Informed Consent Documentation

Obtaining informed consent is a basic ethical obligation and a legal requirement for researchers unless the IRB issues a waiver of informed consent.  The requirement for informed consent is one of the central protections of human subjects, defined by:

  • Department of Health & Human Services (HHS) regulations at 45 CFR part 46
  • Food and Drug Administration (FDA) regulations at 21 CFR part 50
What Is the Requirement?

45 CFR 46.117 (a) Except as provided in paragraph (c) of this section, informed consent shall be documented by the use of a written informed consent form approved by the IRB and signed (including in an electronic format) by the subject or the subject’s legally authorized representative. A written copy shall be given to the person signing the informed consent form.

Waiver of Consent

Per 445 CFR 46.116, in order for an IRB to waive or alter consent, the IRB must find and document:

  1. The research involves no more than minimal risk to the subjects;
  2. The research could not practicably be carried out without the requested waiver or alteration;
  3. 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;
  4. The waiver or alteration will not adversely affect the rights and welfare of the subjects; and
  5. Whenever appropriate, the subjects or legally authorized representatives will be provided with additional pertinent information after participation.

Requirement (ii) is met when:

  1. it will not be possible to obtain informed consent from participants because the research is not engaging in interactions or interventions with participants and it is not possible to obtain consent through other means; or
  2. in the rare circumstances when bias will be introduced into the results unless data about all eligible participants is required.
Waiver of Consent for FDA Regulated Research

In addition to the waiver of consent allowed for minimal risk research, the FDA regulations allow research involving humans to take place under the following conditions:

  1. Planned research in emergency situations when there is no time to obtain informed consent – Emergency Exemption from Prospective IRB approval for Investigational Drug, Biologics, and Devices (for more information click here)
  2. Unplanned use of an investigational drug, device or biologic in an emergency (for more information click here)
Waiver of Consent for Screening, Recruitment, or Determining Eligibility

The IRB may waive the requirement consent specifically for the purposes of screening, recruiting, or determining eligibility. An investigator may obtain information or biospecimens for such purposes without the informed consent of the prospective subject or the subject's legally authorized representative, if either of the following conditions are met:

  1. The investigator will obtain information through oral or written communication with the prospective subject or legally authorized representative, or
  2. The investigator will obtain identifiable private information or identifiable biospecimens by accessing records or stored identifiable biospecimens.
Waiver of Documentation of Consent (e.g., Oral Consent)

The IRB may waive the requirement for the investigator to obtain a signed informed consent form if it finds any of the following:

  1. That the only record linking the subject and the research would be the informed consent form and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject (or legally authorized representative) will be asked whether the subject wants documentation linking the subject with the research, and the subject's wishes will govern;
  2. 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; or
  3. If the subjects or legally authorized representatives are members of a distinct cultural group or community in which signing forms is not the norm, that the research presents no more than minimal risk of harm to subjects and provided there is an appropriate alternative mechanism for documenting that informed consent was obtained.

In cases in which the documentation requirement is waived, the IRB may require the investigator to provide subjects or legally authorized representatives with a written statement regarding the research

How Do I Comply With This Requirement?
Initial Review Application

On the Consent page, you will be asked “Which of the following are involved? (Check all that apply)”

  • Signed Informed Consent: Research subjects will be informed about the research and will sign a consent document prior to enrolling in the research.
  • Information Sheet or Oral Consent: Research subjects will be informed about the research and will agree to participate but will not sign a consent document. Appropriate for some exempt research or with an IRB issued Waiver of Documentation of Consent.
  • No consent process: Research subjects will not be informed about research and will not have an opportunity to agree to participate. Appropriate for some exempt research or under an IRB issued Waiver of Consent.

Select “Signed Informed Consent” to indicate that potential research subjects (or their LAR) will be given information about the research and, after having an appropriate amount of time to decide, will sign a consent document if they choose to enroll in the research. This is appropriate for all greater than minimal risk research and for minimal risk research that does not qualify for a waiver of documentation.

Select “Information Sheet or Oral Consent” if potential research subjects (or their LAR) will be given information about the research and, after having appropriate time to decide, will chose whether to enroll in the research, but they will NOT sign a consent document. The information may be presented orally or in writing. This process is appropriate for some exempt research or when research qualifies for a waiver of documentation of consent. This is often used for research involving interviews, online surveys, or when anonymous sensitive information is collected, and you do not want any paperwork that links the subject to the research study. Note that this is not the same as electronic signature of consent. See additional guidance under “Documentation of Consent”.

