Presented by J. Claire Carbary, JD, CIP, this webinar addresses some of the common issues confronted during ethics review of advertisements, consent forms and study tools from the perspective of the IRB. Development of effective recruitment tools and consent documents is essential to meeting enrollment goals and keeping a clinical trial moving forward. Advertising is the beginning of the informed consent and subject selection process and sets the stage for the consent process. Understanding the regulatory and ethical obligations that form IRB evaluation of advertisements and consent forms is critical during the development of the recruitment and consent plans and tools.

1. IRB Evaluation of Advertisements,
Consent Forms and Study Tools
March 5 & 7, 2013

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3. 3

4. Webinar Housekeeping
• Questions & Answers
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following the presentation
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5. Webinar Housekeeping
• Recording & Slide Deck
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posted on our website within 5 business days
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and/or colleagues
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6. About Quorum Review IRB
Accredited
• Fully Accredited by the Association for Accreditation of
Human Research Protection Programs (AAHRPP) through
2014
• Fully compliant with FDA and OHRP requirements
International capabilities
• Boards available for the review of US and Canadian Studies
Strong Framework
• Approx. 200 employees – one of the largest IRBs in the US
Certified IRB Professionals (CIP)
• 60% of Affiliated IRB members, 40% of Regulatory staff and
20% of study management & study support positions
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7. The Quorum Advantage
• 14 Board meetings each week
• 24-hour site turnaround, 36-hour amendment review,
and same day site changes
• One time CV and audit documentation submission
• Support available 8am-8pm ET
• Dedicated Study Manager
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8. The Quorum Advantage
• Secure portal with Smart Forms, status
reports, and approval documents
• Customized Phase I and Post-Marketing
processes
• Flexible, customized process for AMCs
• 100% Quality Control on all documents
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9. About the Presenter
Regulatory Attorney
J. Claire Carbary, JD, CIP
IRB Experience
– Joined Quorum Review IRB in September 2009
– WIRB prior to Quorum
– CIP certification since 2010
– Member of the Northwest Association for Biomedical Research (NWABR) and
Public Responsibility in Medicine and Research (PRIM&R)
Legal Background
– Juris Doctor from Seattle University
– Member of the Washington State Bar Association (WSBA)
– Member of the Health and Corporate Law Sections of the WSBA
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10. Webinar Overview
IRB Evaluation of Advertisements, Consent
Forms and Study Tools
Discussion Topics Page
Part I Advertisements and Recruitment 11
Part II Consent Forms 33
Part III Study Tools 63
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11. Part I
Advertisements and Recruitment

12. Advertisements
Regulatory Requirements: Review & Recruitment
• The FDA and OHRP regulations give
the IRB “authority to approve, require
modifications in, or disapprove all research
activities” covered by the regulations.
(21 CFR 56.109; 45 CFR 46.109)
• An IRB is also required to ensure that
appropriate safeguards exist to protect the
rights and welfare of research subjects.
(21 CFR 56.107(a) and 56.111; 45 CFR 46.107(a); 46.111)
12

13. Advertisements
Regulatory Requirements: Review & Recruitment
• FDA “considers direct advertising to
subjects to be the start of the informed
consent and subject selection process…”
• “The IRB should review the methods and
material that investigators propose to use to
recruit subjects.”
FDA Guidance Citation: Recruiting Study Subject – Information Sheet, FDA, available at:
http://www.fda.gov/RegulatoryInformation/Guidances/ucm126428.htm, Last Updated 10/18/2010.
13

14. Advertisements
Regulatory Requirements: Review & Recruitment
What does not Require Review?
Communications News stories Publicity Listings of
intended to be intended for clinical trials
seen or heard other audiences on the internet
by health Such as financial page (No additional safeguard
professionals advertisements directed provided by IRB review
toward prospective when the system format
Such as "dear doctor" investors limits the information
letters and doctor-to- provided to basic trial
doctor letters (even information, such as:
when soliciting for study the title, purpose of the
subjects) study, protocol
summary, basic
eligibility criteria, study
site location(s), and how
to contact the site for
further information.)
FDA Guidance Citation: Recruiting Study Subject – Information Sheet, FDA, available at:
http://www.fda.gov/RegulatoryInformation/Guidances/ucm126428.htm, Last Updated 10/18/2010.
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15. Advertisements
Regulatory Requirements: Review & Recruitment
What does Require Review?
Both the
Direct content and
the mode of
advertising communication
Includes, but is not
necessarily limited to:
newspaper, radio, TV,
bulletin boards, posters,
and flyers that are intended
for prospective subjects.
Final copy/format
FDA Guidance Citation: Recruiting Study Subject – Information Sheet, FDA, available at:
http://www.fda.gov/RegulatoryInformation/Guidances/ucm126428.htm, Last Updated 10/18/2010.
15

