Human Research Protection Program: Policy

Obtaining and Documenting Informed Consent

Adopted By: All Campus IRB

Adoption Date: November 10, 2005

Revised: January 22, 2009

Purpose: This document describes how the UW-Madison IRBs evaluates the adequacy of the informed consent documents and process in human research.

Policy

I. To approve research that is not determined to be exempt, UW-Madison IRBs must determine that informed consent will be sought from each prospective participant or the participant’s legally authorized representative in accordance with the requirements of federal regulations, state law and institutional policies and procedures, or that a waiver or alteration of informed consent is appropriate [see, Sections IV.D and IV.E of this policy]. The requirements for obtaining and documenting informed consent may vary depending on the nature of the research project.

II. General Requirements of Informed Consent

A. Unless a waiver of informed consent has been approved by the IRB, no investigator may involve a human being as a participant in research without obtaining the legally effective informed consent of the participant or the participant’s legally authorized representative.

B. UW-Madison IRBs consider the informed consent process to begin when a potential research participant is first contacted.

C. The nature and circumstances of the informed consent process and the consent documentation described in the protocol must:

1. provide sufficient opportunity for potential participants and representatives to consider whether to participate in the research

2. minimize the possibility of coercion or undue influence of potential participants and representatives

3. use language understandable to each potential participant or representative

4. contain no exculpatory language through which the potential participant and representative is made to waive or appear to waive any of the participant’s legal rights or release or appears to release the investigator, sponsor, institution or its agents from liability for negligence.

D. Investigators should be sensitive, throughout the conduct of the research, to participants' understanding of the project and willingness to participate.

E. New findings during the course of a research study may require the re-consenting of study participants.

Procedure

III. Submission Requirements

A. When submitting their application for initial review of a protocol, investigators are required to include:

1. a copy of any consent form that will be used in obtaining consent

Consent Form Wizard (for SBS IRB and ED IRB submissions)

Consent Form Templates (for HS IRB and MR IRB submissions)

Combined Consent/HIPAA Authorization Form Wizard

2. a copy of any assent form or assent script, if relevant, e.g., when enrolling children or adults with impaired decision-making capacity

For additional guidance on assent of participants, see the following:

Assent of Children Guidance

Health Sciences IRBs Assent and Consent Requirements for Children

Research with Adult Subjects Lacking Capacity to Consent Policy

3. a description of the procedure for obtaining consent from each subject or the subject's parent or legally authorized representative

4. the qualifications and role of each individual who will be involved in the consent process

5. a description of the subject population, including where subjects will be found, how many will be enrolled, primary selection and exclusion criteria, recruitment methods including any material inducements, whether vulnerable groups will be included or targeted, and whether any project personnel will receive incentives for recruiting human subjects or for any other purpose directly related to the study

6. whether the investigator is requesting a waiver of the requirement to obtain informed consent or of the documentation of informed consent and the basis for that request.

IV. IRB Review of Initial Submissions

A. The Consent Process

1. UW-Madison IRBs systematically evaluate the following factors when determining whether informed consent will be sought from each prospective participant or the participant’s legally authorized representative in accordance with the requirements of applicable federal regulations, state law and institutional policies and procedures:

a. the nature and circumstances of the consent process in addition to the consent document.

b. the qualifications and training of those who will conduct the consent interview.

c. the timing of obtaining informed consent and of any waiting period (between informing the participant and obtaining the consent) that will be observed.

d. where the consent process will take place.

e. whether the consent form or script is worded so that potential participants can understand it. Although generally the consent form or script should be written at an eighth-grade reading level, the language should be adjusted to an appropriate level for the particular participant population.

2. When a potential participant’s understanding of the research may be impaired due to any of the above factors, the IRB will require modifications in the consent process. (For example, the IRB may require that only the principal investigator or physician collaborator obtain consent or that consent be obtained prior to entry into the cardiac catheterization waiting area.)

3. For Veterans Affairs Medical Center (VAMC) research, if someone other than the investigator conducts the interview and obtains consent for VAMC research, the investigator must formally delegate this responsibility and the person so delegated must receive appropriate training to perform this activity.

