Human Subjects Manual, Section IV

University of Washington
Human Subjects Manual

IV. Informed Consent

General Information - Documenting informed consent - Elements of consent
Types of consent
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General Information

Human subjects asked to contribute their time and effort to research should consent to do so freely. The consent should be given only after the subject understands what he or she is consenting to, and any risks that may be involved. Subjects should be assured that there will be no penalties for declining to participate, and that they are free to withdraw from the research at any time after they have given their initial consent. Federal regulations state this more formally:

"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."

The requirement for informed consent is ordinarily fulfilled by telling the subject, either orally or in writing,
1. the general nature and purpose of the research,
2. the procedures in which the subject is being asked to participate, and the amount of time and effort likely to be required,
3. that the subject's privacy will be respected,
4. that participation is voluntary and the subject is free to withdraw from participation at any time and free to decline to participate in any part of the procedures to which the subject may object, and
5. whom the subject may contact to find out more about the study.
Providing such information to potential participants in research is a matter of common courtesy, and potential subjects will ordinarily be more likely to agree to participate if such information is given.

Human Subjects Review Committees will consider the adequacy of the provision for such informed consent and whether the information given is in compliance with relevant requirements in Federal regulations.

When research involves certain special features or certain special populations, consent requirements specific to those features or populations apply. These requirements are detailed elsewhere in this section.
Documenting informed consent.
Federal regulations require that, in most cases, whenever there is more than minimal risk, consent is to be documented by a signed and dated consent form that has been approved by a Human Subjects Review Committee. A copy must be provided to the participant or the participant's legal representative. There are some exceptions to this requirement that are described below (see following sections on Oral Consent, Proxy Consent and Waiver of Consent.

Informed consent, including a signed and dated consent form, may also be appropriate for research exempt from Federal Regulations. Department chairs are authorized to require appropriate documentation of informed consent when approving exempt research.
Elements of consent

Investigators are advised to read this section carefully. Many of the delays in proposal approval have been due to inadequate attention to including all necessary information in the consent form.
1. Basic Requirements: The following are listed from Title 45, Code of Federal Requirements, Part 46.116:
  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 discomfort 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 description of appropriate alternative procedures or courses of treatment that might be advantageous to the subject;
  5. A statement describing the extent, if any, to which confidentiality of records identifying the subjects 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 subject's rights, and whom to contact in the event of a research-related injury to the subject;
  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.
2. The following are items required by the University of Washington:
  1. A University of Washington heading;
  2. The name, position, department, and telephone number of the investigator(s);
  3. Costs the subject and/or his or her insurer or estate may immediately or ultimately be forced to bear;
  4. Reimbursement of costs or other inducements the subject will receive;
  5. An indication that the study has been explained to the subject;
  6. An indication that the subject has had an opportunity to ask questions before consenting;
  7. Signature and date lines to be completed by the investigator, the subject, and when appropriate, the guardian or subject-advocate.
  8. An indication that a signed copy has been given to the subject
  9. An explanation that if subjects have questions about their rights as research subjects they may call the Human Subjects Division at (206) 543-0098.
3. The following items should be included in an informed consent statement when appropriate:
  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. The consequences of a subject's decision to withdraw from the research, and procedures for orderly termination of participation by the subject;
  4. 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;
  5. The approximate number of subjects involved in the study.
4. Informed consent items to be included in special circumstances:
  1. Questionnaires, Scales, Inventories, and Interviews.
    1. A description of the nature of the questions to be asked, including the most personal and sensitive questions.
    2. A statement that the subject may refuse to answer any question.
    3. An estimate of the length of time needed to complete the activity.
  2. Recordings, Photographs, Films, Videotapes, Audiotapes of the subject.
    1. A description of what tapings, photographs, etc., will be made.
    2. An indication of how long the tapings, photographs, etc., will be retained before being erased or destroyed, and how confidentiality will be assured.
    3. The subjects' permission to make an audio-visual record for analysis by the investigator and/or the investigator's research group is not permission to use that audio-visual record for other purposes, e.g., for instructional or illustrative purposes outside the research group. If such a use is anticipated, the consent form should so state and, in addition, should include:
    4. A description of the use to be made of the subject's audio-visual record outside the research group.
    5. An indication that the subjects will have an opportunity to review the record and delete portions they may consider personally damaging from the record to be used outside the research group.
    6. If the investigator intends to retain the audio-visual record indefinitely or does not indicate a specific time when that record will be erased or destroyed (ordinarily after five years or less), the investigator cannot guarantee that the record will be used exclusively by the research group. In this circumstance, the consent form should indicate that the subjects will have an opportunity to review the "permanent" record and delete portions they may consider personally damaging.
    (NOTE: Some institutions have special consent forms to be used for obtaining permission for making tapes, photographs, etc.)
  3. Medical or academic records.
    1. A description of what information will be drawn from the records.
    2. An explanation of who will have access to this information.
    3. An explicit statement that the subject allows the researcher access to the records as described in the body of the consent form.
  4. Data on illegal or socially sensitive activities.
    1. A clear statement as to how the confidentiality of the data will be maintained and how immune the data are from subpoena.
      Revised Code of Washington 42.48, enacted in 1985, provides protection of research data from subpoena under certain circumstances. This law pertains specifically to data collected in the State of Washington.
      