16. Rcruitment &
Advertisements
Regulatory Requirements: Review Advertising
& Recruitment
Review
Information that should generally be
included:
Does the advertisement provide more information than is necessary?
Name/ Purpose of Summary of Brief list of Time Research
address of research/ eligibility benefits (or other) site
investigator name of criteria commitment location/
study site condition contact
being information
studied
FDA Guidance Citation: Recruiting Study Subject – Information Sheet, FDA, available at:
http://www.fda.gov/RegulatoryInformation/Guidances/ucm126428.htm, Last Updated 10/18/2010.
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17. Advertisements
Regulatory Requirements: Review & Recruitment
Considerations:
 Is the process coercive?

Does it state or imply a certainty of favorable outcome or other benefits
beyond which is outlined in the consent?

If it involves an investigational product, does the ad include a claim of
safety, effectiveness, or equivalence/superiority to other products?

Is there any concern about the size of type and other visual effects as
well as audio and video?

If payment is mentioned, is the payment or the amount of payment
over-emphasized?

Does the advertisement use phrases like “free medical treatment” when
intending to describe study procedures or receiving the study product?
FDA Guidance Citation: Recruiting Study Subject – Information Sheet, FDA, available at:
http://www.fda.gov/RegulatoryInformation/Guidances/ucm126428.htm, Last Updated 10/18/2010.
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18. Therapeutic Misconception

19. Advertisements
Therapeutic Misconception & Recruitment
The therapeutic misconception occurs when
a research subject fails to appreciate the
distinction between the imperatives of clinical
research and of ordinary treatment, and therefore
inaccurately attributes therapeutic intent to
research procedures. The therapeutic
misconception is a serious problem for informed
consent in clinical research.”
Lidz CW, Appelbuam PS.
The therapeutic misconception: problems and solutions.
Med Care. 2002 Sep; 40 (9 Suppl) : V55-63. PubMed PMID: 12226586.
Description from: “The Therapeutic misconception: problems and solutions.”
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20. Advertisements
Therapeutic Misconception & Recruitment
• Although clinical trials may provide benefits to
some participants, the purpose of a clinical trial is
to evaluate an experimental therapy or intervention,
not to provide therapy
• Therapeutic misconception occurs when:
– Trial participants do not understand that research is aimed
primarily at producing knowledge and may not provide any
therapeutic benefit to them
– Participants enter trials without understanding the ways in
which elements of a clinical trial design may interfere with
their own health care objectives
Citation: Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada,
Canadian TCPS and Social Sciences and Humanities Research Council of Canada, Tri-Council Policy Statement: Ethical Conduct for
Research Involving Humans (TCPS 2), December 2010, Chapter 11, Clinical Trials, A. Key Concepts.
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21. Advertisements
Therapeutic Misconception & Recruitment
• Use of terms/phrases
• Logos/mottos/catch- “YOUR ONE-STOP…”
phrases “FINDING CURES
SINCE…”
• Focus on specific details
– Okay, but it necessarily “GET PAID TO…”
provides limited picture of
“PARTICIPATE TO GET
what is involved in the HELP.”
research “FREE TREATMENT.”
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22. Advertisements
The “Mode” & Recruitment
Traditional Advertising Online Advertising
Print Billboards Social Media Websites
Radio TV Email Etc.
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23. Advertisements
Focus on the “Wrong” Information & Recruitment
Emphasis on:
Payment Treatment Free Medical Care Possible Benefits
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24. Advertisements
Study Description: Depression Study & Recruitment
Advertisement Example 1
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25. Advertisements
Study Description: Depression Study & Recruitment
POLL
What would you change?
Remove the word “help” and take
Remove all images.
out payment.
Remove the image of the sun and Remove the image of the sun and
the statement related to payment. the word “help.”
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26. Advertisements
Study Description: Depression Study & Recruitment
POLL
What would you change?
Remove the word “help” and take
Remove all images.
out payment.
Remove the image of the sun and
Remove the image of the sun
the statement related to payment. and the word “help.”
26

