VIII. INFORMED CONSENT
A. INSTRUCTIONS FOR DOCUMENTATION OF INFORMED CONSENT
Informed consent is one of the primary considerations underlying research with human subjects. It is too often forgotten that informed consent is an ongoing educational process that takes place between the investigator and prospective subject; it is not solely a piece of paper that must be signed. Nevertheless, in most cases the federal and California regulations require that informed consent be documented. For medical experiments, see Section IX.A. below for a suggested form pursuant to California Health & Safety Code §§ 24172?24175. It should be reiterated, however, that the consent document does not substitute for discussion.
If informed consent cannot be obtained, the investigator must apply for a waiver of informed consent. See Section VIII.C. below for more detailed information on this process.
According to the federal guidelines, the three necessary elements of the informed consent process are:
- Full disclosure of the nature of the research and the subject's participation. This involves 8 basic elements: (1) description of the research (purpose, duration, procedures); (2) risks; (3) benefits; (4) alternatives; (5) confidentiality; (6) compensation for injury; (7) whom to contact; and (8) right to withdraw or refuse. Additional elements include: (1) risks related to pregnancy; (2) anticipated reasons for termination from the study; (3) costs; (4) consequences of withdrawal; (5) new findings; and (6) number of subjects.
- Adequate comprehension on the part of the potential subjects. Informed consent is not valid unless the consenter understands the information that has been provided. The investigator must consider the nature of the proposed subject population, the type of information to be conveyed, and the circumstances under which the consent process will take place in determining the appropriate way to present the information.
- The subject's voluntary choice to participate. In order to be valid, consent must be freely given, without any form of coercion. In addition to overt forms of coercion, the investigator needs to be sensitive to more subtle forms of coercion, such as social pressure, requests from authority figures, and undue incentive for participation.
Documentation of “legally effective informed consent” usually involves the use of a written consent form signed by the subject or the subject's legal representative. Again, the consent form is merely the documentation of informed consent, and does not, in itself, constitute informed consent. The fact that a subject signed a consent form does not mean that s/he understood what was being agreed to or truly gave his/her voluntary consent.
Federal officials (OHRP) recommend that consent forms meet the following four criteria:
- Be brief, but have complete basic information
- Be readable and understandable to most people
- Be in a format that helps people comprehend and remember the information
- Serve as a script for the face to face discussions with the potential subjects/participants.
Pepperdine IRBs may require that the approval and expiration dates be affixed to all approved informed consent documents and stipulate that copies of these dated documents must be used in obtaining consent. This procedure is recommended by federal officials because it helps ensure that only the current, IRB-approved informed consent documents are presented to subjects and serves as a reminder to the investigators of the need for continuing review.
Below are some additional instructions for preparing the basic written consent form. Please follow the instructions carefully.
- The consent form should be written in LANGUAGE THAT THE SUBJECTS CAN UNDERSTAND. Whenever possible, simple sentences should be used instead of complex ones. Ordinary language should replace technical terms.
- AVOID using EXCULPATORY LANGUAGE through which the subject or the representative is made to waive or appear to waive any of his legal rights or release the investigator, the sponsor, the institution or its agents from liability for negligence.
- Include a HEADING as follows: informed Consent for Research Study
"Title of Study"
In the FIRST PARAGRAPH of the consent form, include the following statement. (NOTE: Adjust the statement to include the name of the legally authorized representative when necessary. Delete any portions of the statement that are not applicable to your study.
I,____________________________ , agree to participate in the research study
under the direction of Drs. ________________________________ and
______________________________ . I understand that while the study will be
under the supervision of Drs.______________________________ , other professional
persons who work with them may be designated to assist or act in their behalf.
If the research is being conducted by a student, the following statement may be used in place of the aforementioned:
I ____________________________ , agree to participate in the research study
being conducted by ________________________________ under the direction of
Dr. __________________________ (list advisor's name here).
- Include an explanation of the PURPOSE(S) of the research.
- Include an explanation of the expected DURATION of the subject's participation and the location of the project.
- Describe the PROCEDURES to be followed including time involved and physical requirements. Identify any procedures which are experimental. If applicable, indicate whether the subject will be required to return for follow?up examinations or procedures. (Procedures that are randomly assigned must be explained in a language that participants can understand.)
- Describe any foreseeable RISKS OR DISCOMFORTS to the subject.
- Describe any BENEFITS to the subject or to others which may reasonably be expected from the research.
