Services | Quorum Review IRB
When selecting an IRB or REB, you want speed and efficiency, but you need trusted decisions. The ethical treatment of those who take part in medical research is a shared commitment, and for twenty five years Quorum has worked with investigators, institutions, and sponsors to ensure we all do our part.
You can have confidence in our board members’ knowledge and expertise. Quorum has held AAHRPP accreditation since 2006, and maintains a rigorous program of board member training. We continue to find better ways to work, but we haven’t changed our core purpose: to ensure the ethical treatment of participants in ground-breaking research.
Today, our experienced boards meet and review every type of submission every day. The teams that support our boards include regulatory attorneys, board secretaries, consent form editors, external consultants, and account managers for every study. Our Six Sigma-certified processes form an infrastructure that collects and provides the information the boards need, documents their decisions reliably, and delivers those decisions to you promptly.
Our early engagement services help customers start studies faster and enroll more sites.
Site Selection & Submission Analysis:
- Regulatory Consultations/Protocol Writing: Our consulting division Kinetiq can help design or write your study protocol.
- Site Match: If you need to find the right sites quickly, we can provide a list of investigators who are interested in your study. Site Match reports can reflect therapeutic expertise, location, history of working with Quorum, or many other data points.
- Site Enrollment: Our site enrollment program will engage with your selected sites, and assist them with their submission packages. This includes a specific focus on institutions. Quorum will approach institutions and guide them through authorizing Quorum to act as a central IRB.
- Chairperson Study Assessment: We can arrange a preliminary assessment of your protocol with our IRB Chair, a regulatory attorney, and representatives of our operational teams. This pre-review can address questions about study design, participant protections, and regulatory requirements.
- Consent Form Pre-Review: Our consent form editors can assess the language and content of draft consent forms and provide comments before you submit the consents formally.
- Clinical Program Coordination: When one clinical program is running multiple protocols, Quorum can help cross-check information across common sites and studies.
Final Submission Preparation
- Quorum Completes Initial Forms: Your Account Manager can complete your protocol submission forms for you, to ensure you have everything in place.
- Data Migration: We can pre-populate information for a protocol and sites if you are transferring a study to us or if you have a useful set of data in hand.
You can save valuable startup time with one or both of our pre-review services. An IRB Chair assessment of your protocol or an early look at your consent forms can identify participant protection issues well ahead of a formal IRB/REB review.
Chairperson Study Assessment
Even before a protocol arrives for IRB review, Quorum can help with important guidance. Our Chairperson Study Assessment provides opinions about all of a protocol or specific elements within it.
On request, we arrange a preliminary assessment of your protocol with our IRB Chair, a regulatory attorney, and representatives of our operational teams. This pre-review can address general questions about the study, or specific issues around study design, participant protections, and regulatory requirements.
Consent Form Consultation/Editing
Quorum welcomes the opportunity to assess any consent form documents prior to a formal submission. On request, our consent form editors and regulatory experts will preview your consent forms and provide feedback. Our consent form editors have extensive training in the required elements of consent forms; their assessments of language and content can anticipate questions the IRB/REB will raise. This service may be conducted independently or in conjunction with Quorum’s Chairperson Study Assessment.
Sponsors and CROs often are pressed to find the right sites for their studies. Site Match, Quorum’s site directory service, can help. From a database with tens of thousands of investigators who have worked with Quorum and want to learn about study opportunities, we can create a tailored list of possible sites.
Site Match reports can include sites grouped by:
- Therapeutic and/or disease area
- Geographic location
- Affiliations with institutions
- Clinical research experience with Quorum
Site Match makes introductions quick and easy.
A last-minute need to translate participant materials, especially a consent form, can delay the enrollment of crucial participants. And finding another vendor for another set of services complicates things even more. Quorum can save you time and effort with its translation solutions.
Quorum supports the translation of informed consent documents, recruitment materials, and other study-related documents into over 100 languages. Our in-house translators understand the regulatory requirements for participant protection, and our IRB reviewers know what to look for. With Quorum, you can have confidence in your translations and save valuable time.
Quorum’s translation services:
- Forward-Translations: We can start translating a document as soon as the IRB has approved its English version.
- Fast-Track Translations: Quorum can expedite the consent form translations so they are completed within 72 hours of the board’s approval.
- Back-Translations: Quorum can verify an existing translation by translating it back to English.
- Translation Comparison Mode: A translation comparison is more efficient than a back-translation, and it often can serve the same purpose. We will compare the meaning of a translated document with its English version and document any significant differences.
We can provide translation services at any time during a study.
For a multiple-site study, enrolling sites and preparing them for IRB review requires valuable time and resources. With Quorum’s Site Enrollment service, customers can delegate the IRB submission process to us. Quorum will reach out to sites you have selected and assist them with their IRB submissions.
With the Site Enrollment Service, more sites enroll successfully in a study and more institutions with local IRBs waive their jurisdiction to Quorum.
Quorum works with over 1,000 research institutions. Our boards can serve as a local IRB for an institution’s research, or as a central IRB in multi-site studies.
When sponsors or CROs approach an institution about a multi-site study, it is not always clear whether that institution can use an independent IRB like Quorum. We help institutions explore the opportunities of working with Quorum. The integrity of Quorum’s AAHRPP-accredited boards and the resources of our institution specialist team ensure reliable oversight and institution-specific attention.
