Quorum Review IRB Archives | Quorum Review IRB

Tag Archive: Quorum Review IRB

  1. Phase I Healthy Study Design and IRB Review

    Comments Off on Phase I Healthy Study Design and IRB Review

    Webinar Recording: Phase I Healthy Study Design and IRB Review

    Optimize Your Phase I Healthy Trial DesignView the slides and recording for our recent webinar, Phase I Healthy Study Design and IRB Review. This webinar was originally broadcast live on October 13, 2015 and October 15, 2015.

    Presented by David C. Babaian, JD, LLM, the webinar covered:

    • Typical Phase I Healthy trial designs
    • Risks and benefits to participants in Phase I Healthy trials
    • Advertising/recruitment, informed consent, and compensation/reimbursement considerations in Phase I Healthy trials
    • Methods to minimize risks to participants in Phase I Healthy trials
    • Trends and case studies

    Webinar Slides:

    Download a PDF of the slides

    Webinar Recording:

    View the recording on YouTube below

    To access other Quorum Review webinar recordings, visit our Resources page.


  2. Possible Next Steps for 21st Century Cures Act: “Advancing Medical Innovation for a Healthier America”

    Comments Off on Possible Next Steps for 21st Century Cures Act: “Advancing Medical Innovation for a Healthier America”

    Possible Next Steps for 21st Century Cures Act: “Advancing Medical Innovation for a Healthier America”

    Jim Gearhart PictureOn July 10, the House of Representatives sent what it called the 21st Century Cures Act to the Senate. Now the bill, with a wide-ranging list of changes for medical research, is in the hands of the Senate’s HELP (Health, Education, Labor, and Pensions) Committee chaired by Lamar Alexander. Two weeks ago, a report came out that Senator Alexander said could influence his committee’s response to the 21st Century Cures Act. The Bipartisan Policy Center, a think tank founded by four former senators in 2007, released “Advancing Medical Innovation,” which lays out a set of recommendations for reforming medical research and the FDA. Since Senator Alexander said that the BPC’s suggestions could end up in the 21st Century Cures Act, it could be worth a look to see what those suggestions are.

    The BPC’s report focuses on the functioning of the FDA, and has four sections:

    1. Improving the Medical Development Process
    2. Increasing Regulatory Clarity
    3. Strengthening the FDA’s Ability to Carry Out Its Mission
    4. Increasing Investment in Medical Products to Address Unmet and Public Health Needs

    The report echoes many themes and suggestions that appeared in the 21st Century Cures (The BPC also released a table comparing their recommendations with the bill), but it also travels over some new ground. Here are some highlights of what could become law from each section of the report.

    Improving the Medical Development Process

    Site-Match-Skyscraper-245x262Both 21st Century Cures and the BPC report call for a greater reliance on clinical data for new drug approvals. Like 21st Century Cures, the BPC report recommends using information from medical practice for approving new indications. The BPC adds to this idea, calling for a change to the FDA’s established Phase I – III approval process. The report endorses a move away from relying solely on randomized, controlled trials to including studies that replicate clinical treatments, using “populations where care is provided under more typical settings.”

    The report includes a packet of recommendations about publicizing off-label uses of medicines. In presenting the report, former Senator (and surgeon) William Frist said that drug sponsors know what off-label uses work and that clinicians deserve to hear about them. The BPC’s report suggests a framework where pharmaceutical companies can provide, “truthful, non-misleading and scientific” data about alternate uses of approved treatments. Senator Frist insisted that current restrictions on those communications were dated and unnecessary.

    The BPC report also called for a greater use of biomarkers and patient-reported outcomes, again showing a parallel with themes prominent in 21st Century Cures.

    Increasing Regulatory Clarity

    The BPC offered a series of suggestions for better defining who should have responsibilities over what at the FDA. A major topic here, as in the 21st Century Cures Bill, was limiting the regulation of health-related software. The FDA should have very little oversight of health apps, the BPC report. Just as 21st Century Cures set boundaries for what programs should fall under the FDA’s jurisdiction, the BPC says the fewer restrictions on new programming the better.

    The BPC report took aim at one new area: the FDA’s regulatory framework around combination products. The report said a product that uses both a device and a drug to work (such as artery stents or asthma inhalers) faces confounding guidance about which FDA division should review it. To accelerate approvals, and to ensure the United States remains competitive, the BPC calls for updating and simplifying these regulations.