      The law provides protection for research data from subpoena of records for the purpose of taking any legal action against an individual subject. RCW 42.48 does not restrict access to individually identifiable research records if:
      1. the subject has given consent for access;
      2. access is required for an audit of the research program;
      3. disclosure of data may prevent harm or minimize injury to some person;
      4. a search warrant exists to inquire into alleged violations of law by the researcher.
        Investigators collecting data on illegal and sensitive data may wish to request a Federal Certificate of Confidentiality from the DHHS. Investigators who have been issued such a Certificate cannot be compelled to identify research subjects in any Federal, state, or local civil, criminal, administrative, or legislative proceedings. Further information on such Certificates may be obtained from the Human Subjects Division.
    2. Statements in the consent form should indicate, as appropriate, the risks of subpoena for data not covered by RCW 42.48 or a Certificate of Confidentiality.
  5. Research entailing the potential for observing evidence of the abuse of children or of dependent adults.
    1. When the investigator asks direct questions relevant to abuse or when data are to be gathered in homes or institutions believed to be likely settings for abuse, the consent form must state the investigator's legal obligation to report such abuse.
    2. If the potential for observing evidence of abuse is deemed to be low, a statement that the data will be confidential within the limits of the law is sufficient. If the potential for observing evidence of abuse is deemed to be high, a statement that, if observed, the investigator is obliged by law to report such evidence of abuse.
  6. Research entailing the use of drugs (including alcohol) and investigational new devices.
    As appropriate, the following should be included in the informed consent statement:
    1. Name of the drug (or device), dosage, how administered, frequency, for what duration, possible side effects, and cautionary statements on the concurrent use of alcohol and of other drugs.
    2. For use of placebo, or single- or double-blind procedure, a statement of what the chances are that the subject may receive a placebo.
    3. A general statement to the effect that "As with any drug (or device), there may be unanticipated adverse effects."
    4. Instructions for action to be taken in the event of adverse effects.
    5. For subjects who are not hospitalized, an emergency around-the-clock telephone number for subjects to call in the event of an adverse effect.
    6. Relevant cautionary statements about the operation of machinery or motor vehicles while experiencing effects of the drug.
    7. A statement to the effect that a drug company will have access to study data or to the subject's personal medical records.
    8. A statement that indicates the phase of testing (e.g., phase 2 of an investigational new device) and whether the number of subjects is limited; and that the FDA has allowed use of this drug (or device) for research.
    9. A statement as to whether the drug (or device) will be available at the conclusion of the study if it is found to be effective for the subject.
    10. A statement indicating the possibility that the FDA may inspect the records of the research and the subjects' medical records.
  7. Radiation.
    An estimate of the hazard in terms readily understandable to the layman, e.g., a multiple of the background radiation to which people are exposed in one year, or as comparable to the exposure allowed radiation workers in one year. (For further information about radiation research, see Section VII.B.)
  8. Electrical equipment.
    Any special risks that may be associated with the equipment, and a description of what equipment will be used and how it will be used in the research.
  9. Bureau of Prisons
    A statement that participation in the research project will have no effect on the inmate-participant's release date or parole eligibility.
Types of consent
1. Written consent
  Written consent is usually appropriate for research involving more than minimal risk. The written consent form normally consists of an information statement from the point of view of the investigator, written in language readily understandable to potential subjects, plus a statement of consent for the subject to sign. For potential subjects who are not English-speakers, the consent form should, of course, be presented in their own language. For special populations (e.g., children, legally incompetent persons), the consent of a legally responsible guardian or subject advocate may also be required. In addition to the written statement, potential subjects must have an opportunity to discuss with the investigator or the investigator's representative their concerns about participation and any questions they may have.
  