27. Advertisements
Study Description: Diabetes Study & Recruitment
Lifestyle and Diet Modifications for Patients
with Type II Diabetes
Advertisement Example 2
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28. Advertisements
Study Description: Diabetes Study & Recruitment
POLL
Lifestyle and Diet Modifications for Patients
with Type II Diabetes
What would you change?
Remove the slogan and reference to “free
treatment.”
Revise “treatment” statement to provide
information about the research, and change
the payment language font.
Change the payment language font.
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29. Advertisements
Study Description: Diabetes Study & Recruitment
POLL
Lifestyle and Diet Modifications for Patients
with Type II Diabetes
What would you change?
Remove the slogan and reference to “free
treatment.”
Revise “treatment” statement to provide
information about the research, and change
the payment language font.
Change the payment language font.
29

30. Advertisements
Study Description: Cancer Study & Recruitment
Drug X in Children with Refractory Solid
Brain Tumors
Advertisement Example 3
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31. Advertisements
Study Description: Cancer Study & Recruitment
POLL
Drug X in Children with Refractory Solid Brain Tumors
Remove slogan, statement indicating
Remove slogan and statement
space is limited, and the word
indicating space is limited.
“treatment.”
Remove the words “cure” and Remove the reference to payment and
“treatment.” statement indicating space is limited.
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32. Advertisements
Study Description: Cancer Study & Recruitment
POLL
Drug X in Children with Refractory Solid Brain Tumors
Remove slogan, statement
Remove slogan and statement
indicating space is limited, and the
indicating space is limited.
word “treatment.”
Remove the words “cure” and Remove the reference to payment and
“treatment.” statement indicating space is limited.
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33. Part II
Consent Forms

34. Consent
Regulatory Requirements: Review Forms
• “An IRB shall require that information given to
subjects as part of informed consent is in accordance
with [the general requirements of informed consent].”
• “…the IRB may require that information, in addition to
that specifically mentioned in [the regulations] be
given to the subjects when in the IRB’s judgment the
information would meaningfully add to the protection
of the rights and welfare of subjects.”
Citation: 21 CFR 56.109(b); 45 CFR 46.109(b)
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35. Consent
Regulatory Requirements: Review Forms
The IRB…is the final
authority on the content of
the consent documents…
presented to the prospective
study subjects”
FDA Guidance Citation: A Guide to Informed Consent – Information Sheet, FDA, available at:
http://www.fda.gov/RegulatoryInformation/Guidances/ucm126431.htm, Updated 08/09/2011.
35

36. Consent
“Understandable” Language Forms
The information that is
given to the subject or the
representative shall be in
language understandable
to the subject or the
representative”
Citation: 21 CFR 50.20; 45 CFR 46.116
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37. Consent
“Understandable” Language Forms
Define terms the first time
they are used: medical AND
Define acronyms Use of second
non-medical terms:
the first time vs.
they are used first person “Placebo”
“we”- investigators/sponsor,
etc. “sponsor”
Boilerplate or “template”
language
with simple explanations of Consistent
Reading level
common procedures, study terminology
software/analysis
designs, sample storage, medical throughout
concepts, and other research-
specific concepts
37

38. Consent
Risks and Alternatives Forms
Most commonly “missed” elements of
consent:
“In seeking informed consent, the following information shall
be provided to each subject:
Risks: “A description of any reasonably foreseeable risks or
discomforts to the subject.” (21 CFR 50.25(2); 45 CFR 46.116(2); See
also ICH 4.8.10(g))
Alternatives: “A disclosure of appropriate alternative
procedures or courses of treatment, if any, that might be
advantageous to the subject.” (21 CFR 50.25(4); 45 CFR 46.116(4);
See also ICH 4.8.10(i))
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39. Consent
Risks Forms
Trying to get it “just right” – not too much or
too little
Reasonably foreseeable risks of any drugs, devices, or
procedures “required” by the protocol that would not
otherwise occur as part of clinical care should be listed.
No need to list risks that you would not expect to see
given the population, safety profile, etc.
39

