1Introduction to the Human Experimentation Web Tour
What is the role of ethics in research with human participants?
The objective of research is to develop generalizable knowledge to improve humankind. The aims of research are recognized as being good, but research has the potential to inflict harm and to treat participants as just a “means to an end”. Therefore, the role of ethics is to ensure that participants are treated with dignity and respect while they contribute to the social good.
Dowload the linked Human Experimentation worksheet as a Word doc to complete as you work through the activity.
2Bioethical Issues: Clinical Trials and Human Subject Research
Overview of the issues involving human research participants. Make sure to click the "More" link to view the entire article.http://www.thehastingscenter.org/Issues/Default.aspx?v=234
3Good Experimental Design
A detailed description of good experiment design.http://www.stat.yale.edu/Courses/1997-98/101/expdes.htm
4Brief History of Research Ethics
Documents that have guaranteed the rights and interests of Human Subjects
(1947) The Nuremberg Code – The tribunal at Nuremberg laid down 10 standards to which physicians must conform when carrying out experiments on human participants in reaction to gross abuses in human experimentation performed in Nazi Germany.
(1964) Declaration of Helsinki was issued by the World Medical Association establishing recommendations to guide medical doctors in biomedical research involving human participants.
Issues addressed in the Declaration of Helsinki include:
- Research with humans should be based on the results from laboratory and animal experimentation
- Research protocols should be reviewed by an independent committee prior to initiation
- Informed consent from research participants is necessary
- Research should be conducted by medically/scientifically qualified individuals
- Risks should not exceed benefits
(1974) The U.S. National Research Act was passed in response to disclosures about the Tuskegee Syphilis Study. It created the National Commission for the Protection of Human participants of Biomedical and Behavioral Research.
- Nazi atrocities in World War II drew attention to the lack of international standards on research with human subjects and led to the formulation of the Nuremberg Code.
- The thalidomide disaster led to the adoption of the "Kefauver Amendments" to the Food, Drug and Cosmetic Act, requiring drug manufacturers to prove to the FDA the effectiveness of their products before marketing them.
- The Declaration of Helsinki is the basis for Good Clinical Practices used today.
- The Tuskegee Syphilis Study is probably the worst case of unethical human subjects research in the history of the United States.
- The National Research Act codified the requirement that human subjects in research must be protected and set the stage for the issuance of the Belmont Report.
(1979) The National Commission for the Protection of Human participants drafted the Belmont Report, a foundational document in for the ethics of human participants research.
Respect for persons
- Individuals should be treated as autonomous agents
- Persons with diminished autonomy are entitled to protection.
- Subjects, to the degree that they are capable, must be given the opportunity to choose what shall or shall not happen to them
- The consent process must include three elements:
- comprehension, and
- Human subjects should not be harmed
- Research should maximize possible benefits and minimize possible harms.
Assessment of risks and benefits
- The nature and scope of risks and benefits must be assessed in a systematic manner
- The benefits and risks of research must be distributed fairly.
Selection of subjects
- There must be fair procedures and outcomes in the selection of research subjects.
Since 1991, the Federal Policy overseeing research on human subjects is often referred to as the Common Rule
The main elements of the Common Rule include :
- requirements for assuring compliance by research institutions;
- requirements for researchers obtaining and documenting informed consent;
- requirements for Institutional Review Board (IRB) membership, function, operations, review of research, and record keeping.
- additional protections for certain vulnerable research subjects-- pregnant women, prisoners, and children
An Institutional Review Board (IRB) is a group of individuals charged with reviewing proposed research involving human subjects to ensure the protection of those subjects and compliance with federal human subjects regulations.
5Human Subject Research Ethics
What are the features of ethically acceptable human research?http://depts.washington.edu/bioethx/topics/resrch.html
Informed Consent Interactive.http://www.phgfoundation.org/tutorials/informedConsent/
7Understanding Clinical Trials
Choosing to participate in a clinical trial is an important personal decision. This site provides detailed information about clinical trials.http://clinicaltrials.gov/ct2/info/understand#Q05
8What kinds of clinical trials are going on right now near you?
Go to the Clinical Trials website. Enter the name of the closest large city to you and see what trials researchers are conducting nearby. List one such trial on your worksheet.http://clinicaltrials.gov/ct2/search