To ensure an effective informed consent process, the Institutional Review Board (IRB) and investigators comply with all applicable federal regulations (e.g., 21 CFR 50, 45 CFR 46.116, 117, and 38 CFR 16.116, 117). These regulations mandate the inclusion of eight basic informed consent elements (described below). Six additional elements may be required, depending on the nature of the research. IRB policy also specifies the information to include in the consent process. 

The informed consent template included in the full and expedited IRB applications outlines the required elements of informed consent. The investigator may use a short form if approved by the IRB in accord with applicable federal requirements.

Informed Consent -- an ongoing educational process that takes place between the investigator and prospective subject, allowing the investigator and the participant to exchange information and ask questions.

Consent -- the act of agreement and is only valid if the person providing consent has been fully informed, possesses the cognitive ability to understand what is being agreed to and also possesses the ability to self determine and is of the legal age or disposition to do so. The term is also used to refer to the consent form itself. 

Assent -- an affirmative agreement of a child or an individual with impaired consent capacity to participate in research. Mere failure to object should not, absent affirmative agreement, be construed as assent. 

Permission -- the agreement of parent(s) or guardian to the participation of their child or ward in research or clinical investigation. Permission includes the element of consent set forth in federal regulations and outlined in the informed consent template included in the IRB expedited and full review applications. 

In Virginia, the terms child or children refer to all individuals under 18 years of age unless the individual(s) is legally emancipated. (See section Emancipated Individuals for details of Virginia state law.) Individuals under 18 years of age who are not emancipated meet the federal definition for child [e.g., Department of Health and Human Services (DHHS), Food and Drug Administration (FDA), and U.S. Department of Education]. 

Legally Authorized Representative (LAR) -- an individual who has the authority to make research participation decisions on behalf of another. In accord with state law and federal regulation, individuals who can serve as legally authorized representatives are as follows: 

1. Permission and/or authorization by a legally authorized representative for children
   1. Consistent with Virginia health care decision statutes for choosing an LAR for children, the following responsible parties in the order of priority listed shall be authorized to make research participation decisions on behalf of the child:
      1. the judicially appointed guardian of the person, if the guardian has been appointed and if the decisions to be made under the consent are within the scope of the guardianship;
      2. the parent of the child.
2. Permission and/or authorization by a legally authorized representative for individuals with impaired consent capacity
   1. Consistent with Virginia health care decision statutes for choosing a legally authorized representative for adult subjects unable to consent, one of the following responsible parties, in the following order of priority (if no individual in a prior class is reasonably available, willing, and competent to act), is authorized to make research participation decisions on behalf of the person:
      1. the judicially appointed guardian of the person, if the guardian has been appointed and if the decisions to be made under the consent are within the scope of the guardianship;
      2. the attorney-in-fact named in a durable power of attorney, if the durable power of attorney specifically includes authority for the decisions to be made under the consent;
      3. the spouse of the person;
      4. an adult child of the person, or if the person has more than one (1) child, the majority of the adult children who are reasonably available for consultation;
      5. the parents of the subject;
      6. the nearest living relative, or if more than one of the same relation, a majority of the nearest living relatives. 

In Virginia, a guardian is an individual who may serve as an LAR as defined above. These individuals must meet the federal definitions for guardian.

Consent by an LAR should involve all the same considerations that informed consent from a competent subject involves. 

In order to obtain true informed consent requires that the potential subject understands the information shared with them about the research study and is able to make a decision based on what is best for themselves. 

The Teach-back method is a proven method to verify the subject understands the information about the study before enrolling. 

For more information, see the Teach-back website.

Principal Investigators are responsible for maintaining original copies of consent/authorization forms signed by subjects, in a secure location, along with the study records until completion of the research and longer, in accordance with state and federal regulations for record retention and the funding source or sponsor requirements. 

Please reach out to UVA Records and Information Management for current storage requirement on research record retention timeframes. 

Additionally, the UVA Records and Information Management office must approve the destruction of study records prior to implementation.

If the study might affect the clinical care of the subject a copy of the informed consent document must be placed in the subject's medical record in accordance with Virginia state and local government regulations. 

In cases where Principal Investigators transfer their research programs to other institutions, the disposition of consent/authorization forms must be discussed with the IRB administrative staff.

Consider the experience of the participant: Are the participants aware that they are participating in a research study? 

If not, then consent has been waived.

The Common Rule (45 CFR 46) allows the IRB to approve a waiver, or an alteration, of the requirement for informed consent to the research if the proposed protocol meets the following specific criteria found at 45 CFR § 46.116(d): 

1. The research involves no more than minimal risk to the privacy of the subjects.
2. The research could not practicably be carried out without the waiver or alteration.
3. The research could not practicably be conducted without access to and use of this identifiable protected health information.
4. Whenever appropriate (generally, when there is a health justification), the subjects will be provided with additional pertinent information after participation. 