  Subjects' consent is documented by their dated signature on the consent form and, when appropriate, by the dated signature of their legally authorized representatives, guardians or subject advocates. The investigator retains one copy of the signed consent form and gives one copy to the subject. Signed consent forms are to be retained by the investigator for a period of eight years.
  
  The Human Subjects Review Committees may waive documentation of written consent in several situations. One is when the study poses minimal risks to the competent adult subject and the study procedures are not ones that would normally require written consent. The second is when the major risk posed to the subject is the existence of a signed consent document. When research is conducted on illegal or very sensitive behavior, subjects may be putting themselves at risk of criminal or civil liability or personal danger by signing a consent form. For example, subjects of research on cocaine dealing or domestic abuse would be ill advised to sign a consent form indicating that they were willing to take part in such studies.
  
  A sample consent form format is included at the end of this manual. Investigators are strongly advised to draft consent forms to comply with the relevant requirements, in the order just listed, to avoid delays in approval.
  
  Investigators are advised not to duplicate large numbers of their informed consent forms prior to approval, since changes may be required. Investigators are also urged to pay special attention to the form, appropriateness, and clarity of their consent forms. Consent forms should be written in short sentences using short words. Use the active rather than the passive voice and avoid jargon and technical language.
2. Oral consent
  Oral rather than written consent may be obtained for research involving no more than minimal risk. Oral consent may also be appropriate under certain other circumstances and with IRB approval. For example, research in which identification by the consent document itself would place the subject at risk ordinarily makes oral consent preferable to written consent. (See Title 45, Code of Federal Regulations, Part 46.117(c).) Also, oral consent may be approved for interviews conducted by telephone under certain circumstances. (See Title 45, Code of Federal Regulations, Part 46.117(c).)
  
  Investigators who request approval of oral consent for research involving more than minimal risk should provide a justification for the use of oral consent and a copy of the information statement to be presented or read to potential subjects. At a minimum, this statement should include the relevant elements of informed consent described in Section IV.C.
3. Proxy consent
  
  All uses of proxy consents must be approved prospectively by a Human Subjects Review Committee. There are several instances in which proxy consent may be approved. It may be approved in situations in which the prospective subject is anticipated to be incompetent to provide informed consent. This may be temporary (for example, when subjects have received sedating or pain-relieving medications and consent must be obtained before the effects of the medication have worn off). The duration of the incompetence may be unknown (for example, when a potential subject is in a coma resulting from traumatic injury). Or the incompetence may be a normal state (for example, when a subject is permanently cognitively impaired). The subject's legally authorized representative is responsible for making the decision about whether or not the subject should participate in the research. This person signs the consent form for the subject and indicates his or her relationship to the subject on the form.
  
