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Informed Consent in Research

Obtaining informed consent for a research study requires open and honest communication between the researcher and the study participant. Much attention has been given to the consent document readability and its comprehension. However, it is important to remember that the document is a proxy and reference for a conversation. The conversation should be based upon the key elements of the consent document which include but are not limited to; the study objectives, procedures, duration, risks, benefits, alternative options, confidentiality of records, contact information for any participant questions, compensation if applicable, additional costs and compensation for research injury if applicable.  It is essential that participants understand that participating in a research study is completely voluntary; they can withdraw from the study at any time or choose not to participate.

Informed consent should be obtained after the participant has been presented with pertinent information, has had adequate time to review the consent document and have all questions answered. Consent should also be obtained prior to any study specific procedures. Participant privacy during the discussion is paramount and the environment should be free of undue influence and coercion from the research team.

For high risk protocols (e.g., Phase l/ll, gene transfer) it may be prudent and/or recommended by the local IRB to include the use of an independent party to be involved in the consent process. An individual obtaining consent may (un)intentionally influence a participant’s decision to consent to a research study. The use of a Research Subject Advocate can improve objectivity in communicating the presented information about the study.

It is important to note that informed consent is a continuous dialogue with the participant which reinforces the key elements of initial consent throughout the duration of the study. New adverse events or important findings that may increase a participant’s risks or willingness to continue in the research study should be disclosed to the participants and to the IRB.

Special Consent Considerations

Clinical research studies that involve children, non-English speaking individuals or the use of a Legally Authorized Representative (LAR) have additional guidances, regulations and processes that may apply.

Documenting the Consent Process

It is important to document the consent process at the time the informed consent form is signed by the study participant or legally authorized representative.  The source document should state the date, participant name, medical record number, study number and study title.  It should state the key elements of the consent that were discussed with the potential participant and any further details of the discussion that are pertinent to the subject's understanding of the study or information that could impact their decision to participate in the study.  It should state that the participant had adequate time to review all information and voluntarily signed the informed consent form(s) with an understanding that they are able to withdraw from the study at any time without penalty. It should also state the participant received a copy of all forms signed and that the participant signed and dated the consent form prior to any research specific tests. It is essential that the forms are completed appropriately, without errors and omissions of signatures, printed names, initials and dates.

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