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Informed Consent
Based on the governing principles of human research outlined in "The Belmont Report," investigators have key responsibility for ensuring voluntary participation of research subjects. The recruitment plan and consent process must be carefully designed so that participants’ consent will be well-informed and freely given.
Potential participants (or his/her legally authorized representative) should be able to understand as completely as possible what procedures, risks, benefits, alternatives and rights are involved, and make the choice about being in the study without pressure or undue inducement to participate. Free and informed consent is not one-time event, but an ongoing process.
With few exceptions, researchers must obtain and document consent from the prospective research participants before initiating any screening or study procedures. Any exceptions must be reviewed and approved by the IRB beforehand. Only the IRB-approved, stamped consent document should be used to enroll participants.
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Consent Process
Consent for participation in research requires an informed consent process. This process involves an information exchange and on-going communication that takes place between the investigator (researcher) and the potential research participant (subject).
The consent process starts with the initial presentation of a research activity to a prospective subjective (including advertisements), continues with a discussion and information exchange between the researcher and the prospective subject, and requires documenting that consent was obtained. The process may also be ongoing through the research activity until the participant decides to end his or her participation or until the study closes.
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Federal Requirements and Elements of Consent
OHRP and the FDA enforce federal regulations covering informed consent in research involving human subjects — 45 CFR 46, Section 46.116-117 and 21 CFR 50, respectively. These regulations are applied to all human research at ETSU.
45 CFR 46.116 describes general requirements for informed consent.
Requirements of Consent: The regulations stipulate what basic required elements of informed consent and additional elements that may be added to a consent form when appropriate. The Consent Form Checklist describes the elements of informed consent and local consent requirements. The ETSU consent form templates satisfy federal and institutional consent requirements.
The consent form is one part of the entire consent process. The consent document serves as a written summary of the information that was presented and is a useful reference for the subject and the investigator.
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Requirement to Publicly Post Consent Forms for Federally-Funded Clinical Trials
In January 2019, the Federal Policy for the Protection of Human Research Subjects (aka The Common Rule) was updated for the first time since 1991. One of the updates to this policy includes the requirement to publicly post clinical trial consent forms (Refer to 46.116(h)).
What studies are affected?
Clinical trials initiated on or after January 21, 2019 that are federally conducted or funded by a Federal department or agency are required to comply with this requirement. Recipients of federal funding subject to the Common Rule and conducting a clinical trial as defined in 45 CFR 46.102(b) must submit one version of an IRB-approved consent form that was used to enroll participants in accordance with Section 46.116(h) after the clinical trial is closed to recruitment, and no later than 60 days after the last study visit by any subject, as required by the protocol.
Please note, if multiple consent forms were used for different participant groups, you are only required to upload one form, but may opt to upload multiple forms.
For studies that are registered on ClinicalTrials.gov, researchers may upload consent forms within their existing ClinicalTrials.gov study record. ClinicalTrials.gov only accepts English language consent forms however, so for studies that do not use English language forms, or are not required to register at ClinicalTrials.gov, consents must be submitted through the comment portal at Regulations.gov. For instructions on how to submit please see HHS.gov. NIH recipients submitting informed consent forms to Regulations.gov should maintain a copy of their Regulations.gov receipt and tracking number.
Resources
To learn more about this requirement please review NIH guidance.
Questions regarding applicability of this requirement may be directed to IRB@etsu.edu.