Humans in Scientific Research


The Ethics of Research with Human Subjects Who are Mentally Ill
A module meant to stimulate discussion among researchers about the ethical issues that arise in conducting research with human subjects who are mentally ill - including topics such as consent, privacy, conflict of interest.
Ethical Challenges in Research with Human Biological Materials
A training module using scenarios and other methods to facilitate discussion about the key ethical issues that arise in doing research with human biological material.
Categories of Human Biological Materials
Definitions of various terms as they apply to research with human biological materials.
National Bioethics Advisory Commission - Ethical and Policy Issues in Research Involving Human Participants
Index of the contents of the NBAC report Ethical and Policy Issues in Research Involving Human Participants Report, Recommendations, and Commissioned Papers.
Privacy and Confidentiality in Health Research
Janlori Goldman and Angela Choy Georgetown University. This paper describes how the public's fear and anxiety over the loss of privacy and confidentiality can threaten the research initiatives meant to benefit them. The federal government, researchers, Institutional Review Boards (IRBs), and research institutions will need to work together to provide strong privacy and confidentiality protections to build public trust and encourage continued participation in research.
An Examination of Issues Presented by Proposals to Unify and Expand Federal Oversite of Human Subject Research
C.K. Gunsalus, University of Illinois at Urbana-Champaign. This paper was commissioned to examine whether NBAC should recommend unifying federal oversight of federal and private human subjects research under a single government office such as the Office for Protection from Research Risks (OPRR).
The History, Function, and Future of Independent Institutional Review Boards
Erica Heath, Independent Review Consulting, Inc. NBAC has requested information about the philosophical and practical issues related to the role of independent institutional review boards (IRBs) in the current medical research community. This paper provides a working definition of independent IRBs, describes their role within a broader framework of protections for human subjects and discusses the strengths and weaknesses of independent IRBs.
Key Ethical Issues in Research With Human Biological Materials
Key ethical issues that arise in doing research with human biological materials; including consent, commercialization, and disclosure.
When is Deception Ethically Justified in Research?
Is it ethical to deceive participants and place them at risk in naturalistic field investigations?
The Ethics of Research with Human Subjects who have Dementia
A teaching module using scenarios and other methods to stimulate discussion of the ethics of doing research with people in various stages of Alzheimer's Disease.
The Ethics of Research with Vulnerable Populations
A teaching module using scenarios and other methods to stimulate discussion of the ethics research with vulnerable populations such as children, mentally ill subjects, and subjects with dementia.
What are Acceptable Risks for Human Subjects in a Treatment Study?
What should be the limits of risk and suffering to patient subjects in studies of the efficacy of treatments for major psychological illness such as clinical depression?
Do the Ends Justify the Means? The Ethics of Deception in Social Science Research
A social psychologist wants to study attitude change and group norms. Is deception of her subjects justifiable?
The Ethics of Research with Children
A training module that uses scenarios and other methods to raise questions and ethical ambiguities in the use of children as research subjects.
Ethical Issues in Longitudinal Research with At-Risk Children and Adolescents
A study is to be conducted with students in grades 4 - 8, the principal agrees to allow students to participate in the study, but says they do not need the parents' permission.
Blowing the Whistle on a Therapeutic Experiment
A head nurse at a private psychiatric facility suspects patient abuse in an experimental program.
Informed Consent for Use of Stored Specimens
Blood samples from an experiment on preterm births are frozen. Another study is to be conducted and using these samples would save time and money. Do the mothers need to be asked for consent again?
Informed Consent and the Collection of Biological Samples from Indigenous Populations
A medical geneticist is working to collect blood samples from the Yuchi to study a possible natural immunity to leukemia. The Yuchi do not want to give any more blood; the geneticist decides to lie to them to convince them to give more samples.
Complex Concerns
A pharmaceutical company is developing a long-term therapeutic trial study of an antiviral compound for children with AIDS.
Ethical Issues in Research with Children
Children are participating in research on asthma.
Does HIV Affect All? Researchers' Duty to Warn
During an interview with a research participant, John, a licensed psychologist,discovers a participant who is HIV positive is having unprotected sex with her boyfriend who is not aware of her HIV status.
Political Points
Dr. Lang is researching the use of sterile needle exchange programs and discovers that the participants showed higher HIV infection rates than nonparticipants.
Part I and Part II,Explanation of Federal Regulations (45CFR46) on research with human subjects.
Reading Questions for the Federal Regulations on research with human subjects.

Relevant Web Resources

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Research Involving Persons With Mental Disorders That May Affect Decisionmaking Capacity.The National Bioethics Advisory Commission's report.
Reading Questionsfor The NBAC report on Research Involving Persons With Mental Disorders That May Affect Decisionmaking Capacity.
DOE's Radiation Research Using Human Subjects
Index of all government materials available on the topic.
Helsinki Declaration of the World Medical Associationon Biomedical Research Using Human Subjects
Guidelines for the Conduct of Research Involving Human Subjects at the National Institutes of Health
Canadian Code of Conduct for Research Involving Humans

Relevant Literature on this Topic

Whitbeck, Caroline. 1998. Ethics in Engineering Practice and Research.
New York: Cambridge University Press. Other keywords for this article: ethics and prudence; preferences vs. values; negligence;trust, distrust; ambiguity; moral ambiguity; responsibilities, general; professional responsibility; public safety; worker safety;laboratory safety; design process; engineering competence;environmental issues, global; environmental issues, chemical;conflict of interest; ethical codes and guidelines from professional societies; harassment, sexual harassment and aggression; workplace relationships; research misconduct; falsification and fabrication; plagiarism; authorship; animals in scientific research.
D. Lin and M. C. Loui, "Taking the byte out of cookies: privacy, consent, and the Web," Computers and Society, vol. 28, no. 2, pp. 39-51, June 1998.
Other keywords for this: database confidentiality; corporate ethics; computers and privacy.

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