This policy describes how the UW-Madison IRBs evaluate the adequacy of informed consent documents and process in non-exempt human participants research.
The University of Wisconsin-Madison follows applicable federal regulations and state laws governing informed consent and requires investigators conducting non-exempt human subjects research to obtain legally effective written documentation of informed consent from each prospective participant or the participant’s legally authorized representative, unless the IRB has granted a waiver of informed consent or a waiver of documentation of informed consent.
UW-Madison IRBs consider the informed consent process to begin when a potential research participant or the participant’s legally authorized representative is first contacted.
The nature and circumstances of the informed consent process and the consent documentation described in the IRB application or other documentation must:
Provide sufficient opportunity for potential participants (or their legally authorized representatives) to consider research participation.
Minimize the possibility of coercion or undue influence of potential participants and representatives.
Use language understandable to each potential participant or representative.
Contain no exculpatory language through which the potential participant or their 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.
Study teams should be sensitive, throughout the conduct of the research, to the participants' (or their legally authorized representatives’) understanding of the project and willingness of the potential participant to enroll in the research .
New findings or changes made during the course of a research study may require the re-consenting of study participants (or their legally authorized representatives).
The Consent Process
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):
The nature and circumstances of the consent process in addition to the content of the consent document(s).
The qualifications and training of those who will conduct the consent process.
The timing of obtaining informed consent and any waiting period (between informing the participant or participant’s representative and obtaining the consent) that will be observed.
Where the consent process will take place.
Whether the consent form or script is worded so that potential participants (or their representatives) can understand it. The language should be adjusted to an appropriate level for the particular participant population.
The degree to which a participant can be included in the process based on the participant’s capacity to provide informed consent.
When a potential participant’s understanding of the research may be adversely affected due to any of the above factors, the IRB will determine how the consent process can be structured to mitigate those effects.
Additional requirements for the consent process in regard to individuals with impaired decision-making capacity and for minors are outlined in the Research with Adult Participants Lacking Capacity to Consent and Review of Research Involving Vulnerable Participants Policies, respectively.
The person obtaining informed consent must provide the prospective participant (or the participant’s legally authorized representative) with the information a reasonable person would want to have in order to make an informed decision about whether to participate in the research and an opportunity to discuss that information.
Informed consent must begin with a concise and focused presentation of the key information that is most likely to assist a prospective participant (or participant’s legally authorized representative) in understanding the reasons why one might or might not want to participate in the research.
The informed consent process as a whole must present information in sufficient detail relating to the research, and must be organized and presented in a way that does not merely provide lists of isolated facts, but rather facilitates the prospective participant’s (or participant’s legally authorized representative’s) understanding of the reasons why one might or might not want to participate.
The consent form or script should be worded so that potential participants (or the participants’ legally authorized representative) can understand it. The language should be adjusted to an appropriate level for the particular participant population.
The investigator, or designee, must give the potential participant or legally authorized representative adequate time to read any applicable consent documents and ask questions before agreeing to participate in the research.
When the IRB requires written consent or for study teams to provide written information to participants (or their legally authorized representatives) in lieu of a signed consent form (e.g., information sheet), a copy of any applicable consent form or associated document must be given to the person providing informed consent.
When reviewing research, UW-Madison IRBs systematically evaluate whether informed consent will be documented as required by the federal, local and state law, University policies, and, if applicable, FDA regulations.
UW-Madison IRBs require informed consent to 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.
When documentation of informed consent is required, all participants (or the participant’s legally authorized representative) must sign and date the most current IRB-approved consent document.
IRB approval and consent form version generally will be documented by a stamp at the bottom of each page of the consent form and required for consent forms that fall under VA regulations.
Signatures on the consent forms should be placed immediately below the text of the form.
Each participant must be given a complete copy of the consent form which may be printed or electronic.
Study teams must keep an entire copy of the signed consent form on file for seven years following the completion of the research.
Informed consent may be documented by the following methods:
A signed document, including a signature in an electronic format.
Research that falls under FDA purview must comply with FDA guidelines and requirements for electronic documentation of informed consent.
An IRB-approved “short form” written consent document stating that the elements of informed consent required by 45 CFR 46.116(b)(1-9) 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. Use of the short form requires the following:
A witness to the oral presentation;
An IRB-approved written summary of what is to be said to the participant or the representative;
The participant or the representative must sign and date the short form;
The witness must sign and date the short form and a copy of the summary;
The person obtaining consent must sign and date a copy of the summary; and
A copy of the summary and a copy of the short form must be given to the participant or the representative.
When permitting the use of broad consent for federally funded research that does not fall under FDA regulations, the UW-Madison will follow the definitions and requirements related to broad consent outlined in the Common Rule, including the restrictions on waivers and alterations of informed consent.
Consent Form Content
The IRB-approved written consent document must include the required elements of informed consent outlined in the Common Rule and FDA regulations, including Good Clinical Practice, unless the IRB approves an alteration of informed consent or documents that the element is not applicable to the research study (e.g., compensation for injury language).
Additional elements described under the Common Rule and FDA regulations, when appropriate.
If other federal policies apply, such as the NIH Certificates of Confidentiality Policy or a study must be posted at clinicaltrials.gov, the consent form may need to include additional language as required by those federal policies.
The informed consent document must provide the prospective participant (or the participant’s legally authorized representative) with the information a reasonable person would want to have in order to make an informed decision about whether to participate in the research and an opportunity to discuss that information.
The informed consent document must begin with a concise and focused presentation of the key information that is most likely to assist a prospective participant (or participant’s legally authorized representative) in understanding the reasons why one might or might not want to participate in the research.
