July 30, 2012 | Volume 2, Issue 3

Institution Bulletin Letter from the CEO

This summer marks the 21st anniversary of Quorum Review IRB. We are proud to have served this industry for over two decades and marvel at the evolution IRB review has taken in this time. Walt and Marilyn Gearhart, founders of Quorum Review and my parents, believed that an IRB can provide high-quality ethics review and also provide responsive, courteous service to researchers. I feel fortunate that my family and our company continues to support these values today. “Family businesses are guided by a long-term outlook,” says Mark Green of Seattle University. “Instead of seeking quick money, traditional family businesses seek sustainable, long-lasting business models.” This is certainly our philosophy at Quorum Review, and we begin our third decade with unlimited passion to continue our mission to support the ethical protection of research participants and provide exceptional customer service. We continue our commitment to maintaining the highest level of quality and professionalism. Earlier this summer Quorum’s Director of Regulatory Affairs, Linda Coleman, was recognized in the Puget Sound Region as the 2012 Outstanding Corporate Counsel at a Small Company. Linda was recognized for her excellent work in building a team of attorneys and regulatory staff who can effectively support our ethics review in multiple states and countries. I believe that much of our customer satisfaction is due to the fact that our ethics boards render consistent, legally sound decisions – and this is thanks in large part to the work of Linda and her teams. I am proud of the mission and values of Quorum Review, and I’m pleased we can share these values with you. To help you with your mission, we have enclosed several articles regarding the ethics review of proposed clinical research. Please contact us if we can be of additional assistance. Sincerely, Cami Gearhart, CEO Quorum Review IRB

J. Walter Gearhart, Jim Gearhart, Cami Gearhart, Marilyn Gearhart

July 30, 2012 | Volume 2, Issue 3

Chairperson Assessment Service During the development of a new study, questions or concerns may come up about the proposed study design or consent process. Quorum Review offers a Chairperson Assessment to discuss such concerns or questions and provide feedback about proposed studies. This service is offered free of charge to our clients. The Chairperson Assessment is designed to assist researchers, sponsors, or other parties involved with the research to address issues that may come up in the context of research and may pose a problem at the time of IRB review. Generally, a Chairperson Assessment is most helpful when a sponsor or research organization has specific questions about a proposed research study prior to the finalization of the study. Quorum requires the submission of a draft of the protocol or study plan, any supplementary materials (i.e., investigator’s brochures, package inserts, or device literature), and the informed consent. In addition, any specific questions should be sent in advance to allow an opportunity to evaluate the questions in the context of the proposed research. The required documents and information should be submitted one week in advance of the scheduled Chairperson Assessment teleconference. The representatives from Quorum will be chosen based on the questions or concerns identified, but generally include the IRB Chairperson or another experienced Board member, and a representative from Quorum’s Study Services and Regulatory Departments. During the teleconference, Quorum’s Chairperson and members of the Quorum staff will answer questions and provide feedback about the proposed study. Quorum representatives can provide guidance based on our experience serving a wide variety of clients across all therapeutic areas. The guidance and opinions provided through a Chairperson Assessment are reflective of the individual Chairperson or Board member and Quorum staff members, and may not always represent the opinions of the fully convened Board. However, the guidance provided can often expedite the study start-up process, particularly if there are questions about whether the IRB will find a proposed aspect of the study to be acceptable. If you would like to schedule a Chairperson Assessment, please contact the Initial Study Support Team at: InitialStudySupport@quorumreview.com

Determining whether the control arm is appropriate in a given patient population

Defining the appropriate age range of participants

Developing an adequate description of the risks and/or benefits of participation in the ICF

Forming a unique approach to obtaining consent, which may involve waivers or alterations of the consent or HIPAA authorization requirements

Examples of research issues

appropriate for consideration for

Chairperson Assessment:

July 30, 2012 | Volume 2, Issue 3

Training for Principal Investigators and Study Staff A quick internet search will turn up an astonishing number of “hits” for clinical research training. This can be discouraging when trying to choose appropriate training for Principal Investigators and study staff. It is important to consider the reason training is required, aside from the obvious benefit of increased knowledge and expertise. HHS Requirements The HHS regulations related to protection of human subjects do not require investigators to obtain training in the protection of human subjects in research. However, an institution holding an OHRP-approved Federal wide Assurance (FWA) is responsible for ensuring that its investigators conducting HHS-conducted or supported human subject research understand and act in accordance with the requirements of the HHS regulations for the protection of human subjects. OHRP does strongly recommend that institutions and their designated IRBs establish training and oversight mechanisms (appropriate to the nature and volume of their research) to ensure that investigators maintain continuing knowledge of, and comply with, the following:

• relevant ethical principles; • relevant federal regulations; • written IRB procedures; • OHRP guidance; • other applicable guidance; • state and local laws; and • Institutional policies for the protection of human

subjects. OHRP explicitly recommends that investigators complete appropriate institutional educational training before conducting human subject research.1

1 OHRP Frequent Questions, Must investigators obtain training of human subjects?, available at: http://answers.hhs.gov/ohrp/questions/7224, accessed July 6, 2012.

