Informed consent guidance document

Except in certain situations, no investigator may involve a human being as a subject in research covered by the Federal Regulations until the following criteria are met:

1. The investigator has obtained the legally effective informed consent of the subject or the subject's legally authorized representative.
2. 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.
3. The information that is given to the subject or the representative shall be in language understandable to the subject or the representative.
4. The information that is given to the subject or the representative shall be in language understandable to the subject or the representative.
5. 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 rights, or releases or appears to release the investigator, the sponsor, the institution, or its agents from liability for negligence.

6. In addition, for federally funded research studies:

   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 rights, or releases or appears to release the investigator, the sponsor, the institution, or its agents from liability for negligence.

7. The prospective subject or the legally authorized representative must be provided with the information that a reasonable person would want to have in order to make an informed decision about whether to participate, and an opportunity to discuss that information.
8. Informed consent must begin with a concise and focused presentation of the key information that is most likely to assist a prospective subject or legally authorized representative in understanding the reasons why one might or might not want to participate in the research. This part of the informed consent must be organized and presented in a way that facilitates comprehension.
9. Informed consent as a whole must present information in sufficient detail relating to the research, and must be organized and presented in a way that does not merely provide lists of isolated facts, but rather facilitates the prospective subject's or legally authorized representative's understanding of the reasons why one might or might not want to participate.

The following information about the study must be provided to research subjects when obtaining informed consent:

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;
2. A description of any reasonably foreseeable risks or discomforts to the subject;
3. A description of any benefits to the subject or to others which may reasonably be expected from the research;
4. A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;
5. A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained, and when applicable, that notes the possibility that the Food and Drug Administration may inspect the records;
6. A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained, and when applicable, that notes the possibility that the Food and Drug Administration may inspect the records;
7. 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;
8. 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; and
9. 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.
10. In addition, for federally funded studies:

    One of the following statements about any research that involves the collection of identifiable private information or identifiable biospecimens is present:

    • 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.

When appropriate, the following information must be provided to each subject:

• 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) which are currently unforeseeable;
• Anticipated circumstances under which the subject’s participation may be terminated by the investigator without regard to the subject’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 which 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.

In addition, for federally funded studies, the following information must be provided to each subject as appropriate:

• 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.
• A statement regarding whether clinically relevant research results, including individual research results, will be disclosed to subjects, and if so, under what conditions.
• 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).

For FDA-regulated studies, the following statement must appear in the consent form verbatim: A description of this clinical trial will be available on Clinical Trials 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.

HCA-HealthONE Local IRB Informed Consent Requirements

• All informed consent documents should be placed on the Investigator’s letterhead.
• The use of footers for version dates of the informed consent should be used.
• Page numbers should reflect X of Y format
• The appropriate HCA-HealthONE IRB reference should be used (IRB Administrative Office, (303) 584-2300).
• Informed consent documents are not considered valid without a current IRB approval stamp.
• For studies that will utilize a HealthONE facility or services:
  • A barcode (3 of 9 font) with the formula *RSHCN* must be placed in the lower left hand corner (footer) of the first page of the document.
  • The NCT # for all applicable clinical trials or N/A must be visible on the first page.

Changes to IRB Approved Informed Consent Documents

There are often circumstances throughout the life of a study which require revisions to the informed consent document. Any revisions to the IRB approved informed consent must be submitted to the HCA-HealthONE IRB through IRBNet along with the Amendment/Modifications Application. A copy of the informed consent showing track changes, as well as a clean copy of the revised informed consent is required in order to obtain approval of the revised informed consent document. Any revisions made to the informed consent document must be approved by the IRB prior to implementation or use.

Informed Consent Template

A sample Informed Consent Template can be accessed from on the IRB’s webpage. This template is meant to assist you with incorporating the required elements and suggested wording. It is the Principal Investigator’s responsibility to insure that all specific information regarding the PI, study site, protocol, disease, etc. are incorporated into the content of the informed consent that is submitted to the IRB. If you are using a sponsor generated informed consent template, please be sure to remove wording that are meant to be site staff instructions, i.e. [Place institution name here], and ensure that all local IRB informed consent requirements have been added.

Guidelines when writing a consent form:

• Use simple language.
• Be concise.
• Use the pronoun “you” consistently throughout (except for the “Signature of Research Subject” on the last page).
• If subjects must be patients with a specific disease/condition, and if they must have tried standard treatments without good results, say so in clear terms. For example: You qualify to participate in this project because you have breast cancer that has not responded well to standard treatment (or that has recurred, in spite of standard treatment).