Presentation by Laurie Herraiz, RD, CCRP in May 2012 at CHR sponsored workshop on UCSF Campus. Topics include, basics of regulatory and recruitment, iMedrRIS application instructions, waivers of consent/authorization for recruitment purposes, examples of approved recruitment materials, and common challenges to recruitment.

1. Basic Study Recruitment
and Regulatory Issues:
Laurie Herraiz, RD, CCRP
Quality Assurance Coordinator,
HRPP QIU
Which Methods are
Laurie.herraiz@ucsf.edu
415. 514.9246
Appropriate?
May 4, 2012

2. 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 technology
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3. 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.
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4. 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 security
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Ross S, et al.. Barriers to participation in randomized controlled trials: a systematic review.
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J Clin Epidemiol. 1999;52(12):11431156 .
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5. 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.
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6. 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?
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7. Bigger Picture…
• Respect for privacy
• Lack of pressure
• Unbiased presentation
• The “Therapeutic Misconception”
• Conflicting concerns
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8. Rationale/Principles
• Use of medical records
• Use of Protected Health Information
• Contact
• Exceptions
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9. 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.
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Research • Study investigators provide their colleagues
Protection with a “Dear Patient” letter describing the study
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10. 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 studies
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11. 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 methods
Human such as snowball sampling, direct approach,
Research use of social networks, and random digit dialing
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12. What to Submit with Application
• Letters to Subjects
• Advertisements
• Scripts
• Web Postings or Pages
Human Any additions or changes to these documents must be
Research submitted as modifications.
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13. 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
participation
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14. 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).
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15. 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 CHR
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16. 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 protocol
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17. 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 investigator
Human – the local investigator does not accept referrals from
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any advertising campaign that uses the video.
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18. 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 CHR
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19. 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
– Exceptions
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20. 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 be
Human reused or disclosed to anyone else
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21. 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 research
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22. 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 event
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23. Human
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24. Human
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25. 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?
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• 3. Do I need CHR approval for these listings?
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26. 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 Form
Human • Data security plan
Research • Self- removal from database
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27. 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 disease
Human specific, campus-wide use
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28. Which methods to use?
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29. 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 men
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30. Group Brainstorm ideas
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31. 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.
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32. 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 recruitment
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33. 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 public
Human and the medical and scientific communities
Research Probstfield, Frye. Strategies for recruitment and retention of participants in clinical trials.
Protection JAMA 2011 Oct 26;306(16):1798-9.
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34. 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 Recruitment
Human http://www.fda.gov/RegulatoryInformation/Guidances/ucm126
Research 428.htm
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