    Strengthening the FDA’s Ability to Carry Out Its Mission

    This section recommended changing the compensation rules for the FDA in order to improve recruitment and retention. It also called for new guidelines around when and how FDA personnel interact with the private sector (such as at conferences).

    Increasing Investment in Medical Products to Address Unmet and Public Health Needs

    Like the 21st Century Cures Act, the BPC report calls for increased attention to developing new antibiotics. It reinforces the bill’s call for less restrictive boundaries around making experimental treatments available to patients. The BPC also recommends new routes for approving what it calls “dormant therapies.”


    It will be interesting to see in the coming months how many of these policy suggestions make it into the next iteration of the 21st Century Cures bill. It stands to reason that those areas of intersection with the current bill – such as monitoring of health IT programs and the use of ‘real-world’ data for approving additional indications – have a good chance of making it through.


    BPC Press Release

    C-span video of Lamar Alexander’s speech

  3. Apple’s ResearchKit Could Change How We Study

    Comments Off on Apple’s ResearchKit Could Change How We Study

    Apple’s ResearchKit Could Change How We Study

    QIRB-jim-gearhart-blog2Earlier this month, Apple announced ResearchKit, an app-builder that could change fundamentally how research teams gather data and communicate with participants. After exploring the five studies that are showcasing the ResearchKit, it strikes me that this software toolkit can support medical research in at least three ways:

    – It could enable medical studies to reach unprecedented numbers of users/participants
    – It can make it much easier to create and administer electronic consent forms
    – It could help transform smart devices into participant study tools

    When Apple announced ResearchKit, it also released a packet of apps that came from it. The apps are for five studies run by respected research institutions. These studies help demonstrate the potential of ResearchKit and the iPhone:

    • Mount Sinai’s Icahn School of Medicine worked with LifeMap Solutions to create Asthma Health, which is studying patterns of asthma symptoms. Among other plans, the study aims to match up a participant’s report of symptom severity with the air quality at that location at that moment.
    • Massachusetts General Hospital has designed GlucoSuccess to help manage diabetes symptoms and study how personal habits affect glucose levels.
    • Stanford has MyHeart Counts, which track how personal habits affect cardiovascular health. MyHeart Counts monitors daily activities, tracks behavior through surveys, and correlates that data with reported cardiovascular health. (I enrolled in this one, as I was eligible.)
    • Sage Bionetworks and the University of Rochester are studying Parkinson’s Disease with mPower. This study uses the iPhone’s accelerometer and touch screen to assess participants’ balance and dexterity.
    • In a collaboration with the Dana-Farber Cancer Institute, Penn Medicine, and UCLA’s Jonsson Comprehensive Cancer Center, Sage Bionetworks also has created Share the Journey, a program to track the daily impact of breast cancer.

    Judging from these first five examples, the ResearchKit can provide a straightforward template for creating study-related apps. According to Apple’s Technical Overview, ResearchKit has three modules for a study app: conducting surveys; completing tasks on the iPhone; and managing informed consent. These inaugural studies have all three modules on clear display.

    The five apps look similar and essentially follow the same workflow. They have introductory screens that cover study procedures, eligibility requirements, risks and benefits. They guide the user/study volunteer through an informed consent process and confirm eligibility. Then they settle into the data-gathering part of the study. Three of the studies include videos that reinforce the essential study information. From what I’ve seen so far, the ResearchKit can lead to new ways to conduct research. Here are some possibilities:
    [ad name=”social-media-research” align=”right”]

    Huge Number of Participants

    Apple’s promotional video touted the potential to bring more volunteers into a study than ever before. Indeed, the cardiovascular study MyHeart Counts exceeded its target of 10,000 participants within 24 hours of Apple’s announcement. The Parkinson’s study, mPower, attracted four times the volunteers as any similar study had before. A large chunk of those numbers likely came from the excitement of the product launch, but even a fraction of those enrollment numbers would represent an impressive recruitment program.

