Informed Consent

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Informed Consent

Vulnerable Subjects Deception Informed Consent Document Guidelines Request for Waiver or Alteration of Informed Consent (FORM) Request for Waiver of Written Documentation of Informed Consent (FORM)

Informed consent is a process in which the researcher fully informs the subject about the research (its purpose, scope, risk/benefit, and other characteristics), and the subject is given an opportunity to consider whether or not to participate without undue influence or coercion. If the subject (or the subject's legally authorized guardian) agrees to participate s/he signs two copies of an Informed Consent Form acknowledging that agreement. One copy is retained by the subject, the other copy is kept by the researcher. (In cases where written consent cannot be used, as for instance with recorded telephone interviews or where the subjects are illiterate, oral consent may be obtained. Documentation of such consent may be provided by a tape recording of the consent process or by signatures of witnesses on a consent document. In the case of consent obtained via email, the subjects should include their typed "signature" on the returned document.)

The consent form should be written in the voice of the subject (for example, "My participation will require ..." or "The researcher will protect my privacy by ...") or in the second person (for example, "Your participation will require ..." or "The researcher will protect your privacy by ...").

Vulnerable Subjects
When the human subjects include minor children, disabled individuals, or other persons who may be vulnerable, particular steps must be taken to obtain legally valid informed consent and to comply with government regulations.

Minor children:
The special requirements for obtaining legally valid informed consent for children to be the subjects of research are set out in 45 CFR 46.401 et seq. Minor children themselves cannot give legally valid informed consent. That must be sought from the legal parents or court-appointed guardian of the child. Thus, the child's parents or guardian must be informed about the research and sign the Informed Consent form giving permission for the child to be a subject. When the research involves no more than minimal risk, the IRB may find that the permission of only one parent, rather than both, is sufficient. When the child is old enough to understand what is being asked of him or her, the researcher should also inform the child about the research and seek the child's uncoerced assent to be a subject. The child's assent must be an affirmative agreement to participate, and not simply a failure to object. The child's assent must be documented. When possible, have the child sign either the parent's or guardian's consent form or a separate consent form.

In determining whether to seek the assent of child subjects, the researcher should take into account their ages, maturity levels, psychological states, and the nature of the research and invitation to be posed. If you determine that the capabilities of the children are so limited that they cannot reasonably be consulted, you may ask the IRB to "waive" obtaining the child's assent in accordance with 45 CFR 46.116(c) or (d).

Mentally disabled:
If the subject is an adult who is developmentally disabled, retarded, or mentally ill, s/he may have a court-appointed legal guardian. If so, that guardian must give informed consent and sign the Informed Consent form, just as a parent does for a child. The researcher should also seek the adult subject's assent, just as the researcher would with a child subject.

Many adults with disabilities do not have court-appointed guardians. Such a person's parent or social worker cannot give legal consent simply by virtue of the relationship. If a disabled adult does not have a court-appointed guardian, the disabled adult is legally entitled to handle his/her own affairs and to give consent to be a subject of research. However, the researcher must consider whether such an individual is, in fact, able to make that decision. When the research involves no more than minimal risk, and when the subject's activities can be concretely described to and understood by the subject, the subject may well be able to give informed consent even if s/he has a disabling condition or other mental limitations.

When seeking Informed Consent from such a disabled adult (or seeking assent to accompany a guardian's consent), the researcher must describe the research clearly and concretely so that the disabled adult can understand and reach an informed decision. In that situation, it may be wise for the researcher to arrange for a trusted adult who knows the subject well to be present when informed consent or assent is sought. The trusted adult can assist the researcher in discovering whether the subject understands the information and is making an informed decision. The researcher may wish to provide a place for the trusted adult to sign as a witness that the individual was informed and did understand and agree to be a subject. Whenever someone other than the subject is involved in or assists the decision, it is important that the s/he have no interests that conflict with the subject's interests and have no separate interest in the research itself.

When a disabled adult has no court-appointed guardian, but does have a family member who is involved in helping the subject make decisions in his or her life, it is prudent to obtain and document the informed consent of this involved family member. Although the consent of a family member is not required if the subject can and does give consent, obtaining informed consent from both the subject and the involved family member may avoid any future dispute about the propriety of the research and the validity of the subject's own consent.

Non-native speakers of English:
If the subjects are individuals who are not fluent in English, care must be taken to insure that the subjects fully understand the information provided to them. These subjects can be given an Informed Consent form that is written in both English and the subject's native language.

Other vulnerable groups:
If the subjects are prisoners, parolees or probationers, the researcher should consult 45 CFR 46.301 et seq. (subpart C).

Deception

If the research design requires that the subject not receive full or correct information prior to participation in the research, the researcher should insure that the deception will have no adverse effect on the subject. The researcher must justify to the IRB why such misinformation or deception is necessary and demonstrate that no adverse effects will accrue to the subjects as a result.

