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VIII. INFORMED CONSENT

8.1 General Information

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.

8.2 Basic Elements of Informed Consent.

To document informed consent, unless otherwise specified in the following section, the IRB requires a human subject's (and/or a human subject's parent or legal guardian) signature (s) on an informed consent form approved by the IRB for use in connection with that research project:

  • Purpose: The consent form should include a statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, and the approximate number or human subjects involved in the research.
  • Procedures: The consent form should provide a step-by-step detailed description of the procedures to be followed and identification of any procedures that are experimental (including experimental use of an approved drug, biologic or device)
  • Risks: The consent form should include a detailed description of any reasonably foreseeable risks or discomforts to the subject;
  • Benefits: The consent form should describe any benefits to the subject or to others which may reasonably be expected from the research;
  • Treatment Alternatives: The consent form should disclose appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;

Confidentiality: The consent form should include a statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained. To further protect a subject's confidentiality, subjects will be required to sign or refuse to sign an Authorization Form.

  • Costs: For research involving more than minimal risk, the consent form should explain 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. The consent forms should also specify any additional costs that may result from participating in the research study;
  • Contacts: The consent form should include 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
  • Participation is Voluntary: The consent form should include 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.
  • Additional Risks: The consent form should include 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;
  • Termination: The consent form should include a statement that explains anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent;
  • Procedures for Withdrawal: The consent forms should specify the consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject;
  • New Information: The consent form should include 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.
  • Bill of rights for Patients: Patients should be given a copy of his/her bill of rights as patients.
  • Consent/Assent Statement: The consent form should include a statement that all elements of the research have been explained to the subject, that the subject has had an opportunity to ask questions, and that the subject will receive a copy of the consent form.
  • Signatures and Dates: The consent form must be signed and dated by the subject (or the subject's parent or guardian and the investigator (or the investigator's representative who has explained the research to the subject.) It is recommended that the form also be signed by a witness. (45 CFR 46.116)

8.3 Additional Elements of Informed Consent

When appropriate, one or more of the following elements of informed consent shall be provided to each human subject:

  • Number of Participants: Where appropriate, a subject should be informed about the approximate number of subjects involved in a study.
  • Biological Materials Banking/ Genetic Research: For research in which biological materials (i.e. blood, tissue, etc.) are to be analyzed and /or stored for future research, the consent form must comply with the guidelines for human cell repositories.

Conflicts of Interest/Financial Interest: The consent form must specify any interest held by the Principal Investigator and/or staff which might be considered as creating a conflict of interest relating to the research and/or its outcomes.

8.4 Non-Preemption of Federal, State, or Local Law

The informed consent requirements in this policy are not intended to preempt any applicable Federal, State, or local laws which require additional information to be disclosed in order for informed consent to be legally effective. Nothing in these policies is intended to limit the authority of a physician to provide emergency medical care, to the extent the physician is permitted to do so under applicable Federal, State, or local law.

8.5 Exculpatory Language

No informed consent, whether oral or written, may include any exculpatory language through which the subject 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. 45 CFR 46.116; 21 CFR 50.20)

8.6 FDA Exception to Requirements for Informed Consent

Under normal circumstances, obtaining informed consent is deemed feasible unless, before use of the test article (except as provided in paragraph (2) of this section), both the investigator and a physician who is not otherwise participating in the research verify in writing all of the following;

  • The human subject is confronted with a life-threatening situation necessitating the use of the test article.
  • Informed consent cannot be obtained from the human subject because of an inability to communicate with, or obtain legally effective informed consent from the human subject.
  • Time is not sufficient to obtain informed consent from the human subject's legal representative.

8.7 Emergency Use (Informed Consent)

If immediate use of the test article is, in the investigator's opinion, required to preserve the life of the human subject, and time is not sufficient to obtain the independent determination required in paragraph (1) of this section in advance of using the test article, the determination of the clinical investigator shall be made, and within five working days after the use of the article, be reviewed and evaluated by a physician who is not participating in the test article.

8.8 Submission to the Board

The documentation required by this section shall be submitted to the Board within five working days after the use of the test article.

8.9 Documentation of Written (Physical Documentation of Informed Consent)

Informed consent shall be documented by the use of a written consent form approved by the IRB and signed by the subject or the subject's legally authorized representative. A copy shall be given to the person signing the form. The consent form may be either of the following:

(a) A written consent document that embodies the elements of informed consent required by 45 CRF 46.116. This form may be read to the subject or the subject's legally authorized representative, but in any event, the investigator shall give either the subject or the representative adequate opportunity to read it before it is signed; or

(b) A short form written consent document stating that the elements of informed consent required by 45 CFR 46.116 have been presented orally to the subject or the subject's legally authorized representative. When this method is used, there shall be a witness to the oral presentation. Also, the IRB shall approve a written summary of what is to be said to the subject or the representative. Only the short form itself is to be signed by the subject or the representative. However, the witness shall sign both the short form and a copy of the summary, and the person actually obtaining consent shall sign a copy of the summary. A copy of the summary shall be given to the subject or the representative, in addition to a copy of the short form.

8.10 Waivers or Alterations to Approved Informed Consent Requirements

An IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent set forth above, or waive the requirement to obtain informed consent provided the IRB finds and documents that:

  • the research involves no more than minimal risk to the subjects;
  • the waiver or alteration will not adversely affect the rights and welfare of the subjects;
  • the research could not practicably be carried out without the waiver or alteration; and
  • whenever appropriate, the subjects will be provided with additional pertinent information after participation.

Nothing in this policy is intended to limit the authority of a physician to provide emergency medical care, to the extent the physician is permitted to do so under applicable Federal, State, or local law.

8.11 Surrogate Consent

Department of Health and Human Services (HHS) regulations for the protection of human subjects at 45 CFR 46.116 stipulate that no investigator may involve a human being in research covered by the HHS regulations unless the investigator has obtained the legally effective informed consent of the subject or the subject's legally authorized representative. HHS regulations at 45 CFR 46.102(c) define legally authorized representative as an individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject's participation in the procedure(s) involved in the research. The following may give consent for treating an incompetent adult:

1) a legally appointed guardian (one appointed by a court of competent jurisdiction) with plenary (full) guardianship powers or powers granted specifically for healthcare decisions;

2) A person with a Durable Power of Attorney for Health Care or;

A Willing surrogate under the Illinois Surrogate Act chosen from the list in order of priority (guardian of person, spouse, adult child, parent, adult sibling, adult grandchild, close friend, guardian of estate.) (Powers of Attorney for Health Care 755 ILCS 45/4-1; Health Care Surrogate Act 755 ILCS 40) (Web link)

8.11.1 Assent

Regardless of their legal incapacity to consent to participate in research, prospective subjects must be offered the right to assent and object to participating in the research with their assent being documented in accord with the level of comprehension maintained by the subject. Objection to participation must be honored (even against the wishes of the legally representative) unless there is clear and convincing evidence of likely therapeutic benefit

8.11.2 Research in Which Surrogate Consent is allowed:

A legal surrogate may consent on behalf of an incompetent adult subject:

  • Where the subject may benefit by participation in the research, the scientific information supporting the possibility of the therapeutic benefit is convincing and the method of gaining consent from a surrogate is acceptable and adequate to protect the subject rights;
  • Where the subject may benefit by participation in the research, the scientific information supporting the possibility of therapeutic benefit is convincing and the protocol has been approved for emergency use;
  • If the subject has a terminal condition for which all treatments and/or therapies have been tried unsuccessfully and they may be eligible for an experimental program which may or may not improve their condition; or
  • A clinical last resort to save the life of the subject in the absence of any advance directives. In any case, if there is a valid DNR or other advance directive, it will take precedence over the surrogate's decision.

8.12 Informed Consent for NON-English Speakers

Department of Health and Human Services regulations for the protection of human subjects require that informed consent information be presented "in language understandable to the subject" and, in most situations, that informed consent be documented in writing (45 CFR 46.117 and 45 CFR 46.117)).

Where informed consent is documented in accordance with 45 CFR 46.117(b) (1), the written consent document should embody, in language understandable to the subject, all the elements necessary for legally effective informed consent. Subjects who do not speak English should be presented with a consent document written in a language understandable to them.

Alternatively, 45 CFR 46.117(b)(2) permits oral presentation of informed consent information in conjunction with a short form written consent document (stating that the elements of consent have been presented orally) and a written summary of what is presented orally. A witness to the oral presentation is required, and the subject must be given copies of the short form document and the summary.

When this procedure is used with subjects who do not speak English, (i) the oral presentation and the short form written document (see sample attached - Web link) should be in a language understandable to the subject; (ii) the IRB-approved English language informed consent document may serve as the summary; and (iii) the witness should be fluent in both English and the language of the subject.

At the time of consent, (i) the short form document should be signed by the subject (or the subject's legally authorized representative); (ii) the summary (i.e., the English language informed consent document) should be signed by the person obtaining consent as authorized under the protocol; and (iii) the short form document and the summary should be signed by the witness. When the person obtaining consent is assisted by a translator, the translator may serve as the witness.

The IRB must receive all foreign language versions of the short form document as a condition of approval under the provisions of CFR 46.117(b) (2). Expedited review of these versions is acceptable if the protocol, the full English language informed consent document, and the English version of the short form document have already been approved by the convened IRB.

It is the responsibility of the IRB to determine which of the procedures at CFR 46.117(b) is appropriate for documenting informed consent in protocols that it reviews.

8.13 Witness

A competent adult should witness the process of informing the subject about the research protocol and signing of the informed consent form.

8.14 Record Keeping of Informed Consent Forms

The Principal Investigator must document in the subject's chart who explained the research and to whom. The signed informed and authorization form must be included in the subject's chart. There must also be appropriate documentation that the subject was mentally incapable of making this decision. For any compassionate use or clinical last resort use, Principal Investigator must notify the IRB within three days of administration.

8.15 Authorization Form Under Health Insurance Portability and Accountability Act of 1996 (HIPAA)

Each research subject will be required to read, understand and sign an Authorization Form as stipulated in the Health Insurance Portability and Accountability Act of 1996 (HIPAA). The Authorization form will be attached to the regular consent form. All health care researchers are required to obtain a research subjects' permission before using their Private Health Information (PHI) in clinical research. A template is available through the Web link The Authorization Form must:

  • Specify the private health information that will be used and disclosed during a clinical research study.
  • Identify the people/organizations that may use or disclose the private health information.
  • Identify the people/organizations who will receive the private health information.
  • Specify the purpose of the use or disclosure of the private health information.
  • Specify an expiration date for ceasing the use and disclosure of private health information
  • Include a statement that human subjects have the right to refuse to sign the Authorization Form. In order to maintain the integrity of a clinical study, subjects who do not sign the authorization form may be excluded from the study. A statement must be included that explains this outcome.

Include a statement that explains the right of a subject to revoke his/her authorization in writing. The name and address of the Principal Investigator must be included.