Before you prepare your consent document, please review the information below and carefully review the Consent Requirements, Consent Templates, and other helpful resources.
The ethical principle of respect for persons requires that subjects be given the opportunity to choose what shall and shall not happen to them. Valid informed consent requires:
- That consent must be Prospectively Obtained from the subject or the legally authorized representative of the subject;
- The information must be Conveyed in Understandable Language and Subject Comprehension is attained;
- Disclosure of relevant information to prospective subjects about the research;
- Voluntary Agreement , free of coercion and undue influence, obtained from the prospective research participation prior to participation; and,
- Subjects must not be made to give up legal rights or be given the impression that they are being asked to do so
Informed Consent is a process not just a form. Ideally, informed decision-making is a process that includes discussion between the prospective participant and the Principal Investigator (PI) or research assistants as appropriate, and obtaining a signature on the written informed consent document. Depending on the nature, type and duration of the research, ongoing discussion and education of subjects about the study may continue long after the informed consent document is signed.
Except as provided elsewhere in this policy, no investigator may involve a human being as a subject in research covered by this policy unless the investigator has obtained the legally effective informed consent of the subject or the subject’s legally authorized representative. An investigator shall seek such consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence. The information that is given to the subject or the representative shall be in language understandable to the subject or the representative. No informed consent, whether oral or written, may include any exculpatory language through which the subject or the representative is made to waive or appear to waive any of the subject’s legal rights, or releases or appears to release the investigator, the sponsor, the institution or its agents from liability for negligence.
The following items are required elements:
- NEW: A summary of key information about the study that explains to the person how to think about the provided information in terms of making a decision. It should be presented in a concise and focused manner and must be provided at the beginning of the consent form.
- 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 that 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, and whom to contact in the event of a research-related injury to the subject;
- 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;
- NEW: One of the following statements about any research that involves the collection of identifiable private information or identifiable biospecimens:
- A statement that identifiers might be removed from the identifiable private information or identifiable biospecimens and that, after such removal, the information or biospecimens could be used for future research studies or distributed to another investigator for future research studies without additional informed consent from the subject or the legally authorized representative, if this might be a possibility; or
- A statement that the subject’s information or biospecimens collected as part of the research, even if identifiers are removed, will not be used or distributed for future research studies..
The following additional items are to be included when appropriate:
- A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) that are currently unforeseeable;
- Anticipated circumstances under which the subject’s participation may be terminated by the investigator without regard to the subject’s or the legally authorized representative’s consent;
- Any additional costs to the subject that may result from participation in the research;
- The consequences of a subject’s decision to withdraw from the research and procedures for orderly termination of participation by the subject;
- A statement that significant new findings developed during the course of the research that may relate to the subject’s willingness to continue participation will be provided to the subject;
- The approximate number of subjects involved in the study;
- NEW: A statement that the subject’s biospecimens (even if identifiers are removed) may be used for commercial profit and whether the subject will or will not share in this commercial profit;
- NEW: A statement regarding whether clinically relevant research results, including individual research results, will be disclosed to subjects, and if so, under what conditions;
- NEW: For research involving biospecimens, whether the research will (if known) or might include whole genome sequencing (i.e., sequencing of a human germline or somatic specimen with the intent to generate the genome or exome sequence of that specimen).
Informed Consent Templates
Protocols that are submitted to the FIU IRB are required to utilize the FIU Informed Consent Templates. Clinical trials being submitted to WIRB are required to use the WIRB Informed Consent Template. The templates are revised frequently, so please visit the IRB website prior to submitting any protocols to verify that you are using the latest template. Any new information regarding protocols must be submitted on the latest form released by the IRB.
Informed Consent Translations
Protocols that involve non-English participants will need to have the Consent Form(s) translated into the native language under one of the following two translation methods:
If utilizing the Informed Consent Translation Affirmation Form, there will be a total of two translators involved in the translation process. The first translator will convert the English version into the non-English language (e.g., Spanish, Kreyòl, etc.). The second translator will then take that non-English translated version and then back-translate it into English (without seeing the original English version). The back-translator cannot be affiliated with the research protocol. Both translators are required to sign the affirmation form.
Retention of Informed Consent Forms
Investigators are required by HHS regulations to keep signed informed consent forms for at least 3 years after the completion of the study. Investigators are required to keep signed HIPAA Authorization Forms for at least 6 years from the date of creation or the date when it last was in effect, whichever is later.
Posting of Clinical Trial Consent Forms
Effective January 21, 2019: For each federally funded clinical trial, one IRB-approved informed consent form used to enroll subjects must be posted to ClinicalTrials.gov or to a docket folder on Regulations.gov (docket ID: HHS-OPHS-2018-0021). The informed consent form must be posted 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.