The FDA is seeking input on modernizing its regulations and practices for clinical trials to address increased complexity and globalization of trials. It is asking how it can encourage innovative methods to build quality into trials and eliminate challenges posed by its regulations. A public hearing was held in April where several industry speakers presented, including the CEO recommending regulatory harmonization and relief from IND safety letters. Comments can be submitted to the FDA until May 31. The newsletter then discusses two research topics - a FDA guidance on IRB continuing review criteria, emphasizing the sponsor's role in providing study-wide information, and state laws regarding consent for research with pregnant minors.

1. Institution Bulletin
Letter from the CEO
Last fall, the FDA kept us busy by soliciting comments on a sweeping proposal to
revise the Common Rule. This spring, the FDA again is keeping us busy – this
time by asking for input on “Modernizing the Regulation of Clinical Trials and
Approaches to Good Clinical Practice.”
The agency has asked how to:
 Modernize the Agency’s GCP regulations, policies, and practices;
 Mitigate the challenges resulting from increased clinical trial complexity and
globalization;
 Encourage adoption of innovative methods for building quality into the
conduct of trials; and
 Eliminate challenges presented by FDA’s GCP regulations, policies, or practices
to building quality into the clinical trial process.
A public hearing was held in Washington, DC, on April 23. Several notable industry speakers presented. On behalf of the
Consortium of Independent Review Boards (CIRB), I recommended regulatory harmonization among the federal agencies
and relief from the burden of IND Safety Letters.
Do you have a recommendation for the FDA? You can submit electronic comments until May 31, 2012, to
http://www.regulations.gov.
While it is laudable that the FDA is encouraging us to think outside the box on how to improve the clinical trial process, we
also need to support the day-to-day work of ethics review. To that end, this edition of our Institutional Newsletter covers
two critical research topics. We share insights from the recent finalized FDA guidance on IRB continuing review and
criteria, and provide additional info on regulations for research with regard to pregnant minors.
Quorum Review IRB is here to help support your human research participant protection program. Feel free to contact us
with your questions and research needs.
Sincerely,
Cami Gearhart, CEO
Quorum Review IRB

2. April 27, 2012 | Volume 2, Issue 2
The Sponsor’s Role:
IRB Continuing Review after Clinical Investigation Approval
In February 2012, the FDA issued a final guidance regarding IRB Continuing Review after Clinical
Investigation Approval1, which supersedes the Information Sheet Continuing Review After Study
Approval.2 The guidance describes the Agency’s current thinking on continuing review and
provides recommendations about criteria, process, and frequency of continuing review.
The guidance covers four areas the FDA recommends IRBs consider carefully: 1) Risk
Assessment; 2) Adequacy of Informed Consent; 3) Local Issues, and 4) Trial Progress. The FDA is
updating its recommendations relating to the continuing review obligations under 21 CFR
56.108(a) and 21 CFR 56.109(f).
The FDA recognizes the challenge IRBs have staying well-informed about events across all study sites within a multi-site study. The
guidance highlights, since individual sites are typically unable to provide current, comprehensive information about the status of
all site enrollments, it’s best to have the sponsors provide multi-center studies information to the IRB. The FDA recommends the
sponsor provides such information to the investigator, who then reports it to the IRB per the IRB’s requirements and format.
In addition, the FDA suggests sponsors submit aggregate information about relevant regulatory actions occurring since the last
review that could affect safety and risk assessments. An example of this would be withdrawal or suspension from marketing in any
country on the basis of safety or reports of recalls and device required by 21 CFR 812.150(b)(6)).
During continuing review of a study, the FDA further suggests sponsors should consider providing existing reports (prepared by
the sponsor for some other purpose or entity) to the IRB. For example, as noted above, sponsors of investigational drug studies are
required by 21 CFR 312.33 to submit annual reports to the FDA on the progress of their studies. Sponsors of investigational
device studies are already required, at least annually, to provide progress reports to all reviewing IRBs (21 CFR 812.150(b)(5)).
Submitting the annual report for drug studies or the progress report for device studies is one mechanism of providing the IRB
with pertinent information for consideration at the time of continuing review.
By stating the sponsor is in the best position to provide study wide information, the FDA’s Guidance for Industry is also
consistent. See Adverse Event Reporting to IRBs – Improving Human Subject Protection3 for more information.
The guidance also refers to the FDA’s regulations for device studies which specifically assign general responsibility to sponsors
“…for ensuring IRB review and approval are obtained and ensuring that any reviewing IRB and FDA are promptly informed of
significant new information about an investigation…”4
Lastly, the FDA also suggests it’s useful for sponsors to inform IRBs when a Data Monitoring Committees (DMC) has met, even if
no problems are identified and the DMC recommends continuation of a study as designed. This information can be transmitted
by the investigator or directly by the sponsor.
The Federal Register notice of availability: http://www.regulations.gov/#!documentDetail;D=FDA-2009-D-0605-0024. The final
guidance is available at http://www.regulations.gov/#!documentDetail;D=FDA-2009-D-0605-0025.
1
IRB Continuing Review after Clinical Investigation Approval : http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM294558.pdf
2
September 1998, Office of Health Affairs, FDA
3
Adverse Event Reporting to IRBs – Improving Human Subject Protection : http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm126572.pdf
4
21 CFR 812.40.