B. Elements of Informed Consent

1. When reviewing research, UW-Madison IRBs systematically evaluate whether the informed consent documents and processes disclose to participants or their legally authorized representatives the information required by the federal Common Rule [45 CFR 46.116] or, if applicable, the FDA regulations [21 CFR 50.25], ethical principles, local and state law and University policies.

2. UW-Madison IRBs require that the following basic elements of informed consent be provided to each participant unless the IRB has approved an alteration of the basic elements, as described in Section IV.E of this policy:

a. 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;

b. A description of any reasonably foreseeable risks or discomforts to the subject;

c. A description of any benefits to the subject or to others which may reasonably be expected from the research;

d. A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;

e. A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained;

f. 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;

g. An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject; and

h. 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.

See, 45 CFR 46.116(a)(1-8); 21 CFR 50.25(a)(1-8).

3. UW-Madison IRBs may also require, when appropriate, that one or more of the following additional elements of information will also be provided to each subject: [45 CFR 46.116(b)(1-6); 21 CFR 50.25(b)(1-6)]

a. a statement that the particular treatment or procedure may involve risks to the participant (or to the embryo or fetus, if the participant is or becomes pregnant) that are currently unforeseeable (e.g., when the research involves procedures that have limited experience in humans and in all research protocols that involve an investigational drug or device).

b. the anticipated circumstances under which the participant's participation may be terminated by the investigator without regard to the participant's consent (e.g., when the protocol describes situations where participants should be withdrawn from the research or if it is reasonable to expect that participants will be withdrawn from the research without their consent).

c. any additional costs to the participant that may result from participation.

d. the consequences of a participant's decision to withdraw from the research and procedures for orderly termination of participation by the participant (e.g., when withdrawal from the research might place a participant at risk of harm).

e. a statement that significant new findings developed during the course of the research that may relate to the participant's willingness to continue participation will be provided to the participant.

f. the approximate number of participants involved in the study (e.g., when a reasonable person would find the information useful in making a decision to participate in the research).

4. Information provided in the consent documents regarding the purpose, risks, and benefits of the research must be consistent with information in the application forms, protocol, and/or investigator’s brochure.

5. The consent form must set forth all information concerning payments to participants, including the amount and schedule of payments.

6. When appropriate, UW-Madison IRBs will require that the consent form include information required by state law.

See, Applying State Law in Human Subjects Research Policy.

7. When appropriate, UW-Madison IRBs will require that the consent form include information required by institutional policies.

For additional guidance on consent, see the following guidance documents:

Adventitious Findings Language

Consent Requirements for Image and Audio Recording (See, Section IV.B.8, below)

Genetic Research and Use of Storable Tissues

International Research

Oral Consent/Waiver of Documentation of Informed Consent

Research-Related Injury Language

Radiation-Related Risks Language

Reconsenting Subjects

Recruitment of Participants with Status Relationships

Research with Adult Subjects Lacking Capacity to Consent Policy

Waiver of Consent

8. For Veterans Affairs Medical Center (VAMC) research:

a. The consent process is required to disclose that in the event of a research-related injury the VAMC must provide necessary medical treatment to a participant injured by participation in a research study approved by a Department of Veterans Affairs (VA) Research and Development Committee and conducted under the supervision of one or more VAMC employees.

Except in limited circumstances, the necessary care must be provided in VA medical facilities. Exceptions include: situations where VA facilities are not capable of furnishing economical care; situations where VA facilities are not capable of furnishing the care or services required; and situations involving a non-veteran participant. Under these circumstances, VA medical center directors may contract for such care. This requirement does not apply to treatment for injuries that result from non-compliance by a participant with study procedures.

b. The consent process is required to explain the VA’s authority to provide medical treatment to participants injured by participation in a VA research study.

c. The consent process is required to include a statement that a veteran participant will not be required to pay for care received as a participant in a VA research project except in accordance with Title 38 United states Code (U.S.C.) 1710(f) and 1710(g). Certain veterans are required to pay co-payments for medical care and services provided by VA. Veterans receiving medical care and services from VA that are not rendered as part of the VA-approved research study, must pay any applicable co-payment for such care and services.

