October 18, 2012 | Volume 2, Issue 4

Institution Bulletin

Letter from the CEO

This month, two researchers were honored for basic research conducted in academic settings. The Nobel Assembly awarded the 2012 Nobel Prize in Physiology or Medicine to John B. Gurdon and Shinya Yamanaka, investigators who discovered a way to develop stem cells from adult skin cells—thus removing the need to use and destroy human embryos. The work of these two scientists illustrates the importance of basic research conducted every day in institutions across the country. In 1962, Dr. Gurdon’s work was revolutionary in opening the door to cloning. When coupled with the work of Dr. Yamanaka and other scientists, his work now may pave the way for radical advances in medicine that allow damaged or diseased tissues to be regenerated in the lab - or even inside patients' bodies. Here at Quorum Review, we are privileged to review clinical research made possible by the tenacity and ingenuity of researchers in hospitals and universities across the country. When an institution is ready to use a central IRB, we are committed to supporting the organization with a high quality review and strong staff support. Today’s newsletter delves more deeply into how to work with Quorum Review, from waiving jurisdiction to developing a consent form. We look forward to an opportunity to work with you. Sincerely,

Cami Gearhart, CEO Quorum Review IRB

CEO Cami Gearhart , JD

October 18, 2012 | Volume 2, Issue 4

Quorum Services: Custom Consent Form Service Quorum Review offers a Custom Consent Form service to clients who would prefer to have Quorum develop the consent document. Quorum draws on the combined expertise of legal, medical, and consent form development staff to produce the consent forms needed for a given study. When clients elect to use the Custom Consent Form service, they can expect consent documents to include: In general, documents produced through the Custom Consent Form service will be based on Quorum Review’s internal consent form templates. These templates can be modified to be appropriate for a wide variety of research studies. In addition, upon request, the documents can incorporate relevant client template language between Quorum Review and the client. The time needed to create consent documents depends on the complexity of the study and the number of consent forms that may be required. In general, most Custom Consent Form service requests can be fulfilled within four to seven business days after the request submitted to Quorum. Upon receipt of a Custom Consent Form service request, clients will be provided with a quote containing estimated costs and delivery times for the client’s review and approval. Clients will be asked to provide some information with a Custom Consent Form service request, including:

Descriptions of the risks of study-related products, including the study drug or device, rescue medications, prophylactic drugs, and other products specifically indicated in the protocol

Risks of protocol procedures Alternative treatments The plan for compensating subjects in the event of illness or injury

If a client is not able to provide the information described above, this may extend the time needed to create the consent documents and additional development charges may be incurred.

An accurate summary of relevant information about the presented in language that is understandable to the lay reader

Elements required by Quorum Review standards, which include regulations in the United States and Canada, and relevant U.S. state and Canadian provincial law

HIPAA statements for U.S. consent forms and PIPEDA statements for Canadian consents

Quorum Review’s preferred style and standards

October 18, 2012 | Volume 2, Issue 4

Waiving Jurisdiction to Another IRB For various reasons, a hospital, academic medical center, or other research organization may need to waiver jurisdiction to an outside IRB. Institutions with a Federal Wide Assurances (FWA) from the Office of Human Research Protections (OHRP) must ensure that the arrangements made with the outside IRB are documented in a written agreement between the institution and the IRB if the research is covered by the FWA1. Although this agreement is only required for research covered by an FWA, it is a best practice to ensure that arrangements for IRB review of a study by an outside IRB are always documented in writing, regardless of whether the research would fall under an institution’s FWA. The agreement should cover the following points:

Outline the relationship between the Institution and the organization or institution operating the IRB Include a commitment that the IRB will adhere to the requirements of the institution’s FWA.

OHRP provides a sample authorization agreement that includes the required language but Institutions may have good reason to expand upon this language and develop their own agreement. The agreement must be kept on file by both organizations and must be made available to OHRP or any U.S. federal department or agency conducting or supporting research covered by the FWA upon request. If an institution will rely on multiple external IRBs, the institution must ensure that its FWA designates the external IRB that reviews the largest percentage of the research covered by the FWA. The institution should also ensure that any IRB that will be reviewing research covered by their FWA is registered with OHRP2. Quorum Review solicits information with each new study submission to determine whether the investigator is affiliated with an institution that has jurisdiction over the study. If so, the investigator is instructed to obtain permission from the institution to rely on Quorum Review as the IRB for the study. It is important to note that institutions must still authorize the jurisdiction to an outside IRB even if the institution does not maintain its own internal IRB. An institution can waive jurisdiction to an outside IRB for a single study or multiple studies. Quorum Review has an Institutional Jurisdiction Waiver Form and Institutional Authorization Agreement (IAA) that can be used by institutions waiving to jurisdiction to Quorum. Quorum will also accept the template authorization agreement developed by OHRP.

1 Assurance Process - FAQs, U.S. Department of Health & Human Services, Office of Human Research Protections, available at:

http://answers.hhs.gov/ohrp/categories/1563, accessed 09/25/2012.

2 2 Id.

October 18, 2012 | Volume 2, Issue 4

Healthy Recipe

Pear Salad with Raspberry Dressing This is a great fall salad and will be popular with the whole family. The combination of fruit with nuts and raspberry dressing is pleasing to the palate. This easy recipe also works well in diabetic menus.

2 medium pears, chopped, not peeled (~3 cups) 1 tablespoon lemon juice 10–12 ounces mixed salad greens (~2 quarts) 1/4 cup chopped walnuts or almonds 1/2 cup reduced-fat raspberry salad dressing Optional: 2-3 ounces blue cheese, crumbled

In a large salad bowl, mix chopped pears with lemon juice to prevent browning. Add salad greens and nuts. Pour dressing over salad and toss. Optional: Top with blue cheese.

Note: One serving is an excellent source of fiber.

Most of the fat in the recipe is heart-healthy omega-3 fat and polyunsaturated fat.

Makes 10 cups or 5 servings

Each Serving: 2 cups Carb Servings: 1 1/2

Nutrient Analysis

calories 158 total fat 7g saturated fat 0g cholesterol 0mg sodium 243mg total carbohydrate 23g dietary fiber 5g sugars 15g protein 3g

Source: Quick & Healthy Recipes and Ideas, 3rd Edition, ©2008, Brenda J. Ponichtera, R.D, Published by Small Steps Press, publishing health conscious books for the general population, a division of the American Diabetes Association; www.QuickandHealthy.net

Healthy Tip

Fast Food Choices

There are several easy ways today to reduce calories and still enjoy an occasional meal at a fast food restaurant. Consider the simple reduction of calories by as much as 100 – 150 by skipping the mayonnaise or special sauce. Or try substituting the fries. More chains are including fruits and vegetables, which are lower in calories if they are not deep fried or covered with rich sauces. Before eating out at a fast food restaurant, take a moment to calculate the calories you’ll be consuming. Calories charts are available in most chain stores and on the internet. If you own a smart phone, a plethora of apps are available to download that will give you fast food caloric info on the go. Here are a few online references that are easy to print:

http://www.foodfacts.info

http://www.menshealth.com/nutrition/eating-out-restaurants-nutritional-charts

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.

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