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.
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 "Ethics and Clinical Research" (1966)
Beecher identified ethical lapses in research carried out by physician and other scientists. He demonstrated that poor treatment of human subjects was not confined to the practices of Nazi doctors. This article prompted a reconsideration of research practices that is part of the foundation for today's ethical codes and review committees.
Beecher's "The Powerful Placebo" (1955)
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."
Belmont Report (1979)
The Belmont Report summarizes ethical principles and guidelines for research involving human subjects.
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.
Common Rule (1991 and 2017)
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.
Council for International Organizations of Medical Sciences (CIOMS)
The Council for International Organizations of Medical Sciences (CIOMS) is an international, non-governmental, non-profit organization established jointly by WHO and UNESCO in 1949. CIOMS mission is to advance public health through guidance on health research including ethics, medical product development and safety.
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 is one of the cornerstone documents on human research ethics.
Ethical Research Involving Children (ERIC)
ERIC aims to assist researchers and the research community to understand, plan and conduct ethical research involving children and young people in any geographical, social, cultural or methodological context. This website provides a repository of information and resources to assist researchers, and guide and improve research involving children.
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 Compilation of Human Research Standards
The International Compilation of Human Research Standards is a listing of over 1000 laws, regulations, and guidelines (collectively referred to as standards) that govern human subjects research in 130 countries and from many international organizations. Most of the listings provide hyperlinks to the source document.
International Council on Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E11 Guideline (Adopted in 2000 and Revised in 2016)
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. But, pediatric drug development has evolved since the original ICH E11 Guideline (2000). This required consideration of regulatory and scientific advances relevant to pediatric populations. The ICH E11 (R1) addendum (2016) 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 (1974)
The National Research Act was passed in response to the recognition of research misconduct, e.g., the Tuskegee Syphilis Study, that had been occurring leading up to 1974. 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
United Nations 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.
- Caldwell PH, Murphy SB, Butow PN, Craig JC. Clinical trials in children. Lancet. 2004;364(9436):803-11.
- 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;32(2):361-80.
- Edelsohn GA. Ethics and research with vulnerable children. J Am Acad Child Adolesc Psychiatry. 2012;51(6):566-8.
- Fleischman AR. Ethical issues in neonatal research involving human subjects. Semin Perinatol. 2016 Jun;40(4):247-53.
- 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.
- 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.
- Laventhal N, Tarini B, Lantos J. Ethical issues in neonatal and pediatric clinical trials. Pediatric clinics of North America. 2012;59(5):1205-20.
- Sondheimer A. Ethics and risk management in administrative child and adolescent psychiatry. Child Adolesc Psychiatr Clin N Am. 2010 Jan;19(1):115-29.
- Shaddy RE, Denne SC; Committee on Drugs and Committee on Pediatric Research. Clinical report--guidelines for the ethical conduct of studies to evaluate drugs in pediatric populations. Pediatrics. 2010 Apr;125(4):850-60.
- Podany AT. Ethical considerations in pediatric research. In: Buck ML, Manasco KB, eds. PedSAP 2017 Book 1 Research and Study Design in Pediatrics. Lenexa, KS: American College of Clinical Pharmacy; 2015.