    Electronic Informed Consent

    Interest in eConsent is growing in the area of clinical research. Some tools are available on the market, more studies are starting to try electronic consent, and the FDA just released draft guidance on using them. It looks like the ResearchKit will offer a way to create and offer eConsents with relative ease. Videos, interactive screens, and comprehension tests are all possible. For documentation, each of the studies delivers a PDF of the consent, and Apple promises electronic signatures will be available.

    Participant Study Tools

    The iPhone (and other devices, if Apple makes good on its promise to release the ResearchKit as open source) could become a portable monitoring device, just by utilizing the features it already contains (i.e., accelerometer, touch screen, GPS, microphone, camera). This could simplify data gathering on a wide range of studies, and help realize the potential of BYOD (bring your own device) convenience in research.

    Of course, these are the first days of ResearchKit, with questions and uncertainties remaining. In an upcoming post I’ll take a closer look at some of the issues, mainly from the perspective of an IRB.

  4. Week in Review

    Comments Off on Week in Review
  5. Christmas Holiday Office Closure

    Comments Off on Christmas Holiday Office Closure

    Quorum Review’s offices will be closed on December 24 & 25, 2014 in observance of the Christmas holiday.

  6. Quorum Review’s Mitchell Parrish Presenting at DIA 2014 Conference

    Comments Off on Quorum Review’s Mitchell Parrish Presenting at DIA 2014 Conference

    DIA_2014_QIRBSEATTLE, WA (May 29, 2014): Quorum Review IRB, the industry leader in central IRB services, announces Mitchell E. Parrish, JD, RAC, CIP, as a presenter at DIA’s 50th Annual Meeting. The event takes place June 15-19, 2014 at the San Diego Convention Center in San Diego, California.

    Mr. Parrish speaks on the topic of Research Consent in Acute Settings at 10:30 AM on June 17, 2014. The presentation focuses on the inherent obstacles of this type of research, as well as concrete ways to obtain effective consent while concurrently respecting the research participant, study design, and enrollment numbers. Quorum Review’s Business Development Team will also be present in the exhibition hall at Booth #2030 during the conference dates.

    Mitchell Parrish ImageMr. Parrish is a Regulatory Attorney for Quorum Review, where he provides legal counsel on U.S. and Canadian laws and regulations related to medical product research and development. Mr. Parrish is a member of the Regulatory Affairs Professionals Society, Public Responsibility in Medicine & Research, Association of Corporate Counsel, and Washington State Bar Association. He also has his Regulatory Affairs Certification (RAC) and is a Certified IRB Professional (CIP). Prior to Quorum, Mr. Parrish served as a Regulatory Consultant to the National Cancer Institute.

    DIA’s Annual Meeting is the nation’s largest multidisciplinary event bringing together a community of life sciences professionals at all levels and across all disciplines involved in the discovery, development, and life cycle management of medical products. These professionals share a common goal to foster innovation that will lead to the development of safe and effective medical products and therapies to patients.

  7. Learning from 2013 Warning Letters to IRBs

    Comments Off on Learning from 2013 Warning Letters to IRBs

    Institutional Bulletin vol 4,  issue 2

    In the recent edition of our sister publication, The Quorum Forum, we discussed reflecting on the past year as a means to formulate possible improvements to IRB procedures.  A review of FDA warning letters to IRBs from 2013 provides an opportunity to evaluate your IRB procedures and policies and evaluate them against the regulatory requirements for IRBs. If you are interested in the specifics, FDA warning letters are posted publicly on the FDA website, here.

    The handful of warning letters issued to IRBs list several failings that may seem straightforward; however, it is worthwhile to review the issues FDA raised and evaluate your own IRB procedures and policies. This exercise can help to ensure that each of these regulatory requirements is met.

    For ease of reference covering the points noted in warning letters, Quorum Review has developed a checklist for your use:


    Another important point to consider is whether the study file provides adequate documentation that the above-referenced procedural requirements are followed. Once procedures have been identified that meet the regulatory requirements, it would be prudent to self-audit study files to ensure the documentation in the files clearly records that the IRB is following procedures and fulfilling regulatory obligations. 

    In addition, to procedural failings, the FDA warning letters addressed a lack of appropriate documentation in IRB minutes. Again, it may be worthwhile to review examples of recent minutes to ensure the following information is documented in minutes appropriately.

    For your convenience, Quorum Review has developed a checklist for Board minutes: