Web Resources on Research Ethics

U.S.A. Code of Federal Regulations, Title 45 Public Welfare and Human Services, part 46 (45 CFR 46) - These regulations are derived from the ethical principles discussed in the Belmont Report. Here you will find definitions of research and human subject, and regulations regarding (i) IRB membership, functions, review of research, and (ii) requirements for informed consent.

ohrp.osophs.dhhs.gov/humansubjects/guidance/45cfr46.htm

U.S.A. Code of Federal Regulations, Title 21 Food and Drugs, part 50: Protection of Human Subjects (21 CFR 50) - These regulations apply to clinical investigations regulated by the U.S. Food and Drug Administration and regard informed consent.

www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=50&showFR=1

U.S.A. Code of Federal Regulations, Title 21 Food and Drugs, part 56 (21 CFR 56) - These regulations apply to clinical investigations regulated by the U.S. Food and Drug Administration and regard Institutional Review Boards.

www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=56&showFR=1

U.S.A. Code of Federal Regulations, Title 21 Food and Drugs, part 312 (21 CFR312) - These regulations apply to clinical investigations regulated by the U.S. Food and Drug Administration and regard Investigational new drugs and the investigational use of FDA approved drugs.

www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=312&showFR=1

Canadian Tri-Council Policy - This Tri-Council Policy statement describes standards and procedures for governing research involving human subjects." This document includes an ethics framework, discussion of IRB review of research, informed consent, privacy and confidentiality, conflict of interest, research involving aboriginal peoples, clinical trials, human genetic research, research involving human gametes, embryos or fetuses, and human tissue. (You can choose to read this site and the guidelines there in English or French.)

pre.ethics.gc.ca/english/policystatement/policystatement.cfm

2016 International ethical guidelines for health-related research involving humans

"CIOMS is an international, non-governmental, non-profit-making organization established jointly by WHO and UNESCO in 1949. A main objective of CIOMS is to facilitate and promote international activities in the field of biomedical sciences."

https://cioms.ch/publications/product/international-ethical-guidelines-for-health-related-research-involving-humans/

International Conference on Harmonization (ICH) General Considerations for Clinical Trials - A product of the regulatory authorities of Europe, Japan, and the United States, this document is intended among other things to: "describe internationally accepted principles and practices in the conduct of both individual clinical trials and overall development strategy for new medicinal products." Topics discussed include the protection of clinical trial subjects and scientific approach in design and analysis.

www.fda.gov/cber/ich/ichguid.htm

Indian Council of Medical Research Ethical Guidelines for Biomedical Research on Human Subjects - Written in 2000 the Central Ethics Committee on Human Research of the Indian Council of Medical Research, this document presents (a) a statement of ethical principles and (b) guidelines for the following: (i) Clinical evaluation of drugs/devices/diagnostics/vaccines/herbal remedies, (ii) epidemiological research, (iii) human genetics research, (iv) transplantation research, including fetal tissue transplantation, (v) assisted reproductive technologies.

icmr.nic.in/ethical.pdf

Other Ethics of Research with Human Subjects Documents

The Nuremberg Code - Written in 1947 as part of the judgment issued at the conclusion of the Nazi doctors trial at the end of World War II, this ten-point code is one of the earliest formalized research ethics codes and is an attempt to formulate universal standards for research with human subjects.

www.med.umich.edu/irbmed/ethics/Nuremberg/NurembergCode.html

HIV Prevention Trials Network (HPTN) Ethical Guidance for Research - A draft of this document is now available for review and comment; at this time the document is intended for discussion purposes only. "The document is presented in 5 parts. The first part provides a brief overview of the HPTN and the ethical framework for the document; the second part provides a summary of each of the guidance points in a tabular format for easy reference; the third part outlines the mechanism of translating each guidance point into action; and the fourth part provides specifications and justifications for the guidance points. The fifth part provides background information on the ethical challenges that led to the development of this guidance and the ethical debates surrounding these challenges." "The document is built on HPTN aspirations and synthesizes best practices and accepted standards for the conduct of ethical research."

