Studies in Which Subjects Are Audio or Videotaped May Qualify as Exempt From Continuing Irb Review

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Waiver of Documentation of Consent

Criteria for Waiver of Documentation of Consent

§46.117(c):
An IRB may waive the requirement for the investigator to obtain a signed consent course for some or all subjects if it finds either:

(i) That the only tape linking the subject and the research would be the informed consent class and the chief risk would exist potential damage 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'due south wishes will govern;

(ii) That the research presents no more than than minimal risk of damage to subjects and involves no procedures for which written consent is ordinarily required outside of the research context; or

Notation: This is equivalent to §56.109(c)(1).

(three) 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 in that location is an appropriate alternative mechanism for documenting that informed consent was obtained.

Oftentimes called Verbal Consent, the process is more correctly referred to as Informed Consent with Waiver of Documentation. The investigator must obtain consent following the same requirements as written consent but the subject does non sign a consent form.

Waiver of documentation of consent is permitted under a express set up of circumstances. The starting time requirement is that the inquiry is not greater than minimal. This process is sometimes referred to as verbal consent. To waiver documentation of consent, the research must run across the regulatory criteria of 45 CFR 46.117(c) or 21 CFR fifty.109(c).

Obtaining Verbal Consent

When a waiver of documentation of informed consent is issued by the IRB the consent process needs to attach to all of the requirements of consent. In addition, if the report is subject to HIPAA, written HIPAA potency may withal be required unless the study also qualifies for alteration of the requirement for written HIPAA Say-so. The IRB's preference is for the investigator to create consent certificate using the usual consent template just with a substitution for the usual signature page with ane that allows the investigator to certificate the subject's verbal consent. Examples of situations and options for exact consent are included below:

• Consent course using the CHOP consent template without a page for subject or investigator signatures. This selection would use when the basis of waiver was 45 CFR 46.117(c)(1)(i) where the consent form would have been the only link to the inquiry. It could also utilise when the plan is to document the consent procedure place in the inquiry or medical records. This latter situation is risky because it may be hard to prove during an inspect that consent took place.

• Consent form using the CHOP consent template but substituting the usual signature folio with the IRB's documentation of exact consent page. When assent must be obtained, consent form should also include the page for documentation of exact assent. A typical scenario for this would be when consent, assent and HIPAA Authority are obtained over the phone.

• Consent form using the CHOP consent template with a page for documentation of verbal consent by the investigator and a stand-alone HIPAA potency. Some studies will qualify for waiver of documentation of consent but still not authorize for exact HIPAA authorization. For example, the IRB could waive the requirement for written consent for subjects seen in dispensary but the study wouldn't see the criteria for alteration of HIPAA considering it would be practicable to obtain written HIPAA Potency.

• Two consent forms, ane for written consent and HIPAA Authorization and 1 for exact consent. In many studies, some subjects volition be seen in-person in clinic and others volition be consented over the telephone. The consent of subjects who are seen in clinic include written consent and HIPAA authorization (or verbal consent + written HIPAA Authorization) and the consent of subjects who are enrolled via telephone, would be exact.

• Consent script compliant with the regulatory requirements to guide the conversation. The IRB does not encourage the use of scripts but they practise remain an option.

Special Example: Consent process when the invitation is by mail or email

This option most often applies to surveys and questionnaires but tin can also include a specimen collection kit. The questionnaire or specimen collection kit should be accompanied by a letter, webpage or consent form inviting the individual to participate. The letter, webpage instructions or consent form should include:

• The required elements of consent; and
• A statement that completion and return of the questionnaire, web survey, specimen kit, etc. indicates willingness to participate.

This process is sometimes referred to as unsaid consent, which is non a term recognized by OHRP. They would consider this to be informed consent with waiver of documentation (provided the IRB has waived documentation under 45 CFR 46.117(c)(1)(i), (2) or (iii)). See OHRP's website for a give-and-take about implied consent.

Documenting Exact Consent

Depending on the circumstances, it may however be advisable to document that the consent process took place.

Waiver nether 45CFR46.117(c)(i)(i)
When a waiver is issued under 45CFR46.117(c)(1)(i) consent should only be documented when the subject requests to be linked to the research. A consent form should exist available when using a waiver of documentation under 45CFR46.117(c)(1)(i) in case the subject area wishes to exist linked. The form of documentation could include any of the post-obit:

• Notation written in the study subject'due south record
• On a consent/assent documentation grade with a signature page
• On a consent grade with a page for documentation of verbal consent and when applicable, assent and HIPAA Authorization

Waiver nether 45CFR46.117(c)(i)(two)
When a waiver is issued nether 45CFR46.117(c)(i)(two) consent documentation could include whatever of the following:

• No documentation (strongly discouraged)
• Note written in the study subject'south research or medical tape
• On a form created specifically for documentation of verbal consent and when applicable, assent and HIPAA Authorization
• On a consent grade with a folio for documentation of exact consent and when applicable, assent and HIPAA Authorization

If the programme is to document consent on a re-create of the consent class, substitute signature blocks are bachelor in the Special Signatures Folio department of the Consent Form Templates page.

