Client Guide to

Consent Form Evaluation

This guide details the process used by Quorum Review to evaluate consent forms submitted by clients for Board review. If you have any questions about this process, please feel free to contact Quorum Review.

Regulations, Laws and Guidance

Quorum evaluates submitted consent formsto confirm that the language is in compliance with applicable regulations, laws, and guidelines in the United States and/or Canada. In doing so, we utilize federal and state regulations, FDA and OHRP guidance, ICH guidelines, and other sources. A list of our most commonly used references is provided below.

Regulations and Guidance
FDA (U.S.)
FDA 21 CFR 50.20
FDA 21 CFR 50.25
FDA 21 CFR 50.27
A Guide to Informed Consent – Information Sheet
HHS (U.S.)
HHS 45 CFR 46.116
HHS 45 CFR 164.508
HHS 45 CFR 46, Subpart D
OHRP (U.S)
Office for Human Research Protections (OHRP), Secretary’s Advisory Committee on Human Research Protections (SACHRP), Appendix D
TCPS 2 (Canada)
TCPS 2, Article 3
TCPS 2, Article 5
TCPS 2, Article 12
Personal Information Protection and Electronic Documents Act (PIPEDA) (Canada)
S.C. 2000, c. 5
AHRPP
AHRPP E.I.6.B. / U.S. State Laws
California
California Civil Code Section 56.11
California Health and Safety Code Section 24173
Indiana
Indiana Code 16-39-1-4
New York
New York Civil Rights Law Section 79-I
ICH Guidelines
ICH 4.8.4
ICH 4.8.7
ICH 4.8.8
ICH 4.8.9
ICH 4.8.10
ICH 4.8.11
ICH 4.8.12

In addition to evaluating the template language for compliance with applicable regulations, laws, and guidelines, Quorum also reviews client template language to address Quorum Review’sguidelines for participant protection and formatting/administrative needs. For example, consent formmay be revised toallow for site-specific modifications to the consent form.

Quorum’s Editing Processes

  1. Quorum Reviewapplies any required edits to the consent form(s) provided by clients using the “Track Changes” feature in Microsoft Word. To simplify review, any minor changes to formatting that do not impact content or meaning are not tracked or documented.
  2. After the Board has reviewed and approved the consent form(s), Quorum sends tracked and clean versions of each edited consent form to the client for review. (The tracked version shows Quorum’s suggested changes, tracked in with Word’s Track Changes feature. The clean version also includes those proposed changes, but the changes are not “tracked in” the document—the changes are included without any tracking.)
  3. After review, if the client has any additional changes to request to the consent form(s), they should provide those changes as tracked-in revisions to the clean Word document provided and should include written rationale for each of the requested changes. The rationale may be provided in a document separate from the revised consent form, or it may be provided in comments inserted into the revised consent form. Quorum may request clarification if the client does not provide rationale.
  4. Quorum Review evaluates the client-proposed changesand accompanying rationale. If the changes meet Quorum’s requirements, they will be incorporated as appropriate. Changes to the consent form will be sent through expedited review for approval. This process may be repeated until the consent form language is accepted.

Superscripts

To assist with communication, edits to consent form language are followed by a superscript number representing the rationale for the specific change. Please see below for the list of superscripts and their rationales.

Rationale for Change
#1 / To reflect regulations, laws, ICH guidelines, or standard research-related guidance (such as FDA Information Sheets)
#2 / To reflect protocol specifications
#3 / To reflect Board preferences regarding language that may be seen as coercive or overly reassuring (e.g., the Board may prefer the use of “study drug” instead of “study medication” )
#4 / To reflect words, phrases, paragraphs, or changes specifically requested by the client
#5 / To remove duplication of information
#6 / To improve participant protection and/or safety
#7 / To move information from another area of consent form
#8 / To change point-of-view
#9 / To simplify language for readability, clarification, or consistency

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