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 |
From inside the book
Results 1-5 of 30
Page 2
... patients long before the death who had experienced serious side ef- fects and had said the informed consent form the investigators gave patients devi- ated from the one the agency had approved . I thought that was interesting and timely ...
... patients long before the death who had experienced serious side ef- fects and had said the informed consent form the investigators gave patients devi- ated from the one the agency had approved . I thought that was interesting and timely ...
Page 3
... patient representa- tives to monitor and enforce ethical research standards . Federal regulations require that a non - scientist and an individual not affili- ated with the institution be included in each of the IRB panels . Under OPRR ...
... patient representa- tives to monitor and enforce ethical research standards . Federal regulations require that a non - scientist and an individual not affili- ated with the institution be included in each of the IRB panels . Under OPRR ...
Page 22
... patient data bases to find potential human subjects ? What about the payment of fees to physicians referring their patients as potential subjects ? What are the standards or guidelines to answer such questions ? Where are they ? We end ...
... patient data bases to find potential human subjects ? What about the payment of fees to physicians referring their patients as potential subjects ? What are the standards or guidelines to answer such questions ? Where are they ? We end ...
Page 36
... What about when investigators mine Criminal Justice , Drug Policy , and Human Resources Subcommittee December 9 , 1999 patient databases to find potential subjects ? Should investigators offer House Government Reform Committee Page 12 36.
... What about when investigators mine Criminal Justice , Drug Policy , and Human Resources Subcommittee December 9 , 1999 patient databases to find potential subjects ? Should investigators offer House Government Reform Committee Page 12 36.
Page 37
... patient databases to find potential subjects ? Should investigators offer fees to physicians when the physicians refer their patients as subjects ? Few guidelines exist to help answer such questions . Continued Need for Federal Action A ...
... patient databases to find potential subjects ? Should investigators offer fees to physicians when the physicians refer their patients as subjects ? Few guidelines exist to help answer such questions . Continued Need for Federal Action A ...
Other editions - View all
Common terms and phrases
African American approved behavioral problems benefit Bioethics Bronx CASSELL Chairman clinical committee concerns conducted Criminal Justice December 9 Director Drug Policy Ellis ethical experimental experiments families Federal regulations fenfluramine challenge fenfluramine study funded Gary Ellis 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 NYPI Office for Protection OLDHAM OPRR OPRR's oversight participants patients placebo potential procedures protecting human subjects Protection from Research protection of human psychotic recommendations record research involving research protocol research subjects Resources Subcommittee December responsibilities schizophrenia serotonin Shamoo Steven testimony Thank there's Timothy Walsh tion Towns treatment vulnerable WALSH YESSIAN York Psychiatric Institute York State Psychiatric ZUCKER
Popular passages
Page 18 - A description of any benefits to the subject or to others which may reasonably be expected from the research; §27.114 §27.116 (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...
Page 18 - ... 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 18 - 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 50 - 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 18 - ... are experimental. (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...
Page 16 - 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 14 - 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.
Page 16 - B the rights and welfare of subjects are maintained in other ways as well. This is particularly important when subjects are likely to be vulnerable to coercion or undue influence.
Page 15 - In order to approve research covered by this policy, the IRB shall determine that all of the following requirements are satisfied: 1. Risks to subjects are minimized: (i) by using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk, and (ii) whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes. 2. Risks to subjects are reasonable in relation to anticipated benefits, if any,...
Page 21 - ... promotes the pursuit of new knowledge. By doing so, we protect the rights and welfare of our fellow citizens who make a remarkable contribution to the common good by electing to volunteer for research studies. We owe them our best effort. Thank you, Mr. Chairman.