irb evaluation of advertisements, consent forms and study tools

March 5 & 7, 2013

IRB Evaluation of Advertisements, Consent Forms and Study Tools

• Questions & Answers

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during the webinar using the chat box on your

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following the presentation

4

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5

Webinar Housekeeping

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6

About Quorum Review IRB

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7

The Quorum Advantage

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reports, and approval documents

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processes

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8

The Quorum Advantage

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

9

About the Presenter

http://www.quorumreview.com/about-us/key-contacts/claire-carbary/


Advertisements and Recruitment 11

Consent Forms 33

Study Tools 63

10

Webinar Overview

Part I

Part III

Part II

Discussion Topics Page

Advertisements and Recruitment

Part I

• 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)

Regulatory Requirements: Review Advertisements

& Recruitment

12

http://www.gpo.gov/fdsys/search/pagedetails.action?browsePath=Title+21/Chapter+I/Subchapter+A/Part+56/Subpart+C/Section+56.109&granuleId=CFR-2011-title21-vol1-sec56-109&packageId=CFR-2011-title21-vol1&collapse=true&fromBrowse=true&bread=true

http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html

http://www.gpo.gov/fdsys/granule/CFR-2012-title21-vol1/CFR-2012-title21-vol1-sec56-107/content-detail.html

http://www.gpo.gov/fdsys/pkg/CFR-2004-title21-vol1/pdf/CFR-2004-title21-vol1-sec56-111.pdf


• 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.”

Regulatory Requirements: Review

Citation: Recruiting Study Subject – Information Sheet, FDA, available at:

http://www.fda.gov/RegulatoryInformation/Guidances/ucm126428.htm, Last Updated 10/18/2010. FDA Guidance

Advertisements

& Recruitment

13

http://www.fda.gov/RegulatoryInformation/Guidances/ucm126428.htm

What does not Require Review?



http://www.fda.gov/RegulatoryInformation/Guidances/ucm126428.htm, Last Updated 10/18/2010.

Communications intended to be seen or heard

by health professionals

Such as "dear doctor" letters and doctor-to-doctor letters (even when soliciting for study subjects)

News stories Publicity intended for

other audiences

Such as financial page advertisements directed toward prospective investors

Listings of clinical trials

on the internet

(No additional safeguard provided by IRB review when the system format limits the information provided to basic trial information, such as: the title, purpose of the study, protocol summary, basic eligibility criteria, study site location(s), and how to contact the site for further information.)

FDA Guidance

Advertisements

& Recruitment

14


What does Require Review?




Advertisements

& Recruitment

15

Direct advertising Includes, but is not

necessarily limited to: newspaper, radio, TV,

bulletin boards, posters, and flyers that are intended

for prospective subjects.

Both the content and the mode of

communication

Final copy/format


Information that should generally be

included:



http://www.fda.gov/RegulatoryInformation/Guidances/ucm126428.htm, Last Updated 10/18/2010.

Does the advertisement provide more information than is necessary?

Name/

address of

investigator

study site

Purpose of

research/

name of

condition

being

studied

Summary of

eligibility

criteria

Brief list of

benefits

Time

(or other)

commitment

Research

site

location/

contact

information

FDA Guidance

Rcruitment &

Advertising

Review

Advertisements

& Recruitment

16


http://www.quorumreview.com/sites/participant-recruitment/

Considerations:




Advertisements

& Recruitment

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?

17


Therapeutic Misconception

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.”

Therapeutic Misconception Advertisements

& Recruitment

19

• 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,

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.

Advertisements

& Recruitment

Canadian TCPS

20

http://www.pre.ethics.gc.ca/pdf/eng/tcps2/TCPS_2_FINAL_Web.pdf




• Use of terms/phrases

• Logos/mottos/catch-

phrases

• Focus on specific details

– Okay, but it necessarily

provides limited picture of

what is involved in the

research

Therapeutic Misconception Advertisements

& Recruitment

“YOUR ONE-STOP…”

“FINDING CURES

SINCE…”

“GET PAID TO…”

“PARTICIPATE TO GET

HELP.”

“FREE TREATMENT.”

21

Traditional Advertising Online Advertising

22

The “Mode”

Billboards Print

Radio TV

Social Media Websites

Email Etc.

Advertisements

& Recruitment

http://www.quorumreview.com/irb-review-recruitment-advertising/

http://www.quorumreview.com/irb-review-website-content-research-conducted-online/

Emphasis on:

Focus on the “Wrong” Information Advertisements

& Recruitment

Payment Treatment Possible Benefits Free Medical Care

23

Study Description: Depression Study Advertisements

& Recruitment

Advertisement Example 1

24

What would you change?