3. April 27, 2012 | Volume 2, Issue 2
Research Involving Pregnant Minors
Under the federal regulations, an IRB must make additional considerations
for research involving minors (children as defined by the local law where the
research is taking place) because they are considered a vulnerable population.1
In most cases, the researcher must obtain permission from the child’s parent
or guardian and assent (a child’s affirmative agreement to participate in
research) from the child. The definition of “child” varies from state to state:
the age of majority in most states is 18, but goes up to 21 in some
jurisdictions. A minor may also become emancipated prior to the age of
majority, becoming an “adult” under the law. The requirements for
emancipation vary from state to state.
There are many states that address consent to medical treatment or therapy by
minors, but most are silent on the issue of when minors can consent to
participate in research. Guidance from the Office of Research Protections
(OHRP) indicates that if the research solely involves treatments or procedures
for which a minor can give consent outside the research context, then the
minors are not considered children under Subpart D and may provide their
own informed consent for the research.2
A common misconception is that a minor who is pregnant is emancipated,
and therefore considered an adult under the law. Generally, pregnancy does not result in automatic emancipation. Therefore,
most pregnant minors cannot, through their pregnant status alone, be considered an adult for purposes of consent to research.
Many states have laws allowing minors to provide consent to particular types of treatment. Notably, All fifty states and the District
of Columbia allow minors to consent to testing and treatment for sexually transmitted infections thirty-seven states and the
District of Columbia have laws regarding a minor’s ability to consent to prenatal care.3 Per the above-referenced OHRP guidance,
a pregnant minor can likely provide consent to research involving testing or treatment of STIs or prenatal care. On the other
hand, if the research does not involve treatment, or is unrelated to the pregnancy, a pregnant minor is unlikely to be able to
provide consent for themselves.
Researchers should be familiar with the laws of that state where the research is conducted. Institutions should develop clear
policies about consent for research that may involve pregnant minors based on the local law. The specifics of each proposed
research study may need to be evaluated on a case-by-case basis to determine whether a pregnant minor could provide consent for
themselves in the context of the study and the applicable law in your jurisdiction. In the case where the pregnant minor is legally
emancipated, legal documentation of this status should be obtained before proceeding with any screening or consent process.
1
See 45 CFR 46, Subpart D; 21 CFR 50, Subpart D
2
Research with Children Frequently Asked Questions, OHRP, accessed April 1, 2012 : http://www.hhs.gov/ohrp/policy/childrenfaqsmar2011.pdf
3
Guttmacher Institute, State Policies in Brief, Minors’ Access to Prenatal Care and Minors’ Access to STI Services, March 1, 2012.

4. April 27, 2012 | Volume 2, Issue 2
Healthy Recipe of the Month Healthy Tip of the Month
Baked Meatballs Incorporating Insoluble Fiber in your diet
These are so quick and easy because you cook them in the Studies indicate that insoluble fiber prevents
oven. Make this large amount and freeze for later use. problems associated with the colon such as
This recipe also works well in constipation, diverticulosis, hemorrhoids, and colon
diabetic menus. and rectal cancer. These fibers are also associated
with a decreased risk of cardiovascular disease.
1 cup oatmeal or oat bran
1 cup fat-free milk
1/2 cup egg substitute (=2 eggs) So how do you get that good
1 tablespoon dried parsley stuff in your diet?
2 teaspoons onion powder
1/4 teaspoon ground nutmeg Try incorporating sources
1 teaspoon salt (optional)
1/2 teaspoon ground black pepper
such as wheat bran, barley,
2 pounds extra-lean ground beef or ground turkey (7% fat) oats, rye, corn, popcorn, and fiber-rich vegetables. In
the vegetable category, fiber-packed veggies like
Preheat oven to 425 degrees. carrots, beets, turnips, cabbage, cauliflower, and
Brussels sprouts are great options to achieve optimal
Mix the first eight ingredients. Add ground meat and mix well.
Shape into 1 1/2-inch balls. Arrange on baking sheets that have health benefits from insoluble fiber.
been sprayed with nonstick cooking spray. Bake for 12 minutes
Source: Quick & Healthy cookbook author, © Brenda J. Ponichtera, RD,
or until done. ScaleDown Publishing, Inc.; All rights reserved. www.QuickandHealthy.net
Serving suggestion: Add to spaghetti sauce and serve over pasta,
or make a sandwich by serving with sauce in a whole grain roll.
Makes 48 meatballs total, 12 servings
Contact Quorum
The Institution Bulletin is a special publication of the
Each Serving: 4 meatballs
Carb Servings: 1/2
Quorum Forum, and brought to you by the Institution
Exchanges: 1/2 starch, 2 lean meat Team at Quorum Review IRB.
Nutrient Analysis
calories 146 Interested in learning more about Quorum Review IRB?
total fat 6g Our Institutional Specialists are ready to answer your
saturated fat 2g
cholesterol 47mg inquiries regarding your organization’s specific
sodium 85mg institutional IRB needs.
total carbohydrate 6g
dietary fiber 1g
sugars 1g Courtney Scott Nancy Jane Earnhardt
protein 17g Institutional Specialist Institutional Specialist
cscott@quorumreview.com nearnhardt@quorumreview.com
Source: Quick & Healthy Recipes and Ideas, 3rd Edition, © 2008 Brenda T | 206-708-9497 T | 919-930-5198
J. Ponichtera, R.D.; Published by Small Steps Press, a division of the
American Diabetes Association; All rights reserved.