Basic Study Recruitment and Regulatory Issues: Which Methods are Appropriate?

Basic Study Recruitment and Regulatory Issues:Laurie Herraiz, RD, CCRPQuality Assurance Coordinator,HRPP QIU Which Methods areLaurie.herraiz@ucsf.edu415. 514.9246 Appropriate?May 4, 2012

Outline • This discussion will cover… – Big Picture – Basics of regulatory/recruitment – iMedRIS Application instructions – Waiver of Consent/Authorization for Recruitment purposes – Examples of flyers – Registries and databases – Mini Break Out Session: Challenges & Solutions – PRS and technologyHumanResearchProtectionProgram 2

Patients Attitudes: • 28% participated in clinical trials, • 82% unaware of online information • 76% expected treating physician to inform them • Contact: 80% mail, 63% phone. • 91% wanted to know findings and 68% would not participate • 93% felt safety and privacy were protected Sood A, et al. Mayo Clin Proc. 2009 Mar;84(3):243-7. Patients attitudes and preferences about participation and recruitment strategies in clinical trials.HumanResearchProtectionProgram 3

Barriers to participation • Additional demands of study- procedures, appointments, travel, cost • Preference for one treatment not placebo • Worry about uncertainty of treatment • Concerns about information securityHuman Ross S, et al.. Barriers to participation in randomized controlled trials: a systematic review.ResearchProtection J Clin Epidemiol. 1999;52(12):11431156 .Program 4

WE WANT YOU… to share your time, blood, sweat and tears (and other bodily specimens) for the advancement of science, while incurring a uncertain amount of risk to your well-being and/or privacy, with or without any direct benefit to you.HumanResearchProtectionProgram 5

Ask yourself… • Do participants know their role in the project? • How are they approached and treated? • Why should people care? • What’s in it for them? • Is overcoming mistrust an issue?HumanResearchProtectionProgram 6

Bigger Picture… • Respect for privacy • Lack of pressure • Unbiased presentation • The “Therapeutic Misconception” • Conflicting concernsHumanResearchProtectionProgram 7

Rationale/Principles • Use of medical records • Use of Protected Health Information • Contact • ExceptionsHumanResearchProtectionProgram 8

Recruitment Section in • Study investigators recruit their own patients directly in person or by phone • Study investigators recruit their own patients by letter. Attach the letter for review • Study investigators send a “Dear Doctor” letter to colleagues asking for referrals of eligible patients.HumanResearch • Study investigators provide their colleaguesProtection with a “Dear Patient” letter describing the studyProgram 9

Recruitment Section in (cont’d) • Advertisements, notices, and/or media used to recruit subjects • Study investigators identify prospective subjects through chart review (Waiver of Authorization needed) • Large-scale epidemiological studies and/or population-based studiesHumanResearchProtectionProgram 10

Recruitment Section in (cont’d) • Direct contact of potential subjects who have previously given consent to be contacted for participation in research • Study investigators list the study on the School of Medicine list of UCSF Clinical Trials website or a similarly managed site • Study investigators recruit potential subjects who are unknown to them through methodsHuman such as snowball sampling, direct approach,Research use of social networks, and random digit dialingProtectionProgram 11

What to Submit with Application • Letters to Subjects • Advertisements • Scripts • Web Postings or PagesHuman Any additions or changes to these documents must beResearch submitted as modifications.ProtectionProgram 12

But what about…. • Recruiting Researchers’ Students and Staff – Researchers should not directly ask their students or staff to be research subjects – It may be hard to refuse such a request – The CHR prefers that researchers post flyers and allow volunteers to initiate contact about the study. – No pressure should be applied to encourage participationHumanResearchProtectionProgram 13

Recruitment in Classrooms – Potential participation in research must be presented as a voluntary option – Participation cannot be tied to grades. It must be clear that there will be no stigmatization of students who decline to participate. – If class time will taken for research participation, alternative activities should be provided for those who decline (especially in pre-college levels).HumanResearchProtectionProgram 14

Telephone Scripts • The initial recruitment call sometimes leads directly into the consent process • Elements to include in script • Sensitive information • The interviewers should have phone numbers of PI and CHRHumanResearchProtectionProgram 15

Incentives and Referral Fees • Per-patient incentive payments or referral fees, are not permitted • May encourage recruiters to put inappropriate pressure on participants and are illegal in California • Lump-sum payments not tied to the number of patients enrolled may be allowed in particular studies • Investigators should include all information about incentives and/or referral fees in the recruitment section of the protocolHumanResearchProtectionProgram 16

Videos • If used in subject recruitment must be reviewed and approved by the CHR • Investigators should obtain CHR approval for a concept or script before making a major investment in video production • When a video has been prepared in advance by a sponsor, it should be submitted for review. • If the video is not approved, the CHR may allow the study to proceed – video is not used by the local investigatorHuman – the local investigator does not accept referrals fromResearch any advertising campaign that uses the video.ProtectionProgram 17

