Recruitment of Research Participants. Dorean J. Flores IRB Manager

Transcription

1 Recruitment of Research Participants Dorean J. Flores IRB Manager

2 CME Disclosure Statement The North Shore LIJ Health System adheres to the ACCME s new Standards for Commercial Support. Any individuals in a position to control the content of a CME activity, including faculty, planners, and managers, are required to disclose all financial relationships with commercial interests. All identified potential conflicts of interest are thoroughly vetted by the North Shore-LIJ for fair balance and scientific objectivity and to ensure appropriateness of patient care recommendations. Course Director, Kevin Tracey, has disclosed a commercial interest in Setpoint, Inc. as the cofounder, for stock and consulting support. He has resolved his conflicts by identifying a faculty member to conduct content review of this program who has no conflicts. Dorean Flores, Amanda Galvin, Gila Klein, and Sally Kaplan have nothing to disclose.

3 What is recruitment? Recruitment refers to the process of attracting, screening, and selecting a qualified person to fill an area of need. For human subject research, the area of need is the research study.

4 How is recruitment different when applied to a research study? Recruitment of subjects is considered the start of the consent/assent process. It is important for investigators to consider how study subjects will be recruited both before a study is initiated as well as throughout the course of the study. In order to fulfill its responsibility in protecting the rights and welfare of human subjects, the IRB must review the methods, materials, procedures, and tools used to recruit potential research subjects before they are implemented.

5 What is the role of the IRB in evaluating recruitment initiatives? Federal Regulations (45 CFR ) state that the selection of subjects must be equitable this includes the methods, materials, procedures, and tools used to recruit potential research subjects. In making this assessment, the IRB takes into account - the purpose of the research and the setting in which the study will be conducted the special challenges of research involving vulnerable populations, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons. The IRB must also determine that the procedure for recruitment is not coercive or presents undue influence, and that it accurately describes the likely risks and benefits of study participation.

6 What is the role of the IRB in evaluating recruitment initiatives (cont d)? FDA Guidance - The IRB uses the principles set forth in the FDA guidance on Recruiting study Subjects, when reviewing advertising materials for clinical trials and other studies that advertise for potential subjects. The guidance can be found at:

7 Recruitment Guidelines All advertisements should have appropriate information for a potential subject to determine basic eligibility and interest. This includes the following: Indicate that the project is a research study Contact information including location, investigator, and facility Condition under study Purpose of the study Eligibility criteria in bullet or summary form Briefly list participation benefits (if any) Time or other commitment required of the subjects.

8 Recruitment Guidelines (cont d) Additionally, when appropriate the recruitment method or advertisement shall: Err on the side of underestimating benefits Not make claims of safety, equivalence, or superiority Avoid phrases such as new treatment, new medicine or new drug without explaining that the test article is investigational Avoid using the word free -use at no cost instead If using a recruitment letter -explain the study, its purpose, and the reason why the person is being asked to participate. It should clearly state if a follow-up phone call will be made for lack of response State that participation is voluntary State the right to refuse without any loss of benefit Not specifically list the amount of compensation provide. Instead indicate You will be compensated for your time and effort

9 Direct Advertising Flyers Posters Brochures Recruitment Tools These types of advertisements are typically placed in strategic locations in hopes of targeting the population being studied. In addition to obtaining IRB approval for use of such advertisements, it may also be necessary for an investigator to obtain approval from the various sites where the flyer, poster, and/or brochure will be placed.

10 Media Advertisements Newspaper Television Radio Internet Press Releases Recruitment Tools (cont d) These types of advertisements have the capability to reach a large number of potential subjects by allowing the dissemination of research information to many people over the course of their daily lives. In addition to obtaining IRB approval prior to the use of media research advertisements, all materials to be utilized for recruitment (print media such as internet/electronic advertisement, newspapers, television and/or radio air time) may need to be reviewed by the NSLIJHS Marketing Department. The Marketing Department will assure that the materials are designed and presented in accordance with Health System guidelines.

