IRB FAQs – Informed Consent

What is the definition of Informed Consent?

It is a process that involves conveying accurate and relevant information about the study and its purpose; disclosing known risks, benefits, alternatives, and procedures; answering questions; and enabling the potential participant to make an informed decision about whether to participate. Informed consent represents the basic principle of “respect for persons” in which the autonomy of an individual (i.e., the individual’s right to determine what will happen to them) is respected. There are federal guidelines that govern the consent process as well as consent documents to be used in human research. Please be reminded that informed consent is a communication process that continues during the entire study.

What makes an informed consent valid?

In order for consent to be valid, it should be based on the following critical elements:

  • The participant must be competent to begin the informed consent process. If the participant is not competent because of age, illness, incapacity, or any other reason, special protections apply, or the participant may not be included in the research.
  • The research team must disclose all relevant information to the potential participant. The information must be sufficient to allow the potential participant to decide whether to participate. It is generally accepted that the potential participant must be given the following information:
    • The purpose of the study;
    • Nature of the procedure;
    • Reasonable alternatives to the proposed intervention; and
    • Risks, benefits, and uncertainties of each possible intervention.
  • The participant must comprehend the information. The research team must evaluate the potential participant’s ability to understand the proposed intervention in the study.
  • The participant must agree to the proposed intervention in the research study.
  • The participant’s agreement must be voluntary and free from coercion.
  • Participants must be informed that even after they have made a voluntary agreement to participate in the study, they may withdraw such agreement at any time without penalty.

How do I prepare a consent document for IRB Review?

The document should include all the elements required by the federal guidelines governing human research, as well as any other information prospective participants might need to make an informed decision about participation. Consent documents should be written in nontechnical language that can be understood by the proposed participant population consistent with their educational level, familiarity with research, and cultural views.

The consent document must make clear that participation in research is voluntary, and it should not include any language waiving or appearing to waive participants’ rights.

We provide consent templates for your use. We have incorporated the required elements, as well as additional elements into the templates along with instructions on how to complete the document for use for your study. You may find these templates on the UMCIRB website on the Form and Docs page or in the electronic submission system.

The UMCIRB consent templates should be used for all studies where informed consent will be required and there is no sponsor informed consent template(s). If the study team has been provided with an informed consent template by a study sponsor which contains the essential elements of informed consent and, if necessary, the additional elements of informed consent and FDA required ClinicalTrials.gov language they may use that template for their study consent document. However, you must insert certain institutionally required language into the consent document in order for the IRB to approve the document for use. The required language that must be inserted into the sponsor’s template is contained in the Information Sheet for the Use of a Sponsor’s Informed Consent Document (Word) template.

Advertisements, fliers or brochures prepared to recruit and inform potential participants about a study are considered part of the informed consent process and, as such, also require review and approval by the IRB.

What are the essential and additional elements of consent?

The essential elements of consent include:

  • A statement that the study involves research, an explanation of the purposes of the research and expected duration of the subject’s participation, a description of the procedures to be followed, and identification of any procedures which are experimental.
  • A description of any reasonably foreseeable risks or discomforts to the subject.
  • A description of any benefits to the subject or to others that may reasonably be expected from the research.
  • A disclosure of appropriate alternative procedures or courses of treatment, if any, which might be advantageous to the subject.
  • A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained. The possibility that the Food and Drug Administration may inspect the records should be noted.
  • For research involving more than minimal risk, an explanation as to whether there is any compensation for injury, 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.
  • An explanation of whom to contact for answers to pertinent questions about the research and research subject’s rights, and who to contact in the event of a research related injury to the subject.
  • A statement that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and that the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.
  • One of the following statements about any research that involves the collection of identifiable private information or identifiable bio-specimens:
    • A statement that identifiers might be removed from the identifiable private information or identifiable biospecimens and that, after such removal, the information or bio-specimens could be used for future research studies or distributed to another investigator for future research studies without additional informed consent from the subjects or the legally authorized representative, if this might be a possibility; or
    • A statement that the subject’s information or bio-specimens collected as part of the research, even if identifiers are removed, will not be used or distributed for future research studies.

Additional elements of informed consent include:

  • A statement that the particular treatment or procedures may involve risks to the participant (or the embryo or fetus if the woman is or may become pregnant), which are currently unforeseeable.
  • Anticipated circumstances under which the subject’s participation may be terminated by the investigators without regard to the subject’s consent.
  • Any additional costs to the subject that may result from participation in the research.
  • The consequences of a subject’s decision to withdraw from the research and procedures for orderly termination of participation by the subject.
  • A statement that significant new findings developed during the course of the research which may relate to the subject’s willingness to continue participation will be provided to the subject.
  • The approximate number of subjects involved in the study.
  • A statement that the subject’s bio-specimens (even if identifiers are removed) may be used for commercial profit and whether the subject will or will not share in this commercial profit.
  • 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 bio-specimens, whether the research will (if known) or might include whole genome sequencing (i.e., sequencing of a human germline or somatic specimen with the intent to generate the genome or exome sequence of that specimen).

