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Informed Consent Policy

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Informed Consent Policy
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Informed Consent Policy

Last updated: 2022-04-30

Information

For studies involving human participants, authors are responsible for including a statement that the studies have been approved by the appropriate institutional or national research ethics committee and have been performed by the ethical standards noted in the 1964 Declaration of Helsinki and its later amendments or comparable ethical standards.

For studies involving experiments on animals, authors should indicate whether the institutional and national standards for the care and use of laboratory animals were followed appropriately.

Emerging Infectious Diseases follows the ICMJE recommendations for the Protection of Research Participants and reserves the right to request that authors provide documentation from the review board or ethics committee confirming approval of the research. 

The informed consent process involves three key features: 

(1) disclosing to potential research subjects information needed to make an informed decision; 

(2) facilitating the understanding of what has been disclosed; 

(3) promoting the voluntariness of the decision about whether or not to participate in the research. Informed consent must be legally effective and prospectively obtained.

The regulations require that the following information must be conveyed to each subject:

  • a statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject’s participation, a description of the procedures to be followed, and identification of any procedures which are experimental;
  • a description of any reasonably foreseeable risks or discomforts to the subject;
  • a description of any benefits to the subject or to others that may reasonably be expected from the research;
  • a disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;
  • a statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained;
  • for research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained;
  • an explanation of whom to contact for answers to pertinent questions about the research and research subjects’ rights, whom to contact in the event of a research-related injury to the subject; and
  • a statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.

The procedures used in seeking and obtaining informed consent should be designed to communicate with the subject population in terms that they can understand. Information about a research project must be presented in such a way that enables each person to voluntarily decide whether or not to participate as a research subject. Thus, the information must be conveyed in language understandable to those being asked to participate as subjects in the research.

For most research, informed consent is documented using a written document that provides key information regarding the research. The consent form is intended, in part, to provide information for the potential subject’s current and future reference and to document the interaction between the subject and the investigator. However, even if a signed consent form is required, it alone does not constitute an adequate consent process. The informed consent process is an ongoing exchange of information between the investigator and the subject and could include, for example, the use of question-and-answer sessions, community meetings, and videotape presentations. In all circumstances, however, individuals should be provided with an opportunity to have their questions and concerns addressed on an individual basis.