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Developing a Consent Form with Quorum Review
Consent Form Negotiations
Reviewing and negotiating the specific language of a study's Informed Consent Form is often a time-consuming and potentially contentious part of study start-up. It is during this process that important issues arise between a site or sponsor and an IRB. During protocol review an IRB must ensure that a consent form meets all regulatory requirements and that it informs a participant about any potential risks. At Quorum Review we seek to enhance consent form negotiations with a team of consent form editors, a sizable library of sample model consent form language, and negotiated sponsor template language for consent forms.
The Consent Form Development Process at Quorum
More often than not, Quorum IRB requests changes to a customer's Informed Consent Forms. The requested changes frequently range from substantial changes to minor edits. Our revision process intends to produce a consent form that meets all regulatory requirements, provides adequate participant protection, and maintains the content, style, and presentation of the submitted form. When editing a new consent form, Quorum's consent form editors and the IRB look specifically at the following items:
- Readability. Federal regulations require an IRB to review each proposed consent form to determine whether it is understandable to potential participants. According to literacy statistics, the median readability level of Americans is at an eighth-grade level. Quorum Review IRB uses this measure as a target for readability of our finalized consent forms. In order to achieve this measure, the IRB frequently replaces a customer's proposed language with our sample model consent form language.
- Regulatory Requirements. When suggesting edits to consent forms, Quorum's Consent Form Editors and the IRB consider the requirements of numerous regulations, including 21 CFR 50, 45 CFR 164.508, and FDA and ICH guidelines. These sources include the elements of informed consent such as:
- purposes of the research
- reasonably foreseeable risks
- benefits
- alternatives to participation
- compensation
- HIPAA and the use and disclosure of study records
- guidance on research practices
- Protocol Reflection. It is Quorum policy that the consent form accurately reflect the protocol. Quorum considers the protocol to be the source document for the consent form and any information in the consent form should be referenced in the protocol.
- IRB Considerations and Preferences. Over the years, the Board has developed preferences about how information is presented to potential participants. These preferences include formatting and style, specific word choices or phrases, and a target length. The Consent Form Development group takes these preferences into account when making changes to submitted forms.
Our sample model consent forms are revised at least once a year to refine language and incorporate requested changes from our Consent Form Development group and the Board. Since our group sees only consent forms, we have been able to make numerous revisions over the years to create what we believe is a highly functional and easily readable consent form. In making our changes to sponsor- or site-submitted forms, we are applying the knowledge gained from years of experience and thousands of consent forms.
Potential Pitfalls for Consent Form Finalization
Using the standard process for consent form negotiations presents some pitfalls for customers, especially those concerned with the speed of finalization. The Consent Form Development group has identified ways the consent form finalization process can be slowed down:
- Rationale. As part of the consent form negotiation process, Quorum requires customers to provide a rationale for their suggested changes. Often a rationale for customer-requested revisions to consent forms is not included with the changes, or customers do not provide sufficient information for the Board to review.
- Tracked Changes Errors. Quorum requires customers to "track" their suggested changes into a clean copy of the forms we provide using the track-changes feature of Microsoft Word. Doing so allows Quorum to keep track of which party is making the revisions in the negotiation process. In many cases the feature is not properly used, resulting in further delays between Quorum and the customer.
- Inadequate Information. As mentioned above, the Board likes to see specific information in its finalized consent forms. In some instances, this information is not provided in the protocol or the submitted consent form, resulting in an information request that extends the time for finalization.
Advantages of Sponsor Template Language
When a sponsor works with Quorum to create sponsor template language, the agreed-upon sections of the consent form, which can include certain sections or the entire form itself, is "locked-in." This means whenever Quorum receives a submitted form from the customer we automatically apply the Board- and sponsor-approved language, easing the consent form review and negotiation process. The specific advantages of sponsor template language include:
- Speed. Template language takes the guesswork out of the consent form for both Quorum and the customer. When we see a sponsor's submitted form we immediately apply only the approved language in the relevant consent form sections, thus speeding the editing process and giving the customer more time to answer inquires before the Board meeting. Furthermore, since the language is "locked," there is less discussion about consent form language at convened meetings.
- Customer Preferences and Consistency. If a customer has specific preferences for consent form language,
arrangement, or formatting that differs from the Quorum sample forms, the sponsor template language process is the ideal venue for negotiating those preferences with the Board. Sponsor template language is essentially prior review of non-study-specific consent form sections, which means changes to these sections are off limits during the consent form development process because the negotiations have already taken place. Customer and Board preferences can be ironed out well in advance of any study submission. This process creates consistency for the customer across all forms.
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