Our institutional outreach includes:
- Existing relationships with over 1,000 research institutions
- A dedicated institution specialist team to help establish jurisdiction agreements and tailor any processes as necessary
- The negotiation and management of institution-specific consent form language
- Regulatory attorneys in-house, ready to assist with the concerns of an institution, a sponsor, or a CRO
Not all research is subject to IRB oversight. If specific criteria are met, a study may be exempt from IRB review. The determination can be complex, but Quorum’s regulatory team and IRB experts can assess and confirm whether your proposal qualifies.
Quorum can provide exemption determinations for research conducted in the US or in Canada. We will assess whether the conditions of exemption apply to your project, such as finding:
- It is not research, such as Quality Improvement assessments or case reports
- It is not research involving human subjects, such as studies without interactions or interventions, or that use anonymized data
- The research is generally exempt from review, such as surveys, interviews, and the use of existing records
Electronic consent (eConsent) is a powerful tool available to researchers. The use of eConsent offers improved participant engagement, reduces consent documentation errors, and ensures compliance and security. That is why more and more researchers are incorporating eConsent solutions into their trials.
Quorum Review IRB has years of experience reviewing eConsent solutions of all varieties. We understand the technology’s potential, its limitations, and how it fits within regulatory requirements.
Quorum offers a full suite of services for eConsent studies.
- Dedicated Staff: Each study that utilizes eConsent is assigned an account manager, consent form editor, regulatory attorney, and the support of an IT professional to ensure a timely and comprehensive review.
- Experienced Board: Our board panels have years of experience with eConsent and its unique requirements and IRB considerations.
- Streamlined Review: Our industry-leading process for reviewing eConsent is easy and in sync with oversight agency recommendations, including the FDA’s Final Guidance, Use of Electronic Informed Consent, Questions and Answers.
- Technological Expertise: Board panels include leading experts in developing eConsent-enabled trials. They understand the process and the technology, and they serve to ensure the ethical review thoroughly covers technological elements. Plus, board members see an eConsent document just as a participant would—whether by PC, tablet, or other device.
- Platform-Agnostic Approach: Quorum can review electronic consents developed by any industry vendor in any format. We do not limit ourselves to working with one vendor, or to one operating system.
- Thought Leadership: Quorum, the leading expert on eConsent, has numerous publications—from blog articles to whitepapers to webinars—offering insights into eConsent from all angles. And Quorum leadership are regularly asked to present on the topic at industry conferences hosted by organizations including the Association of Clinical Research Professionals (ACRP), Model Agreements and Guidelines International (MAGI), and the Association for the Accreditation of Human Research Protection Programs (AAHRPP).
Quorum now offers consulting services and regulatory support through its division Kinetiq. Kinetiq’s team of legal, ethics, medical and regulatory experts can assist clients around the world on a wide array of issues related to research and clinical trial oversight. Kinetiq offers services including regulatory advice, accreditation preparation, and GCP and compliance assessments. Let our medical writing specialists help develop grant proposals, protocols, consent forms, clinical trial result summaries, and other study documents.
The HIPAA (Health Insurance Portability and Accountability Act) Privacy Rule imposes important privacy and security requirements on investigators, research organizations, and institutions that qualify as “covered entities.” Before an investigator at a covered entity can use or disclose anyone’s Protected Health Information (PHI) for research, the investigator must either:
- Obtain the participant’s written authorization to use or disclose PHI; or
- Receive a waiver for the need of authorization.
Quorum can help investigators with these often complex requirements. Regarding HIPAA and consent forms, Quorum prefers that consent forms include language that satisfies HIPAA standards rather than a stand-alone HIPAA document.
The HIPAA Privacy Act authorizes IRBs to approve waivers to some research-related requirements. Quorum’s boards can consider and approve any one of the three HIPAA waivers for research:
- “Partial Waiver”: For example, an investigator may wish to use existing PHI to contact potential participants or collect and record PHI via telephone screens before potential research participants visit the research site
- “Complete Waiver”: For example, an investigator may ask to access PHI contained in patient medical charts for a retrospective chart review study without contacting the patients
- “Alteration”: For example, an investigator or sponsor with a waiver of a documentation of consent also would like to waive the requirement for a signed HIPAA authorization.
Expeditable Research Review
Everyone’s time is valuable: yours, your research participants’, and our board members’. When the circumstances of research allow it, expedited reviews save time for everyone. Quorum’s accredited processes refer qualifying submissions to expedited review whenever possible, and our team of reviewers (authorized members of the IRB/REB) assesses submissions daily. These items often qualify for expedited review:
- Most recruitment materials
- Many administrative changes to research.
- Investigative sites that are joining an approved protocol
In addition, certain protocols may be eligible for expeditable research review. We can review and approve research that falls within one of seven categories and is considered minimal risk. Expeditable research does not wait for a scheduled meeting; it can go straight to a reviewer as soon as it is ready.
If the research qualifies — Phase IV studies often do, as do Retrospective Chart Reviews and surveys — we’ll rely on expedited review to review and oversee your study, saving you and your participants valuable time.
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