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Providing Participants with an Accessible Consent Copy

After the consent discussion, participants need to be able to find the information they may want to review.

Representative research photograph: Providing Participants with an Accessible Consent Copy
Photo: Capt. Charles An · License: Public domain · Cropped and resized.
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After the consent discussion, participants need to be able to find the information they may want to review. Paper copies, secure electronic access and suitable accessible versions involve different arrangements. Saying a document was delivered does not alone demonstrate that the person can reach it later.

Define the workflow

Confirm that the copy relates to the correct study and version. If access uses a link, explain how it works and whom to contact for help. Do not assume a personal email account is available; consider suitable options through study arrangements and required approvals.

Worked example

For example, someone receives a temporary link that no longer opens the following week. Staff check the access arrangement instead of treating it only as a forgotten password. They provide an appropriate route to the correct copy, verifying identity and version rather than sending an easily found document from another study.

Practical checks

  • Appropriately check that the copy matches the person, study and relevant document.
  • Explain an access format the individual can actually use and a clear support pathway.
  • Keep suitable follow-up records when a link, version or delivery problem occurs.

Decision and boundaries

A good arrangement supports further review and questions. Access to a copy does not replace a new clinical explanation or any necessary renewed consent discussion. Protect confidentiality in the sharing channel and follow the appropriate incident process for misdelivery. Do not blame participants for losing a document or obstruct subsequent questions about the research.

Frequently asked questions

Is an electronic link suitable for everyone?
No. Consider actual access conditions and study arrangements, explaining an appropriate available alternative when one exists.
Does requesting another copy require a new signature?
Access to an existing document and a new consent requirement are different questions; use study conditions and authorized assessment.

Sources

  1. EMA — ICH E6 Good Clinical Practice
  2. FDA — Informed consent guidance