IRB Evaluation of Advertisements, Consent Forms and Study Tools

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IRB Evaluation of Advertisements, Consent Forms and Study Tools

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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 ...

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.

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  • 1. IRB Evaluation of Advertisements,Consent Forms and Study Tools March 5 & 7, 2013
  • 2. 2
  • 3. 3
  • 4. Webinar Housekeeping• Questions & Answers• Feel free to submit questions at any point during the webinar using the chat box on your webinar dashboard• Responses will be sent by the presenters following the presentation4
  • 5. Webinar Housekeeping• Recording & Slide Deck• The webinar recording and slide deck will be posted on our website within 5 business days• We will email you a link to view the recording as soon as it is available• Feel free to share the link with your staff and/or colleagues5
  • 6. About Quorum Review IRBAccredited • Fully Accredited by the Association for Accreditation of Human Research Protection Programs (AAHRPP) through 2014 • Fully compliant with FDA and OHRP requirementsInternational capabilities • Boards available for the review of US and Canadian StudiesStrong Framework • Approx. 200 employees – one of the largest IRBs in the USCertified IRB Professionals (CIP) • 60% of Affiliated IRB members, 40% of Regulatory staff and 20% of study management & study support positions6
  • 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 Manager7
  • 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 documents8
  • 9. About the PresenterRegulatory AttorneyJ. Claire Carbary, JD, CIPIRB 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 WSBA9
  • 10. Webinar OverviewIRB Evaluation of Advertisements, ConsentForms and Study Tools Discussion Topics Page Part I Advertisements and Recruitment 11 Part II Consent Forms 33 Part III Study Tools 6310
  • 11. Part IAdvertisements and Recruitment
  • 12. AdvertisementsRegulatory 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. AdvertisementsRegulatory 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. AdvertisementsRegulatory Requirements: Review & RecruitmentWhat 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 10/18/2010.14
  • 15. AdvertisementsRegulatory Requirements: Review & RecruitmentWhat 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/formatFDA 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 & AdvertisementsRegulatory Requirements: Review Advertising & Recruitment ReviewInformation that should generally beincluded:Does the advertisement provide more information than is necessary?Name/ Purpose of Summary of Brief list of Time Researchaddress of research/ eligibility benefits (or other) siteinvestigator 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 10/18/2010.16
  • 17. AdvertisementsRegulatory Requirements: Review & RecruitmentConsiderations:  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 10/18/2010.17
  • 18. Therapeutic Misconception
  • 19. AdvertisementsTherapeutic 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.”19
  • 20. AdvertisementsTherapeutic 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.20
  • 21. AdvertisementsTherapeutic 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.”21
  • 22. AdvertisementsThe “Mode” & RecruitmentTraditional Advertising Online Advertising Print Billboards Social Media Websites Radio TV Email Etc.22
  • 23. AdvertisementsFocus on the “Wrong” Information & RecruitmentEmphasis on: Payment Treatment Free Medical Care Possible Benefits23
  • 24. AdvertisementsStudy Description: Depression Study & Recruitment Advertisement Example 124
  • 25. AdvertisementsStudy Description: Depression Study & Recruitment POLLWhat 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.”25
  • 26. AdvertisementsStudy Description: Depression Study & Recruitment POLLWhat 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. AdvertisementsStudy Description: Diabetes Study & RecruitmentLifestyle and Diet Modifications for Patientswith Type II Diabetes Advertisement Example 227
  • 28. AdvertisementsStudy Description: Diabetes Study & Recruitment POLLLifestyle and Diet Modifications for Patientswith Type II DiabetesWhat 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.28
  • 29. AdvertisementsStudy Description: Diabetes Study & Recruitment POLLLifestyle and Diet Modifications for Patientswith Type II DiabetesWhat 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. AdvertisementsStudy Description: Cancer Study & RecruitmentDrug X in Children with Refractory SolidBrain Tumors Advertisement Example 330
  • 31. AdvertisementsStudy Description: Cancer Study & Recruitment POLLDrug 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.31
  • 32. AdvertisementsStudy Description: Cancer Study & Recruitment POLLDrug 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.32
  • 33. Part IIConsent Forms
  • 34. ConsentRegulatory 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)34
  • 35. ConsentRegulatory Requirements: Review FormsThe IRB…is the finalauthority on the content ofthe consent documents…presented to the prospectivestudy 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 FormsThe information that isgiven to the subject or therepresentative shall be inlanguage understandableto the subject or therepresentative”Citation: 21 CFR 50.20; 45 CFR 46.11636
  • 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/analysisdesigns, sample storage, medical throughout concepts, and other research- specific concepts37
