Regulatory Requirements | ICFs

By regulation, the informed consent form (ICF) must contain certain basic information and may contain additional elements if they apply. If broad consent will be obtained, additional information and optional elements, if they apply, must also be included. Investigators should check the ICF to make sure that each required element and any applicable additional element has been included. Additional elements should only be included when they provide information that could impact a potential subject’s decision to participate.

If the document will combine consent and written authorization, then it must also contain all the required elements of a valid HIPAA Authorization in addition to the requirements for consent.

Concise Summary

The Common Rule requires the informed consent form to be focused and understandable 45 CFR 46.166(a)(4). To accomplish this, there is now a requirement that a concise summary explaining the research precede the body of the consent form. For examples of concise summaries, see Template Concise Summary Document.

Basic and Additional Elements of Consent

The Common Rule requirements for the elements of consent are enumerated in 45 CFR 46.116(b) and (c). The FDA's consent regulations can be found in 21 CFR 50.25. All of the basic elements of consent (below) except #6, must be in all consent forms, unless a waiver of one or more of the elements has been approved by the IRB. When appropriate, one or more of the additional elements of consent shall also be provided to each subject.

45 CFR 46.116 and 21 CFR 50.25

(a) Basic Elements of Informed Consent (Element Added with the 2018 Common Rule)
Invitation to Participate, Purpose of Research, and Procedures (1) 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;
Risks (2) A description of any reasonably foreseeable risks or discomforts to the subject;
Benefits (3) A description of any benefits to the subject or to others which may reasonably be expected from the research;
Alternatives (4) A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;
Privacy & Confidentiality (5) A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained;
Injury Compensation (6) 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;
Contact Information (7) 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;
Subject Rights (8) 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; and
Future Use of Data or Specimens (9) One of the following statements about any research that involves the collection of identifiable private information or identifiable biospecimens:
(i) 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
(ii) 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.
Requirement for FDA-regulated clinical trials (10) The following statement must be included: "A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time."
(b) Additional Elements of Informed Consent (Elements Added with the 2018 Common Rule)
Pregnancy (1) 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;
Discontinuation from Research (2) Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's or legally authorized representative’s consent;
Costs (3) Any additional costs to the subject that may result from participation in the research;
Consequences of Withdrawal (4) The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject;
New Findings (5) A statement that significant new findings developed during the course of the research which may relate to the subject's willingness to continue participation will be provided to the subject;
Number of Participants (6) The approximate number of subjects involved in the study;
Commercial Profit Use (7) 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;
Return of Clinically Relevant Results (8) A statement regarding whether clinically relevant research results, including individual research results, will be disclosed to subjects, and if so, under what conditions; and
Genetic Testing or Sequencing (9) 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).

Elements of Broad Consent

The Common Rule requirements for the elements of broad consent are enumerated in 45 CFR 46.116(d). Broad consent is a new concept, introduced with the 2018 revisions to the Common Rule. Broad consent is consent for the storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens (collected for either research studies other than the proposed research or non-research purposes). Broad consent is permitted as an alternative to the basic consent requirements (as outlined above).

Please note that CHOP is not implementing broad consent institution-wide. The information outlined below would only be relevant for an investigator who is implementing broad consent within a specific research study. The elements of broad consent are not included in the main consent form template.

(c) Elements of Broad Consent
Elements of Consent required for Both Consent and Broad Consent (1) Required elements of consent (2), (3), (5) and (8) and optional elements of consent (7) and (9) as outlined above;
Types of Research (2) A general description of the types of research that may be conducted with the identifiable private information or identifiable biospecimens. This description must include sufficient information such that a reasonable person would expect that the broad consent would permit the types of research conducted;
Information and Specimens that May be Used (3) A description of the identifiable private information or identifiable biospecimens that might be used in research, whether sharing of identifiable private information or identifiable biospecimens might occur, and the types of institutions or researchers that might conduct research with the identifiable private information or identifiable biospecimens;
Duration of Storage, Maintenance and Use (4) A description of the period of time that the identifiable private information or identifiable biospecimens may be stored and maintained (which period of time could be indefinite), and a description of the period of time that the identifiable private information or identifiable biospecimens may be used for research purposes (which period of time could be indefinite);
Information about Future Research Studies (5) Unless the subject or legally authorized representative will be provided details about specific research studies, a statement that they will not be informed of the details of any specific research studies that might be conducted using the subject's identifiable private information or identifiable biospecimens, including the purposes of the research, and that they might have chosen not to consent to some of those specific research studies;
Research Results (6) Unless it is known that clinically relevant research results, including individual research results, will be disclosed to the subject in all circumstances, a statement that such results may not be disclosed to the subject; and
Contact Information (7) An explanation of whom to contact for answers to questions about the subject's rights and about storage and use of the subject's identifiable private information or identifiable biospecimens, and whom to contact in the event of a research-related harm.

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