  Consent from the subject's legally authorized representative should be obtained by the researcher in person and documented on the approved consent form. If this is not possible, the consent form may be sent to the representative by facsimile transmission, express mail or regular mail and returned using the same mechanisms. In circumstances in which the Human Subjects Review Committee has approved a waiver of the documentation of informed consent (see below, Waiver of consent; consent may be provided by the representative over the telephone. When obtaining consent by telephone, the researchers must follow these procedures:
  1. Establish a means of verifying the identity of the person who will be providing consent by telephone (driver's license number, "Describe the patient to me," etc.).
  2. Use a consent script which has been approved by the Human Subjects Review Committee which includes all the relevant elements of consent.
  3. Arrange to have the telephone consent process witnessed by a third party who is able to hear both sides of the dialogue.
  4. Follow up immediately with procedures to obtain written consent, if stipulated by the Human Subjects Review Committee.
  Consent provided by a proxy (whether by telephone, in writing, or in person, cannot override refusal by the prospective subject to take part in the research.
4. Waiver of consent
  Under certain conditions described in the Federal Regulations, a Human Subjects Review Committee may approve a consent procedure which does not include, or which alters, some prescribed elements of informed consent, or a Committee may waive the requirement that informed consent be obtained. The essential conditions to allow a waiver are
  1. that the research pose no more than minimal risk to subjects,
  2. no adverse effects as a result of the waiver or alteration,
  3. without the waiver or alteration the research in question could not be carried out, and
  4. information will be provided after participation is completed, if appropriate.
  If these conditions seem to apply, Principal Investigators should consult the federal regulations for additional information (see Title 45 Code of Federal Regulations 46.116(d)).
  
  Under special circumstances, consent may also be waived for the use of an FDA-regulated test article (drug, device, or biologic). In this case, the investigator shall consult with the Human Subjects Division and a Human Subjects Review Committee Chair. In order to waive consent both the investigator and a physician who is not otherwise participating in the clinical investigation certify in writing all of the following:
  1. The human subject is confronted by a life-threatening situation necessitating the use of the test article.
  2. Informed consent cannot be obtained from the subject because of an inability to communicate with, or obtain legally effective consent from, the subject.
  3. Time is not sufficient to obtain consent from the subject's legal representative.
  4. There is available no alternative method of approved or generally recognized therapy that provides an equal or greater likelihood of saving the life of the subject.
  The requirement for a written, signed consent form may be waived by a Human Subjects Review Committee if
  1. the signed consent form itself might compromise the confidentiality of the data describing the subject and the subject prefers that no signed consent form be used; or
  2. the research presents no more than minimal risk and involves no procedures for which written consent is normally required outside the research context.
  If a principal investigator wishes a waiver of the requirement for a consent form this should be indicated on Form UW 13-11 and complete justification of the request for the waiver showing compliance with the regulations governing waivers should be provided.
  
  Waiving the requirement for a written form does not waive the requirement that subjects be informed of the nature of the research, and that their consent (or the consent of their legal representatives) be obtained whenever appropriate.
  