11 Recruitment Tools (cont d) Social Networking/Social Media Recruitment NSLIJ Facebook & NSLIJ Twitter posts and ads The NSLIJ Facebook and Twitter pages may be good recruitment methods depending on the type of audience you are targeting, understanding the security limitation of using social networking websites, and how frequently you would like to communicate with your audience. You can use the NSLIJ Facebook and Twitter pages to recruit regardless of your IRB of record. Usage of social networking sites is limited to NSLIJ Facebook and Twitter because there is already an established health system monitoring plan in place to protect against HIPAA violations as well as other regulations for security purposes. Requests to recruit via NSLIJ Facebook/NSLIJ Twitter are to be submitted to the IRB of record at the time of initial submission, continuing review, or as a modification. The IRB of record will review and once the request is approved, will send to the Social Media Specialist for the Public Relations Department to create the post or advertisement on NSLIJ Facebook/NSLIJ Twitter.

12 Recruitment Tools (cont d) Social Networking/Social Media Recruitment NSLIJ Facebook ads vs. NSLIJ Facebook posts Facebook ads have a fee, but it should be less than the cost of a newspaper advertisements. Facebook ads will have to be approved by the health system s Marketing Department and the IRB of record before posting. If you have money for advertising, Facebook ads are highly recommended versus Facebook posts for the following reasons: Ads are more enduring and may have greater marketing potential. For example, as the post get older, it is displayed further down on the Facebook page and may not be readily seen by Facebook users. However, an ad will appear on the right hand side of Facebook users pages and can be readily seen depending on the users profiles and settings at every log-in. Facebook ads will have a greater impact than newspaper advertisements. Facebook ads have the ability to target very specific demographics while Facebook posts do not.

13 Recruitment Letters Recruitment Tools (cont d) Depending the nature of the research, the recruitment letter may or may not need to include all of the elements normally disclosed in an informed consent document. The investigator may choose to explain the purpose of the research, what participation will involve, the risks and benefits associated with subject participation, whether any compensation will be offered, and that participation in voluntary. If the research study involves sensitive material, the investigator may choose to keep the recruitment letter vague. For example, in an effort to protect the privacy of a potential subject, an investigator may decide not to disclose many details of the study in case the letter gets into the hands of someone other than the potential subject for whom it was intended. The letter should explain how the investigator obtained the potential subjects name.

14 Word of Mouth Recruitment Tools (cont d) Subjects may be drawn to participation in a research study simply through word of mouth. Information about research studies is often disseminated to appropriate target audiences at organized meetings, such as advocacy groups, business workshops, or peer meetings. For example, physicians often inform their peers about their need for research subjects within the peer s community or area of expertise. If investigators consider information disclosed through word of mouth to be among their recruitment tools, then this should be acknowledged and mentioned in the written protocol. The investigator should submit any written materials that may be discussed or given out at such advocacy groups, business workshops, or peer meetings to the IRB for review and approval.

15 In-Person Recruitment Recruitment Tools (cont d) The first step of the recruitment process often occurs through the efforts of research personnel approaching potential research subjects in person. Issues involved in directly approaching individuals for possible inclusion that should be considered include the following: The time at which an individual is approached it should be a time that is convenient for the potential subject and should not occur at a time that would likely increase a person s anxiety level (i.e., right before major surgery). The location of recruitment research studies of more sensitive nature may require privacy, in which case an individual examination room or office may be the most appropriate environment for discussing and/or completing aspects of the study.

16 In-Person Recruitment (cont d) Recruitment Tools (cont d) It is important to note that the investigator may not always be the best person to recruit, as he or she may unduly influence the potential research subject. For example, if the investigator is also the potential subject s physician, the patient may confuse the physician s role as a clinician with the role as a researcher. Potential coercion could also occur if a researcher attempts to recruit individuals from his/her own staff. It is important to keep in mind the NS-LIJHS IRB policy on recruiting one s own patients and colleagues/employees.

17 Situations in which IRB approval is not first required for recruitment materials Dear Doctor Letters Internet postings such as clinialtrials.gov, when information posted is limited to: the title; purpose of the study; protocol summary; basic eligibility criteria; study site location(s); and how to contact the site for further information. Examples of clinical trial listing services that do not require prospective IRB approval include the National Cancer Institute's cancer clinical trial listing (PDQ) and the government-sponsored AIDS Clinical Trials Information Service (ACTIS).