& Recruitment

Remove the image of the sun and

the statement related to payment.

Remove all images. Remove the word “help” and take

out payment.


the word “help.”

25

POLL



& Recruitment


the statement related to payment.

Remove all images. Remove the word “help” and take

out payment.

Remove the image of the sun

and the word “help.”

26

POLL

Lifestyle and Diet Modifications for Patients

with Type II Diabetes

27

Study Description: Diabetes Study Advertisements

& Recruitment






& Recruitment

Revise “treatment” statement to provide

information about the research, and change

the payment language font.

Remove the slogan and reference to “free

treatment.”

Change the payment language font.

28

POLL





& Recruitment

Remove the slogan and reference to “free

treatment.”

Change the payment language font.

Revise “treatment” statement to provide

information about the research, and change

the payment language font.

29

POLL

Drug X in Children with Refractory Solid

Brain Tumors

30

Study Description: Cancer Study Advertisements

& Recruitment


Drug X in Children with Refractory Solid Brain Tumors

31


& Recruitment

Remove the words “cure” and

“treatment.”

Remove slogan and statement

indicating space is limited.

Remove slogan, statement indicating

space is limited, and the word

“treatment.”

Remove the reference to payment and

statement indicating space is limited.

POLL

Drug X in Children with Refractory Solid Brain Tumors

32


& Recruitment

Remove the words “cure” and

“treatment.”

Remove slogan and statement

indicating space is limited.

Remove the reference to payment and

statement indicating space is limited.

Remove slogan, statement

indicating space is limited, and the

word “treatment.”

POLL

Consent Forms

Part II

• “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)

Consent

Forms

34

http://www.quorumreview.com/quorum-qa-informed-consent/



The IRB…is the final

authority on the content of

the consent documents…

presented to the prospective

study subjects”


Citation: A Guide to Informed Consent – Information Sheet, FDA, available at:

http://www.fda.gov/RegulatoryInformation/Guidances/ucm126431.htm, Updated 08/09/2011. FDA Guidance

Consent

Forms

35

http://www.quorumreview.com/slides-available-quorum-review-webinar-research-hipaa-recruitment-consent/

http://www.fda.gov/RegulatoryInformation/Guidances/ucm126431.htm, Updated 08/09/2011.

The information that is

given to the subject or the

representative shall be in

language understandable

to the subject or the

representative”

“Understandable” Language

Citation: 21 CFR 50.20; 45 CFR 46.116

Consent

Forms

36

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=50.20


“Understandable” Language

Define acronyms the first time they are used

Use of second vs.

first person

Define terms the first time they are used: medical AND

non-medical terms:

“Placebo” “we”- investigators/sponsor,

etc. “sponsor”

Boilerplate or “template” language

with simple explanations of common procedures, study

designs, sample storage, medical concepts, and other research-

specific concepts

Consistent terminology throughout

Reading level software/analysis

Consent

Forms

37

Most commonly “missed” elements of

consent:

Risks and Alternatives

“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))

Consent

Forms

38



http://ichgcp.net/48-informed-consent-of-trial-subjects






Trying to get it “just right” – not too much or

too little

Risks

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.

Consent

Forms

39

Alternatives Consent

Forms

Are there

alternative drugs?

List them.

Is there a “widely

used” alternative

or non-western

treatment

approach used?

List those too. If so the option of

“comfort care” or

“no treatment”

should generally

be included.

Is the condition

terminal?

Say so:

“There are no

approved

treatments in the

U.S. for XYZ.”

Is there no

alternative

approach used?

40

Terminology • Use of Specific Terms and Phrases:

41

Therapeutic Misconception Consent

Forms

Treatment, patient

Doctor

Closely monitor

“For your health”

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).



http://www.fda.gov/RegulatoryInformation/Guidances/ucm126431.htm, Updated 08/09/2011. FDA Guidance

Consent

Forms

42






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.”

Consent

Forms

FDA Guidance

43



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)

Exculpatory Language Consent

Forms

44



2 General types of exculpatory language that

come up in consent forms:

• Language related to sample

ownership and payment for

commercial advances

• Language related to injury of

the individual

Exculpatory Language Consent

Forms

WILL I RECEIVE

PAYMENT?

WHAT WILL HAPPEN

TO MY SAMPLES?

WHAT IF I GET HURT OR

SICK WHILE I AM IN THIS

STUDY?