If you select “Information Sheet or Oral Consent” you will be asked for the following study details.

  • Does this research involve any procedures for which written consent is usually required? For example, surgery, imaging, release of educational records, etc.
  • Is the consent document the only document linking the participant to the research?
  • Are the research subjects members of a distinct cultural group or community in which signing forms is not the norm?

Select “No consent process” to indicate that there is no consent process for your research. This means that research subjects (or their LAR) will not receive information about the research and will not decide whether to participate. Generally, this option is only used for secondary analysis of private identifiable data or specimens.

If you select “No consent process” you will be asked if any of the following are true. Select all that apply.

  • The research team will have no direct contact with potential research subjects.
  • Obtaining consent could pose a risk to subjects’ privacy, physical safety, or psychological wellbeing.
  • Failure to obtain a complete or representative data set would prevent this study from drawing reliable conclusions.
  • Other
Consent Documents and Information Sheets

The Einstein IRB provides several template consent documents for your use. Download any template and customize the details to describe your specific research. These templates contain standard language and instructions to assist researchers in providing potential subjects all necessary information for a complete consent process. For each new study, the IRB must confirm that all elements of consent are present in the informed consent form.

Remote Consent

While the elements of consent are consistent for research, the setting in which consent is obtained varies depending upon the study. There are times when an in-person consent process is not feasible. In these cases, the IRB will consider if a remote consent process is appropriate and acceptable.

Telephone Consent and Consent Using Facilitated Technology (e.g. Zoom)

Research does not need to be specifically approved for telephone consent; however, the research team must ensure they have resources to obtain a signed consent form prior to the research subject completing any study related activities unless the study has been granted a waiver of documentation of consent. When consent is done remotely, the requirements are the same as if the research team were conducting the consent process in person. The research subject or LAR should be provided a copy of the consent document. After having the research team provide the potential subject or LAR information about the study, the subject/LAR should have an opportunity to ask questions and be given adequate time to make an informed decision about participation.

Faxing of Signed Consent Forms

When consent is conducted over the phone or using facilitated technology (e.g. Skype), it is permissible for subjects to fax a signed copy of the consent form to the research team. If there are questions and/or check boxes embedded throughout the document for the subject to complete, the research team should check to ensure that these pages are included. Good Clinical Practice (GCP) or other guidelines may require that the study team receive a complete copy of the signed consent form. In cases where subjects are faxing a consent form to the research team, the subject need not provide the investigator with the original signed consent document.

Online Consent

For web-based surveys or questionnaires, the consent form may be presented online, and require participants to perform some action, such as clicking “I agree,” before proceeding with any research activities (e.g., answering survey questions on a website). This is an acceptable approach for minimal risk research conducted online. However, be aware that this method does not document informed consent and therefore may only be used if the IRB has waived documentation of consent for the study.

For research that poses more than minimal risk, the research team should consider how they will be able to evaluate a subject’s understanding of the procedures and risks related to their participation. Tools to evaluate this understanding could include a comprehension quiz requiring a score of 100% in order to proceed, or the provision of contact information of a member(s) of the study team, in order to enable direct communication for subjects who have questions or concerns, among other options.

Confirming Identities in Online Research

A study’s data validity or reliability could be fallible without verifying subjects’ identities. Examples include when there are critical eligibility criteria, or when there is a likelihood of repeat or fraudulent participation, whether for mischief or to collect multiple payments. When designing a research study, investigators should take into consideration the importance of identity to their study.

Studies that pose more than minimal risk, or that involve the transmission of sensitive information, may consider implementing a process by which they confirm identities using authentication that relies upon multiple factors, for example a password that is delivered to subjects by telephone or by postal service, or by using identity verification software.

For FDA-regulated studies, if any or all of the consent process takes place remotely and is not personally witnessed by study personnel, the electronic system must include a method of identity verification. Acceptable examples include state-issued ID, biometric methods, visual methods, or personal questions.

HIPAA Authorization

If the research includes access to or use of private health information (PHI), you might also need to obtain the individual’s HIPAA authorization. HIPAA authorization is separate from consent for participation in research and a separate signed authorization from is required. Do not submit the HIPAA authorization form to the IRB for approval.

Sometimes the IRB can waive the requirement for a signed authorization form.

Use of An Impartial Witness

ICH Good Clinical Practice (GCP) defines an Impartial Witness as “a person, who is independent of the trial, who cannot be unfairly influenced by people involved with the trial, who attends the informed consent process if the subject or the subject’s legally acceptable representative cannot read, and who reads the informed consent form and any other written information supplied to the subject.” This definition contains four parts, all of which must be met. Here they are presented separately for emphasis and analysis:

  • “Who is independent of the trial:” This could be a person who is a family member. It would not be a member of the site staff involved with the study.
  • “Who cannot be unfairly influenced by people involved with the trial:” This would be a person free from potential coercion or undue influence or conflicted interest.
  • “Who attends the informed consent process if the subject or the subject’s legally acceptable representative cannot read:” This emphasizes the participation of the witness throughout the consent process, not just when the subject signs. A robust informed consent process will likely result, on the part of the person obtaining consent.
  • “Who reads the informed consent form and any other written information supplied to the subject:” This responsibility has the witness confirming the subject was presented sufficient information to assure truly informed consent of the subject.
Including Participants Who Cannot Read

When a prospective participant is competent but cannot read because of blindness or other reason, you should:

  1. Ensure an impartial witness is present during the consent process
  2. Read the entire consent document to the prospective participant
  3. Answer all of the participant’s questions
  4. Ask the participant questions to assess comprehension
  5. Obtain agreement from the participant only after assessing that the participant comprehends the information in the consent document
  6. Obtain the signature (or mark) and date from the participant
  7. Obtain a signature and date from the witness
  8. Sign and date the consent document as the individual obtaining consent
  9. These statements should be included in the research record:
    • A statement indicating that informed consent took place;
    • A statement indicating the participant (or LAR) could not read the consent document and the document was read to the participant in the presence of an impartial witness;
    • The participant (or LAR) apparently understood the information and voluntarily agreed to participate;
    • A copy of the signed and dated consent document was provided to the participant or LAR;
    • The time and date the process took place.
Including Participants Who Cannot Physically Sign and Date the Consent Document

In rare instances, a potential participant may be competent to provide consent but may not be able to sign and date the consent document because of a physical impairment. In these instances, you should conduct the consent process in the presence of an impartial witness who will attest that the participant comprehended the information and agreed to participate but was unable to sign and date the consent document. You should also document the consent process and include a statement indicating the reason for the participant’s inability to sign the document and a statement that an impartial witness was present during the process.

Consent Forms for Non-English Speaking Research Subjects

Unless written consent has been waived as a requirement for the study, the subjects who do not speak English must be provided with:

  • A written consent document in a language understandable to them, and
  • An interpreter fluent in both English and the subject’s spoken language to aid in the consent process (Note: The interpreter should sign and date the consent form. For greater than minimal risks studies, the time should be included as well.)

Depending upon the research, the written consent document can be either a translation of the entire English version of the IRB approved consent document, or a “short form” consent document stating that the elements of consent have been fully presented orally. For more information on the short form process related to non-English speaking subjects, please refer to the document “Short Form Procedure for NonEnglish Speaking Subjects.”

A fully translated consent form is required for studies that anticipate enrolling more than 5 subjects speaking the same non-English language. A fully translated consent form is also required once 5 subjects speaking the same non-English language have been enrolled via the short form procedure.

If a study has the potential for direct benefit to subjects, it should not exclude non-English speaking subjects. If you will exclude non-English speaking subjects, you must provide justification in the IRB application.

Examples of situations that require a translated consent form:

  • The investigator is targeting a non-English speaking group
  • Research will be done in a foreign country
  • The investigator anticipates that more than 5 subjects who speak the same non-English language will want to enroll in the study

Translations can be obtained through a translation service of the investigator’s choice. An “Affidavit of Accuracy” is required. Alternatively, the translation can be prepared “in house.” This method requires that one individual translate the document into the appropriate language and another individual convert the translated document back into English. The two English documents can then be compared side by side for accuracy and completeness. For the “in house” translation, both the translated and back-translated consent forms must be submitted to the IRB, along with the names and qualifications of the individuals involved in the process.

Since any changes made by the Einstein IRB to the submitted English version of the informed consent document must be included in the translation of the informed consent document, investigators are advised to have the translation completed after Einstein IRB approval of the English version of the informed consent document.

Posting Clinical Trial Consent Forms to a Federal Website

For each clinical trial conducted or supported by a Federal department or agency that received initial IRB approval on or after January 21, 2019, one IRB-approved informed consent form used to enroll subjects must be posted on either ClinicalTrials.gov or Regulations.gov.

The informed consent form must be posted after the clinical trial is closed to recruitment, and no later than 60 days after the last study visit by any subject, as required by the protocol.