18 Recruitment of Subjects with Limited English Proficiency Investigators who plan on enrolling subjects with limited English proficiency from a particular population must provide the subjects with recruitment materials translated in their native/preferred language. For in-person recruitment, an investigator may use someone on the floor or in the office who speaks the subjects native/preferred language, the telephonic interpreter service, or a family/friend/non-hospital resource serving as an interpreter. If a family/friend/non-hospital resource is serving as an interpreter, the investigator must determine the following: The interpreter is at least 18 years old Competent to act as interpreter Able to understand and maintain confidentiality Free of any conflicts of interest that would influence his ability to interpret without bias

19 Recruitment Activities Not Allowed by the IRB The IRB will review the appropriateness of recruitment activities. The IRB does not permit the following recruitment activities: "Open reads" for radio or television: Open reads are live discussions by a person on radio or television that are intended as advertisements. For example, when a radio host talks about how great a particular store is, and people are led to believe that it is his/her personal opinion when, in fact, he/she is reading or acting out an advertising script. Enrollment of employees working directly under investigator s supervision is usually not allowed. In most cases, investigators will not be allowed to recruit employees who work directly under their supervision as this is considered potentially coercive. The final decision to allow employees as subjects will be made by the IRB on a case-by-case basis. In addition, the IRB may make recommendations or impose requirements for an alternative process to enroll these subjects.

20 Recruitment Activities Not Allowed by the IRB (cont d) Money or bonuses given to the PI or research team as incentives to recruit or refer subjects. Investigators and other members of the study staff (study coordinators, research assistants, etc.) shall not accept monetary or other bonuses as incentives to recruit or refer patients to research studies. This includes any payment from study sponsors above and beyond payment that has been approved in the study budget. Examples of such bonuses include but are not limited to payments for rapid recruitment, extravagant gifts such as computer or other office equipment, expensive meals, books, etc. Such payments or incentives may lead to the appearance of inappropriate practices in an effort to increase enrollment for personal gain, and might compromise the integrity of the research.

21 Clinical Research Service (CRS) Recruitment Unit Assistant Research Coordinator Develop departmental and protocol-specific recruitment strategies Foster participation of under-served populations Collaborate with health system health fairs and screenings to promote clinical research participation Update protocol listings on Feinstein website Recruitment Registry

22 The Recruitment Registry The Recruitment Registry s goal is to bring together people who would like to participate in clinical research studies and researchers who are looking for people to participate in their studies. It is a free and secure registry that has been developed by The Feinstein Institute. The purpose is to involve the public in the mission of helping today s studies make a real difference for everyone s health in the future. *Volunteers of any age, race, ethnicity or health status are invited to join!

23 Why is The Recruitment Registry Important? Often, many clinical research studies end prior to finding an answer because there are too few volunteers. Also, there are many people who want to join clinical research studies, but do not know how to do so. The Recruitment Registry is an important resource to help individuals find out about studies of interest for which themselves or a family member may be qualified. Approximately: 50% of sites under-enroll or fail to enroll a single patient 30% of sites provide 70% of all evaluable subjects 1 in every 4 volunteers screened for a clinical trial completes it Source: S. Redfearn, Advocacy groups use Internet to target patients for diseasespecific recruitment, The CenterWatch Monthly, November 2010; 1, 14-19

24 How Does The Recruitment Registry Work? Participants call Recruitment Registry Hotline GO-NSLIJ ( ) Explain what type of research is done at Feinstein and the Recruitment Registry Collect name, contact information, type of study interested in, and disease of interest. We keep this information for up to 5 years, or until participant asks to be removed Send participant a brochure and Feinstein Clinical Trial Recruitment Registry Optional Authorization for Research Contact Form

25 Investigator Directions for Human Subject Recruitment Requests 1. Investigators who wish to be supplied a list of potential human subjects for recruitment from the Feinstein Institute for Medical Research s recruitment core must submit an application for approval to the core, including the following: Human Subject Recruitment Core Database Request form Copy of IRB approval for the recruiting protocol All requests must be associated with a valid IRB approved protocol. Once the request is reviewed and approved by the core, a list of potential subjects in the recruitment database meeting criteria defined in the request will be supplied to the principal investigator/investigative team. 2. The recruitment core reserves the right to disapprove requests from investigators with a history of non-compliance with federal regulations or the operations of the recruitment core.