40. Consent
Alternatives Forms
Are there Is there a “widely Is there no Is the condition
alternative drugs? used” alternative alternative terminal?
or non-western approach used?
treatment
approach used?
List them. List those too. Say so: If so the option of
“There are no “comfort care” or
approved “no treatment”
treatments in the should generally
U.S. for XYZ.” be included.
40

41. Consent
Therapeutic Misconception Forms
Terminology
• Use of Specific Terms and Phrases:
Treatment, patient
Doctor
Closely monitor
“For your health”
41

42. Consent
Therapeutic Misconception Forms
Over-emphasis of benefits:
• Consent documents should not contain unproven claims of
effectiveness or certainty of benefit, either explicit or implicit, that
may unduly influence potential subjects.
• Overly optimistic representations are misleading and violate
FDA regulations concerning the promotion of investigational
drugs (21 CFR 312.7) or investigational devices (21 CFR 812.7(d))
as well as the requirement to minimize the possibility of coercion
or undue influence (21 CFR 50.20).
FDA Guidance Citation: A Guide to Informed Consent – Information Sheet, FDA, available at:
http://www.fda.gov/RegulatoryInformation/Guidances/ucm126431.htm, Updated 08/09/2011.
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43. Consent
Therapeutic Misconception Forms
Minimization or unclear explanation of risks
or study procedures:
The explanation of risks of the test article
should be based upon information presented
in documents such as the protocol and/or
investigator's brochure, package labeling,
and previous research study reports. For IND
studies, the IRB should assure that the
clinical investigator submits the investigator's
brochure (when one exists) with the other
study materials for review.”
FDA Guidance Citation: A Guide to Informed Consent – Information Sheet, FDA, available at:
http://www.fda.gov/RegulatoryInformation/Guidances/ucm126431.htm, Updated 08/09/2011.
43

44. Consent
Exculpatory Language Forms
No informed consent, whether
oral or written, may include any
exculpatory language through
which the subject is made to
waive or appear to waive any of
the subject's legal rights, or
releases or appears to release
the investigator, the sponsor,
the institution, or its agents from
liability for negligence.
(45 CFR 46.116; 21 CFR 50.20)
44

45. Consent
Exculpatory Language Forms
2 General types of exculpatory language that
come up in consent forms:
• Language related to sample WILL I RECEIVE
PAYMENT?
ownership and payment for
commercial advances
WHAT WILL HAPPEN
• Language related to injury of TO MY SAMPLES?
the individual
WHAT IF I GET HURT OR
SICK WHILE I AM IN THIS
STUDY?
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46. Consent
Exculpatory Language Forms
Injury/Illness
• Examples of exculpatory and acceptable language
I waive any possibility of compensation for injuries that I
may receive as a result of participation in this research.
The hospital is not able to offer financial compensation
 nor to absorb the costs of medical treatment should you
be injured as a result of participation in this research.
The hospital makes no commitment to provide free