Waiver nether 45CFR46.117(c)(1)(three)
When a waiver is issued under 45CFR46.117(c)(1)(iii) consent documentation could exist any ane of the post-obit:

• Note written in the study subject's enquiry or medical tape
• On a form created specifically for documentation of verbal consent and when applicable, assent and HIPAA Authorisation
• On a consent grade with a page for documentation of verbal consent and when applicative, assent and HIPAA Authorisation

If the plan is to document consent on a copy of the consent form, substitute signature blocks are bachelor in the Special Signatures Page section of the Consent Grade Templates folio.

Delight notation that these criteria crave that an appropriate culling method is available for documenting that informed consent was obtained.

Example Signature Page to Document Consent Process:

Audio or Videotaping a Verbal Consent

Although sound and videotaping are considered to be minimal risk procedures, CHOP Policy Recording or Filming of Patients requires written consent when CHOP patients are involved. Since the requirements of 45 CFR 46.117(c)(1)(ii) specify that a waiver can be granted when the inquiry "involves no procedures for which written consent is normally required exterior of the enquiry context" audiotaping and videotaping do non more often than not qualify. If the participants practise not come across the definition of a CHOP patient as defined in the CHOP policy so written consent is not required. This could include physicians and nurses at CHOP or parents of patients.

CHOP legal counsel has concluded that if the consent process for a CHOP patient/subject is taped and so retained as evidence of the consent, then this recording volition meet CHOP'south requirement for documentation of consent. Nether this circumstance, the IRB may waive the requirement for written consent. The details of the requirements are included beneath and in an email outlining the requirements from CHOP legal counsel.

When tin the IRB waive the requirement for written consent for audiotaping for patient-subjects?

If the bailiwick is physically nowadays and is a patient at CHOP, the IRB cannot waive the requirement. This effectively eliminates waivers for videotaping of patient-subjects. If the research involves a phone interview, then the IRB will consider a request for a waiver. The investigator must exercise the following:

• Inform the prospective subject that they would like to audiotape the conversation (to comply with state wiretapping laws);
• If the prospective participant agrees, the consent conversation, including the required information well-nigh audiotaping must be recorded;
• If the subject consents, the audiotape of the consent conversation must be retained for 6 years (to meet HIPAA and infirmary policy).

Waiver of Documentation of HIPAA Authorisation

45 CFR 164.164.512:
Uses and disclosures for which an authorization or opportunity to agree or object is not required.

When the research qualifies for a Waiver or Alteration of HIPAA under 45 CFR 164.512(i)(2)(ii) so "A covered entity may use or disclose protected health data without the written authorization of the private, as described in §164.508, or the opportunity for the individual to agree or object as described in 164.510, in the situations covered by this section, subject to the applicative requirements of this section. When the covered entity is required by this department to inform the individual of, or when the individual may concur to, a apply or disclosure permitted by this section, the covered entity's information and the individual's agreement may be given orally."

1. What is the difference between a waiver of documentation of consent and a waiver of consent?

   When the IRB grants a waiver of consent, consent is non necessary for enrollment.

   When the IRB grants a waiver of documentation of consent, the investigator needs to obtain the subject's consent just not the subject'southward signature to certificate information technology. In this example, the investigator can document having obtained consent (e.g. on the exact consent form or in the report chart).

2. Tin I tape whatsoever individually identifiable individual information and obtain a waiver of documentation of consent under 46.117(c)(1)(i)?

   In order to waive documentation under (c)(one)(i), all of the data collected must exist bearding which means recorded without any identifying data.

3. If the report is FDA-regulated, tin I obtain a waiver of documentation under 46.117(c)(one)(i)?

   The FDA regulations mandate that all subjects exist identifiable in order to permit an audit of the source documents then there is no FDA equivalent to 46.117(c)(1)(i).

4. Which enquiry procedures can have identify and all the same waive documentation of consent?

   To waive the requirement for documentation under 46.117(c)(1)(2) or 56.109(c)(one), the procedures in the research must exist limited to those that don't require written consent as part of clinical care. Examples include: Claret draw, Questionnaires, Breast X-ray, and DXA scan.

5. Why does the IRB crave that I take a consent grade approved if I have obtained a waiver of documentation of consent?

   The IRB must ensure that the subject is provided with the necessary information to make an informed decision most report participation. The waiver of documentation is simply related to the requirement for a subject field to sign, and thus certificate, their consent.

6. When do I demand to requite the discipline an information sheet?

   When the IRB waives documentation of consent under (c)(ane) or under l.109(c) of the FDA regulations, it can crave the investigator to provide the field of study an Information Canvass when the IRB decides that subjects should take some information to refer back to subsequently completion of the study. The contents of the Information Sheet do not demand to match those of a consent form just should comprise at a minimum:

   • The title of the inquiry
   • Contact information for the investigator
   • An explanation of the purpose of the enquiry
   • A description of the procedures

7. What if HIPAA applies to the enquiry, can I notwithstanding obtain a waiver of documentation of consent?

   HIPAA at 45 CFR 164.512 permits oral authority instead of written dominance provided that the written report meets the criteria for alteration or waiver of HIPAA. If the enquiry involves individually identifiable health information, and then the investigator must likewise exercise ane of the following:

   • Request an amending (sometimes referred to equally a partial waiver) of Written Authorization, or
   • Obtain Written Authorization for employ of PHI using a stand-lone HIPAA Authorization

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Source: https://irb.research.chop.edu/waiver-documentation-consent

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