Obtaining Informed Consent

Definition of Informed Consent

State and Federal Informed Consent Requirements

Elements of Informed Consent

Waiver or Alteration of Consent

Waiver of Written Documentation of Consent

Proxy Consent

Research Involving Deception

Consent Forms

Date Stamping of Consent Forms

 

Definition of Informed Consent

Informed consent is one of the primary ethical principles governing human subjects research; it assures that prospective human subjects will understand the nature of the research and can knowledgeably and voluntarily decide whether or not to participate.

"Informed consent" means the knowing consent of an individual, or his/her legally authorized representative, who is able to exercise free power of choice without undue inducement or any form of force, fraud, deceit, duress or other form of constraint or coercion.

State and Federal Informed Consent Requirements

New York State: defines “Voluntary informed consent” (NY Public Health Law, Article 24-A; Section 2442; March 1998) as the legally effective knowing consent of an individual or his legally authorized representative, so situated as to be able to exercise free power of choice without undue inducement or any element of force, fraud, deceit, duress or other form of constraint or coercion.

Elements of informed consent

Informed consent will be sought from each prospective participant or the participant’s legally authorized representative in keeping with the criteria outlined below.

The process for obtaining consent must incorporate all of the following:

  • The investigator will obtain the legally effective informed consent of the participant or the participant’s legally authorized representative.
  • Consent will be sought only under circumstances that provide the prospective participant or the representative sufficient opportunity to consider whether or not to participate.
  • Consent will be sought only under circumstances that minimize the possibility of coercion or undue influence.
  • The information that is given to the participant or the representative shall be in language understandable to the participant or the representative.
  • The informed consent does not include any exculpatory language through which the participant or the representative is made to waive or appear to waive any of the participant’s legal rights.
  • The informed consent does not release or appear to release the investigator, the sponsor, the institution, or its agents from liability for negligence.

Information that must be provided as part of the interaction with the participant and in the documentation of the consent process, unless waived or altered:

  • A statement that the study involves research.
  • An explanation of the purposes of the research.
  • The expected duration of the participant’s participation.
  • A description of the procedures to be followed.
  • Identification of any procedures which are experimental.
  • A description of any reasonably foreseeable risks or discomforts to the participant.
  • A description of any benefits to the participant or to others which may reasonably be expected from the research.
  • A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the participant.
  • A statement describing the extent, if any, to which confidentiality of records identifying the participant will be maintained.
  • An explanation of whom to contact for answers to pertinent questions about the research.
  • An explanation of whom to contact for answers to pertinent questions about the research participant’s rights.
  • An explanation of whom to contact in the event of a research-related injury to the participant.
  • Contact information for the research team for questions, concerns, or complaints.
  • Contact information for someone independent of the research team for problems, concerns, questions, information, or input.
  • A statement that participation is voluntary.
  • A statement that refusal to participate will involve no penalty or loss of benefits to which the participant is otherwise entitled.
  • A statement that the participant may discontinue participation at any time without penalty or loss of benefits to which the participant is otherwise entitled.

For FDA-regulated research:

  • A statement that notes the possibility that the Food and Drug Administration may inspect the records.

For research involving more than minimal risk:

  • An explanation as to whether any compensation is available if injury occurs.
  • If compensation is available, what it consists of, or where further information may be obtained.
  • An explanation as to whether any medical treatments are available if injury occurs.
  • If medical treatments are available if injury occurs, what it consists of, or where further information may be obtained.

Additional information, to be provided to each participant, when appropriate:

  • A statement that the particular treatment or procedure may involve risks to the participant which are currently unforeseeable.
  • A statement that if the participant is or may become pregnant the particular treatment or procedure may involve risks to the embryo or fetus that are currently unforeseeable.
  • Anticipated circumstances under which the participant’s participation may be terminated by the investigator without regard to the participant’s consent.
  • Any additional costs to the participant that may result from participation in the research.
  • The consequences of a participant’s decision to withdraw from the research.
  • Procedures for orderly termination of participation by the participant.
  • A statement that significant new findings developed during the course of the research which may relate to the participant’s willingness to continue participation will be provided to the participant.
  • The approximate number of participants involved in the study.
  • The amount and schedule of all payments to the participant.

Waiver or Alteration of Consent

The consent process may be waived or altered under one of two sets of conditions:

Most common set of conditions for a waiver or alteration

  • The research involves no more than minimal risk to the participants.
  • The waiver or alteration will not adversely affect the rights and welfare of the participants.
  • The research cannot practicably be carried out without the waiver or alteration.
  • Whenever appropriate, the participants will be provided with additional pertinent information after participation.
  • The research is not FDA-regulated.

Less common set of conditions for a waiver or alteration -

  • The research or demonstration project is to be conducted by or subject to the approval of state or local government officials and is designed to study, evaluate, or otherwise examine public benefit or service
  • programs; procedures for obtaining benefits or services under those programs; possible changes in or alternatives to those programs or procedures; or possible changes in methods or levels of payment for benefits or services under those programs.