medical care or payment for any unfavorable outcomes
resulting from participation in this research. Medical
services will be offered at the usual charge.
Citation: “Exculpatory Language” in Informed Consent, Office for Protection from Research Risks (OPRR), November 15, 1996,
available at: http://www.hhs.gov/ohrp/policy/exculp.html
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47. Consent
Exculpatory Language Forms
Sample ownership and commercial gain
• Examples of exculpatory language re: Samples
By agreeing to this use, you should understand that you
will give up all claim to personal benefit from commercial
or other use of these substances.
I voluntarily and freely donate any and all blood, urine,
and tissue samples to the U.S. Government and hereby
relinquish all right, title, and interest to said items.
By consent to participate in this research, I give up any
property rights I may have in bodily fluids or tissue
samples obtained in the course of the research.
Citation: “Exculpatory Language” in Informed Consent, Office for Protection from Research Risks (OPRR), November 15, 1996,
available at: http://www.hhs.gov/ohrp/policy/exculp.html
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48. Consent
Exculpatory Language Forms
Sample ownership and commercial gain
• Examples of acceptable language re: Samples
Tissue obtained from you in this research may be used to
 establish a cell line that could be patented and licensed.
There are no plans to provide financial compensation to
you should this occur.
By consenting to participate, you authorize the use of your
 bodily fluids and tissue samples for the research described
above.
Citation: “Exculpatory Language” in Informed Consent, Office for Protection from Research Risks (OPRR), November 15, 1996,
available at: http://www.hhs.gov/ohrp/policy/exculp.html
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49. Consent
Exculpatory Language Forms
Sample ownership and commercial gain
• Reverses OPRR (OHRP) position with respect
to biospecimens language indicating a subject
gives up the legal right to be compensated for the use of
specimens is “an acceptable way to accurately inform
subjects that they will not be receiving any financial
compensation, now or in the future, for the use of those
biospecimens”
FDA Guidance Citation: Draft: Guidance on Exculpatory Language in Informed Consent, FDA, OHRP, August 19 2011, available at:
http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM271036.pdf
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50. Consent
Exculpatory Language Forms
Draft
Guidance
Sample ownership and commercial gain
• “Exculpatory Language” has the general effect of freeing or
appearing to free an individual or entity from malpractice, blame,
fault, or guilt
• A waiver in an informed consent document of any legal right may
be permissible IF that waiver does not free an individual/entity from
malpractice, blame, fault or guilt
• OHRP and FDA understand the practice of investigators/sponsors
not to compensate subjects who agree to provide specimens even
when used later for commercial purposes
• OHRP and FDA are not aware of any federal or state laws or
policies that suggest research subjects have a legal right to such
compensation if they voluntarily sign an informed consent form that
clearly stated they would not be paid or otherwise compensated for
providing specimens
FDA Guidance Citation: Draft: Guidance on Exculpatory Language in Informed Consent, FDA, OHRP, August 19 2011, available at:
http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM271036.pdf
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51. Consent
Exculpatory Language Forms
Draft
Guidance
Sample Ownership and Commercial Gain
• Examples of Acceptable Language under Draft
Guidance:
Although future research that uses your samples may lead
 to the development of new products, you will not receive
any payments for these new products.
By agreeing to this use, you are giving up all claims to any
 money obtained by the researchers from commercial or
other use of these specimens.
I voluntarily and freely donate any and all blood, urine,

and tissue samples to the [name of research institution]
and hereby relinquish all property rights, title, and interest
I may have in those samples.
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52. Consent
Exculpatory Language Forms
Draft
Guidance
Sample Ownership and Commercial Gain
• Examples of Acceptable Language under Draft
Guidance:
By consenting to participate in this research, I give up any
 property rights I may have in bodily fluids or tissue
samples collected during this research.
Although the results of research, including your donated

materials, may be patentable or have commercial value,
you will have no legal or financial interest in any
commercial development resulting from the research.
Tissue obtained from you in this research may be used to

establish a cell line that could be patented and licensed.
No financial compensation will be provided to you should
this occur.
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53. Consent
Injury/Illness Language (Example 1) Forms
POLL
The sponsor will not pay for injuries caused by the
study drug if you did not follow the direction of the study
doctor.
The sponsor will pay for injuries related to this research if you follow the
directions from your study doctor. The sponsor will not pay for injuries caused
by the study drug if you did not follow the direction of the study doctor.
The sponsor will pay for injuries related to this research if you follow the
directions from your study doctor. The sponsor will not pay has no plans to pay
for injuries caused by the study drug if you did not follow the direction of the
study doctor.
The sponsor will pay for injuries related to this research.
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54. Consent
Injury/Illness Language (Example 1) Forms
POLL
The sponsor will not pay for injuries caused by the
study drug if you did not follow the direction of the study
doctor.
The sponsor will pay for injuries related to this research if you follow the
directions from your study doctor. The sponsor will not pay for injuries caused
by the study drug if you did not follow the direction of the study doctor.
The sponsor will pay for injuries related to this research if you follow the
directions from your study doctor. The sponsor will not pay has no
plans to pay for injuries caused by the study drug if you did not follow
the direction of the study doctor.
The sponsor will pay for injuries related to this research.
54