- Describe appropriate ALTERNATIVE PROCEDURES or courses of treatment, if any, that might be advantageous to the subject.
- Describe the extent to which CONFIDENTIALITY of records identifying the subjects will be maintained.
- Include an explanation as to whether any COMPENSATION for participation in the study will be provided. Specify the nature of the compensation (i.e., amount, etc.) and the terms of payment (e.g., I will receive $10 after each appointment).
- Include the following statement, when appropriate: I understand that in the EVENT OF PHYSICAL INJURY resulting from the research procedures in which I am to participate, no form of compensation is available. Medical treatment may be provided at my own expense or at the expense of my health care insurer which may or may not provide coverage. If I have questions, I should contact my insurer.
- Include an explanation of WHOM TO CONTACT for answers to pertinent questions about the research and the research subject's rights and whom to contact in the event of a research?related injury to the subject. Federal regulations require that consent forms should include at least these 2 contacts – one internal to the study, and one external to the study. Student investigators should include their faculty sponsor as a third contact.
- Indicate that the subject will receive a copy of the consent form.
- Include the following statement:PARTICIPATION is voluntary; refusal to participate will involve no penalty or loss of benefits to which I am otherwise entitled. I understand that I may discontinue participation at any time without penalty or loss of benefits to which I am otherwise entitled.
- In addition, when appropriate one or more of the following elements of information
should be included on the consent form:
- A statement that the particular treatment or procedure may involve RISKS to the subject 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.
- Provide a place for:
- The signature of the subject (or the legally authorized representative);
- The date of receipt of that signature.
- I have explained and defined in detail the research procedure in which the subject has consented to participate.
Principal Investigator Date
(Adjust the statement above if the legally authorized representative is signing the form.)
- If the RESEARCH INVOLVES THE PARTICIPATION OF MINORS (under 18 years of age), please read the Description of Requirements for Research Involving Children which is attached. Additional requirements concerning the parental consent forms and children assent forms are discussed.
- If the RESEARCH ACTIVITIES ARE DIRECTED TOWARD PREGNANT WOMEN, please see subpart B of the federal guidelines for rules as to whether the mother and/or father must give consent after having been fully informed regarding the impact on the fetus. For children as defined in Sec. 46.402(a) who are pregnant, assent and permission are obtained in accord with the provisions of subpart D.
- Instructions for Informed Consent Procedures for Human Participant/Subjects Who Do Not Speak English
- The federal 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 §46.116 and §46.117).
Where informed consent is documented in accordance with §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. Federal officials (OHRP) strongly encourage the use of this procedure whenever possible.
Alternatively, §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) 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 §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 §46.117(b) is appropriate for documenting informed consent in protocols that it reviews.
B. DESCRIPTION OF REQUIREMENTS FOR RESEARCH INVOLVING CHILDREN
Research Involving Children
Federal regulations (15 CFR 45, Subpart D) require additional protections for research involving children because they are considered a vulnerable research population as persons who have not attained the legal age for consent in the jurisdiction in which the research will be conducted (45 CFR 46.402(d) )
Note that whenever feasible, appropriate studies should be conducted on animals, adults, and older children before young children are involved as research subjects.
The IRB must find that the activity represents one of four permissible categories of research, and that adequate provisions are made for soliciting the assent of the children and the permission of each child's parents or guardian. --- 45 CFR 46.404-408
Children who are wards of the State or any other agency, institution, or entity can be included in research only under certain conditions. --- 45 CFR 46.409
The Institutional Review Board is required to consider the degree of risk inherent in the proposed research and the methods for obtaining the assent of the children as well as the permission of parents or legal guardians. The IRB's policy with respect to obtaining consent from the parents or legal guardians and assent from minors is specified below:
In most cases, parental consent must be obtained if the research involves minors under the age of 18. A written consent form must be used to document informed consent. Both parents must sign the consent form unless this requirement is waived by the IRB. (The requirement for parental consent may be inappropriate in some cases such as research on child abuse.)
Minor subjects/participants 6 years of age or older should be involved in the decision to participate in a research project unless:
- The subject/participant is incapable, mentally or emotionally, of being reasonably consulted;
- The IRB specifically waives this requirement.
