Regulatory Science Symposium: Clinical Trial Startup Session 3: Recruiting and Screening Subjects: Marketing, Social Media, and EHR/Interacting with IRB (2016)

1. Presentation Title: Recruiting and Screening Subjects: Marketing, Social Media, and Electronic Health Records
   1. USC Chapel Hill CTSI
   2. Presented by Susan Pusek, MPH, MS
2. Agenda:
   1. Review regulatory and ethnical principles related to screening and recruitment
   2. Identify the SMART way to recruit subjects
   3. Discuss the integration of new technologies (electronic health records and social media) into recruitment
   4. Example of social media for trial recruitment
3. Recruitment begins the informed consent process
   1. Federal regulations, FDA Info Sheets, HIPAA, GCP, local IRB
4. Regulatory and ethical principles in recruitment
   1. Nuremberg Code, Declaration of Helsinki and Belmont Report
   2. Representative population, beneficence, justice, respect for persons/autonomy
5. Applications of ethical principles in recruitment
   1. Waivers
   2. HIPAA defines protected health info (PHI) – 18 types ex. age
   3. Providers should only have access to current medical information
   4. Researchers must get permission to screen records for recruitment ie. IRB
6. Clinical trial recruitment demands site resources
   1. Increased competition between sites, fewer treat naïve patient, increased number of inclusion criteria, complex protocol
7. The “push” and “pull” concept of recruitment
   1. Mass adds, Networks, Recruitment companies, PI, providers, signs, letters, medical recorded searchers
   2. Letters remain one of more effective ways for recruitment
8. The SMART way to approach recruitment
   1. S – Site is research friendly
      1. Friendly to subjects, team members ie. Reception, research personnel
   2. M – Multiple recruitment and modalities necessary
      1. Telling potential individuals 3 times
      2. Using simple/easy to understand language
      3. Research binder- about ongoing information in waiting room or exam room
      4. Ask prior participants about what how study attracted them
   3. A – Awareness of importance of research and specific studies
      1. Public is willing to hare personal health data for altruistic reasons
      2. Mindful of sensitives
      3. Lack of diversity
      4. Explanation Template: Then, Now, Imagine
      5. Public dislikes the lack of financial transparency between site and sponsor
      6. Create a “pitch” for the media and subjects
      7. “Branding” - image of research
      8. Market to patients who are enrolled and not enrolled
   4. R – Relationship building
      1. With subjects: Individuals want to be more than research subjects
         1. Patient education in the community, advocacy groups, fairs
         2. Patients want to see what the output is
      2. With providers: 2006 CenterWatch survey cited lack of knowledge about study products as main barrier to referral from physicians
         1. Not confident about their knowledge of the study
         2. “Working relationship” with an investigator
         3. Physician fears losing patients to other centers/competition
      3. Sometimes approval studies take a while for it to be approves so subjects forget they were enrolled
   5. T – Technology extends your reach
      1. Electronic Health Records (EHRs)
      2. Social Media
9. EHRs are gaining widespread use
10. EHRS stimulate research in multiple ways (receive/initiate research)
11. Recruitment can be embedded into EHR systems
    1. Using a phone call at clinic and if patient is interested, clicking a button to send information digitally to the research system
12. EHRs also present challenges
    1. “alert” fatigue, incomplete data, patients with access to EHRs results in more questions, Choice of “opt-in or opt-out”, patients will bring electronic records with questions
13. EHR enhancements for recruitments and screening
    1. i2b2, data warehouses, mHealth, linkage of EHRs to expedite media centers
    2. Social media: “go where the customers are”
14. Provide insights about patients ie. health and beliefs toward health

