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).

Historical and Foundational Documents

Belmont Report (1979)
The Belmont Report summarizes ethical principles and guidelines for research involving human subjects. Its three core principles identified are:

  1. Respect for persons (autonomy),
  2. Beneficence, and
  3. Justice.

Website

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:

  1. Research with humans should be based on the results from laboratory and animal experimentation;
  2. Research protocols should be reviewed by an independent committee prior to initiation;
  3. Informed consent from research participants is necessary;
  4. Research should be conducted by medically/scientifically qualified individuals; and,
  5. Risks should not exceed benefits.

Website

Nuremberg Code (1948)
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.
Website

US Common Rule (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.
Website

Henry K. 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."
Website

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.
Website

National Bioethics Advisory Commission's Report
This link provides links to the National Bioethics Advisory Commission's publications.
Website

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.
Website

Practical Documents and Sites

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).
Website

The 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 research.
Website

AACAP News

  1. Decoding Iceland: "Genethics" at the Millennium (AACAP News, January/February 2000)

Other Articles

  1. 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.
  2. 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.
  3. 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.
  4. 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.