Informed consent as a whole must present information in sufficient detail relating to the research, and must be organized and presented in a way that does not merely provide lists of isolated facts, but rather facilitates the prospective participant’s (or participant’s legally authorized representative’s) understanding of the reasons why one might or might not want to participate.
The IRB may require that additional information be given to participants (or their legally authorized representatives) when, in the IRB’s judgement, the information would meaningfully add to the protection of the rights and welfare of the participants.
Informed Consent for Screening, Recruiting, or Determining Eligibility
An IRB may approve a research proposal in which a study team will obtain information or biospecimens for the purpose of screening, recruiting, or determining the eligibility of prospective subjects without the informed consent of the prospective subject or the subject’s legally authorized representative, if either of the following conditions are met:
The study team will obtain information through oral or written communication with the prospective subject or legally authorized representative, or
The investigator will obtain identifiable private information or identifiable biospecimens by accessing records or stored identifiable biospecimens.
Alterations or Waivers of Informed Consent
IRBs may waive or alter informed consent under 45 CFR 46.116 (or, if applicable, 38 CFR 16.116) and FDA guidance only when the IRB finds that research meets either of the following:
The required conditions stated in 45 CFR 46.116(e) (or, if applicable, 38 CFR 16.116(e)):
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.
The required conditions stated in 45 CFR 46.116(f) or, if applicable, 38 CFR 16.116(f):
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;
For research subject to the Common Rule, if the research involves using identifiable private information or identifiable biospecimens, the research could not practicably be carried out without using such information or biospecimens in an identifiable format.
The research could not practicably be carried out without the waiver or alteration; and
Whenever appropriate, the subjects will be provided with additional pertinent information after participation.
A waiver or alteration of informed consent will not be granted solely for the convenience of the investigator.
If informed consent was obtained pursuant to the broad consent provision in the Common Rule, the IRB cannot waive or alter consent for the storage, maintenance or secondary research use of the identifiable private information or identifiable biospecimens.
For research subject to FDA regulations, a waiver of informed consent will also be allowed 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 research subject to the Family Educational Rights and Privacy Act (FERPA):
A waiver of informed consent to access personally identifiable information from student education records will be allowed only under the following circumstances:
The information is student “directory information,” as defined in 34 CFR 99.3, or
The information is not student “directory information,” as defined in 34 CFR 99.3, but the request meets the requirements of 34 CFR 99.31(a)(6)(i), in that the disclosure is to organizations conducting studies for, or on behalf of, educational agencies or institutions to: (A) develop, validate or administer predictive tests; (B) administer student aid programs; or (C) improve instruction.
The disclosure of student education records must be to authorized representatives of the Secretary of the Department of Education or of State and local educational authorities in connection with an audit or evaluation of Federal or State supported education programs, as required by 34 CFR 99.31(a)(3).
Waiver of the Requirement to Obtain Documentation of Informed Consent
UW-Madison IRBs may only grant a waiver of documentation of informed consent under 45 CFR 46.117 (or, if applicable, 38 CFR 16.117) and according to FDA guidance when the IRB finds that the research meets any of the following conditions:
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.
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.
For research that does not fall under FDA regulations, the IRB determines, in consultation with the study team and others as applicable, that the participants or participants’ legally authorized representative are members of a distinct cultural group or community in which signing forms is not the norm, the research presents no more than minimal risk of harm to participants, and there is an appropriate alternative mechanism for documenting that informed consent was obtained.
For research that is subject to FDA regulations, a waiver of documentation of informed consent also can be approved when the IRB finds, for some or all subjects, that the requirements in 50.24 of this chapter for an exception from informed consent for emergency research are met.
A waiver of the requirement for documentation of informed consent will not be granted solely for the convenience of the investigator.
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.
Withdrawal of Consent in Research that is Subject to FDA Regulations
When a participant withdraws from a study, any data collected about the participant, up to the time of withdrawal, remains part of the study database and may not be removed. The consent document cannot give the participant the option of having data removed.
An investigator may ask a participant who is withdrawing whether the participant (or legally authorized representative) wishes to provide continued follow-up and further data collection subsequent to their withdrawal from the interventional portion of the study. Under this circumstance, the discussion with the participant should distinguish between study-related interventions and continued follow-up of associated clinical outcome information, such as medical course or laboratory results obtained through non-invasive chart review, and should address the maintenance of privacy and confidentiality of the participant’s information.
The investigator must obtain the participant’s (or the participant’s legally authorized representative’s) consent for this limited participation in the study (assuming such a situation was not described in the original consent document). The IRB must approve the consent document.
If a participant withdraws from the interventional portion of a study and does not consent to continued follow-up of associated clinical outcome information, the investigator must not access for purposes related to the study the participant's medical record or other confidential records requiring the participant’s consent. However, an investigator may review study data related to the participant collected prior to the participant 's withdrawal from the study, and may consult public records, such as those establishing survival status.
Posting of Clinical Trial Consent Forms
For federally funded studies that meet the definition of a clinical trial, one IRB-approved consent form used to enroll subjects must be posted to a publicly available website identified by OHRP.
The informed consent form must be posted after the trial is closed to enrollment, but no later than 60 days after the last study visit by any subject.
Research Subject to the European Union’s General Data Protection Regulation (GDPR)
Research that collects personal data about individuals residing in countries that have adopted GDPR must comply with GDPR requirements. Additional requirements for the consent process for research that is subject to GDPR are outlined in UW-Madison’s guidance titled "The European Union (EU) General Data Protection Regulation (GDPR)."