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

2. 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 Examples of research issues
up in the context of research and may pose a problem at the time of IRB
appropriate for consideration for
review.
Chairperson Assessment:
Generally, a Chairperson Assessment is most helpful when a sponsor or
research organization has specific questions about a proposed research  Determining whether the
study prior to the finalization of the study. Quorum requires the control arm is appropriate
submission of a draft of the protocol or study plan, any supplementary in a given patient
population
materials (i.e., investigator’s brochures, package inserts, or device
literature), and the informed consent. In addition, any specific questions  Defining the appropriate
should be sent in advance to allow an opportunity to evaluate the age range of participants
questions in the context of the proposed research.  Developing an adequate
description of the risks
The required documents and information should be submitted one week and/or benefits of
in advance of the scheduled Chairperson Assessment teleconference. The participation in the ICF
representatives from Quorum will be chosen based on the questions or  Forming a unique
concerns identified, but generally include the IRB Chairperson or approach to obtaining
another experienced Board member, and a representative from Quorum’s consent, which may involve
Study Services and Regulatory Departments. During the teleconference, waivers or alterations of the
Quorum’s Chairperson and members of the Quorum staff will answer consent or HIPAA
questions and provide feedback about the proposed study. authorization requirements
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

3. 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 Most granting agencies will specify the training
subjects do not require investigators to obtain program that has been designated to meet the
training in the protection of human subjects in requirements of the grant or contract. All
research. However, an institution holding an investigators receiving funding from the National
OHRP-approved Federal wide Assurance (FWA) is Institutes of Health (NIH) after October 1, 2000, for
responsible for ensuring that its investigators projects involving human subjects, must provide a
conducting HHS-conducted or supported human description of education completed in the protection
subject research understand and act in accordance of human subjects for each individual identified as
with the requirements of the HHS regulations for "key personnel" in the proposed research. 2 “Key
the protection of human subjects. OHRP does personnel” include all individuals who are directly
strongly recommend that institutions and their responsible for the design and conduct of the human
designated IRBs establish training and oversight subjects part of the research. Although NIH does not
mechanisms (appropriate to the nature and volume require a specific course, they do provide an online
of their research) to ensure that investigators web-based tutorial. 3
maintain continuing knowledge of, and comply with,
the following: FDA Requirements
The Food and Drug Administration (FDA)
• relevant ethical principles; requirements related to investigator training and
• relevant federal regulations; education are set forth in the FDA Form 1572. This
• written IRB procedures; form is signed by the investigator prior to the
• OHRP guidance; initiation of any clinical study under FDA
• other applicable guidance; jurisdiction. The Form lists the responsibilities of
• state and local laws; and the investigator—specifically that the investigator will
• Institutional policies for the protection of human be knowledgeable about the conduct of clinical trials
subjects. and the sponsor’s expectations as well as the federal
expectations pertaining to conducting trials.
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 2
NIH Notice OD-00-039.
subjects?, available at: http://answers.hhs.gov/ohrp/questions/7224, accessed
3
July 6, 2012. See http://phrp.nihtraining.com/users/login.php, accessed July 6, 2012.