Who May Recruit • Individuals initiating contact with potential subjects must have – basic knowledge about the study – training in the voluntary nature of research participation – the phone number of the CHRHumanResearchProtectionProgram 18

What is Waiver of Consent/HIPAA for recruitment purposes? • Waivers are granted in three primary situations: – In minimal risk studies in which subjects will be not be contacted (e.g., many chart review studies) – If the study requires researchers to access PHI about patients who will then be contacted and asked to be in the study – Enrolling subjects with verbal consent • The CHR’s usual policy – ExceptionsHumanResearchProtectionProgram 19

Waiver of Consent for Recruitment (cont’d) Requirements: Collect the least amount of PHI needed for recruitment. Plan to protect the identifiers from improper use and disclosure Plan to destroy the identifiers at the earliest opportunity consistent with the conduct of the research Written assurance that the PHI will not beHuman reused or disclosed to anyone elseResearchProtectionProgram 20

Ads, Flyers, and Media Guidelines • “Do’s” – The name and address of the investigator or research facility – The condition under study – The purpose of the research – Summary of the criteria used to determine eligibility – Brief list of participation benefits, if any (e.g., a no- cost health examination) – Time or other commitment required – Location of the researchHumanResearch – Person or office to contact for further informationProtectionProgram 21

Ads, Flyers, and Media Guidelines “Don’ts” • Benefits beyond what is in the consent • Claims that the research procedures are safe/effective • Claims that the research procedures are known to be equivalent or superior to others • Use terms such as “new treatment,” or “new medication,” without explaining that the test article is investigational • Promise “free treatment” • Emphasize the payment by such means as larger or bold type • Include any language that the PI cannot be held liable for any research related eventHumanResearchProtectionProgram 22

HumanResearchProtectionProgram 23

Searchable websites: Participants look for studies • ClinicalTrials.gov • 1. Why should I list my study on these type of sites? – Mandatory for publication – “Any research study that prospectively assigns humans to one or more interventions to evaluate the effects on health outcomes” – Helpful in recruitment, for both PI and participant 2. Should I include the posted text in my CHR application?HumanResearch • 3. Do I need CHR approval for these listings?ProtectionProgram 25

Databases and Registries: PIs look for participants • Q. Can databases or registries be created under HIPAA? Can I create a research database without obtaining an authorization from every single research subject? • A. Yes. HIPAA allows for the creation of databases for research purposes. – CHR approved Waiver of Authorization for Recruitment – CHR must approve • Consent FormHuman • Data security planResearch • Self- removal from databaseProtectionProgram 26

On-Campus Registries • Usually done at the departmental or clinic level • Clinicians in the department recruit own patients • Must have consent form for contact for future research • At departmental level, usually consent for a particular condition • PRS- New approach, not diseaseHuman specific, campus-wide useResearchProtectionProgram 27

Which methods to use?HumanResearchProtectionProgram 28

Different Populations = Different Methods • Healthy Volunteers • Pregnant women • Specific ethnic or racial groups • Emergency department and inpatients • Healthy children as controls • Economically disadvantaged, marginally housed, substance misuse • HIV+ gay menHumanResearchProtectionProgram 29

Group Brainstorm ideasHumanResearchProtectionProgram 30

Big Picture barriers: • PCP as gatekeepers • Patient lack of knowledge for which they may be eligible • Entrenched cultural and historical views and suspicions of clinical trials and medical establishment in general Probstfield, Frye. Strategies for recruitment and retention of participants in clinical trials. JAMA 2011 Oct 26;306(16):1798-9.HumanResearchProtectionProgram 31

Practical Solutions: • Telephone reminders to non-respondents of mailings • Open designs: participants know which treatment • Culturally sensitive recruitment materials • Involve and train staff doing the recruitmentHumanResearchProtection • Use of business modelProgram 32

Blue Sky Solutions: • A national campaign to increase public awareness and participation in clinical trials • Educate health care professionals and the general public to promote clinical trial participation. • Clinical trial participation must be established as a valued contribution to the general publicHuman and the medical and scientific communitiesResearch Probstfield, Frye. Strategies for recruitment and retention of participants in clinical trials.Protection JAMA 2011 Oct 26;306(16):1798-9.Program 33

Questions & Resource Information • Call or email the CHR and ask for the Analyst of the Day 415-476-1814 • Recruitment section of HRPP Website: http://www.research.ucsf.edu/chr/Recruit/chrRecruit.asp • Social Media Best Practices http://www.ucsf.edu/about/social-media-best-practices • Healthy Kids in Research http://www.nhlbi.nih.gov/childrenandclinicalstudies/index.php • Writing Clear Advertisements http://hub.ucsf.edu/sites/hub.ucsf.edu/files/Writing_Clear_Ad vertisements.pdf • FDA Guidance on RecruitmentHuman http://www.fda.gov/RegulatoryInformation/Guidances/ucm126Research 428.htmProtectionProgram 34

Basic Study Recruitment and Regulatory Issues: Which Methods are Appropriate?

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