Recruitment Dos & Don ts NU IRB Brown Bag Session 2/26/2014

Transcription

1 Recruitment Dos & Don ts NU IRB Brown Bag Session 2/26/2014 Suzanne Sokalski IRB Education Specialist

2 NU Recruitment Materials Guidelines All materials aimed at recruiting subjects into a research study must be reviewed and approved by the IRB prior to use Printed advertisements, bulletin boards, posters, fliers Scripts Audio or video tapes Web sites Newspaper ads (including online versions) Radio, TV spots Bulk contents Anything intended to be seen/heard by prospective subjects to solicit their participation

3 IRB Approval Not Required For Communications to health professionals i.e. dear doctor letters However, your plan to use the process must be approved News stories that do not contain recruitment information Publicity intended for other audiences i.e. financial page ads directed toward prospective investors Information posted on a clinical trial website limited to directory listings with basic descriptive information ClinicalTrials.gov website National Cancer Institute's Physician Data Query (PDQ) AIDS Clinical Trials Information Service (ACTIS)

4 IRB Review of Recruitment Materials The material must make it clear that participation is voluntary Risk and potential benefit information must be presented in a balanced and fair manner not misleading not promising or implying a benefit beyond that potentially provided by the research

5 Incentives Monetary and non-monetary (i.e. access to services or programs) Should not create undue influence on a potential subject's decision about participation compromise a prospective subject's assessment of the risks affect the voluntariness of his/her choices

6 NU Required Elements for Recruitment Materials Study title and IRB study number The word "research" -- Make it clear that this is a research study "Northwestern University" The PI's Department A contact name and phone number or Brief summary of eligibility criteria if applicable, especially if payment depends on meeting these criteria i.e. age range, disease or other characteristic, skill/ability required for participation

7 NU Required Elements Payment Description State whether participants will be paid for their time and effort The amount of payment should not be the most prominent element on the page Payment amount should not be excessive in relation to the nature of the project Amounts should be stated as a range, or "at least" or "up to" for prorated payments dependent on the extent of participation

8 NU Recommended Elements for Recruitment Materials State the purpose of the project Briefly state what is expected of the subject Include the time commitment Include the location where the research will take place Avoid phrases such as help needed or "subjects wanted." The recommended wording is "You are invited" or "Participants invited"

9 Elements of Recruitment Materials that are not allowed by NU The name of commercial sponsors or products Offers of compensation such as a coupon or discount for the product (Typo in HSPPP manual- will be corrected in forthcoming version) Claims that state or imply a certainty of a favorable outcome Claims of benefits beyond those in the consent document and protocol Claims that the investigational product (IP)is safe or effective for the purpose under investigation Claims about the IP that are inconsistent with FDA labeling

10 NU Elements that are not allowed, continued Terms such as "new treatment," "new medication," or "new drug" without explaining that the test article is investigational Use of the term free in reference to treatment or procedures Exculpatory language (prospective subjects waive or appear to waive any of their legal rights) Emphasis on payment or the amount to be paid (i.e. bold print, enlarged font)

11 Use of PHI in Recruitment NU s HIPAA policy covers certain accepted scenarios Preparatory-to-Research Activities Direct Recruitment Recruitment via the healthcare provider

12 Preparatory-to-Research Activities NU researchers can access necessary medical records for the sole purpose of preparing for a research project including: designing a study assessing the feasibility of conducting a research study assessing whether a sufficient and appropriate subject pool exists to support the study Applies to records from NMH, NMFF, and RIC Cannot remove any individually identifiable PHI Not considered research activities - do not require prior IRB review

13 Sensitive Records Examples HIV/AIDS status genetic information substance abuse diagnosis or history mental health diagnosis or history Additional requirements for confidentiality under IL law Must contact General Counsel's office first

14 Authorized research personnel may approach a potential subject in the clinic or in the hospital Direct Recruitment but only after someone already known to the patient (i.e. the treating physician, nurse, or clinic staff) has obtained permission from the patient to be approached

15 If the Investigator is also the Treating Physician Authorized Research Personnel listed on the study may Review their PI's clinic schedules to look for new patients Access these patients' medical records and record minimal contact information and medical information to assess pre-eligibility Approach the PI's patients about participation

