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 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
In This Section
- What Is The Requirement?
- Waiver of Consent
- How Do I Comply With This Requirement?
- Elements of Consent
- IRB Review of Consent Documents
- Ethical Considerations
- Remote Consent
- HIPAA Authorization
- Use of an Impartial Witness
- Including Participants Who Cannot Physically Sign and Date the Consent Document
- Including Participants Who Cannot Read
- Overcoming Language Barriers
45 CFR 46.111 (4) Informed consent will be sought from each prospective subject or the subject’s legally authorized representative, in accordance with, and to the extent required by, §46.116 General requirements for informed consent.
46.116(f)(3) Requirements for waiver and alteration. In order for an IRB to waive or alter consent as described in this subsection, the IRB must find and document that:
(i) The research involves no more than minimal risk to the subjects;
(ii) The research could not practicably be carried out without the requested waiver or alteration;
(iii) 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;
(iv) The waiver or alteration will not adversely affect the rights and welfare of the subjects; and
(v) 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:
- 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)
- Unplanned use of an investigational drug, device or biologic in an emergency (for more information click here)
Initial Review Application
On the Consent page, you will be asked “Which of the following are involved? (Check all that apply)”
- A written consent form signed by study participants
- IRB waiver of the requirements for signed consent form
- IRB approved waiver of consent
Select “A written consent form signed by study participants” 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 “IRB waiver of the requirements for signed consent form” to request for a waiver of documentation of consent. This means that potential research subjects (or their LAR) will be given information about the research and, after having appropriate amount of time to decide, will chose whether to enroll in the research, but they will NOT sign a consent document. The waiver of documentation process is often used in minimal risk research involving the administration of online or mailed surveys, telephone interviews, 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”.
Select “IRB approved waiver of consent” to indicate that there is no consent process for your research. This option 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 existing private identifiable data or specimens. When the data or specimens are not in existence at the time of the IRB submission, the IRB will expect the researcher to make every effort to obtain consent from research subjects for the use of data or specimen.
If you are requesting a waiver of the requirements for signed consent form or an IRB approved waiver of consent you will be asked to justify the waiver.
The UC Davis IRB has written standard operating procedures (SOPs) for consent process (HRP-090) and consent documentation (HRP-091). These SOPs are designed for use by researchers and provide the legal and ethical guidelines for consent process and consent documentation. You will be asked if you will follow HRP-090 and HRP-091.
You will be asked about the research setting and resources available. In these sections, describe where the consent process will take place and provide any information necessary regarding the setting or conditions under which research subjects will provide consent.
Consent Documents and Information Sheets
The UC Davis 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.
Unless the IRB waives one or more elements, the following information must be included in the informed consent document:
- For research involving a “medical experiment” (Health and Safety Code Section 24174), the California Experimental Subject’s Bill of Rights must be included.
- A statement that the study involves research
- An explanation of the purposes of the research
- The expected duration of the subject’s participation
- A description of the procedures to be followed
- Identification of any procedures which are experimental or investigational
- A clear description of any reasonably foreseeable discomforts or risks which the subject might encounter during participation in the research
- A clear description of any benefits to the subject or to which may reasonably be expected from the research – Note – compensation should not be included as a benefit
- A statement describing how confidentiality of records identifying the subject will be maintained
- – Note – if the research is subject to FDA jurisdiction, this section must include a statement that the FDA may inspect the records
- A statement that participation is voluntary and that the participant will not be penalized or lose benefits for refusing to participate
- A statement that the participant may withdraw or discontinue participation at any time without penalty or loss of benefit
- Where this is appropriate (usually where the experimental procedure involves treatment of some type), the consent form must include information about alternative procedures that would be of advantage to the subject
- For research involving more than minimal risk, an explanation as to whether any compensation or medical treatment is available if injury occurs
- An explanation about whom to contact for answers to questions about the research (Include individual’s title, email address and phone number)
- A statement that participants should call the IRB for questions about their rights as participants (Include IRB email address and phone number)
- An explanation about whom to contact if a research-related injury occurs to the subject (Include individual’s title, email address and phone number)
- If the research is a clinical trial that requires posting on clinicaltrials.gov, this statement must be included on the consent document: “A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.”
The following additional information must be provided to prospective participants, when applicable:
- For research investigating risks of a drug, device or procedure: 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 unforeseeable.
- If participants may be withdrawn from the research: Anticipated circumstances under which participation may be terminated by the investigator without regard to the participant’s consent.
- If participants will incur any costs if they participate: A description of the costs to the participant that may result from participation in the research.
- If participants will face risk when they withdraw from participation: The consequences of a subject’s decision to withdraw from the research and procedures for orderly termination of participation by the subject (i.e. the need to taper study drug, etc.)
- A statement that significant new findings obtained during the research which may relate to the subject’s willingness to continue participation will be provided to the subject.
- For most research: The approximate number of subjects involved in the study.
- For research which includes the collection and/or analysis of biospecimens, a statement that the subject will not be entitled to share in any profit derived from their specimens or derived from the data obtained from their specimens.
If the study is Federally-funded and initially approved by the IRB after January 21, 2019 or new Federal funding is received for an ongoing project after January 21, 2019, the following additional elements/structure will also be required:
- The informed consent must begin with a concise and focused presentation of key information that is most likely to assist a subject (or their LAR) in understanding why a person might or might not want to participate.
- The informed consent must be organized in such a way that it does not merely present isolated facts, but rather facilitates subject (or LAR) understanding of why a person might or might not want to participate.
- If the research will collect identifiable private information or biospecimens, one of the following statements is required:
- Identifiers might be removed from the information or biospecimens and after such removal the information or biospecimens could be used for future studies by the PI or other investigators without additional informed consent.
- Even if identifiers are removed from the information or biospecimens collected, they will not be used for future studies by the PI or other investigators.
Note – The IRB strongly suggests that investigators use statement a above so as not to limit themselves in the future.
The following additional information must be provided to prospective participants, when applicable:
- A statement regarding whether clinically relevant research results, including individual research results, will be disclosed to subjects, and if so, under what conditions.
- For research involving biospecimens, whether the research will (if known) or might include whole genome sequencing.
The potential research subjects must be able to understand the information presented in the consent document. Follow these guidelines to improve the readability of the consent document:
- Write at or below an 8th grade reading level
- Use short sentences; < 15 words
- Use the active form (first person)
- Use 12 point font
- Avoid jargon and acronyms
Format information to improve visual understanding by using:
- Bulleted lists
- White space
- US Government Plain Language Checklist
- KP Washing Program for Readability in Science & Medicine (PRISM)
- Presenting Information for Effective Communication (Video, PDF)
- OHRP: What’s New in Informed Consent: Revisions to the Common Rule (26:50)
The consent document must include accurate information. Compare the consent document to the protocol (and investigators brochure, when applicable) to ensure that procedures, risks and other information are correct, complete and consistent throughout all documents.
The IRB must approve your consent form before you use it. A stamped version of the approved consent forms will be provided in Reviews section of IRBNet.
If you make revisions to your protocol or if new risk information is obtained, you may need to revise the consent document so it is accurate and complete. According to Office for Human Research Protections (OHRP) Guidance, you cannot enroll participants into a study if the consent document is inaccurate or incomplete.
Whenever you revise the consent document, you must submit the revised version to the IRB as a modification and the IRB must approve the new version before the version can be used.
Unless otherwise instructed by the IRB in writing, you must use the most current approved version of the consent document when enrolling participants.
Obtaining consent is an ongoing process that involves much more than providing a document to a prospective participant and obtaining a signature. The requirement for consent is based on the principle of respect for persons, one of the three ethical principles governing human subjects research described in the Belmont Report. The principle of respect for persons requires that individuals be treated as independent agents who must be allowed to choose what will happen to them. According to the Belmont Report, there is widespread agreement that the consent process can be analyzed as containing three elements:
Researchers must provide adequate information about the research. The elements of consent outline the required information.
Researchers must ensure that potential participants understand the information provided to them before obtaining consent. The information provided during the consent process must be in a language the participant can understand. For more information on including non-English speaking speakers review the Overcoming Language Barriers guidance below. Researchers should carefully review the terminology used in the consent document to ensure that it is understandable and that scientific or other complex phrases are explained. During the consent process, the person obtaining consent should assess the participant’s understanding by asking the participant open-ended questions such as:
- Are we offering you your usual medical care or are we asking you to be in a research study?
- What is the purpose of the study?
- Tell me what will happen to you in this study.
- Tell me about the risks you will face if you join this study.
- Tell me about any benefits you could receive if you join this study.
- What will happen to you if you decide not to be in this study?
- Suppose you want to drop out of the study – when can you drop out?
It is the researcher’s responsibility to provide sufficient information so the subject can correctly answer questions similar to those listed above.
Participants’ agreement must be voluntary and free of coercion and/or undue influence. The consent process should be conducted by an individual not in an authority position over the potential participant because the potential participant might feel intimidated or coerced into participation. Likewise, the participant should not be made to feel threatened if he or she does not agree to participate.
To avoid undue influence, information must be provided in an unbiased manner without emphasis on potential benefits or compensation. The consent process should include no claims that an investigational drug or device is safe or effective for the purposes under investigation, or that the test article is equivalent or superior to any other drug, biologic or device. Participants must not feel unduly influenced into agreeing to participate or staying in a study when the participant does not want to continue.
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. Skype)
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.
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.
