Informed Consent Frequently Asked Questions (FAQ)

Approved Consent Forms

Can I use an IRB approved consent form in my consenting process as long as it is used during the approval period documented in the header of the document?

The short answer is: it depends…
Yes, as long as no changes have been made to the consent document, during the approval period and the information is accurate and complete.
No, if the consent document has been revised. Once the IRB approves a revised consent form to replace a previous consent form, previous consent form can no longer be used.

Is it okay to make revisions directly on the consent form that is signed by the participant?

No. Handwritten revisions should not be made directly to the consent form that is being used to consent a subject. All revisions, including, but not limited to, a change in study team contact information, stipend information, new safety information or a change in the conduct of the study, must undergo IRB review and approval prior to use.

Dating/Signing Consent Forms

Who can date the consent document for the subject?

MCW/FH IRB Standard Operating Procedures (SOP) and FDA Regulations require the subject to sign and date the consent document for him/herself. Changes to this process must be submitted to and approved by the IRB. Examples of modifications to the documentation process include the following: 1) If the study involves participants who are unable to physically sign/date the consent document, the plan for documentation on informed consent must be presented to the IRB for review and approval; and 2) Circumstances when a legally authorized representative should be included in the consenting process of decisionally impaired individuals; in this case, the legally authorized representative should sign and date the consent and the enrollee provide assent.

Documentation

If the subject requests the original signed informed consent document can the site retain a photocopy?

No. Per MCW/FH IRB Standard Operating Procedures the original signed informed consent document must be retained with the study files and a copy given to the subject or the subject’s legally authorized representative who signed the consent form.

Is it okay to destroy or discard the signed consent forms of those who later decide not to participate in the study?

No. A signed informed consent document should be kept in the study file; it should not be destroyed or discarded.

What can the member of the study team obtaining informed consent do to ensure the signed consent form is a complete and accurate consent document?

Prior to providing the subject with a signed photocopy of the informed consent, the study coordinator should review the document and ensure:

-The subject signed the most recent IRB approved version of the consent for that study.
-The subject signature is present in addition to the subject’s name.
-The subject dated for him/herself and the date is correct.
-If the subject or study staff made an error, the error was corrected by drawing a signal line through the error.
-All pages of the informed consent document are present.

Study Staff Responsibility

Are all individuals identified as members of the study team automatically authorized to consent subjects?

No. Only individuals clearly identified to the IRB in the study application (SmartForm section: 16.1) as being involved in the consenting process should consent subjects.

Can the study team member use the translated consent forms found on the IRB website to consent a non-English speaking subject?

Any study related activity, including screening, should take place after informed consent is obtained, unless the IRB has granted a waiver of consent for that activity. If you have questions or concerns regarding this issue, contact us.

Subjects Responsibility

Can subjects undergo screening or study procedures prior to giving written informed consent?

Yes. When a potential subject who does not speak English is unexpectedly encountered, federal regulations allow for use of a “short form” in a language the subject understands, to document that all required elements of informed consent were presented orally.

-The entire consent form in English should be discussed with the subject and translators.

-The translator should be independent of the subject not related or associated with the subject.

-The short form, in a language the subject the subject understands (currently available in Spanish, Russian, and Hmong), must be presented to and signed by the subject.

-A witness to the oral presentation is required; the translator may be witness.
-A reportable event should be filed within 5 days to the IRB.

If the investigator plans to enroll additional individuals who do not speak English, the investigator should contact the IRB.