4. July 30, 2012 | Volume 2, Issue 3
AAHRPP Requirements
Facilities with accreditation through the Association One well-accepted online program is the
of Accreditation of Human Research Protection Collaborative Initiative Training Program (CITI)
Programs (AAHRPP) must follow the standards which is a subscription program that individuals and
established for achieving and maintaining institutions can use to provide training to staff and
accreditation. These standards emphasize investigators. CITI offers a wide range of topics.
responsibility on the part of individuals and Categories of staff can be directed to specific topics
institutional officials for education, process to fulfill training requirements. Quorum actually
improvement and communication that stresses offers the CITI program to its clients free of charge.
human subject protection. Specifically, the AAHRPP The NIH and its many institutes also have online
accreditation instrument states: “The Organization training programs that are free to the public.
has an education program that contributes to the
improvement of the qualifications and expertise of Training programs for corrective action, audit
individuals responsible for protecting the rights and responses and other remedial responses
welfare of research participants.” 1 While most auditors are not permitted to suggest
training programs or specific trainers from
Institutional or Local Requirements companies specializing in education and quality
Academic institutions may also impose requirements improvement, it is possible to network with other
related to training for investigators and staff. Often sites and institutions to obtain recommendations
these requirements are more specific and may give about companies and independent contractors who
investigators and their staff more direction as to what provide such services. Blogs such as the one
types of training are considered appropriate. Some available as a member of ACRP and Linked In
have developed programs of their own. interest groups are useful forums for referrals for
these types of programs.
Training Options
Professional associations such as the Association of Summary
Clinical Research Professionals (ACRP) offer No matter the reason or motivation for training
training opportunities to investigators, clinical programs at any clinical research site or institution,
research coordinators and clinical research monitors. the necessity of such programs is indisputable.
Others, such as the Society of Clinical Research Protecting human subjects should be of paramount
Associates (SOCRA) offer training to coordinators concern for anyone involved in research—and
and monitors. Both organizations offer certification training of investigators and study staff can be an
opportunities. important step in preventing issues or addressing
them as they arise.
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.

5. July 30, 2012 | Volume 2, Issue 3
Healthy Summer Recipe Healthy Summer Tip
Mandarin Yogurt Delight Grocery Store Preparation
The orange color makes this an Get organized before your
attractive dessert. Serve in sherbet next trip to the grocery
dishes with a dollop of fat-free store. With a little bit of
whipped topping. This refreshing and preparation, you can save
easy recipe also works well as a fruit
salad. A perfect summer dish. This recipe also works well in
time and money and get the
diabetic menus. healthy ingredients you need
for a healthy summer!
1 package (0.3 ounces) sugar-free orange-flavored gelatin
3/4 cup boiling water Here are some ideas you can
8 ounces fat-free vanilla yogurt, sweetened with implement today to make
artificial sweetener your trip to the grocery store Need to a quick start shopping
1 can (11 ounces) mandarin oranges, in juice, drained efficient and easy:
list? Try this free template from
grocerylists.org.
Dissolve gelatin in boiling water. Add yogurt and stir until  Post your grocery list in the kitchen and encourage family
smooth. Chill until the consistency of egg whites, about 20 members to add to it.
minutes.  Plan meals in advance and add the ingredients to the list.
 Shop once a week using your grocery list.
Add drained fruit. Spoon into sherbet dishes and refrigerate
until set. Pick a routine that works and stick with it. This is a
proven method to avoid extra stops at the grocery
Makes 2 1/2 cups or 5 servings store—which will save precious time and money.
Each Serving: 1/2 cup
Carb Servings: 1/2 Source: Quick & Healthy cookbook author, © Brenda J. Ponichtera, RD,
Exchanges: 1/2 carbohydrate ScaleDown Publishing, Inc.; All rights reserved. www.QuickandHealthy.net
Nutrient Analysis
calories 40
total fat 0g
Contact Quorum Review
saturated fat 0g
cholesterol 1mg Interested in learning more about Quorum Review?
sodium 66mg Our Institutional Specialists are ready to answer your
total carbohydrate 7g inquiries regarding your organization’s specific
dietary fiber 0g
sugars 5g institutional IRB needs.
protein 3g
Courtney Scott Nancy Jane Earnhardt
Institutional Specialist Institutional Specialist
Source: Quick & Healthy Vol.2, 2nd Edition, © 2009. Brenda J.
Ponichtera, R.D.; Published by Small Steps Press, a division of the cscott@quorumreview.com nearnhardt@quorumreview.com
Healthy Tip of
American Diabetes Association; All rights reserved. T | 206-708-9497 T | 919-930-5198
The Institution Bulletin is a special publication of the Quorum Forum, and
brought to you by the Institution Team at Quorum Review.