45

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.

Injury/Illness

• Examples of exculpatory and acceptable language

Exculpatory Language

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

Consent

Forms

46

http://www.hhs.gov/ohrp/policy/exculp.html

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.

Consent

Forms

47


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.

Consent

Forms

48


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”


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 FDA Guidance

Consent

Forms

49

http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM271036.pdf

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

50


Citation: Draft: Guidance on Exculpatory Language in Informed Consent, FDA, OHRP, August 19 2011, available at:


Consent

Forms

FDA Guidance

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.

Consent

Forms

51

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.

Consent

Forms

52

Draft

Guidance

The sponsor will not pay for injuries caused by the

study drug if you did not follow the direction of the study

doctor.

Injury/Illness Language (Example 1)

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.


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.

Consent

Forms

53

POLL

The sponsor will pay for injuries related to this research.


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 not pay for injuries caused by the

study drug if you did not follow the direction of the study

doctor.

Injury/Illness Language (Example 1) Consent

Forms


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.

54

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


Consent

Forms

55

POLL

You cannot receive free medical care for injuries related to

this research. You will be responsible for paying for care you



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


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


Consent

Forms

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


56

POLL

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.


Forms

The sponsor has no plans to will not pay for injuries if:


condition;





condition;



You or your insurance company will be billed for other injuries that the sponsor does not

pay for.

57

POLL



condition;




Forms

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;





condition;



You or your insurance company will be billed for other injuries that the sponsor does not

pay for.

58

POLL

By signing this form, you agree to donate

these samples to the sponsor and relinquish all

rights to ownership of your tissue.

Sample Ownership Language (Example 4) Consent

Forms

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

POLL

By signing this form, you agree to donate

these samples to the sponsor and relinquish all

rights to ownership of your tissue.


Forms

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

POLL

Your samples may be used for future research

and may lead to commercial development. You

will not be paid for these developments.


Forms

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

POLL

Your samples may be used for future research

and may lead to commercial development. You

will not be paid for these developments.


Forms

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

POLL

Study Tools

Part III

Defining “Study Tools” Study

Tools

Diaries Questionnaires PRO Tools

64

• 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)

Regulatory Requirement: Review Study

Tools

65

http://www.quorumreview.com/faqs/describe-regulatory-authorities-quorum-operates/



http://www.gpo.gov/fdsys/granule/CFR-2012-title21-vol1/CFR-2012-title21-vol1-sec56-107/content-detail.html

http://www.gpo.gov/fdsys/pkg/CFR-2012-title21-vol1/pdf/CFR-2012-title21-vol1-sec56-111.pdf


• 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

Patient Reported Outcome (PRO) Instruments

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. FDA Guidance

Study

Tools

66

http://www.fda.gov/downloads/Drugs/Guidances/UCM193282.pdf

• 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

Patient Reported Outcome (PRO) Instruments

Study

Tools

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. FDA Guidance

67

http://www.fda.gov/downloads/Drugs/Guidances/UCM193282.pdf

Is the use of the “study tool” appropriate in

the context of the research?

IRB Review Study

Tools

Health status of subjects

Nature of the study

Risks to confidentiality/privacy


68

http://www.quorumreview.com/faqs/quorum-protocol-study-tools-2/

• Is it a concern at this stage of the

research?

• Distinguish between pre- and post- consent

study activity.

Therapeutic Misconception Study

Tools

69

Contractual Agreements and Releases as “Study Tools”

Study

Tools

Confidentiality

Agreement Medical

Information

Releases

Agreement

to Abide by

Study Center

Rules

70

“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.

Contractual Agreements as “Study Tools” Study

Tools

71

• 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

Releases as “Study Tools” Study

Tools

72

• 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

Center Rules as “Study Tools” Study

Tools

• 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

Summary

• You may submit questions during our webinar

survey, or

• You may email your questions to:

[email protected]

• We will do our best to follow-up individually or

answer your questions in the Q&A we post on

our website

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Additional Questions

mailto:[email protected]

• 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

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Webinar Follow-Up

Connect with us! facebook.com/QuorumReview

@quorumreview youtube.com/quorumreview

linkedin.com/company/quorum-review

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http://www.facebook.com/QuorumReview

http://www.twitter.com/quorumreview

http://www.twitter.com/quorumreview

http://www.youtube.com/quorumreview

http://www.linkedin.com/company/quorum-review



Thank You for Attending!

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March 5 & 7, 2013


irb evaluation of advertisements, consent forms and study tools

Documents