26 Investigator Directions for Human Subject Recruitment Requests 3. Requests are protocol specific. Investigators may use this list to contact human subjects for participation for a specific protocol during the protocol s approval period. Once IRB approval expires no potential subject may be contacted for participation 4. If a potential subject indicates that they do not wish to participate in the investigator s study, their choice must be honored and they should not be called again for that study 5. If a potential subject indicates they do not wish to participate in any studies and wish to have their name withdrawn from the database, the investigator/investigative team is required to notify the recruitment core so that the withdrawal may be processed 6. Investigators must maintain a copy of lists provided in study regulatory binders under the subject enrollment log tab.

27 We Need Your Help! Hand out Recruitment Registry brochures to people who may be interested in research Tell current participants in your studies about the Recruitment Registry

28 Support Groups Access to individuals with a specific health condition Individuals may be seeking new treatment options due to previous treatments not working Before Attending: Make sure you have IRB approval Contact the head of the support group to gain permission to attend and discuss research study Make sure to be empathetic when speaking to support group members

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33 NSLIJ Intranet system HealthPort Make sure all text is IRB approved prior to submitting a request Pulse Will remain on HealthPort for 1 week Event Can make advertisement re-occurring throughout the year

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37 Community Events Health Fairs Worksite Fairs College Fairs Visit to view a calendar of Health & Wellness Observances

38 Stay in Touch with Past Participants The most effective way to recruit is staying in touch with someone who s been in a study and had a good experience. Generally, when people finish a study, they never hear from anyone at the site about the study s results or anything else. The site says See ya, and the patient feels dropped. -Thomas Littlejohn, president and executive medical director of PMG PMG gets the study s results to patients whenever possible, as well as newsletters, s, and prompts to read blogs about research. About 12% of patients who participated in one trial and stayed connected via the website have returned to take part in another study. Source: S. Redfearn, New recruitment tools abound, but results remain unclear, The CenterWatch Monthly, April 2011; 16-19

39 Contact Information Amanda Galvin Assistant Research Coordinator

40 Researcher Initiative Study Population Base Research Recruitment plan Gila Klein Project Coordinator, BioGene Bank, Department of Genomics and Human Genetics

41 I Have an Idea

42 The Vision Recruit every patient that come to the Health System Create Massive population-based prospective database. Collect blood samples for DNA and link it to health Information through EMR. NOT disease specific research.

43 Where Do I Start? Planning Planning Planning Recruitment Goals: Subjects and Sites Create Recruitment material Budget Staff Challenges Large recruitment goal Need for diversity Mistrust in genetic research

44 The Must Have Tools Educational and Informational Tools Website - update it as often as possible Brochure Posters Short Consents Create Publicity: Stories in local papers Participants experiences P.I. give talks about your study

45 System Wide Study Need to obtain recruitment permission and awareness Michael Dowling Medical boards Directors of every recruitment site Nurse managers Phlebotomist

46 Build Trust and Awareness Internally in the Health System Health System Sites: educational and information sessions (serve food if possible ) Make everybody feel important for the success of the study. Streamline the study, make it part of the routine patient care as possible. Utilize the independent recruitment sites as your partners.

47 Externally Patients and the Community Research dependent on partnership between researchers and the community. Community Outreach Community Advisory Board Learn about the community concerns Seek opportunities to introduce the project Health Fairs Colleges Libraries Religious and Social groups

48 Keep Thinking Out of the Box Create study app You Tube Video Create a video for the Health System close TV Recruit a famous person to be your spokesman Population Base Research is a Balance of -- ethical issues public s perception (a key component) community involvement

49 Autoimmunity in Sisters of Systemic Lupus Erythematosus Patients Affected Sister diagnosed 40 Unaffected Sister(s) currently

50 Recruitment Plan Evaluate the needs of your target population Brainstorming sessions Track recruitment progress; adjust accordingly

51 Types of Recruitment Print media Community involvement Collaborative recruitment Social Media

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53 Social Media as a Recruitment Tool craigslist

54 The Lupus Sister Research Study- My sister and I are participating! -Lissa s World Blog

55 A Cautionary Tale Clinical trial recruiting website/3 month free trial Googled SisSLE This is an archived study that is no longer available, Autoimmunity in Sisters of Lupus Patients - Full Text View... This study is currently recruiting participants. Verified January 2012 by..