Research and Other Scholarly Activities
This section provides links to ethical documents most relevant to researchers and other scholars. It is imperative that researchers and other scholars know both the relevant ethical and professional issues and obligations are and what resources are available. This section is divided in two parts: 1) historical and foundational documents (which are important for teaching about research ethics, and for theoretical discussions) and 2) practical documents and sites (which are resources that any child and adolescent psychiatrist doing research needs to know about and be familiar with).
- Chen DT, Shepherd LL. When, why, and how to conduct research in child and adolescent psychiatry: practical and ethical considerations. Psychiatr Clin North Am. 2009 Jun;32(2):361-80. doi: 10.1016/j.psc.2009.03.003. PubMed PMID: 19486819.
- Hein IM, Troost PW, de Vries MC, Knibbe CA, van Goudoever JB, Lindauer RJ. Why do children decide not to participate in clinical research: a quantitative and qualitative study. Pediatr Res. 2015 Jul;78(1):103-8. doi: 10.1038/pr.2015.74. Epub 2015 Apr 9. PubMed PMID: 25856170.
- Kölch M, Ludolph AG, Plener PL, Fangerau H, Vitiello B, Fegert JM. Safeguarding children's rights in psychopharmacological research: ethical and legal issues. Curr Pharm Des. 2010;16(22):2398-406. Review. PubMed PMID: 20513231.
- Sondheimer A. Ethics and risk management in administrative child and adolescent psychiatry. Child Adolesc Psychiatr Clin N Am. 2010 Jan;19(1):115-29. doi: 10.1016/j.chc.2009.08.002. Review. PubMed PMID: 19951811.
American Academy of Pediatrics (AAP) Guidelines for the Ethical Conduct of Studies to Evaluate Drugs in Pediatric Populations
The American Academy of Pediatrics (AAP) provides guidelines regarding testing of drugs in the pediatric population.
Beecher's Landmark Papers
In "The Powerful Placebo," Beecher stated that "placebos have a high degree of therapeutic effectiveness in treating subjective responses" and can also result in "toxic effects." His papers have encouraged numerous physicians and others to study "placebo effects."
In "Ethics and Clinical Research," Beecher identified ethical lapses in research carried out by physician and other scientists. In this paper, Beecher demonstrated that poor treatment of human subjects was not confined to the practices of Nazi doctors that had been documented by the Nuremberg war crimes tribunal. Beecher's paper prompted a reconsideration of research practices that is part of the foundation for today's ethical codes and review committees.
Belmont Report (1979)
The Belmont Report summarizes ethical principles and guidelines for research involving human subjects. Its three core principles identified are:
- Respect for persons (autonomy),
- Beneficence, and
Code of Conduct (Committee on Publication Ethics (COPE))
COPE created the Code of Conduct to define the best practice in the ethics of scholarly publishing and to assist editors, editorial board members, owners of journals and publishers to achieve this.
Code of Federal Regulations Title 45: Public Welfare, Part 46 (45 CFR 46)
The Code of Federal Regulations Title 45: Public Welfare, part 46 (45 CFR 46) provides protection for human subjects in research carried out or supported by most federal departments and agencies. 45 CFR 46, includes five subparts:
- Subpart A - Basic HHS Policy for Protection of Human Research Subjects (also known as the Common Rule);
- Subpart B - Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research;
- Subpart C - Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects;
- Subpart D - Additional protections for children; and,
- Subpart E - Registration of Institutional Review Boards (IRBs).
In 1991, the Federal Policy for the Protection of Human Subjects or the Common Rule is a rule of ethics regarding biomedical and behavioral research involving human subjects in the US.
In 2017, for the first time since the Common Rule was issued in 1991 it was updated.
Here is the OHRP website page on the revised common rule.
Here is the PRIM&R website page on the revised common rule.
Declaration of Helsinki
The Declaration of Helsinki is a set of ethical principles regarding medical research involving humans developed by the World Medical Association. It addresses:
- 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; and,
- Risks should not exceed benefits.
Health Insurance Portability and Accountability Act of 1996 (HIPAA) and Research
The HIPAA Privacy Rule establishes the conditions under which protected health information may be used or disclosed by covered entities for research purposes.
International Council on Harmonisation (ICH) of Technical Requirements for Pharmaceuticals for Human Use
- The ICH E11 Guideline (2000) provides an outline of critical issues in pediatric drug development and approaches to the safe, efficient, and ethical study of medicinal products in the pediatric population.
- Pediatric drug development has evolved since the original ICH E11 Guideline (2000), requiring consideration of regulatory and scientific advances relevant to pediatric populations. The ICH E11 (R1) addendum does not alter the scope of the original guideline.
National Bioethics Advisory Commission's Report
This link provides links to the National Bioethics Advisory Commission's publications.
National Research Act
The National Research Act was passed in response to the recognition of research misconduct that had been occurring leading up to 1974. The most notorious example was the Tuskegee Syphilis Study. The Act created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, which was charged to identify the basic ethical principles to provide the foundation for the conduct of biomedical and behavioral research involving human subjects and to develop guidelines.
The Nuremberg Code (1948) states that "The voluntary consent of the human participant is absolutely essential," making it clear that participants should give consent and that the benefits of research must outweigh the risks.
Office for Human Research Protections (OHRP)
The Office for Human Research Protections (OHRP) provides leadership in
the protection of the rights, welfare, and wellbeing of human subjects
involved in research conducted or supported by the U.S. Department of
Health and Human Services (HHS).
Secretary's Advisory Committee on Human Research Protections (SACHRP)
The Secretary's Advisory Committee on Human Research Protections
(SACHRP) provides expert advice and recommendations to the Secretary of
HHS on issues pertaining to the protection of human subjects in
UN Convention on the Rights of the Child and the Rights of Persons with Disabilities
The UN Conventions on the Rights of the Child and the Rights of Persons with Disabilities set out rights to be respected in child and adolescent psychiatric treatment.