55. Consent
Injury/Illness Language (Example 2) Forms
POLL
You cannot receive free medical care for injuries related to
this research. You will be responsible for paying for care you
receive at the XYZ Medical Center.
If you are injured you can receive medical care at XYZ Medical Center. You
cannot receive The hospital will not offer free medical care for injuries related to
this research. You or your insurance company will be billed responsible for
paying for care you receive at the XYZ Medical Center.
You cannot receive The hospital will not offer free medical care for the injuries
related to this research. You or your insurance company will not be billed
responsible for paying for care you receive at the XYZ Medical Center.
You cannot receive The hospital will provide free medical care for injuries
related to this research. You will not be responsible for paying for care you
receive at the XYZ Medical Center.
55

56. Consent
Injury/Illness Language (Example 2) Forms
POLL
You cannot receive free medical care for injuries related to
this research. You will be responsible for paying for care you
receive at the XYZ Medical Center.
If you are injured you can receive medical care at XYZ Medical Center. You
cannot receive The hospital will not offer free medical care for injuries
related to this research. You or your insurance company will be billed
responsible for paying for care you receive at the XYZ Medical Center.
You cannot receive The hospital will not offer free medical care for the injuries
related to this research. You or your insurance company will not be billed
responsible for paying for care you receive at the XYZ Medical Center.
You cannot receive The hospital will provide free medical care for injuries
related to this research. You will not be responsible for paying for care you
receive at the XYZ Medical Center.
56

57. Consent
Injury/Illness Language (Example 3) Forms
The sponsor will not pay for injuries if: POLL
I. They were caused by your participation in the research and not an underlying
condition;
II. You followed the directions of the study doctor; and
III. You promptly contacted the study doctor after the injury.
The sponsor has no plans to will not pay for injuries if:
I. They were caused by your participation in the research and not an underlying
condition;
II. You followed the directions of the study doctor; and
III. You promptly contacted the study doctor after the injury.
The sponsor will not pay for injuries if:
I. They were caused by your participation in the research and not an underlying
condition;
II. You followed the directions of the study doctor; and
III. You promptly contacted the study doctor after the injury.
You or your insurance company will be billed for other injuries that the sponsor does not
pay for.
57

58. Consent
Injury/Illness Language (Example 3) Forms
The sponsor will not pay for injuries if: POLL
I. They were caused by your participation in the research and not an underlying
condition;
II. You followed the directions of the study doctor; and
III. You promptly contacted the study doctor after the injury.
The sponsor has no plans to will not pay for injuries if:
I. They were caused by your participation in the research and not
an underlying condition;
II. You followed the directions of the study doctor; and
III. You promptly contacted the study doctor after the injury.
The sponsor will not pay for injuries if:
I. They were caused by your participation in the research and not an underlying
condition;
II. You followed the directions of the study doctor; and
III. You promptly contacted the study doctor after the injury.
You or your insurance company will be billed for other injuries that the sponsor does not
pay for.
58

59. Consent
Sample Ownership Language (Example 4) Forms
POLL
By signing this form, you agree to donate
these samples to the sponsor and relinquish all
rights to ownership of your tissue.
By signing this form you agree to provide donate these samples to
the sponsor and relinquish. The sponsor plans to own your tissue.
By signing this form, you agree to donate these samples to the
sponsor and give up relinquish all rights to ownership of your tissue.
59

60. Consent
Sample Ownership Language (Example 4) Forms
POLL
By signing this form, you agree to donate
these samples to the sponsor and relinquish all
rights to ownership of your tissue.
By signing this form you agree to provide donate these
samples to the sponsor and relinquish. The sponsor plans to
own your tissue.
By signing this form, you agree to donate these samples to
the sponsor and give up relinquish all rights to ownership of
your tissue.
60

61. Consent
Sample Ownership Language (Example 5) Forms
POLL
Your samples may be used for future research
and may lead to commercial development. You
will not be paid for these developments.
Your samples may be used for future research and may lead to
commercial development. You will not be paid for these
developments.
Your samples may be used for future research and may lead to
commercial development. You will not be paid There are not plans to
pay you for these developments.
61

62. Consent
Sample Ownership Language (Example 5) Forms
POLL
Your samples may be used for future research
and may lead to commercial development. You
will not be paid for these developments.
Your samples may be used for future research and may lead
to commercial development. You will not be paid for these
developments.
Your samples may be used for future research and may lead
to commercial development. You will not be paid There are
not plans to pay you for these developments.
62