For additional information, see, VA Research Policies and Forms on the HS IRBs website: (http://info.gradsch.wisc.edu/research/compliance/humansubjects/hsirbs/2.va.html)

9. If the research involves the use of image or audio recording of participants, for research to be approved by the UW-Madison IRBs, the consent form should clearly state that fact and should include the following additional information:

a. how the recordings will be used

b. how long they will be kept

c. who will see/hear the recording

d. where the recording will be used (e.g., in a classroom, professional meeting).

e. For protocols reviewed by the SBS IRB, if the investigator wants permission for the recording to be viewed or heard by anyone other than the research staff, or, if it involves sensitive material, participants should also be given an opportunity to view, or listen to, the recording after it is completed, and permission for the tape to be used should then be obtained.

C. Documentation of Consent

1. When reviewing research, UW-Madison IRBs systematically evaluate whether the informed consent will be documented as required by the federal Common Rule [45 CFR 46.116] or, if applicable, the FDA regulations [21 CFR 50.25], ethical principles, local and state law and University policies.

2. UW-Madison IRBs require informed consent be documented by the use of a written consent form approved by the IRB and signed by the participant or the participant’s legally authorized representative, unless the IRB has approved a waiver of documented consent in accordance with Section IV.F of this policy.

3. When documentation of informed consent is required, all participants must sign and date the most current IRB-approved consent document. IRB approval will be documented by a stamp on the first page of the consent form that indicates the dates of IRB approval and expiration.

4. The consent form or script should be worded so that potential participants can understand it. A general recommendation is to use an eighth-grade reading level for the writing style, but investigators should adjust the language to an appropriate level for the particular participant population.

5. Consent must be documented in one of the following ways:

a. An IRB-approved written consent document that embodies the elements of informed consent required in 45 CFR 46.116(a)(1-8) and 21 CFR 50.25(a)(1-8).

i. Before the consent document is signed, the investigator must discuss the critical information that needs to be shared with the potential participant or legally authorized representative.

ii. The investigator must give the potential participant or legally authorized representative adequate time to read the consent document and ask questions before it is signed (and dated if it is FDA-regulated research). See, 45 CFR 46.117 and 21 CFR 50.27.

iii. A copy of the consent form must be given to the person signing the form.

b. An IRB-approved “short form” written consent document stating that the elements of informed consent required by 45 CFR 46.116(a)(1-8) and 21 CFR 50.25(a)(1-8) have been presented orally to the participant or the participant’s legally authorized representative. This is generally allowed only in the case of illiterate subjects, blind subjects or subjects with limited capacity to understand English. See, 45 CFR 46.117 and 21 CFR 50.27.

Use of the short form requires the following:

i. A witness to the oral presentation;

ii. An IRB-approved written summary of what is to be said to the participant or the representative;

iii. The participant or the representative must sign the short form (and date the form if the research is FDA-regulated);

iv. The witness must sign the short form and a copy of the summary;

v. The person obtaining consent must sign a copy of the summary; and

vi. A copy of the summary and a copy of the short form must be given to the participant or the representative.

6. Signatures on the consent forms should be placed immediately below the text of the form.

7. Each participant must be given a complete copy of the consent form.

8. Investigators must keep a copy of the signed consent form on file for seven years following the completion of the research.

See, IRB Record Retention Policy.

9. For Veterans Affairs Medical Center (VAMC) research:

a. Department of Veterans Affairs (VA) Form 10-1086 must be used for both the long and short forms of documentation of the informed consent process.

b. The IRB must approve the wording of the consent to be documented through the use of a stamp on each page of the VA Form 10-1086 that indicates the date of the most recent IRB approval of the document.

c. If the consent form for VAMC research was amended during the protocol approval period, the consent form must bear the approval date of the amendment rather than the date of the approved protocol.

d. The participant or participant’s legally authorized representative must sign and date the consent document.

e. A witness to the participant’s signature or the participant’s legally authorized representative’s signature must sign and date the consent document.

f. The person obtaining the informed consent must sign and date the consent document.

g. There must be a witness to the consenting process in addition to the witness to the participant’s signature and, if the same person serves both capacities, then a note to that effect must be placed under the witness’s signature line.

h. A copy of the signed informed consent document must be provided to the participant or the participant’s legal representative.