Documenting the consent process:

  • Informed consent will be documented.

When the long form of documentation is used:

  • The consent document embodies the basic and appropriate additional elements of disclosure.
  • The participant or the participant’s legally authorized representative will sign (and date for FDA-regulated research) the consent document.
  • A copy of the consent document will be given to the person signing the consent document.
  • The investigator will give either the participant or the representative adequate opportunity to read the consent document before it is signed.

When the short form of documentation is used:

  • The consent document states that the elements of disclosure required by regulations had been presented orally to the participant or the participant’s legally authorized representative.
  • A written summary embodies the basic and appropriate additional elements of disclosure.
  • There will be a witness to the oral presentation.
  • For participants who do not speak English, the witness is conversant in both English and the language of the participant.
  • The participant or the participant’s legally authorized representative will sign (and date for FDA-regulated research) the consent document.
  • The witness will sign both the short form and a copy of the summary.
  • The person actually obtaining consent will sign a copy of the summary.
  • A copy of the short form will be given to the participant or the representative.
  • A copy of the summary will be given to the participant or the representative.

Waiver of Written Documentation of Consent

The requirement to document the consent process may be waived under one of two sets of conditions:
Condition 1

  • The research presents no more than minimal risk of harm to participants.
  • The research involves no procedures for which written consent is normally required outside of the research context.
  • The oral or written information provided to participants includes all required and appropriate additional elements of consent disclosure.
  • The IRB has determined whether the participant should be provided written information.

Condition 2

  • The only record linking the participant and the research will be the consent document.
  • The principal risk will be potential harm resulting from a breach of confidentiality.
  • Each participant will be asked whether the participant wants documentation linking the participant with the research, and the participant’s wishes will govern.
  • The research is not FDA-regulated.
  • The oral or written information provided to participants includes all required and appropriate additional elements of consent disclosure.
  • The IRB has determined whether the participant should be provided written information.

Proxy Consent

New York State Law states that surrogate consent, other than that of a parent or legal guardian, (a legal guardian is defined as an individual who has obtained legal guardianship through the Surrogate Courts Proceedings Act §1700 ff., Domestic Relations Law §81 and Article Six of the Family Court Act) is not allowable, unless there is a legal document that specifically authorizes another to act on behalf of someone for research purposes (Public Health Law Section 2442). For example, the consent of a friend would not be allowed. Those individuals allowed to give consent to a third party include:

  • Persons appointed as health care agents
  • Court appointed guardians
  • Next of kin in the following order: spouse, adult child, parent, and adult sibling when there is a legal document that specifically authorizes another to act on behalf of someone for research purposes as per Public Health Law Section 2442.

Research conducted outside New York State

  • It is the Principle Investigators responsibility to ensure that Federal Guidelines 45.102(c) is followed: (c) Legally authorized representative means 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.. Therefore the Principal Investigator must provide to the HSRRC documentation of State Law, where the research is being conducted, concerning proxy care and these laws must be incorporated in the consent process.

VA requirements regarding informed consent state:

  • person must be legally able to give consent. If their legal consent is relinquished, then consent must come from their legal guardian.

Comprehension

Informed consent is not valid unless the consenter understands the information that has been provided. While no one can guarantee that another person has understood the information presented, it is the responsibility of the investigator to do what he/she can to enhance each prospective subject's comprehension of the information. To determine the appropriate way to present the information, the investigator must consider:

  • the nature of the proposed subject population
  • the type of information to be conveyed
  • the circumstances under which the consent process will take place (e.g., manner, timing, place, personnel involved)
Factors such as age, education level, cognitive ability, and language fluency directly affect subject comprehension of information. The manner of presentation, including the specific wording of the information, must be tailored to facilitate comprehension by each individual subject.
  • Technical terms and complex sentences should be avoided, even for the educated layperson. Technical terms should be replaced with ordinary language, and short sentences using active tense rather than passive tense verbs should be used.
  • If English is not the subject population's primary language, the explanations and forms may need to be translated.
  • For children, care must be taken to ensure that the language is appropriate to their age level.
  • For elderly subjects, oral information may have to be presented slowly and loudly and forms printed in large type.
  • When the subject population is not homogeneous, different consent procedures may be required with different populations.
The investigator should be aware that, even if the HSRRC has approved a consent procedure, it is his/her responsibility to ensure that each potential subject understands the information and to take whatever steps are necessary to gain that comprehension. Individuals may not be used as research subjects unless they understand the information that has been provided.

 

Research Involving Deception

Sometimes information must be withheld from subjects or false information provided to them. This may be for substantive reasons (e.g., to distinguish perceptual causes from other causes) or methodological reasons (e.g. to ensure natural reactions or to avoid placebo effects). These circumstances inherently involve a breach of the concept of informed consent. Consequently, several serious concerns must be met before such research can take place.