63. Part III
Study Tools

64. Study
Defining “Study Tools” Tools
Diaries Questionnaires PRO Tools
64

65. Study
Regulatory Requirement: Review Tools
• The FDA and OHRP regulations give the
IRB “authority to approve, require
modifications in, or disapprove all research
activities” covered by the regulations.
(21 CFR 56.109; 45 CFR 46.109)
• An IRB is also required to ensure that
appropriate safeguards exist to protect the
rights and welfare of research subjects.
(21 CFR 56.107(a) and 56.111; 45 CFR 46.107(a); 46.111)
65

66. Patient Reported Outcome Study
(PRO) Instruments Tools
• FDA released guidance on the use of PRO
Instruments “to support claims in approved medical
product labeling”
• PRO Instrument:
– Any report on the status of the patient’s health condition that
comes directly from the patient, without interpretation of the
patient’s response by a clinician or anyone else
– A questionnaire plus the information and documentation that
supports its use
– A means to capture PRO data used to measure treatment
benefit or risk in medical product clinical trials
FDA Guidance Citation: Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims,
FDA Guidance, December 2009, available at: http://www.fda.gov/downloads/Drugs/Guidances/UCM193282.pdf.
66

67. Patient Reported Outcome Study
(PRO) Instruments Tools
• Generally, findings measured by a well-defined
and reliable PRO instrument in appropriately
designed investigations can be used to support a
claim in medical product labeling if the claim is
consistent with the instrument’s documented
measurement capability
• Developed for patients—not for use in clinical trials—
validated instruments cannot be modified, or their
validity is called into question
FDA Guidance Citation: Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims,
FDA Guidance, December 2009, available at: http://www.fda.gov/downloads/Drugs/Guidances/UCM193282.pdf.
67

68. Study
IRB Review Tools
Is the use of the “study tool” appropriate in
the context of the research?
 Health status of subjects
 Nature of the study
 Risks to confidentiality/privacy
 Therapeutic Misconception
68

69. Study
Therapeutic Misconception Tools
• Is it a concern at this stage of the
research?
• Distinguish between pre- and post- consent
study activity.
69

70. Contractual Agreements and Releases as Study
Tools
“Study Tools”
Confidentiality Medical Agreement
Agreement Information to Abide by
Releases Study Center
Rules
70

71. Study
Contractual Agreements as “Study Tools” Tools
“By signing this form, you are agreeing not to
share information about this study with anyone”
• Subjects should be allowed/encouraged to share information
with their friends, family members, and doctor in determining
whether to be involved in the study
• The consent form is not a contract
• Subjects can be asked not to share information about the
product
• Subjects can be informed that if they do share information
about the product they will be withdrawn from the study,
especially if they post information online, etc.
71

72. Study
Releases as “Study Tools” Tools
• The consent or a separate authorization
form can authorize the release of information
BUT that may not meet the requirements of a medical
records release under state law
OR the requirements of a particular organization
• Many organizations require their own forms to be
signed and submitted before they will release records
72

73. Study
Center Rules as “Study Tools” Tools
• House or Center Rules may need
to be reviewed by the IRB
• They are something that is required of the
subject in order to participate
• Clear communication of consequences for
not following rules is essential
• Watch out for denial of payment after
payment has been “earned”
73

74. Summary
• Be cognizant of the issues of therapeutic
misconception and exculpatory language
• Remember the “do’s” and “don’ts” for advertisements
• The elements of consent are standard across
studies—pay close attention to risks and alternatives
and the understandability of the language you use
• Avoid contractual language in consent forms or other
study documents

75. Additional Questions
• You may submit questions during our webinar
survey, or
• You may email your questions to:
clientrelations@quorumreview.com
• We will do our best to follow-up individually or
answer your questions in the Q&A we post on
our website
75

76. Webinar Follow-Up
• The webinar Recording, Slide Deck, and Q&A
will be posted on our website
• We will email you a link to view these items
as they become available
• We value your opinion – please take our
SURVEY and provide us with feedback
76

77. Connect with us!
linkedin.com/company/quorum-review facebook.com/QuorumReview
@quorumreview youtube.com/quorumreview
77

78. Thank You for Attending!
78

79. IRB Evaluation of Advertisements,
Consent Forms and Study Tools
March 5 & 7, 2013