See, VA Handbook 1200.5.

D. Waiver of Requirement to Obtain Informed Consent

1. UW-Madison IRBs may grant a waiver of informed consent under 45 CFR 46.116 only when the IRB finds that research is not subject to FDA regulations and meets either of the following:

a. the required conditions stated in 45 CFR 46.116(c):

i. 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

ii. The research could not practicably be carried out without the waiver or alteration.

b. the required conditions stated in 45 CFR 46.116(d):

i. The research involves no more than minimal risk to the subjects;

ii. The waiver or alteration will not adversely affect the rights and welfare of the subjects;

iii. The research could not practicably be carried out without the waiver or alteration; and

iv. Whenever appropriate, the subjects will be provided with additional pertinent information after participation.

2. For research subject to the FDA regulations, a waiver of informed consent will be allowed only if research meets the criteria specified in 21 CFR 50.23, emergency use of a test article, or 21 CFR 50.24, planned emergency research. For more information, see UW-Madison’s Emergency Use of Test Articles Policy. See, also, FDA’s IRB Information Sheets - Updated 9/98.

3. A waiver of informed consent will not be granted solely for the convenience of the investigator.

4. When approving a waiver of informed consent, the IRB minutes will document the IRB’s justifications and findings regarding the determinations stated in 45 CFR 46.116(c), 45 CFR 46.116(d), 21 CFR 50.23 or 21 CFR 50.24 or the IRB’s agreement with the findings and justifications as presented by the investigator on IRB forms.

E. Approval of a consent process that does not include, or alters, some or all of the required elements of consent. [45 CFR 46.116(a)(1-8)]

1. UW-Madison IRBs may only approve an alteration of the required elements of consent when the IRB finds that research is not subject to FDA regulations and meets the required conditions stated in 45 CFR 46.116(c) or 45 CFR 46.116(d). See, Section IV.D, above, for the required elements.

2. An alteration of the required elements of informed consent will not be granted solely for the convenience of the investigator.

3. When approving an alteration of the elements of informed consent, the IRB minutes will document the IRB’s justifications and findings regarding the determinations stated in 45 CFR 46.116(c) or 45 CFR 46.116(d) or the IRB’s agreement with the findings and justifications as presented by the investigator on IRB forms.

F. Waiver of the requirement for investigator to obtain documentation of informed consent.

1. UW-Madison IRBs may only grant a waiver of documentation of informed consent under 45 CFR 46.117 when the IRB finds that the research is not subject to FDA regulations and meets either of the following conditions:

a. 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. 45 CFR 46.117(c)(1).

b. 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. 45 CFR 46.117(c)(2).

2. For research that is subject to FDA regulations, a waiver of documentation of informed consent will be approved only when the research meets either of the required conditions stated in 21 CFR 56.109(c)(1):

a. The IRB may, for some or all subjects, waive the requirement that the subject, or the subject's legally authorized representative, sign a written consent form if it finds 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 the research context; or

b. The IRB may, for some or all subjects, find that the requirements in 50.24 of this chapter for an exception from informed consent for emergency research are met.

3. A waiver of the requirement for documentation of informed consent will not be granted solely for the convenience of the investigator.

4. When approving a waiver of documentation of informed consent the IRB minutes will document the IRB’s justifications and findings regarding the determinations stated in 45 CFR 46.117(c)(1), 45 CFR 46.117(c)(2), or 21 CFR 56.109(c)(1) or the IRB’s agreement with the findings and justifications as presented by the investigator on IRB forms.

5. In cases in which the informed consent documentation requirement is waived, the IRB will determine whether written information regarding the research should be given to participants and, if so, will review the written information before it is given to the participants. 21 CFR 56.109(c)(1) and 45 CFR 46.117(C)(1 and 2).

