Informed Consent
Informed Consent—Guidance for Investigators and Sample Consent Forms
Foremost in responsibility for the investigator is to secure informed consent from the subjects participating in a study. Clear communication is central to achieving that goal, including providing an easily understood description of the research to be conducted (geared to the level of the subject), a careful explanation of the subject’s rights, the compensation (if any) the subject will receive by participating, and contact information. When a study involves any form of deception, a processed debriefing is required.
Most informed consent is obtained in writing. There are, however, circumstances when informed consent may instead be obtained orally, based upon the nature of the study and the low risk involved through participation.
Research involving minors requires an assent by the child and accompanying parental/guardian permission; in New York and most states, the age of majority is 18, so these requirements come into play for all studies involving participants that are younger than eighteen. Note that New York state law requires licensed professionals, as well as certified teachers and administrators, to report any instances of suspected abuse (investigators working in other states should carefully research and comply with the appropriate statutory requirements, and cite those requirements in the proposal to the IRB). If Touro students or staff are working with the subjects who are children and suspect abuse they should immediately inform the investigator. Investigators conducting research with children should discuss their studies with the Chair of the IRB to arrive at the appropriate assent/permission format and content to be used prior to submission of their proposals to the IRB for review.
Research with other special populations may require additional informed consent protections. Investigators should consult the appropriate regulations and discuss the circumstance with the IRB Chair prior to submission of their proposals for review.
Requests to waive or modify basic elements of informed consent may be sought from the IRB, but generally approval is rare.
The federal requirements for, and documentation of, informed consent are detailed below. These requirements should be taken into account as you decide how to pursue informed consent while conducting your study and for preparing the informed consent material you must include as part of your proposal to the IRB. When evaluating the informed consent section of your proposal and rendering its decision, the IRB will use the federal Informed Consent guidelines among other considerations. Investigators are encouraged to consult with the Chair of the IRB or with individual members of the IRB, particularly if they are from the same academic discipline or School, for additional guidance on implementation of the informed consent requirements.
General Requirements for Informed Consent (45 CFR 46.116)
Except as provided elsewhere under federal 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.
(a) Basic elements of informed consent. Except as provided in paragraph (c) or (d) of this section, in seeking informed consent the following information shall be provided to each subject:
(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;
(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;
(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; and
(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.
(b) Additional elements of informed consent. When appropriate, one or more of the following elements of information shall also be provided to each subject:
(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) which are currently unforeseeable;
(2) Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject'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 which may relate to the subject's willingness to continue participation will be provided to the subject; and
(6) The approximate number of subjects involved in the study.
(c) 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:
(1) The research or demonstration project is to be conducted by, or is subject to, the approval of state or local government officials and is designed to study, evaluate, or otherwise examine: (i) public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs; and
(2) The research could not practicably be carried out without the waiver or alteration.
(d) 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 in this section, or waive the requirements to obtain informed consent provided the IRB finds and documents that:
(1) The research involves no more than minimal risk to the subjects;
(2) The waiver or alteration will not adversely affect the rights and welfare of the subjects;
(3) The research could not practicably be carried out without the waiver or alteration; and
(4) Whenever appropriate, the subjects will be provided with additional pertinent information after participation.
(e) 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.
(f) 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.
Documentation of Informed Consent (45 CFR 46.117)
(a) Except as provided in paragraph (c) of this section, 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.
(b) Except as provided in paragraph (c) of this section, the consent form may be either of the following:
(1) A written consent document that embodies the elements of informed consent required by §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
(2) A short form written consent document stating that the elements of informed consent required by §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.
(c) An IRB may waive the requirement for the investigator to obtain a signed consent form for some or all subjects if it finds either:
(1) That the only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject's wishes will govern; or
(2) That the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context.
In cases in which the documentation requirement is waived, the IRB may require the investigator to provide subjects with a written statement regarding the research.
Samples Consent Format/Forms
Below are sample consent formats and forms. Note that investigators are not bound by these models; rather, the formats and forms are merely illustrative. The format an investigator ultimately chooses to use should address the requirements for informed consent as they pertain to an individual study.
Telephone, Internet Survey and Pen and Paper Survey Scripts
The following templates may be used for minimal risk surveys on non-protected populations. The information in brackets must be provided, but an investigator should feel free to alter the remaining text to suit his/her particular needs:
(a) Telephone Script
Hello, my name is [INSERT NAME] from [INSERT INSTITUTION]. I am calling to ask if you would be interested in participating in a research study about [INSERT PURPOSE OF THE STUDY]. It will take approximately [INSERT TIME]. Is this a good time to talk? (If not, ask for a different time). Your responses will be kept confidential as I have not written down your name or phone number on the answer sheet. Feel free to skip any questions that you do not want to answer. Let me give you a number where I can be reached if you have any questions after the study is over [INSERT CONTACT NUMBER]. Are you ready to begin?
(b) Internet Survey Script
Hello, my name is [INSERT NAME] from [INSERT INSTITUTION]. I am a conducting a research study about [INSERT PURPOSE OF THE STUDY]. Would you be willing to take [INSERT APPROXIMATE TIME REQUIRED] to fill out the survey attached to this introduction? Your responses will be anonymous; there is no way for me to know who completed a survey. Feel free to skip any questions that you do not want to answer. If you have questions about the survey, please feel free to email me at [INSERT CONTACT INFORMATION—you may also include a phone number or use a phone number instead of an email address. If you choose to participate, please click on I ACCEPT at the bottom of the screen to begin the survey. Thank you in advance for your time.
(c) Pen and Paper Survey Script
Hello, my name is [INSERT NAME] from [INSERT INSTITUTION]. I am conducting a research study about [INSERT PURPOSE OF THE STUDY]. Would you be willing to take [INSERT APPROIXIMATE TIME REQUIRED] to fill out the survey? Your responses will be anonymous; there is no way for me to know who completed a survey. Feel free to skip any questions that you do not want to answer. If you have questions about the survey, please feel free to email me at [INSERT CONTACT INFORMATION]—you may also include a phone number or use a phone number instead of an email address. If you choose to participate, please take a survey packet that includes a self-addressed envelope that you can use to mail me the completed survey. (If appropriate, use “please deposit your survey in the drop box located at [INSERT LOCATION]”). Thank you in advance for your time.
Written Consent Forms
The following written consent forms—Standard Adult Consent Form, Minor Assent Form, andParent/Guardian Permission Form—are basic outlines containing the absolute minimum information required. Please develop your forms to be inclusive of all requirements as they apply to the study you are undertaking. Note that the consent/assent/permission forms complement information that has been conveyed orally to the subject, and in key areas confirm the information conveyed orally.