APA Code of Ethics for Research
The Belmont Report
The report provides the philosophical underpinnings for current federal laws governing research involving human subjects. The NIH embraces The Belmont Report and holds investigators responsible for conducting their research activities in keeping with its principles and guidelines. The Belmont Report establishes three fundamental ethical principles that are relevant to all research involving human subjects: respect for persons, beneficence, and justice.
Code of Federal Regulations: Federal Policy for the Protection of Human Subjects
Title 45 CFR Part 46 is not a set of rules that can be applied rigidly to make determinations of whether a proposed research activity is ethically “right” or “wrong.” Rather, these regulations provide a framework in which investigators and others can ensure that serious efforts have been made to protect the rights and welfare of research subjects.
Computer Based NIH Training for Investigators
Beginning on October 1, 2000, the NIH will require education on the protection of human research participants for all investigators submitting NIH applications for grants or proposals, for contracts, or receiving new or non-competing awards for research involving human subjects.
Human Participant Protections Training for Research Teams
A free, Web-based course developed at the National Institutes of Health for physicians, nurses, and other members of clinical research teams. This online course satisfies the NIH human subjects training requirement for extramural researchers obtaining Federal funds.
Handing Research Misconduct
This web resource provides an overview of the process established by the Public Health Service (PHS) for responding to allegations of research misconduct in biomedical and behavioral research or research training supported by the PHS. Factors such as the scope of the misconduct, the length of time the misconduct went undetected, the prestige of the individuals or institutions involved, the possible impact on public health or clinical treatment, retaliation against the complainant or other mishandling of the allegation, as well as the extent of media coverage can all play a role in the impact that a particular case may have on individual researchers or their institutions.
With the aim of helping individuals and groups explore the vast array of issues in bioethics, the information accessible through this portal spans a wide range of topics, including human subjects and animal research, institutional review boards (IRBs; also known as research ethics committees), clinical ethics, international research ethics issues, genetics, and neuroethics, among others.
Creating Consent Forms – Readability Resources & Tutorials
Program for Readability in Science & Medicine (PRISM). Plain language web tutorial for creating consent forms
Examples of Improved Readability. Before and after “snapshots” of plain language revisions to original text taken from actual participant materials
Examples of Improved Formating. Techniques for improving readability through formatting changes are illustrated with three before and after examples: an advance letter, a consent form, and a study information sheet. While the focus is on improved formatting, all three examples also illustrate other plain language techniques.
Repository of Readability Resources and References . A clearinghouse of web-based resources focused on health literacy, readability, plain language, and informed consent, plus a short bibliography of articles related to literacy and readability in health research.
The PRISM Readability Toolkit. A free, 81-page plain language handbook for researchers illustrating why health literacy is important and how to improve the readability of consent forms and other participant materials.
NIH Bioethics Links
The HIPAA Privacy Rule and Research
This Web site has been developed to provide the research community with information about the HIPAA Privacy Rule and how it might affect research.
Human Subject Regulations Decision Tree
This link will help you to determine if your research requires review by the IRB based on principles contained in Title 45 CFR Part 46. The Office for Protection from Research Risks (OPRR) provides the associated graphic aids to clarify portions of the Department of Health and Human Services (DHHS) human subject regulations at Title 45 Code of Federal Regulations Part 46 (45 CFR 46).
This guidebook for IRBs was first produced in the 1980s by Public Responsibility in Medicine and Research (PRIM&R), a Boston-based, nonprofit organization that sponsors annual conferences on topics related to the protection of human subjects. The current second edition was prepared by the Poynter Center for the Study of Ethics and American Institutions, an independent ethics center at Indiana University, in consultation with the Office for Protection from Research Risks and its numerous advisors.
National Institutes of Health Ethics Program: Conflict of Interest
A “Conflict of Interest” arises when an employee is involved in a particular matter as part of his/her official duties with an outside organization with which he/she also has a financial interest, or one which is imputed to him/her… more
Protecting Personal Health Information in Research: Understanding the HIPAA Privacy Rule
On this page, you can download a booklet that contains information about the “Privacy Rule,” a Federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that protects certain health information. The Privacy Rule was issued to protect the privacy of health information that identifies individuals who are living or deceased. The rule balances an individual’s interest in keeping his or her health information confidential with other social benefits, including health care research. This booklet provides researchers with a basic understanding of the Privacy Rule and how it may affect health research. It also addresses how researchers may be directly or indirectly affected by the rule when their research requires the use of, or access to, an individual’s identifiable health information.
US Department of Health and Human Services Office for Protection of Human Subjects
The Office for Human Research Protections (OHRP) provides leadership and oversight on all matters related to the protection of human subjects participating in research conducted or supported by the U.S. Department of Health and Human Services (HHS). OHRP helps ensure that such research is carried out in accordance with the highest ethical standards and in an environment where all who are involved in the conduct or oversight of human subjects research understand their primary responsibility for protecting the rights, welfare, and well-being of subjects.