Most granting agencies will specify the training program that has been designated to meet the requirements of the grant or contract. All investigators receiving funding from the National Institutes of Health (NIH) after October 1, 2000, for projects involving human subjects, must provide a description of education completed in the protection of human subjects for each individual identified as "key personnel" in the proposed research.2 “Key personnel” include all individuals who are directly responsible for the design and conduct of the human subjects part of the research. Although NIH does not require a specific course, they do provide an online web-based tutorial.3 FDA Requirements The Food and Drug Administration (FDA) requirements related to investigator training and education are set forth in the FDA Form 1572. This form is signed by the investigator prior to the initiation of any clinical study under FDA jurisdiction. The Form lists the responsibilities of the investigator—specifically that the investigator will be knowledgeable about the conduct of clinical trials and the sponsor’s expectations as well as the federal expectations pertaining to conducting trials.

2 NIH Notice OD-00-039. 3 See http://phrp.nihtraining.com/users/login.php, accessed July 6, 2012.

July 30, 2012 | Volume 2, Issue 3

AAHRPP Requirements Facilities with accreditation through the Association of Accreditation of Human Research Protection Programs (AAHRPP) must follow the standards established for achieving and maintaining accreditation. These standards emphasize responsibility on the part of individuals and institutional officials for education, process improvement and communication that stresses human subject protection. Specifically, the AAHRPP accreditation instrument states: “The Organization has an education program that contributes to the improvement of the qualifications and expertise of individuals responsible for protecting the rights and welfare of research participants.”1 Institutional or Local Requirements Academic institutions may also impose requirements related to training for investigators and staff. Often these requirements are more specific and may give investigators and their staff more direction as to what types of training are considered appropriate. Some have developed programs of their own. Training Options Professional associations such as the Association of Clinical Research Professionals (ACRP) offer training opportunities to investigators, clinical research coordinators and clinical research monitors. Others, such as the Society of Clinical Research Associates (SOCRA) offer training to coordinators and monitors. Both organizations offer certification opportunities. Professional associations for physicians, such as the American Association of Pharmaceutical Scientists and specialty societies and the American Association of Psychology provide training and education opportunities for its membership. 1 AAHRPP Standards, Organizations, Element I.1.E.

One well-accepted online program is the Collaborative Initiative Training Program (CITI) which is a subscription program that individuals and institutions can use to provide training to staff and investigators. CITI offers a wide range of topics. Categories of staff can be directed to specific topics to fulfill training requirements. Quorum actually offers the CITI program to its clients free of charge. The NIH and its many institutes also have online training programs that are free to the public. Training programs for corrective action, audit responses and other remedial responses While most auditors are not permitted to suggest training programs or specific trainers from companies specializing in education and quality improvement, it is possible to network with other sites and institutions to obtain recommendations about companies and independent contractors who provide such services. Blogs such as the one available as a member of ACRP and Linked In interest groups are useful forums for referrals for these types of programs. Summary No matter the reason or motivation for training programs at any clinical research site or institution, the necessity of such programs is indisputable. Protecting human subjects should be of paramount concern for anyone involved in research—and training of investigators and study staff can be an important step in preventing issues or addressing them as they arise.

July 30, 2012 | Volume 2, Issue 3

Need to a quick start shopping list? Try this free template from grocerylists.org.

Healthy Summer Recipe

Mandarin Yogurt Delight

The orange color makes this an attractive dessert. Serve in sherbet dishes with a dollop of fat-free whipped topping. This refreshing and easy recipe also works well as a fruit salad. A perfect summer dish. This recipe also works well in diabetic menus.

1 package (0.3 ounces) sugar-free orange-flavored gelatin 3/4 cup boiling water 8 ounces fat-free vanilla yogurt, sweetened with artificial sweetener 1 can (11 ounces) mandarin oranges, in juice, drained

Dissolve gelatin in boiling water. Add yogurt and stir until smooth. Chill until the consistency of egg whites, about 20 minutes. Add drained fruit. Spoon into sherbet dishes and refrigerate until set. Makes 2 1/2 cups or 5 servings Each Serving: 1/2 cup Carb Servings: 1/2 Exchanges: 1/2 carbohydrate Nutrient Analysis

calories 40 total fat 0g saturated fat 0g cholesterol 1mg sodium 66mg total carbohydrate 7g dietary fiber 0g sugars 5g protein 3g

Healthy Tip of

Healthy Summer Tip

Grocery Store Preparation

Get organized before your next trip to the grocery store. With a little bit of preparation, you can save time and money and get the healthy ingredients you need for a healthy summer!

Here are some ideas you can implement today to make your trip to the grocery store efficient and easy:

Post your grocery list in the kitchen and encourage family members to add to it. Plan meals in advance and add the ingredients to the list. Shop once a week using your grocery list.

Pick a routine that works and stick with it. This is a proven method to avoid extra stops at the grocery store—which will save precious time and money. Source: Quick & Healthy cookbook author, © Brenda J. Ponichtera, RD, ScaleDown Publishing, Inc.; All rights reserved. www.QuickandHealthy.net

Contact Quorum Review Interested in learning more about Quorum Review? Our Institutional Specialists are ready to answer your inquiries regarding your organization’s specific institutional IRB needs.

Courtney Scott Institutional Specialist cscott@quorumreview.com T | 206-708-9497

The Institution Bulletin is a special publication of the Quorum Forum, and brought to you by the Institution Team at Quorum Review.

Source: Quick & Healthy Vol.2, 2nd Edition, © 2009. Brenda J. Ponichtera, R.D.; Published by Small Steps Press, a division of the American Diabetes Association; All rights reserved.

Nancy Jane Earnhardt Institutional Specialist nearnhardt@quorumreview.com T | 919-930-5198