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.
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.
When a prospective participant is competent but cannot read because of blindness or other reason, you should:
- Ensure an impartial witness is present during the consent process
- Read the entire consent document to the prospective participant
- Answer all of the participant’s questions
- Ask the participant questions to assess comprehension
- Obtain agreement from the participant only after assessing that the participant comprehends the information in the consent document
- Obtain the signature (or mark) and date from the participant
- Obtain a signature and date from the witness
- Sign and date the consent document as the individual obtaining consent
- 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.
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.
When preparing your study for initial review, consider whether you may enroll individuals who cannot read the English consent document because their native language is not English.Generally, any research that holds the prospect of direct benefit should allow the enrollment of those unable to read English to ensure the principle of justice in subject selection for research is met. There are two processes available to enroll subjects who are unable to read English because it is not their native language:
- Translated Documents
- Short Form Process
If it is apparent that some or all of the participants in the research will not be able to read the English consent document, then the consent document should be translated into the participants’ native language so you will have a document ready for the consent process. If you do not anticipate enrolling subjects who are unable to read the English version of the consent document, the Short Form consent process can be used.
On the Consent Language page of the Initial Review Application you will be asked “Will you be enrolling participants who are unable to speak or read English?”. Mark “yes” to indicate you may enroll subjects using either translated consent documents or the short form process. You will then be asked for details about your plans for overcoming language barriers.
It is best practice is to submit English versions of all documents when applying for initial review. Once the English versions are approved, translated documents can be submitted as a modification. Translated documents must be submitted to the IRB and approved before use.
Greater than minimal risk studies: A professional or certified translation of the consent form(s) and recruitment material(s) is the best method for translation of documents for studies that pose more than minimal risk to subjects. For a professional translation, you must provide the qualifications of the individual who translated the informed consent documents and recruitment materials. Submit any credentials, certifications, education, native language fluency, etc. When UCD Health Systems Translation Services is used to translate documents, a statement to that effect is sufficient.
Minimal risk studies: The IRB will accept documents translated by an individual fluent (i.e., can speak, read and write) in a given language. The qualifications of the individual performing the translation will be assessed by the IRB. A letter from the translator describing his/her qualifications must be provided with the translated documents,. As noted above, include certifications, education, native language fluency, etc.
During the consent process, an interpreter should be present to help with explanations and answers to the participant’s questions. You should also plan for interpretation during the participant’s study visits and for emergencies, if applicable.
Short Form Consent Process
Sometimes an individual who cannot read English might qualify for your study and you do not have a translated consent document available. When such an event occurs, consider the options carefully. If there is sufficient time to obtain a translated consent document for the individual, you should not enroll this person until you obtain the translated document and obtain IRB approval. If there is insufficient time to obtain a translated consent document for this individual, enrollment should depend upon the risk benefit analysis. For example, if participation involves significant risk, then the participant should not be enrolled in the study unless there is a significant potential for benefit that would not otherwise be available to the individual.
If you decide to enroll an individual who cannot read the English version of the consent document, you should:
- Check your IRB application to see if you indicated you would enroll individuals who cannot read English. If you did not, you must submit a modification requesting approval to enroll the individual.
- Check the IRB’s website to see if a HRP-507 Short Form exists in a language the participant can read. Download the form. If there is not a Short Form available in a language the individual can read, contact the IRB Office.
- Ensure that the information in the consent document is accurately translated orally into a language the individual can understand. You should also ensure that you will have an ability to adequately communicate with the individual during study visits and and for emergencies.
- Obtain an impartial witness to observe the consent process.
- With the witness present, the consent form should be presented (read) orally to the individual in a language the individual understands. The individual’s questions should be answered and the person obtaining consent should ask questions of the individual through the translator to assess the individual’s comprehension.
- When you are certain the individual has adequate comprehension and is voluntarily agreeing to be in the study you must:
- Obtain the participant’s (or the participant’s LAR) signature and date on the Short Form;
- Obtain the witness’s signature (and date) on the Short Form and a copy of the consent document;
- The person obtaining consent must sign the consent document;
- Provide a copy of the Short Form and the consent document to the participant or the participant’s LAR;
- Document the following in the research record:
- A statement indicating that informed consent took place by using the Short Form consent process;
- A qualified translator was available during the process;
- An impartial witness observed the consent process;
- The participant (or LAR) apparently understood the information and voluntarily agreed to participate;
- A copy of the Short Form and consent document were provided to the participant and LAR;
- The time and date the process took place.
Informed Consent means a research subject’s voluntary agreement to participate in research.
Informed Consent Form (ICF) is a written document that provides research subjects with all necessary information to make an informed choice regarding participation in research.
Legally Authorized Representative (LAR) is an individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject’s participation in the procedure(s) involved in the research.