  • 38. ConsentRisks and Alternatives FormsMost commonly “missed” elements ofconsent: “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))38
  • 39. ConsentRisks FormsTrying to get it “just right” – not too much ortoo 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. ConsentAlternatives Forms Are there Is there a “widely Is there no Is the conditionalternative 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. ConsentTherapeutic Misconception FormsTerminology • Use of Specific Terms and Phrases: Treatment, patient Doctor Closely monitor “For your health”41
  • 42. ConsentTherapeutic Misconception FormsOver-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 08/09/2011.42
  • 43. ConsentTherapeutic Misconception FormsMinimization or unclear explanation of risksor study procedures: The explanation of risks of the test article should be based upon information presented in documents such as the protocol and/or investigators brochure, package labeling, and previous research study reports. For IND studies, the IRB should assure that the clinical investigator submits the investigators 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. ConsentExculpatory Language FormsNo informed consent, whetheroral or written, may include anyexculpatory language throughwhich the subject is made towaive or appear to waive any ofthe subjects legal rights, orreleases or appears to releasethe investigator, the sponsor,the institution, or its agents fromliability for negligence.(45 CFR 46.116; 21 CFR 50.20)44
  • 45. ConsentExculpatory Language Forms2 General types of exculpatory language thatcome 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?45
  • 46. ConsentExculpatory Language FormsInjury/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.html46
  • 47. ConsentExculpatory Language FormsSample 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.html47
  • 48. ConsentExculpatory Language FormsSample 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.html48
  • 49. ConsentExculpatory Language FormsSample 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.pdf49
  • 50. ConsentExculpatory Language Forms Draft GuidanceSample 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 specimensFDA 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.pdf50
  • 51. ConsentExculpatory Language Forms Draft GuidanceSample 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.51
  • 52. ConsentExculpatory Language Forms Draft GuidanceSample 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.52
  • 53. ConsentInjury/Illness Language (Example 1) Forms POLLThe sponsor will not pay for injuries caused by thestudy drug if you did not follow the direction of the studydoctor. 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.53
  • 54. ConsentInjury/Illness Language (Example 1) Forms POLLThe sponsor will not pay for injuries caused by thestudy drug if you did not follow the direction of the studydoctor. 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. ConsentInjury/Illness Language (Example 2) Forms POLLYou cannot receive free medical care for injuries related tothis research. You will be responsible for paying for care youreceive 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. ConsentInjury/Illness Language (Example 2) Forms POLLYou cannot receive free medical care for injuries related tothis research. You will be responsible for paying for care youreceive 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. ConsentInjury/Illness Language (Example 3) FormsThe 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. ConsentInjury/Illness Language (Example 3) FormsThe 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. ConsentSample Ownership Language (Example 4) Forms POLLBy signing this form, you agree to donatethese samples to the sponsor and relinquish allrights 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. ConsentSample Ownership Language (Example 4) Forms POLLBy signing this form, you agree to donatethese samples to the sponsor and relinquish allrights 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. ConsentSample Ownership Language (Example 5) Forms POLLYour samples may be used for future researchand may lead to commercial development. Youwill 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. ConsentSample Ownership Language (Example 5) Forms POLLYour samples may be used for future researchand may lead to commercial development. Youwill 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 IIIStudy Tools
  • 64. StudyDefining “Study Tools” Tools Diaries Questionnaires PRO Tools64
  • 65. StudyRegulatory 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 trialsFDA 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 questionFDA 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. StudyIRB Review ToolsIs the use of the “study tool” appropriate inthe context of the research?  Health status of subjects  Nature of the study  Risks to confidentiality/privacy  Therapeutic Misconception68
  • 69. StudyTherapeutic 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 Rules70
  • 71. StudyContractual Agreements as “Study Tools” Tools“By signing this form, you are agreeing not toshare 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. StudyReleases 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 records72
  • 73. StudyCenter 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 website75
  • 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 feedback76
  • 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