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Informed Consent (e-Consent, Remote Consent)

Informed Consent

The requirement to obtain the legally effective informed consent of individuals before involving them in research is one of the central protections provided for under the HHS regulations at 45 CFR part 46 and FDA regulations at 21 CFR 50.20 and 21 CFR 50.25.

The detailed requirements for WVU researchers to obtain informed consent for research can be found in the WVU Standard Operating Procedures (SOPs).

This requirement is founded 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 autonomous agents and that the rights and welfare of persons with diminished autonomy be appropriately protected.

Autonomous Agent - An individual capable of deliberation about personal goals and of acting under the direction of such deliberation. Respect for persons requires that prospective research subjects “be given the opportunity to choose what shall or shall not happen to them”.

For most research, informed consent is documented using a written document that provides key information regarding the research. The consent form is intended, in part, to provide information for the potential participant as current and future reference and to document the interaction between the subject and the PI. However, a signed consent form alone does not constitute an adequate consent process.

Informed Consent can be obtained using a paper or electronic process and can be fulfilled in-person or remote. Note that remote consent has additional requirements. 

However consent is to be obtained, the process, documents and technology must be fully and clearly explained in the protocol application and all supporting information must be provided (videos, survey form links, hyperlinks, etc.).

Informed Consent Process

  1. Disclose the information needed to make an informed decision to a potential participant.

    This is accomplished through the Informed Consent document. The WVU IRB has standard approved Informed Consent templates that must be used when WVU is the IRB of Record. Complete a draft template and submit the draft with your protocol submission.

    When WVU is relying on another IRB of Record, the WVU Informed Consent language must be used in the consent document. The informed consent document must be uploaded with the approved protocol after approval by the IRB of Record.

  2. Facilitate the understanding of what has been disclosed.

    This is accomplished by a research team member who has been authorized as a "consenting individual" scheduling time to converse with a potential participant in person, by telephone, or by using an approved video conferencing systems. The potential participant must be informed of how their questions will be answered and be given the opportunity to ask questions.

  3. Promote the voluntariness of the decision about whether or not to participate in the research project. 

    The WVU IRB approved informed consent document templates include language regarding the decision to participate being completely voluntary and that choosing not to participate will have no impact on the potential participant.

NOTE: Informed consent must be legally effective and prospectively obtained meaning that the person signing the document must not be of diminished capacity, be a legally authorized representative(LAR), or a legal guardian.  In the case of a foster child or a ward of the state, consent must be obtained from the Department of Health and Human Services). The signature must be obtained in a manner that is legally effective by the state of West Virginia. The WVU approved electronic methods for obtaining electronic signatures are considered legally effective.

Consent is prospectively obtained when it is legally documented with the potential participant before the research begins.

WVU IRB Criteria for Approval

All criteria must be met:

  1. The consent process will be legally effective
  2. Circumstances provide the prospective subject or LAR sufficient opportunity to consider whether to participate
  3. Circumstances minimize the possibility of coercion or undue influence
  4. The information will be provided be in language understandable to the subject or LAR
  5. The consent contains information that a reasonable person would want to have in order to make an informed decision about whether to participate.
  6. The consent begins with the key information why one might or might not want to participate in the research**
  7. There is no exculpatory language
    Exculpatory language is language through which the subject or LAR is made to waive or appear to waive any of the subject’s legal rights, or releases or appears to release the investigator, the sponsor, the institution or its agents from liability for negligence.
  8. The required and appropriate additional elements of consent are included in the informed consent document.
  9. For remote and electronic consent, sufficient information must be provided describing the entire consent process, the remote consent and the electronic methods and products that will be used.