www.hptn.org/ResearchEthics/HPTN_Ethics_Guidance.htm

UNAIDS guidance document Ethical considerations in HIV preventive vaccine research - This document, containing 18 guidance points, "highlights, from UNAIDS' perspective, some of the critical elements that must be considered in HIV vaccine development activities… It is hope that this document will be of use to potential research participants, investigators, community members, government representatives, pharmaceutical companies, and ethical and scientific review committees involved in HIV preventive vaccine development. It suggests standards, as well as processes for arriving at standards…"

www.unaids.org/publications/documents/care/index.html

American Association of Medical Colleges (AAMC)*

http://www.aamc.org/research/dbr/compliance/models.htm

• • Sample ethical research policies and procedures from several dozen major US universities, including links to the research ethics policies of all major US funding agencies (http://www.aamc.org/research/dbr/compliance/regs.htm) and US federal oversight agencies (http://www.aamc.org/research/dbr/compliance/oversight.htm), and on-line curricula for training programs in ethical research (http://www.aamc.org/research/dbr/compliance/curricula.htm).

Declaration of Helsinki

http://www.wma.net/e/policy/pdf/17c.pdf

Food and Drug Administration (United States)

http://www.fda.gov/oc/gcp/default.htm

• • Includes complete requirements and guidelines for Good Clinical Practice in FDA-regulated clinical trials

Health Care Ethics Committee Forum (HEC Forum)

http://www.kluweronline.com/issn/0956-2737

• • “HEC Forum is an international, peer-reviewed publication featuring original contributions of interest to practicing physicians, nurses, social workers, risk managers, attorneys, ethicists, and other HEC committee members.” A lot of very useful subject related titles.

Indian Council of Medical Research

http://www.icmr.nic.in/ethical.pdf

• • This site contains the Council’s “Ethical Guidelines for Biomedical Research on Human Subjects, 2000,” including specific principles for clinical trials, epidemiological studies, genetic research, transplantation research, and assisted reproductive technologies.

National Institutes of Health*

http://www.nih.gov/sigs/bioethics/

• • A large collection of official resources on ethics from the US National Institutes of Health, with the emphasis on research ethics, not publication ethics. Examples include

    • • detailed guidelines for Institutional Review Boards, ethical principles in human research (http://ohsr.od.nih.gov/guidelines.php3),

      • an on-line tutorial on the protection of human subjects

      • (http://ohsr.od.nih.gov/cbt/nonNIHpeople.html),

      • other on-line educational materials

      • (http://ohrp.osophs.dhhs.gov/educmat.htm),

      • a collection of web resources on conflict of interest

      • (http://www.nih.gov/sigs/bioethics/conflict.html),

      • a collection of web resources on international ethics in developing countries

      • (http://www.nih.gov/sigs/bioethics/internationalresthics.html).

Public Responsibility in Medicine & Research (PRIM&R)

http://www.primr.org/

• • An extensive site focussing primarily on medical research ethics, including the operation of institutional review boards (IRBs) and institutional animal care and use committees (IACUCs); educating for the responsible conduct of research; and scientific integrity and conflicts of interest.

University of Pittsburgh

http://www.edc.gsph.pitt.edu/survival/

• • This site is a store house of information. It provides information on the workshops conducted to teach survival skills to professionals. These include those on writing skills, ethics, conducting research, etc.

  • The resources page has a bibliography of resources that include those on doing research, oral communication, ethics of conducting research in developing countries, responsible scientific conduct, teaching and writing.

United States Federal Regulations

• • Regulations regarding human subjects protection contained in Title 45 of the Code of Federal Regulations, Chapter 46 (45 CFR 46) accessible at: http://www.access.gpo.gov/cgi-bin/cfrassemble.cgi?title=199845 using the search term "46." This is an excellent resource when you need to know the content of a specific US Federal Regulation.

World Medical Association (WMA)

http://www.wma.net/e/policy/17-c_e.html

• • The Declaration of Helsinki, plus basic and ethical principles for medical research.