , and results . Our recommendations included a number of actions , many of which , in the near - term , could help to address the vulnerabilities in the system . Some of our ...
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Common terms and phrases
approved behavioral problems benefit Bioethics CASSELL Chairman clinical Committee concerns conducted Criminal Justice December 9 Drug Policy Ellis ethical experimental experiments families Federal regulations fenfluramine challenge fenfluramine study Gary Ellis Government Reform Health and Human hearing Hispanic Human Radiation Experiments Human Resources Subcommittee Human Services human subject research human subjects protections Iloperidone important individuals informed consent Institutional Review Board investigators IRB members IRB review issues LAWRENCE mental disorders mentally ill MICA minimal risk NBAC Office for Protection Oldham OPRR OPRR's oversight panel participants patients placebo potential procedures protecting human subjects Protection from Research protection of human psychotic pulmonary hypertension recommendations record research involving research protocol research subjects responsibilities schizophrenia Secretary serotonin Shamoo Steven Subcommittee December 9 testimony Thank there's Timothy Walsh Towns treatment vulnerable WALSH YESSIAN York Psychiatric Institute York State Psychiatric ZUCKER
Popular passages
Page 17 - ... injury occurs and, if so, what they consist of, or where further information may be obtained 7. An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject 8.
Page 16 - A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental...
Page 17 - A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained; (6) For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained; (7) An explanation of whom to contact for answers to pertinent questions about the research and research subjects'...
Page 8 - Illinois DANNY K. DAVIS, Illinois JOHN F. TIERNEY, Massachusetts JIM TURNER, Texas THOMAS H. ALLEN, Maine HAROLD E. FORD, JR., Tennessee JANICE D. SCHAKOWSKY, Illinois BERNARD SANDERS, Vermont (Independent) KEVIN BINGER, Staff Director DANIEL R.
Page 54 - IRB shall be sufficiently qualified through the experience and expertise of its members, and the diversity of the members, including consideration of race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects.
Page 17 - ... (2) A description of any reasonably foreseeable risks or discomforts to the subject. (3) A description of any benefits to the subject or to others which may reasonably be expected from the research. (4) A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject. (5) A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained and that notes the possibility that the Food...
Page 134 - IRB finds that: a. the risk represents a minor increase over minimal risk; b. the intervention or procedure presents experiences to subjects that are reasonably commensurate with those inherent in their actual or expected medical, dental, psychological, social or educational situations; c. the intervention or procedure is likely to yield generalizable knowledge about the subjects...
Page 15 - When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these subjects.
Page 13 - Ideally, it is a local review, by individuals who are in the best position to know the resources of the institution, the capabilities and reputations of the investigators and staff, and the prevailing values and ethics of the community and likely subject population.
Page 13 - Board is, by federal regulation, to be established at the local level and has a minimum of five people, including at least one scientist, one nonscientist, and one person not otherwise affiliated with that institution. The nonscientist must be present to achieve a quorum.