Informed Consent from Human Subjects in Scientific Research
- 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.
- 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.
- 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.
- 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.
- Blowing the Whistle on a Therapeutic Experiment
- A head nurse at a private psychiatric facility suspects patient abuse in an experimental program.
- Crossing Cultural Barriers: Informed Consent in Developing Countries
- Does the promise of U. S. style medical care undermine informed consent in a study?
- An Asthmatic Child
- A scenario meant to stimulate discussion regarding ethical issues in conducting research with children: Parents approach you to ask if their child can be enrolled in a study.
- Disagreement About Consent
- A scenario meant to stimulate discussion about the ethical issues that arise when members of the health care team disagree about whether a mentally ill patient has actually given informed consent.
- The Monitor's Consent
- A scenario meant to stimulate discussion about the ethical issues that arise when a mentally ill patient's monitor is asked to give informed consent.
- When Should We Accept Consent?
- A scenario meant to stimulate discussion about the ethical issues that arise when a researcher is unsure if a study participant is too incapacitated to actually give informed consent.
- Conflicts of Interest and Informed Consent?
- A scenario meant to stimulate discussion about the ethical issues that arise when a researcher must decide if a patient is unable to give informed consent but the patient's spouse wishes to enroll the patient.
- 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.
- 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.
- The Ethics of Research with Human Subjects Who are Mentally Ill
- A training module that uses scenarios and other methods to raise questions and ethical ambiguities in the use of mentally ill patients as research subjects.
- Ethical Challenges in Research with Human Biological Materials
- A training module that uses scenarios and other methods to raise questions and ethical ambiguities in the use of human biological materials.
- 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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- Tips on Informed Consent
- The process of obtaining informed consent must conform to the requirements of 45CFR46.116 and the documentation of it must conform to the requirements of 45CFR46.117. OPRR explains these requirements and gives helpful suggestions in this document.
- Checklist of the basic (and additional) elements of the informed consent document
- Presented by the OPRR. Includes the specifications of a written form that contains all of the required elements or a short form written consent which states that all of the elements of informed consent have been presented orally to the subject or subject's legally authorized representative.(When the second option is chosen, you must have a witness to the oral presentation.)
- 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
- 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.