AP Research Ethics

Nuremberg Code
"A set of international ethical guidelines for conducting research with humans."​

Belmont Report
"The Belmont Report, which was written by an advisory committee created by Congress and published in 1979."​

Respect for Persons
"The principle of respect for persons acknowledges that individuals make decisions about how they want to live their lives, including if they want to volunteer for research studies."​

Beneficence
"The principle of beneficence acknowledges that research could bring about important contributions to public good."​

Justice
"The principle of justice is concerned with the fair distribution of burdens and benefits."​

Common Rule
"Subpart A of the regulations is referred to as the Common Rule because many other Federal departments and agencies have also adopted it to protect participants in the research they conduct or fund."​

Office for Human Research Protections (OHRP)
"OHRP is part of the U.S. Department of Health and Human Services (HHS). OHRP oversees and enforces the Common Rule and other HHS regulations for protecting people in research that is funded with HHS money."​

Institutional Review Board (IRB)
"IRBs are committees that make sure researchers follow the HHS rules and ethical guidelines as they carry out their studies."​

Federalwide Assurance (FWA)
"This assurance is called an FWA, which stands for Federalwide Assurance. Through the FWA, institutions commit to comply with the regulations, comply with additional human subjects regulations and policies as applicable, establish certain required written procedures, and support IRB activities and review."​

Informed Consent
"The Common Rule generally requires that researchers get informed consent from volunteers who participate in research. This includes giving them information about the study, including risks and benefits."​

These are the primary terms, laws, and definitions found in the document, all given exactly as they appear in the source.​

add all people and their word for word signifigance too. how many subparts in common rule etc

Here are the key people and their significance in ethical research, plus details about the Common Rule subparts, all extracted word-for-word from the provided document:

Henry Beecher (1966):
"An anesthesiologist and researcher, published a widely cited New England Journal of Medicine article detailing numerous examples of unethical experiments involving human subjects that were conducted at various U.S. institutions."​

U.S. Department of Health and Human Services (HHS)
"The Federal Health Department what is now the Department of Health and Human Services, or HHS oversaw the development of the regulations. Currently, the HHS Office for Human Research Protections or OHRP is responsible for oversight of these regulations for HHS."​

National Institutes of Health (NIH)
"HHS agencies include, for example, the National Institutes of Health NIH and the Centers for Disease Control and Prevention CDC. Human research funded by these agencies falls under OHRPs oversight."

Centers for Disease Control and Prevention (CDC)
"HHS agencies include, for example, the National Institutes of Health NIH and the Centers for Disease Control and Prevention CDC. Human research funded by these agencies falls under OHRPs oversight."​

U.S. Food and Drug Administration (FDA)
"The U.S. Food and Drug Administration FDA is also a part of HHS. Part of FDAs broad mission includes ensuring the safety, efficacy, and security of drugs, biological products, and medical devices available to the American public."
"The FDA has its own regulations that apply to the clinical investigations it oversees. These regulations align with the Common Rule but also differ in some important ways. While there is an ongoing effort to harmonize them, it is important for investigators and IRBs to know which regulations are applicable for a particular research project."​

Institutional Review Boards (IRBs)
"IRBs are committees that make sure researchers follow the HHS rules and ethical guidelines as they carry out their studies."
"IRBs Review and oversee research to ensure that research volunteers are adequately protected according to ethical standards and relevant rules."​
nformed Consent:
A process ensuring participation in research is voluntary, informed, and comprehended by the participant.​

Documentation of Informed Consent:
Consent must be recorded in writing and signed by either the participant or an authorized representative.​

Diminished Autonomy:
Factors like age or illness may reduce a person's ability to independently consent to research.​Decisional Capacity and Legally Authorized Representatives:
Researchers must make provisions for subjects who cannot make their own decisions by involving authorized representatives.​Assent and Permission for Children’s Participation:
Children’s ability to agree to join research depends on their age and development, as judged by the IRB.​Risk-Benefit Analysis:
Researchers must weigh and justify the risks to participants against the expected value of the new knowledge gained.​Compensation for Research Participation:
Payment is to reimburse participants for effort or inconvenience, not to serve as a benefit of the study itself.​Undue Inducement:
Overly attractive offers may unfairly influence or impair judgment in research participation decisions.​Privacy and Confidentiality:
Privacy is protection from unapproved intrusion, and confidentiality means keeping a person's information secret without their permission.​Coded Private Information and Human Subjects Research:
Research involves human subjects if researchers can link private information to identities, but not if they cannot.​Anonymized Data:
Data is anonymized when no one can identify which individual it comes from, protecting participant identities.​

Beneficence: The ethical principle of doing good and maximizing benefits while minimizing harm in research or care.

Maleficence: The ethical principle of avoiding harm or causing injury to others.

Autonomy: The right of individuals to make their own informed decisions freely and independently.

Justice: The principle of fairness in distributing benefits, risks, and resources equally among people.

Confidentiality: The responsibility to keep personal and private information secure and undisclosed without consent.