  • Deception cannot be used in any study where there is risk to subjects
  • The consent document should 1) never contain anything that is untrue, or be part of the deception, and 2) subjects must be provided with sufficient information for them to decide whether to participate and, as in all other human subjects research, be allowed to withdraw at any point without penalty
  • No information can be withheld from subjects that could significantly affect their decision to participate (i.e. the subjects would likely participate anyway if they knew all the information)
  • When the deception involves a falsehood told, no information can be provided to subjects that would have a harmful effect on them if the statement were believed
  • Human Subjects need to be informed about the nature of the research in a way that does not invalidate the data
  • All subjects must be debriefed regarding the true nature of the research after their participation

The debriefing should:

  • Explain all truths not revealed and all falsehoods told to subjects
  • Address the reasons the deceptions were necessary
  • Reassure subjects that their reactions to the deceptions were normal

If having incomplete or erroneous information is not likely to be harmful to subjects, the HSRRC Office will consider delaying the debriefing until all subjects have completed their participation. Care should be taken in debriefing to protect the well being of the subjects.

All debriefings must be submitted as a written text document to the HSRRC Office. The debriefing should always be a dialogue. Those conducting the debriefing should be trained to elicit and respond to subject concerns.

Information should not be provided that might damage subjects' self-esteem or hurt their feelings. The use of highly evaluative terms (e.g. `We tricked you." Or `We lied to you.") should be avoided in explaining deceptions to the subjects.

Consent Form Design

Documentation of "legally effective informed consent" usually involves the use of a written consent form containing all of the information to be disclosed and signed by the subject or the subject's legal representative. It should be emphasized that the consent form is merely the documentation of informed consent and does not, in and of itself, constitute informed consent. The fact that a subject signed a consent form does not mean that he/she understood what was being agreed to or truly gave their voluntary consent. Informed consent is a process that is documented by a signed consent form.

Consent forms should be designed to meet the needs of the particular research project where it is being used; no one form can be used in every research project. However, it is recommended that consent forms meet four criteria.

  1. Be brief, but have complete basic information. Many potential subjects do not read long consent forms. The longer the form, the fewer the number of people who read it in its entirety, and the smaller the fraction of it that is read by the rest. That is, the quest to be more comprehensive by including more information may actually result in the information transmitted being less comprehensive. Include only the basic information needed by potential subjects ("basic" are the items required by federal regulations) and do not try to answer every conceivable question. "Non-basic information" can be given in a separate handout, perhaps in a Question-and-Answer format. One suggestion is to include a list of questions at the beginning of the handout, to permit each person to go to those questions that most interest him/her.
  2. Be readable and understandable to most people. Articles in most popular magazines are at the 8th grade level. Several computer programs estimate readability by the Flesch, Flesch-Kincaid, and FOG measures. Factors that improve readability include the following
    • Technical terms should be replaced with ordinary language;
    • Use active tense rather than passive tense verbs ("We did" rather than "It was done");
    • Write shorter sentences in general; and
    • Make clear the links of logical sequences and of cause-and-effect, even if doing so makes the sentence much longer. ("We will do this, because that happened".)
  3. Be in a format that helps people comprehend and remember the information. Format can be used to help people comprehend and remember complex material. Good format uses are
    • headings;
    • indents;
    • bolded type;
    • lists;
    • extra spacing between sub-topics;
    • repetition;
    • reasonable-size type; and
    • plenty of margins and empty space in general.

    These formats help the reader to: A) organize the information; B) recognize, know, and remember the key points; and C) go back later to the consent form and retrieve important information (such as telephone number of the investigator to call with questions).

  4. Serve as a script for the face-to-face discussions with the potential subjects.Face-to-face discussions between researcher and potential subject are the most important part of the process of informed consent. These sample forms can be the script for the verbal explanation by the researcher. If the verbal explanation is almost identical to the written consent form, each will reinforce the other and potential inconsistencies will be avoided.
    • One benefit of this approach is that the form/script prompts the researcher to use simple language for the verbal explanation.
    • Another benefit is that the same form/script can be used for potential subjects who have difficulty reading or low literacy or who need a translation, which also should improve consistency of explanation among all subjects. i.e.., researchers need develop only one form/script, not two, to permit people of all literacy levels to be potential subjects.
    • The script could also be used in videotaping the explanation.

Date Stamping Of Consent Forms

In order to ensure that investigators are using the most currently approved consent forms, the HSRRC has decided that consent forms will be date stamped by the HSRR Office, with the expiration date of the HSRRC approval. Investigators using consent forms will submit a clean original to the HSRRC Office for date stamping and will make copies from that original. Subjects are to be informed on the consent form not to sign the form without a date stamp or where the expiration date has lapsed.

The expiration date on the stamped consent document is the date that the protocol has expired, i.e. the first date that the protocol is no longer approved.

The expiration date is the date of the convened HSRRC meeting at which the research was approved or approved with modification plus the approval interval;, not to exceed one year. The calculation of the approval period for research is based on the date of the convened meeting at which the HSRRC approved the protocol or approved the protocol with modifications.

Anyone not using photocopies, but printing consent forms from a computer can have the stamped informed consent e-mailed to them as an attachment. Contact the HSRRC office for more information.

Last Updated: 8/10/16