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Research Methods- Ethics (lecture 6)

Terms in this set (22)

Nuremberg code
ethical code of conduct for research that uses human subjects; "the voluntary consent of the human subject is absolutely essential"; 1st international document to advocate for voluntary participation and informed consent. Not a law.
Declaration of Helsinki (1964)
the World Medical Association established recommendations guiding medical doctors in biomedical research involving human participants. Defines rules for research combined with clinical care. States non-therapeutic research cannot present more than minimal risk. Elaborated on Nuremberg code.
Belmont Report (1979)
Established three basic ethical principles—respect for persons, beneficence, and justice—that are the cornerstones for regulations involving human subjects
Beneficence
Human subjects should not be harmed and research should maximize possible benefits and minimize possible harm
Justice
The benefits and risks of research must be distributed fairly.
Respect for persons
individuals should be treated as autonomous agents and persons with diminished autonomy are entitled to protection
Principles of ethical conduct of research
1. Self-determination
2. scientific excellence
3. minimize risk and harm
4. confidentiality
5. lack of conflict of interest
6. Independent review
Self-determination (autonomy)
Ethical Principle. Freedom of choice to participate. Every participant has a right to be fully informed about:
1. objectives of the study
2. any associated risk/harm
3. uses of collected data
Participants are not required to participate they should not be tied to the researchers in any way.
Scientific excellence (maximize the benefit)
Ethical Principle. The study must be the highest scientific quality feasible given resources. The study must address research questions not already answered but does not mean researchers cannot replicate a study.
Nonmaleficence
Ethical Principle. Minimize risk and harm. All risks should be minimized wherever possible. Participants should be fully informed of any risk.
Lack of conflict of interest
Ethical Principle. A researcher, agency, or institution should not be able to exploit the study for their personal benefit. A researcher, agency, or institution must disclose any funding sources. All effort should be taken to avoid even the appearance of a conflict of interest.
Independent review
Ethical Principle. Researchers outside of those conducting the study should review the work:
1. Peer reviewed journals
2. Conference submissions
3. Institutional research boards
Institutional Review Board (IRB)
A committee charged with carrying out unbiased review of research proposals under regulations of the Office of Human Research Protection (OHRP). Job is to protect the rights and welfare of human participants.
approve, require modification, disapprove (research activities)
The IRB has the authority to:
Informed consent
Requires researchers to explain the study in "plain language". Describes voluntary participation (no coercion, undue influence).
Disclosure: participants are given complete study information to make an informed decision. Obtaining consent is a process.
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