Consent

Investigators are responsible to discuss the research with subjects, and to document the subjects’ consent to participate. The consent process must be adapted to the decision-making needs of the subject.  Different studies--depending on degree of therapeutic benefit and risk--require different emphasis during the consent discussion. The consent form is an important part of this process and is intended to guide the investigator and subject in the consent process.

• Federal regulations describe the required elements of consent.

  1. A statement that the study involves research, an explanation of the purpose and the expected duration of the subject’s participation, and a description of the procedures, noting any procedures which are experimental;
  2. A description of reasonably foreseeable risks or discomforts;
  3. A description of benefits to the subject or others that may reasonably be expected;
  4. Disclosure of appropriate alternative procedures or courses of treatment;
  5. A statement of the degree to which confidentiality of records identifying the subject will be maintained;
  6. For studies involving more than minimal risk, a description of any compensation that will be provided, and of medical treatments that are available in case of injury;
  7. Who to contact for answers to questions about the research, about research subjects’ rights, and about research-related injury;
  8. A statement that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the subject would otherwise be entitled; and
  9. One of the following statements about any research involving the collection of identifiable private information or identifiable biospecimens:
    1. a statement that identifiers might be removed from the identifiable private information or identifiable biospecimens and that, after such removal, the information or biospecimens could be used for future research studies or distributed to another investigator for future research studies without additional informed consent from the subject or the legally authorized representative, if this might be a possibility; or
    2. a statement that the subject's information or biospecimens collected as part of the research, even if identifiers are removed, will not be used or distributed for future research studies.

• There are additional elements that must be included if appropriate.

  1. A statement that there may be unforeseeable risks to the subject (or the embryo or fetus) if the subject is or may be pregnant;
  2. Anticipated circumstances under which the subject’s participation may be terminated without the subject’s consent;
  3. Additional costs that may accrue to the subject as a result of participation;
  4. Consequences of early withdrawal from the research, and procedures for orderly termination of participation in such an event;
  5. A statement that any significant new findings that may relate to the subject’s willingness to continue will be provided;
  6. The approximate number of subjects involved in the study;
  7. A statement that the subject's biospecimens (even if identifiers are removed) may be used for commercial profit and whether the subject will or will not share in this commercial profit;
  8. A statement regarding whether clinically relevant research results, including individual results, will be disclosed to subjects, and if so, under what conditions; and
  9. For research involving biospecimens, whether the research will (if known) or might include whole genome sequencing (i.e., sequencing a human germline or somatic specimen with the intent to generate the genome or exome sequence of that specimen).

• The requirement to obtain informed consent can be altered or waived if all of the following conditions pertain:

  1. The research involves no more than minimal risk to 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 identifable 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.

Waivers/Alteration of Consent and Waiver of Documentation of Consent

Consent or a waiver of consent is no longer necessary for screening, recruiting, or determining eligibility (45CFR46.116(g)(1) or (2)). An IRB may approve a research proposal in which an investigator will obtain information or biospecimens for the purpose of screening, recruiting, or determining eligibility of prospective participants 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.

Telephone screens may require a HIPAA Waiver form (see link).  See also the HIPAA Guidance under Consent.

If your work meets the federal definition of research involving human subjects, then written informed consent is required according the regulations. However, under limited circumstances, defined below, the IRB can consider your request for a waiver or an alteration of consent (45CFR46.116(f)(3)).

  1. The research involves no more than minimal risk;
  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.

A Waiver of Documentation of Consent (45CFR46.117 (c)(1)(2) or (3)) is utilized in a protocol when the signature of the participant is likely the only identifiable link to the participant. In those cases, a waiver of documentation of consent may be requested to remove the signature line for the participant on the consent form in an effort to protect confidentiality. The person obtaining consent will need to sign and date the form. Participants or legally authorized representative should still be provided with a copy of the consent form.

The IRB may waive the requirement for the investigator to obtain a signed informed consent form for some or all subject if any of the following apply:

  1. 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 present 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.