1. Presentation Title: Incorporating Social Media in the Clinical Trial Process: Resources and Tactics for Research Teams
2. Presented by Katja Reuter PhD
3. Study Web Page (Social Media brings them back to the page) ex. The Clinical Studies Directory at USC
4. Pages allow possible subjects to see whether they want to participate, and they learn more about study and requirements
5. Search Engine Marketing - another way to recruit individuals
6. Things to Keep in Mind:
   1. Whoever creates the social media is responsible for the content
   2. Still subject to university, sponsors, and federal regulation
   3. Raise awareness and keep it brief and general
   4. Avoid making claims and use disclaimers
   5. Do not include preliminary results or non-public info
   6. Avoid using social media for eligibility screening
   7. Better to follow them up yourself
7. Successful Approaches on Social Media
   1. Listen to ongoing conversations about the study disease or related aspects to learn ex. The Hashtag Project
   2. Provide links, answer questions and provide value, share random thoughts
   3. Promote, encourage and support others
   4. Target specific populations to increase relevance
8. Using Social to Boost Retention
   1. Send texts or emails as reminders/updates
9. What IRB Needs to Know
   1. Include in your IRB that you are using social media
10. Protections Against HIPAA Violations and Inappropriate Posting
    1. Manage comments that include PHI and recognize that individuals may share more information than is legal

1. Presentation Title: Children’s Hospital Los Angeles and USC: Human Subjects Research
2. Presented by Rebecca Dahl PhD, CIP
3. Challenges:
   1. Increasing complexity of research
   2. Complexity of regulations
   3. Research submissions may need oversight from a variety of committees
   4. Research is multi-site
4. Role of the Principal Investigator
   1. Assure that study subjects are adequately protected
   2. What you say should happen should actually occur
5. Code of Federal Regulations
   1. Codifications of general and permanent rules and regulations aka. Administrative law and is available to read by all
   2. Mandates use of state laws, institutional policies and procedures, and standards of professional practice
6. FDA’s additional definition of research
   1. Code of Federal Regulations labels it as clinical investigation involving a test article and one or more human subjects
7. Definition of Practice
   1. Interventions that are designed solely to enhance well-being of individual patient or client and that have a reasonable expectation of success
   2. Different from research
   3. Example: Randomization of patients and testing a particular practice is not practice. That is research.
8. Quality Improvement
   1. Is not really research
   2. Implements a practice to improve quality of patient care
9. Human Subject
   1. A living individual--- healthy human or patient
10. Intervention
    1. Defn. both physical procedures by which data are gathered and manipulations of subject or subject’s environment that are performed for research
11. Interaction
    1. Defn. communication or interpersonal contact between investigator and subject
12. Privacy
    1. Identifiable information about the subject
    2. IRB is very concerned with the protection of patient info and privacy
13. How is research classified?
    1. According to risk…
       1. Exempt (no risk)
       2. Expedited (min. risk)
       3. Full Committee (a lot of risk)
    2. Minimal risk (Pitfall): probability and magnitude of harm anticipated for a healthy human being
14. Institutional Review Board (IRB)
    1. A group of individuals who have no conflict of interest with the study and whose priority is protection of human subjects
    2. Can approve, disapprove, or require modifications to research study
15. Types of Review (Pitfall)
    1. Protocol outline/summary, grant, study proposal, consent documents, Data Safety Monitoring Plan, Drug/device procedure, advertisements, waivers, surveys, phone script, and questionnaires etc.
    2. Not submitting these documents or not match = unlikely to approved
16. IRB reviews research according to the following:
    1. Risk, Risk/benefit ratio, subject selection, informed consent, documentation of such consent, monitoring data safety, confidentiality, and inclusion of vulnerable populations
17. IRB is overseen by OHRP and FDA
    1. OHRP trusts IRB (Federal wide Assurance)
    2. FDA does not trust IRB (do audits about every 4 years)
18. Belmont Report
    1. Respect for Persons (consent)
    2. Beneficence (risk/benefit analysis)
    3. Justice (subject selection)
19. Research with Children
    1. Children are considered vulnerable populations
    2. Parental permission
    3. Prospect of direct benefit: 404 (minimal risk), 405 (minor increase over minimal risk) vs. No prospect of direct benefit 406 (vital knowledge about disorder), 407 (Address serious problems affecting children and goes to national IRB)
20. Adverse Event Reports
1. This is not a crime.
2. Need to be submitted promptly
21. Revisions to an Approved Protocol
1. Minor: Information revisions & protocol changes with no significant risk to patients
2. Major: Minimal risk (which can be expedited) and Major risk (goes through full committee)
22. What if the project has expired?
    1. Must stop everything until re-review by the IRB or IRB approves continuation 

Accompanying text created by Annie Ly | Undergraduate Research Associate and Provost's First Generation Research Fellow | lyannie@usc.edu