When deception is used, the researcher should provide the subject with pertinent additional information in a debriefing statement at the end of the subject's participation. The debriefing statement should explain why the information was misstated or withheld, and the purpose of the deception. A copy of the debriefing statement must be included after the informed consent document in the application.

THE FOLLOWING INFORMATION, IN THE ORDER LISTED AND WITH SECTION HEADINGS, MUST BE PROVIDED IN INTELLIGIBLE LANGUAGE IN THE INFORMED CONSENT DOCUMENT:

PURPOSE:

State that the study involves research, give the name and affiliation of the person(s) conducting the research, and provide an explanation of the purpose of the research.

PROCEDURES:

Provide a description of the experimental procedures or activities the subject will be involved in. (See the above section on deception for exceptions to this.) When appropriate, provide a description of alternative procedures or courses of treatment that are available to the subject, and discuss the consequences of a subject's refusal to participate in the study (e.g., alternate activities for non-participants in studies performed during class time, or alternate activities for studies that provide extra credit for a class).

DURATION:

State the time commitment expected of the subject, itemized as to how many hours or minutes will be required in a given session, the number of sessions, and the total duration over which the subject will be involved in the project.

CONFIDENTIALITY:

Give a complete description of the procedures used to maintain the confidentiality of the subject and of the records and data pertaining to the subject, how the subject's privacy will be protected, and the conditions under which such confidentiality might be breached (e.g., subpoena of research records in cases of child abuse or other criminal activity, "eavesdropping" when communicating over the Internet, identifying information being intrinsically embedded in the data such as when individuals are videotaped, etc.). Do not "guarantee" confidentiality, but concretely describe what the researcher will do to protect confidentiality. If confidentiality will not be maintained, the Consent Form should so state.

In general, the researcher must make adequate provisions to protect the privacy of the subjects. The following are examples of procedures by which privacy can be protected and confidentiality maintained:

If names must be recorded initially, replace them with a code to identify the subjects as soon as possible. Use independently generated numbers as codes, or pseudonyms, rather than social security numbers, birth dates, addresses, or phone numbers.

When it is necessary to maintain information that will identify the subjects, arrange for the "key" linking subjects to their identifying numbers to be available only to the researcher and a limited number of staff.

If identifying information is intrinsically available in the data (e.g. videotapes of students, data about individuals that are sufficiently detailed so that they might be identified), insure that such identifying information will be available only to the researcher and limited research staff.

It is not necessary to destroy data at the end of the study. However, the researcher should make appropriate arrangements to safeguard the data that have been collected.

RISKS:

Detail the foreseeable potential risks or discomforts to the subject. Include, where appropriate, risks arising from the need to comply with federal and state law, such as the requirement to report evidence of child or sexual abuse. Describe, where appropriate, any additional costs or lost opportunities to the subject that may result from participating in the research.

If there is more than minimal risk associated with the research (i.e., the anticipated risks of harm are greater, considering probability and magnitude, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations), include an explanation as to whether any medical treatment will be available and where further information about it may be obtained. If there is a risk of physical injury, the following statement must be included, verbatim:

In completing this section, the researcher should carefully consider the risks to which the subjects may be exposed, including physical, emotional, psychological, financial, social, educational, legal, and other personal harm. The researcher should design the research so as to minimize all risks.

BENEFITS:

Describe any benefits to the subject or (optionally) to others that may accrue from the research, including any compensation or course credit to be offered to the subject. If tangible benefits are promised, the researcher should explain what will be provided if the subject withdraws early. Where appropriate, state whether or not findings from the study will be made available to the subjects or whether the subject may derive some other benefit from the activities involved in the research.

Compensation may be provided for the subject's inconvenience or time, but not to induce a subject to undertake risk or to coerce a subject into not withdrawing from the study before its completion.

WITHDRAWAL:

Include a statement that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, that the subject may discontinue participation at any time without loss of care or benefits to which he or she would otherwise be entitled, and the procedures for withdrawing from the study.

If test instruments or interviews are involved, state that the subject may refuse to answer any question at his or her discretion.

When appropriate, detail anticipated circumstances in which the subject's participation may be terminated without regard to the subject's consent.

CONCERNS:

Specify whom to contact (ordinarily the researcher) for answers to any questions the subject (or his or her representative) may have about the research or related matters. Also include the IRB office phone number or the number of the Coordinator, Institute for Research to call in case of injury, breach of confidentiality, or other concern that cannot be discussed with the researcher, unless such risks do not exits in the research design.

CONSENT:

Close with a statement that the subject has understood the material in the document and has received a copy of it. Provide a line for the subject's signature and the date. Where appropriate, a line for a witness signature may also be included.