Unless the requirement is waived by the IRB, documentation of assent is required for subjects aged 7-17. In most cases, a written assent form should be used to document assent. A copy of the assent form must be submitted to the IRB for review. The form should include a simplified version of the elements of informed consent which are described in the Instructions for Documentation of Informed Consent. Note that the child should be given an explanation, at a level appropriate to the child's age, maturity and condition, of the procedures to be used, their meaning to the child in terms of discomfort and inconvenience, and the general purpose of the research.
C. RESEARCH INVOLVING PRISONERS
Subpart C of the HHS regulations requires additional protections for research involving prisoners as subjects:
* Prisoner means any individual involuntarily confined or detained in a penal institution, including individuals detained in other facilities which provide alternatives to criminal prosecution or incarceration, and individuals detained pending arraignment, trial, or sentencing.--- 45 CFR 46.303(c)
* At least one member of the Institutional Review Board (IRB) must be a prisoner or a prisoner representative with appropriate background and experience. --- 45 CFR 46.304(b)
* The IRB must find, and certify to OHRP where required, that six additional protections specific to prisoners have been satisfied. --- 45 CFR 46.305
- any possible advantages accruing to the prisoner through his or her participation in the research, when compared to the general living conditions, medical care, quality of food, amenities and opportunity for earnings in the prison, are not of such a magnitude that his or her ability to weigh the risks of the research against the value of such advantages in the limited choice environment of the prison is impaired;
- the risks involved in the research are commensurate with risks that would be accepted by nonprisoner volunteers;
- procedures for the selection of subjects within the prison are fair to all prisoners and immune from arbitrary intervention by prison authorities or prisoners. Unless the principal investigator provides to the IRB justification in writing for following some other procedures, control subjects must be selected randomly from the group of available prisoners who meet the characteristics needed for that particular research project;
- the information is presented in language which is understandable to the subject population;
- adequate assurance exists that parole boards will not take into account a prisoner's participation in the research in making decisions regarding parole, and each prisoner is clearly informed in advance that participation in the research will have no effect on his or her parole; and
- where the IRB finds there may be a need for follow-up examination or care of participants after the end of their participation, adequate provision has been made for such examination or care, taking into account the varying lengths of individual prisoners' sentences, and for informing participants of this fact.
* The IRB must find, and OHRP must determine in certain cases, that the research represents one of four permissible categories of research. Certain research may go forward only after OHRP has consulted with appropriate experts in penology, medicine, and ethics. --- 45 CFR 46.306
- study of the possible causes, effects, and processes of incarceration, and of criminal behavior, provided that the study presents no more than minimal risk and no more than inconvenience to the subjects;
- (Note that the definition of minimal risk for prisoner research at 45 CFR 46.303(d) differs from the definition of minimal risk for other research, contained in 45 CFR 46, subpart A, 45 CFR 46.102(i))
- study of prisons as institutional structures or of prisoners as incarcerated persons, provided that the study presents no more than minimal risk and no more than inconvenience to the subjects;
- research on conditions particularly affecting prisoners as a class (for example, vaccine trials and other research on hepatitis which is much more prevalent in prisons than elsewhere; and research on social and psychological problems such as alcoholism, drug addiction, and sexual assaults) provided that the study may proceed only after the Secretary (through OHRP) has consulted with appropriate experts including experts in penology, medicine, and ethics, and published notice, in the Federal Register, of his intent to approve such research; or
- research on practices, both innovative and accepted, which have the intent and reasonable probability of improving the health or well-being of the subject. In cases in which those studies require the assignment of prisoners in a manner consistent with protocols approved by the IRB to control groups which may not benefit from the research, the study may proceed only after the Secretary (through OHRP) has consulted with appropriate experts including experts in penology, medicine, and ethics, and published notice, in the Federal Register, of his intent to approve such research.
D. WAIVER OF INFORMED CONSENT
Under the federal guidelines (§45CFR46.116), the IRB can approve study procedures that involve the waiver of informed consent in two situations. First, if the following conditions are satisfied:
- 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 waiveRor alteration; and
- Whenever appropriate, the subjects will be provided with additional pertinent information after participation
- 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: (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
- The research could not practicably be carried out without the waiver or alteration.
There is no such process as “implied consent.” If written informed consent is not possible, an investigator must apply to the IRB for a waiver of this requirement. Under CFR §46.117, an IRB may waive the requirement for the investigator to obtain a signed consent form for some or all subjects if it finds either:
- 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
- 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.
The Pepperdine IRB Application for Waiver or Alteration of Informed Consent Procedures form should be used for both waivers of and alterations to the informed consent process.