basic study recruitment and regulatory issues: which methods are appropriate?

Basic Study Recruitment and Regulatory Issues:

Which Methods are Appropriate?

Laurie Herraiz, RD, CCRP Quality Assurance Coordinator, HRPP QIU [email protected] 415. 514.9246 May 4, 2012

Human Research Protection Program

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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


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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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

Ross S, et al.. Barriers to participation in randomized controlled trials: a systematic review.

J Clin Epidemiol. 1999;52(12):11431156.

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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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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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Bigger Picture…

• Respect for privacy

• Lack of pressure

• Unbiased presentation

• The “Therapeutic Misconception”

• Conflicting concerns

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Rationale/Principles

• Use of medical records

• Use of Protected Health Information

• Contact

• Exceptions

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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.

• Study investigators provide their colleagues with a “Dear Patient” letter describing the study

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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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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 such as snowball sampling, direct approach, use of social networks, and random digit dialing

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What to Submit with Application

• Letters to Subjects

• Advertisements

• Scripts

• Web Postings or Pages

Any additions or changes to these documents must be submitted as modifications.

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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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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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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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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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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 – the local investigator does not accept referrals from

any advertising campaign that uses the video.

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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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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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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 reused or disclosed to anyone else

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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 – Person or office to contact for further information

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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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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?

• 3. Do I need CHR approval for these listings?

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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 • Data security plan • Self- removal from database

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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 specific, campus-wide use

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Which methods to use?

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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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Group Brainstorm ideas

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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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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

• Use of business model

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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 and the medical and scientific communities

Probstfield, Frye. Strategies for recruitment and retention of participants in clinical trials. JAMA 2011 Oct 26;306(16):1798-9.

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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_Advertisements.pdf

• FDA Guidance on Recruitment http://www.fda.gov/RegulatoryInformation/Guidances/ucm126428.htm

http://www.research.ucsf.edu/chr/Recruit/chrRecruit.asp

http://www.ucsf.edu/about/social-media-best-practices

http://www.nhlbi.nih.gov/childrenandclinicalstudies/index.php

http://hub.ucsf.edu/sites/hub.ucsf.edu/files/Writing_Clear_Advertisements.pdf

http://hub.ucsf.edu/sites/hub.ucsf.edu/files/Writing_Clear_Advertisements.pdf


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basic study recruitment and regulatory issues: which methods are appropriate?

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