Additional HIPAA Criteria 

The protocol must include, at a minimum, the following elements: 

1. An adequate plan to protect identifiers from improper use and disclosure.
2. An adequate plan to destroy the identifiers at the earliest opportunity consistent with conduct of the research, unless there is a health or research justification for retaining the identifiers or such retention is otherwise required by law; and
3. Adequate written assurances that the protected health information will not be reused or disclosed to any other person or entity, except as required by law, for authorized oversight of the research study, or for the research for which the use or disclosure of protected health information would be permitted. 

If the study is regulated by the FDA (involves use of food, drug, biologics or devices), the IRB cannot grant a waiver of consent. 

The only exceptions are for emergency use of a test article (see FDA 21 CFR 50.23) or planned emergency research (see FDA 21 CFR 50.24).

Consider the experience of the participant: 

If the participant is given all the relevant information, but a written consent document is not signed, then this is an example of a study design where the documentation of consent has been waived by the IRB. 

In these cases, where consent is obtained without a signature, the participant has been asked for consent verbally or to demonstrate that they give their consent through action, like clicking forward on an online survey. 

If you propose to obtain informed consent for the research activity without obtaining the subject’s signature on a consent form you are requesting a waiver of documentation of consent. Waiving the requirement for a written form does not eliminate the requirement for informed consent. Subjects must be informed of the nature of the research, and their consent (or the consent of their legal representatives) must be obtained whenever appropriate. This type of waiver is useful for some telephone or internet surveys, questionnaires, or when signing the consent document could have a negative consequence for the subject. 

The IRB will require the use of an Information Sheet to be given to the potential subject or an oral script to be read to the potential subject. Investigators will use the information sheet or script to guide them through the informed consent discussion/process. You will not need to obtain the subject’s signature on a consent form. The script or information statement must be provided to the IRB at the time of original protocol submission for review and approval. The PI and/or research staff will document the participant's consent, as well as date, and the name of the person conducting consent in the study files. 

In addition to describing the study, the script or information sheet must contain the basic elements of informed consent, as referenced in 45 CFR 46.116(a) and 21 CFR 50.25. 

The script or information sheet should include the following information:  

• State that the study involves research
• Explain the purposes of the research and the expected duration of the subject's participation
• If applicable: describe any foreseeable risk or discomforts to the subject
• If applicable: describe any benefits to subjects or to others that may reasonably be expected from the research
• If applicable: disclose alternatives
• Describe the extent to which confidentiality of records identifying subjects will be maintained, where the records will be stored and who will have access to them
• Provide contact information for answers to pertinent questions about the research, and participants' rights
• Include that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which participants are otherwise entitled, and also that participants may discontinue participation at any time without penalty or loss of benefits to which they are otherwise entitled

According to 45 CFR 46.117(c), an IRB may waive the requirement for the investigator to obtain a signed consent form for some or all subjects if it finds either: 

• Research presents no more than minimal risk* 

AND 

• Research involves procedures that do not require written consent when performed outside of a research setting 45 CFR 46.117(c)(2)

*Definition of Minimal Risk 

An individual is considered to be at more than minimal risk if exposed to the possibility of harm -- physical, psychological, social, legal, or other -- as a consequence of participation as a human subject in any research activity which departs from the performance of routine physical or psychological examinations and tests, or which departs from established and accepted procedures necessary to meet the individual's needs, or which increases the probability or magnitude of risks ordinarily encountered in daily life. 

OR 

45 CFR 46.117(c)(1) 

• Principal risks are those associated with a breach of confidentiality concerning the subject’s participation in the research 

AND

• Consent document is the only record linking the subject with the research 

AND

• Each participant will be asked whether the participant wants documentation linking the participant with the research, and the participants wishes will govern.

For each clinical trial regulated under the 2018 Common Rule and conducted or supported by a federal department or agency, one IRB‑approved informed consent form used to enroll subjects must be posted on ClinicalTrials.gov or Regulations.gov.
 

This posting must occur:

• After the trial is closed to recruitment, and
• No later than 60 days after the last study visit required by the protocol
  (45 CFR 46.116(h))

Definition of a Clinical Trial

A clinical trial is a research study in which one or more human subjects are prospectively assigned to one or more interventions (including placebo or control) to evaluate the effects of those interventions on biomedical or behavioral health‑related outcomes.

Tips

• A consent form must be posted for any study regulated by the 2018 Common Rule that is federally funded or FDA‑regulated.
• Posting is typically completed by the sponsor or the overall Principal Investigator.