  Sometimes investigators wish to use what they call "passive" consent -- absence of a dissent to participate is assumed to imply willingness to take part in a study. "Passive" consent qualifies as a waiver of consent and a request to use "passive" consent must meet all the requirements of a waiver of consent.
5. Waiver of consent in emergency medicine research
  The Committees may grant waivers of consent in compliance with regulations from the FDA and the NIH in certain emergency medicine research activities meeting the regulatory requirements. The Committee must find and document that:
  1. The potential subjects are in a life-threatening situation in which available interventions are unproved or unsatisfactory, and that clinical trials are necessary to determine the safety and effectiveness of interventions;
  2. Gaining prospective consent from potential subjects is not feasible because:
    1. The subjects will not be able to consent to take part in the study because of their medical condition; and
    2. The study intervention must be administered before consent from the subject's legally authorized representative is feasible, and
    3. Eligible subjects cannot be identified prospectively.
  3. Subjects may benefit from the research because:
    1. Subjects are facing a life-threatening situation that necessitates the intervention;
    2. Appropriate animal and pre-clinical studies support the potential of the intervention to provide direct benefit to subjects; and
    3. The risks associated with the intervention are reasonable in light of what is known about the subject's medical condition, the risks and benefits of standard treatment, and the risks and benefits of the proposed intervention.
  4. The research could not practicably be carried out without the waiver.
  5. The researcher has scientifically defined the therapeutic window and is committed to obtaining consent from the subject's legally authorized representative within that window. The researcher will provide a summary of efforts made to contact the subject's authorized legal guardian to the Human Subjects Review Committee at the time of continuing review.
  6. The Human Subjects Review Committee has reviewed and approved the informed consent procedures and consent form to be used where obtaining consent where feasible.
  7. The following additional protections of the rights and welfare of subjects will be provided:
    1. Consultation with representatives of the communities in which the study will be conducted and from which the subjects will be drawn;
    2. Public disclosure to the communities in which the research will be conducted and from which the subjects will be drawn of plans for the study, and its risks and benefits;
    3. Public disclosure of the results of the study after completion;
    4. Establishment of an independent data monitoring committee for the study; and
    5. The Human Subjects Review Committee must insure that procedures are in place to inform each subject, or the subject's legally authorized representative of the subject's inclusion in the study, of the details of the study, of the information contained in the consent form, and that either may decide to discontinue participation at any time.
  Researchers requesting a waiver of informed consent for studies involving an investigational drug or device must obtain a unique investigational new drug application (IND) or investigational drug exemption (IDE) from the FDA even if an IND or IDE for the intervention already exists.
  
  If the Human Subjects Review Committee declines to approve a requested waiver, it must document its findings and report promptly to the researcher and to the sponsor of the research. The research sponsor, in turn, must report this information to FDA and to the sponsor's researchers who are asked to participate in this or a substantially similar trial.
  
  This rule does not apply to protocols involving populations and procedures which are specially protected by law. These include prisoners, fetuses, pregnant women, or in-vitro fertilization procedures.
6. Assent
  Assent is required of all minors who are approached to take part in a research activity. Assent should be appropriate to the age of the child.
  
  Children over the age of twelve may be asked to read, discuss and sign an adult consent form. If the consent form is being used for both adolescent and adult subjects, it should be titled "Assent/Consent Form" and signature, date, and relationship lines should be added to the form. Both the adolescent and the parent or guardian should sign the form.
  
  Children who are between the ages of seven and twelve should be provided with a simplified version of the adolescent assent form written in language appropriate to the ages of the subject. Both the child and the parent or guardian must sign the form.
  
  Oral assent may be used with children who cannot be expected to read, but who can be expected to comprehend the nature of the research procedures to be used.
  
  Children who cannot understand enough to assent to participate in research activities generally cannot be research subjects. The only exception is if the research holds out a prospect of direct benefit to the child which is available only in the context of the research, and if consent is provided by one or both parents, or if the research poses minimal risks to the child which are outweighed by the prospective benefits. It is the responsibility of the Human Subjects Review Committee to make this determination on a case-by-case or protocol-wide basis.
  
  Generally speaking, if minors are the subjects of research, the informed consent of the parent(s) or legal guardian is also required. An exception is made for individuals who have been declared "emancipated" minors and for children in the state of Washington aged fourteen years old and older who are seeking diagnosis or treatment for sexually transmitted diseases. Investigators should direct questions to the Human Subjects Division for information on this subject.
7. Implied consent
  When data are gathered by anonymous questionnaires (i.e., there is no possibility of identifying subjects), the return of the completed questionnaire implies the consent of the subject. No written informed consent form for the subject's signature is required. However, such questionnaires should be accompanied by a cover letter that provides all of the applicable elements of consent

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Section V: Adverse Events

University of Washington Human Subjects Manual

IV. Informed Consent

University of Washington
Human Subjects Manual