Recruitment and Selection of Subjects

After the consent form, include in the application a section that identifies the types of subjects that will be involved (e.g., "college freshman enrolled in Psych 101" or "third-grade students at three Green Bay public elementary schools"). If any of the subjects are minor children, developmentally disabled, emotionally disturbed, economically or educationally disadvantaged, in prison, jail, or on parole or probation, nonnative English speakers, or otherwise vulnerable, make clear why such individuals have been chosen as subjects.

Describe the recruitment process in detail. If subjects are to be recruited from a cooperating agency or other private source, detail how the subjects will be invited to participate in the research. If the names of the potential subjects are not part of the public record, describe how the agency will insure that the researcher will not have access to identifying information about potential subjects from private or confidential sources during the recruitment process. The recruitment process must be entirely open and non-coercive, especially when dealing with children, the disabled, or other vulnerable groups.

If subjects will be selected from among a larger pool of volunteers, describe how they will be selected and/or assigned to experimental or control groups. The selection process must be "equitable" or fair, especially if there are benefits anticipated from being included in one or more of the study groups. Usually, random selection will be "equitable" but other selection processes may also be fair. In cases where benefits are anticipated for members of the experimental group(s), indicate if the experimental intervention will be available to control group subjects after the study is over.

Provide a copy of all recruitment announcements to be used in obtaining subjects. Indicate where the announcements will appear. The recruitment announcement should be entirely factual; it should not promise any benefits to the subjects other than those which can be guaranteed.

Narrative Description

Provide a one page or less, jargon-free description of the nature of the research and the ways in which human subjects will be involved. Set forth the scientific rationale for the study, describe the research procedures (test, observations, etc.) that involve human subjects, and estimate the total number of human subjects to be involved. If a Special Request was made, justify the request.

Describe the process that will be followed in obtaining and documenting informed consent, demonstrating that the process will be noncoercive and how it will protect the subjects' privacy and confidentiality.

Agency Approvals

List all other agencies, organizations or institutions directly involved in the research, and the role they will play (e.g., source of subjects, study site, etc.).

If the research is to be conducted in cooperation with other institutions having IRBs, you may simultaneously apply for approval from the IRB and the other IRBs. If another institution is the primary focus of the study and its IRB has already approved the study, submit the documentation approved by that IRB

When another agency or organization without an IRB is involved in the research, written permission authorizing the research must be obtained from a responsible administrator. This permission should be on agency letterhead, should make clear the administrator's authority to grant such permission, and should indicate that the Informed Consent forms to be used in the research meet with his or her approval.

Although the application to the IRB may be submitted prior to obtaining written permission from cooperating agencies, IRB approval will be contingent upon the receipt of such written permission. The researcher should indicate the status of this process at the time of application.

Instruments Requiring IRB Approval

Include complete copies of tests, surveys, and the like not already on the IRB's approved list of instruments. If open ended interviews or emergent interview designs are to be employed, provide a list of typical interview questions.

Waiver or Alteration of Informed Consent

In two circumstances the IRB may waive the need for the research subjects to give informed consent or may allow some of the elements of informed consent to be altered (see 45 CFR 46.116(c) and (d)). First, if the research is done under the auspices of state or local government to study a public benefits program or public services program, informed consent may be waived. Second, if the research involves no more than minimal risk and could not practicably be carried out without the waiver of informed consent, or the alteration of some of the elements of informed consent, the IRB may waive the need to obtain informed consent or approve of alternation of consent procedures.

In requesting a waiver or alteration for "practicability", explain exactly how and why it would be impracticable to obtain informed consent or certain of the elements of informed consent. Generally the IRB will further require you to demonstrate that the waiver or alternation will not adversely affect the rights of the subjects, and that the subjects will be provided with additional pertinent information whenever appropriate, in accordance with 45 CFR 46.116(d).

To request a waiver or alteration, include the following with your submission to the IRB: Request for Waiver or Alteration of Informed Consent (FORM)

Waiver of Written Documentation of Informed Consent
There are two circumstances in which the subject must give informed consent to the research, but the researcher need not document the subject's consent in writing (45 CFR 46.117).

First, where the only record that might link the subject to the research is the signed consent document and breach of confidentiality is the principal risk, the IRB can waive the need to obtain written documentation of informed consent. However, in this circumstance the researcher must give the subject the option of signing the informed consent form or not.

Second, where the research presents no more than minimal risk and involves procedures for which written consent is not required outside the research context, the IRB may waive the need for a signed consent form.

When informed consent is not documented in writing, the subject must nevertheless be fully informed about the research and must truly consent to it. This can be done by providing the subject with a written statement regarding the research. Establishing this procedure as a formal part of the protocol can serve to demonstrate that the subject had been fully informed about the research.

To request this waiver, include the following with your submission to the IRB: Request for Waiver of Written Documentation of Informed Consent (FORM)

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Last revised: September 6, 2002