16 Recruitment via the Healthcare Provider A researcher may create a form with information about a study that asks patients for contact info Form & procedure must be approved by IRB Form given to patients by their health care provider (NMH, NMFF, or RIC) If patient wants more information about a study, they complete the form and give it back to the clinical staff The clinical team acts as a courier, providing the research team with the completed forms

17 Recruitment on Behalf of the Healthcare Provider Researchers may Ask a treating physician for permission to access patient lists identify potential subjects access their medical records to look for eligibility criteria Only copy the minimal information needed to contact the patient (i.e. name, address, phone number) to assess eligibility for the research study (i.e. age, diagnosis, medical history)

18 Recruitment on Behalf Letters The letterhead of the respective institution must be used Specific procedures required by each organization must be followed State that the patient is being contacted "on behalf" of his/her physician Inform subjects about the study and ask them to contact the researcher Specify if the researcher will follow up the letter with a phone call Obtain approval of the treating physician & IRB before sending Researchers may not call the subject directly, without previously mailing out a letter

19 Social Media For online recruitment, teaser ads may be posted on social media sites where character length is limited, as long as they mention that it is a research project do not use inflammatory language or misleading statements refer the potential participant to a full flyer with all of the required elements

20 Recruiting via Websites When information posted on a clinical trial website goes beyond directory listings with basic descriptive information, it is considered part of the informed consent process and therefore requires IRB review and approval.

21 Basic Descriptive Information study title purpose of the study protocol summary basic eligibility criteria study site location(s) how to contact the study site for further information

22 Website Recruitment Beyond basic descriptive information If identifiable private information is collected via the clinical trial website, plans must be in place for protecting the confidentiality of that information The website must clearly explain how identifiable private information might be used Informed consent must be obtained for the collection of any information about the respondent unless the IRB has determined that the informed consent requirement can be waived

23 Recruitment Strategies that are not allowed at NU Cold Calling An introductory letter or other informational material must first be sent or given directly to subjects prior to telephone contact. Exceptions may be made on a case-bycase basis, for example if the potential subjects have previously agreed to be listed on a research registry for future research studies are currently participating in a study conducted by the same investigator or are frequently seen by or are well known to the investigator

24 Recruitment Strategies not allowed at NU Finder's Fees/Recruitment Incentives NU policy prohibits the acceptance or use of finder's fees, direct recruitment incentives, or bonuses of any type to enroll study subjects General Ads or Flyers describing more than one project Advertisements must be study-specific investigators tend to not keep them up to date and they quickly become obsolete as soon as a change occurs on a single study

25 Resources rch/index.html htm

26 Recruitment Eneke Mwakasisi Research Project Coordinator NUCATS

27 First Steps Know your study population Develop a multifaceted recruitment strategy Develop a way to track how effective the recruitment strategy is

28 Recruitment Methods Recruitment Documents Brochures, Flyers, etc. Clinics Research Match Departmental Registry Recruitment Collaborative Northwestern Medicine Enterprise Data Warehouse (NMEDW) Community Engagement Advertisements

29 Recruitment Documents QR Code Build a webpage for your study

30 Posting recruitment material Recruiting from Clinics

31 Research Match Researchmatch.org Over 52,000 people registered nationwide About 1,700 people registered in the state of Illinois At NU there are: 475 people have said yes to participating, 37 researchers, and 20 studies.

32 Departmental Registry NUCATS General Research Registry Over 1,600 people in the NUCATS registry Searchable fields include: age, height, weight, research interests, medical conditions. $40 to $80 fee for registry search Be sure to maintain contact with people in your registry

33 Recruitment Collaborative

34 EDW $72 per hour Log into the EDW portal and submit a Custom Data request Meet with an analyst to discuss your recruitment needs

35 Community Engagement Bidirectional relationship Engage the community partner early on

36 Advertisements Newspaper Ads Online Ads CTA Train and Bus NU Shuttle TV Ads Radio Ad

37 Retention Customer service approach Follow up and maintain communication Be accommodating Celebrate success!

38 QUESTIONS??? Eneke Mwakasisi Research Project Coordinator NUCATS