#PROTECTING HUMAN RESEARCH PARTICIPANTS ARCHIVE#

The Human Subjects Research Infographic provides a quick overview of NIH policy. The Office of Extramural Research website provides up-to-date information and guidance on human subjects policies and regulations. More information about NIH policies is available in the Human Subjects section of the NIH Grants Policy Statement. This process of informed consent (or assent, if someone else gives permission for an individual to participate, such as for a child) assumes that the potential risks and benefits of research are balanced and that no coercion is involved in a person’s decision to participate in the study.Īll applications to NIH for research involving human subjects or additions to existing awards must include a Protection of Human Subjects section according to instructions for NIH applications. Human subjects protections are designed to give potential participants the information they need when deciding whether to participate in clinical research. In general, human subjects in NIH-funded clinical research, whether healthy volunteers or patient volunteers, are protected under the Federal Policy for the Protection of Human Subjects at 45 CFR 46, also called the Common Rule. Department of Health and Human Services (HHS) issues regulations and guidelines governing HHS-supported human subjects research. To ensure that human subject participation is voluntary and does not pose undue risk, the U.S. When reporting experiments on animals, authors should indicate whether institutional and national standards for the care and use of laboratory animals were followed.Clinical research may involve risk to participants. When informed consent has been obtained, it should be indicated in the published article. The requirement for informed consent should be included in the journal’s instructions for authors. If identifying characteristics are deidentified, authors should provide assurance, and editors should so note, that such changes do not distort scientific meaning. For example, masking the eye region in photographs of patients is inadequate protection of anonymity. Informed consent should be obtained if there is any doubt that anonymity can be maintained.

Nonessential identifying details should be omitted.

#PROTECTING HUMAN RESEARCH PARTICIPANTS ARCHIVE#

Since a journal that archives the consent will be aware of patient identity, some journals may decide that patient confidentiality is better guarded by having the author archive the consent and instead providing the journal with a written statement that attests that they have received and archived written patient consent. Applicable laws vary from locale to locale, and journals should establish their own policies with legal guidance. Patient consent should be written and archived with the journal, the authors, or both, as dictated by local regulations or laws. Authors should disclose to these patients whether any potential identifiable material might be available via the Internet as well as in print after publication.

Informed consent for this purpose requires that an identifiable patient be shown the manuscript to be published. Identifying information, including names, initials, or hospital numbers, should not be published in written descriptions, photographs, or pedigrees unless the information is essential for scientific purposes and the patient (or parent or guardian) gives written informed consent for publication. The Research Investigator has the primary responsibility for protecting the rights and welfare of human research participants and is responsible for complying with all applicable provisions of the College of Charleston’s FWA and institutional policies and procedures. Patients have a right to privacy that should not be violated without informed consent. Responsibilities of the Research Investigator. Approval by a responsible review body does not preclude editors from forming their own judgment whether the conduct of the research was appropriate. If doubt exists whether the research was conducted in accordance with the Helsinki Declaration, the authors must explain the rationale for their approach and demonstrate that the local, regional or national review body explicitly approved the doubtful aspects of the study.

All authors should seek approval to conduct research from an independent local, regional or national review body (e.g., ethics committee, institutional review board). Home Recommendations Browse Roles & Responsibilities Protection of Research ParticipantsĪll investigators should ensure that the planning, conduct, and reporting of human research are in accordance with the Helsinki Declaration as revised in 2013.

Protecting human research participants