What should I do if the participants do not read or write English?

If it is anticipated that a consent form will be needed for those who may speak a foreign language, then the consent form should be translated into the language that the participant understands. The UMCIRB requires that all non-English consents be submitted for review and approval. If this is not included in the original submission, and the study team encounters a potential participant who does not speak English, you will need to submit an amendment to the study to include a “short form”, i.e. a modified version of the informed consent. The short form should be used on only one occasion. If, after this initial encounter, you encounter other participants who do not speak English, then an amendment to the study will need to be submitted which includes a translated version of the entire consent document for use.

What is the definition of assent?

Assent is an agreement by an individual not considered fully autonomous and therefore unable to give valid informed consent (e.g., a child or cognitively impaired person) to participate in research. Whether assent is documented or even carried out depends upon the maturity of the individual being asked to take part in the research and the setting in which the research is being implemented. Often it is appropriate to waive documentation or even the entire assent process.

What is the definition of a legally authorized representative?

An individual or judicial or other body authorized under applicable law to consent to take part in research, on behalf of a prospective participant. The LAR is asked to consider what they believe would be the decision of the person for whom consent is being sought. A LAR will be asked to sign a consent document and that signature will represent what they believe is what the person would want to do. In North Carolina, a LAR is often next of kin, but can also be a significant other, a court-appointed guardian, or even a person’s social worker (in extreme cases). When trying to decide who can act as a LAR, it is usually the same person who can sign permission for medical care.

May informed consent be obtained by telephone from a legally authorized representative?

It is acceptable to send the informed consent document to the LAR by facsimile or other electronic means and conduct the consent interview by telephone when the LAR can read the consent as it is discussed. If the LAR agrees, they can sign the consent and return the signed document to the clinical investigator by facsimile or other electronic means.

Who should be present when the informed consent interview is conducted?

Principal Investigators are ultimately responsible for the informed consent process. However, it may be someone other than the PI who obtains and documents the informed consent of participants or their legally authorized representatives. This person will need to be named in the application to the IRB so that there is enough evidence that the person obtaining and documenting informed consent is appropriate and has had appropriate training in human research protections. There are situations under which the IRB can approve a waiver of informed consent, or a waiver of documentation of informed consent, respectively (45 CFR 46.116 and 45 CFR 46.117). Investigators must give a copy of the informed consent document to each research participant or LAR and keep the signed original or a copy of it for their records (45 CFR 46.117(a) and 45 CFR 46.115(b)).

The FDA does not require a third person to witness the consent documentation unless there is insufficient time to allow the participant or representative enough time to read and discuss the consent document before it is signed (21 CFR 50.27(b)).

How do you obtain informed consent from someone who speaks and understands English but cannot read English?

Illiterate persons who understand English may have the consent read to them and “make their mark” if appropriate under applicable state law. There are federal requirements that state there must be a signature of someone who has witnessed the consent process as well as the signature of the person conducting the consent process. This is specifically important if a short form is used. Investigators should be cautious when enrolling individuals who may not truly understand what they have agreed to do.

When should study participants be informed of changes in the study?

Amendments to a study must receive IRB review and approval before they are implemented, unless an immediate change is necessary to eliminate an apparent hazard to the participants (21 CFR 56.108(a) (4)). Participants who are presently enrolled and actively taking part in the study should be informed of the change if it might relate to their willingness to continue in the study (21 CFR 50.25(b) (5)). FDA does not require re-consenting of participants that have completed their active participation in the study, or of those who are still actively participating when the change will not affect their participation, for example when the change will be implemented only for subsequently enrolled individuals.

However, if the change to the study is being initiated because of identified risks that do not show up during active intervention, then all participants should be notified so that they might be aware that this previously unknown risk has now been seen.

Who should be listed on the consent as the contact to answer questions?

Federal regulations 21 CFR 50.25(a) (7) require three contacts to be provided to participants. There needs to be contact information for the person best suited to answer questions about the research. This is generally the principal investigator. There should be a contact listed for questions about the research participant’s rights, and at ECU that is the director of the UMCIRB Office. Finally, there needs to be contact information for reporting research-related injury. This can be the principal investigator or the person with whom the participant interacts most frequently in the research, such as a research coordinator, research nurse or co-investigator. It is also important that the person named as the contact for reporting research-related injury be someone that can be reached through a direct line, a call service or beeper at any time. Participants experiencing unanticipated problems because of taking part in a research project should not have to leave voice messages or wait a weekend to get a response from someone knowledgeable about the research.