Basic Study Recruitment and Regulatory Issues: Which Methods are Appropriate?
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The document outlines regulatory and recruitment issues related to clinical trials, emphasizing the importance of patient awareness and attitudes toward participation. It discusses barriers to participation, methods for recruitment, and guidelines for ethical practices in advertising and communication. The document also highlights the need for minimizing pressure on potential subjects and ensuring that recruitment is voluntary and transparent.
Basic Study Recruitment and Regulatory Issues: Which Methods are Appropriate?
- 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 Human Research Protection Program 2
- 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. Human Research Protection Program 3
- 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 Human Ross S, et al.. Barriers to participation in randomized controlled trials: a systematic review. Research Protection J Clin Epidemiol. 1999;52(12):11431156 . Program 4
- 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. Human Research Protection Program 5
- 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? Human Research Protection Program 6
- 7. Bigger Picture… • Respect for privacy • Lack of pressure • Unbiased presentation • The “Therapeutic Misconception” • Conflicting concerns Human Research Protection Program 7
- 8. Rationale/Principles • Use of medical records • Use of Protected Health Information • Contact • Exceptions Human Research Protection Program 8
- 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. Human Research • Study investigators provide their colleagues Protection with a “Dear Patient” letter describing the study Program 9
- 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 Human Research Protection Program 10
- 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 Protection Program 11
- 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. Protection Program 12
- 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 Human Research Protection Program 13
- 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). Human Research Protection Program 14
- 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 Human Research Protection Program 15
- 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 Human Research Protection Program 16
- 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 Research any advertising campaign that uses the video. Protection Program 17
- 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 Human Research Protection Program 18
- 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 Human Research Protection Program 19
- 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 Research Protection Program 20
- 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 Human Research – Person or office to contact for further information Protection Program 21
- 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 Human Research Protection Program 22
- 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? Human Research • 3. Do I need CHR approval for these listings? Protection Program 25
- 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 Protection Program 26
- 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 Research Protection Program 27
- 28. Which methods to use? Human Research Protection Program 28
- 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 Human Research Protection Program 29
- 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. Human Research Protection Program 31
- 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 Human Research Protection • Use of business model Program 32
- 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. Program 33
- 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 Protection Program 34