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Basic Elements of a Consent Form for Non-Exempt Research

These are the basic elements that need to be included in a consent form for Non-Exempt Research, as required by Federal Regulations.  See Informed Consent Document Sample with Tips for detailed guidance.

A. There is a new requirement that key information about the study must be provided at the beginning in addition to the basic elements #1-#9 listed below. The aim is to put the really important information in a section at the beginning of the form. This will include information about the purpose, the risks, the benefits, and alternatives, and it will explain to the person how to think about these pieces of information in terms of making a decision. It should be presented in a concise and focused manner. The Basic Elements section of the consent form will repeat the information found in the Key Elements section.

  1. A statement that the study involves research, an explanation of the purposes of the research, the expected duration of a subject's participation, a description of the procedures to be followed, and if applicable identification of any experimental procedures.
  2. A description of any forseeable risks or discomforts to the subject
  3. A description of any benefits to the subject, or society, that may reasonably be expected from the research.
  4. If appropriate, a disclosure of appropriate alternative procedures or treatments, if any, that might be advantageous to the subject.
  5. A statement describing the extent to which confidentiality of records identifying the subject will be maintained.
  6. For research involving more than minimal risk, an explanation of the compensation and medical treatments available if injury occurrs, and where further infromation may be obtained.
  7. Explanation of whom to contact for answers to pertinent questions about the research and subjects' rights, and whom to contact in the event of a research-related injury. 
  8. A statement that taking part in the study is voluntary, refusal to participate will involve no penalty or loss of benefits the subject is otherwise entitled to and the subject may discontinue participation at any time with no penalty or loss of benefits
  9. One of the following statements about any research that invovles the collection of identifiable 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.

 

In some cases you may need to provide additional elements when appropriate:

(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;

(2) 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;

(3) Any additional costs to the subject that may result from participation in the research;

(4) The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject;

(5) 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;

(6) The approximate number of subjects involved in the study;

(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;

(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

(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).

The IRB may impose additional requirements that are not specifically listed in the regulations to ensure that adequate information is presented in accordance with institutional policy and local law.

The words you use should be appropriate for the subject population so they can easily understand what you wrote, and you should explain any complex ideas or large words.

Unless otherwise requested, Exempt category research does not require a signature line. All other research categories should include a line for the subject to sign, and a line for the date.

A copy of the form MUST be given to the subject (or representative).