V. Review of Consent Process on Continuing Review

A. Social and Behavioral Sciences IRB (SBS IRB) and Education Research IRB (ED IRB)

1. In the continuing review application, investigators are asked:

a. to submit a copy of the consent form (or script for oral consent) If participants are still being enrolled. If changes are being proposed in the consent form, to provide one copy with proposed changes underlined and one clean copy.

b. to describe any problems with or complaints from subjects

c. whether the investigator is continuing to use the same procedures exactly as previously described in the protocol.

d. to describe any proposed changes to the project procedures or the subject population since the IRB last approved the protocol (e.g. new research sites, changes in recruitment, or changes in subject population).

e. to provide any additional information that has developed and that would affect the risk or benefits to subjects participating in this research.

2. The IRB will review the consent form to assure that it contains all the required elements of consent just as on initial review and whether changes proposed on continuing review require changes in the consent form or process.

3. If reports of problems with or complaints from subjects, new information or proposed changes in protocol call for changes in the consent form or process, the IRB will require these changes to be made prior to approving the continuing review application.

4. Once the changes in the consent form are approved by the IRB, the investigator will receive a date-stamped copy of the approved consent form.

B. Health Sciences IRB (HS IRB) and Health Sciences Minimal Risk IRB (MR IRB)

1. In the application for continuing review, investigators are asked:

a. to submit a copy of the current consent form, and

b. to briefly summarize any adverse effects (physical, psychological, social) that were both serious and unexpected since the last continuing review and to explain whether the consent form or protocol require changes to include these adverse effects.

c. to summarize any new information affecting the risks, benefits, or alternatives to study participation that has developed since the last continuing review.

2. The IRB will review the consent form to assure that it is consistent with the most recently approved consent form and that no changes are proposed on continuing review that would require changes in the consent form or process.

3. If reports of unanticipated problems or new findings call for changes in the consent process or forms, the IRB will require these changes to be made prior to approving the continuing review application.

4. Once the changes in the consent form are approved by the IRB, the investigator will receive a date-stamped copy of the approved consent form.

VI. Review of Consent Process on Change of Protocol

A. SBS IRB and ED IRB

1. On application for a change of protocol, investigators are asked to:

a. Describe how the proposed changes to the project procedures or the subject population have changed since the IRB last approved the protocol

b. If changes in the consent form are proposed, provide one copy of the consent form with proposed changes underlined or highlighted and one clean copy.

c. provide any additional information that has developed and that would affect the risk to subjects participating in this research.

2. The IRB will review the consent form in the same manner as for the initial review (See, Section IV, above).

3. Once the changes in the consent form are approved by the IRB, the investigator will receive a date-stamped copy of the approved consent form.

4. If protocol changes or new information call for changes in the consent process or forms, the IRB will require these changes to be made prior to approving the change of protocol application.

B. HS IRB and MR IRB

1. In the application for change of protocol, investigators are asked:

a. If there are changes to the consent document(s), to submit one copy of the revised consent document(s) with changes highlighted and one clean copy of the revised consent document(s) with no highlighting.

b. to indicate whether proposed changes in the protocol will require a revision to the consent form (e.g., a change in the risk/benefit ratio).

c. if the proposed change represents a change in the subject population, the IRB will determine whether the consent document and process are appropriate for the new subject population.

c. whether proposed changes in the protocol will require already enrolled subjects to be reconsented. If so, the investigator must describe the reconsenting process. If not, the investigator must explain why reconsenting is not required.

2. The IRB will review the consent form in the same manner as for the initial review (See, Section IV, above).

3. Once the changes in the consent form are approved by the IRB, the investigator will receive a date-stamped copy of the approved consent form.

4. If reports of unanticipated problems or new findings call for changes in the consent process or forms, the IRB will require these changes to be made prior to approving the change of protocol application.

VII. Consent Process on Review of Reportable Incidents

A. Upon review of a report of noncompliance, an unanticipated problem, an adverse event, a change in an investigator drug brochure, or new research findings, UW-Madison IRBs will review the existing consent forms and process to determine whether changes are necessary to protect research participants and will require any changes to be made in order for the research to continue. For additional information, see, Noncompliance Policy and Unanticipated Problem Policy.

B. Reconsenting of already enrolled participants may also be required. See, HS IRBs Guidance on Reconsenting Subjects.

VIII. Special Consent Requirements for Vulnerable Groups

A. See, Review of Research Involving Vulnerable Groups Policy for additional consent requirements for the following vulnerable groups: