Research Subjects Review Board Update

Transcription

1 Research Subjects Review Board Update Kelley O Donoghue, MPH, CIP Executive Director & Kelly Unsworth, MS, CCRC, CIP Board 05 Specialist February 21, 2012

2 Items for Review ROSS Progress Report New Definitions 1.0 Complete/Withdrawn Projects 3.5 Subject Status Definitions erecord Research Chart Consent form Template Updates Enrollment of Non-English Speaking Subjects ROSS 50 Drugs, Devices and Biologics - Drug Profile

3 1.0 Complete/Withdrawn Projects

4 1.0 Complete/Withdrawn Projects 1.11 Completed Study Study completed as planned in the protocol Interventions, data collection, data analysis and other activities as described in the protocol are complete Results obtained and included in the progress report (question 6.1)

5 1.0 Complete/Withdrawn Projects 1.2 Study Closed Before Completion Study began (i.e., open for enrollment and subject participation/data collection), but the study was stopped before activities as described in the protocol were achieved 1.3 Study has not been/will not be conducted Study never began (no subject participation/data collection) Reasons might include lack of funding, study personnel changes, Investigator left the institution, etc.

6 3.5 Subject Status Definitions

7 3.5 Subject Status Definitions Screen Failures Subject provided consent (written or oral) but did not meet eligibility criteria and therefore, did not begin treatment or research interventions Currently undergoing study intervention/ study procedures Subject currently receiving research-related interventions and study procedures

8 3.5 Subject Status Definitions Non-interventional follow up only Subject completed all research-related interventions and study procedures and the only research activity is long-term follow-up (e.g., survival data collected only from public records). No continuing contact with the subject in a research setting. Completed study procedures and follow up Subject completed all research-related interventions and study procedures including research interventions, and follow up data collection.

9 3.5 Subject Status Definitions Withdrawn from study. No further follow up Subject signed consent and began research-related interventions and study procedures, but during the study either withdrew consent to participate or the Investigator decided that the subject should no longer participate and withdrew the subject. Lost to follow up Subject signed consent but no longer comes to study visits and the study team has made every attempt to find the individual but has not been unable to do so.

10 3.5 Subject Status Definitions Deaths [related to the study] Subject died while participating in the study and the cause of death was possibly or probably related to study participation. Deaths [unrelated to study] Subject died while participating in the study and the cause of death was NOT related to study participation.

11 erecord Research Chart Electronic Medical Record (erecord) contains health and treatment t t information Should be available to those providing clinical care and making treatment decisions Research chart contains information related to research study and research procedures Should only be available to those on the study team and those listed in the HIPAA Authorization of the consent form

12 erecord Research Chart In general, research results should not be in the electronic medical record Situations when research information may be in the electronic medical record Treatment studies (e.g. Oncology Research) When utilizing diagnostic services for research (e.g. URMC labs, imaging services)

13 erecord Research Chart When this occurs the consent form must include that information from the research study will be recorded in the electronic medical record Need to understand Research data will be visible to anyone providing care and making treatment decisions No longer just available to study team With MyChart, lab results are available to subjects Automatically pushed to MyChart in 5 days Available May 10 th 2012, retrospectively to November 2010

14 NEW RECRUITMENT & INFORMED CONSENT GUIDANCE DOCUMENT AND CONSENT TEMPLATES

15 Guidance Document Expanded sections on Recruitment & Informed Consent New: Drafting the Informed Consent Document The Informed Consent Process Ongoing Consent Issues after RSRB Approval Appendices: Sample Language, FAQs & Additional Resources

16 Templates Revised for consistency between documents, improved instructions, simplified language, etc. New: Standard/template language g Information Sheet Template for Surveys Translated Short Forms: Spanish, French, & Ukrainian any others?

17 Drafting the Consent Document Review pointers in Drafting section of guidance document Use the template AND the sample language g provided in Appendix 1 Use the plain language g resources in Appendix 3 **MODIFY ACCORDINGLY BASED ON YOUR PROTOCOL** RSRB may still require changes based on review.

18 Whoops Oral Assent for Children 7 and under = No assent script/form required 8-12 year = Age-appropriate assent script Cartoonist: Don Mayne ( cartoons.com)

19 ClinicalTrials.gov New Guidance from FDA: Key Points: Applicable clinical trials initiated on/after 3/7/2012 must be in compliance with new requirement No revision/re-consent required if trial was initiated before 3/7/2012 Must use exact language in 21 CFR 50.25(c) Investigator/Sponsor that is responsible for determining if applicable & including language Contact CTSI-ORS for help with registration, questions about applicability, etc.

20 Enrollment of Non-English Speaking Subjects Anticipated enrollment of non-english speaking subjects, must have a plan to ensure understanding, which includes: Translated consent forms Translation of other applicable study documents (e.g., surveys, drug compliance diaries or other study measures) Plan for communication Translators Bi-lingual study staff

21 Enrollment of Non-English Speaking Subjects Unexpected presentation: Determine if the lack of English proficiency will negatively affect the subject s ability to participate in the study, i.e., understand and follow directions, ability to report problems Have approved documents translated and obtain RSRB approval of translated documents before enrolling the subject If the research is essential for clinical care/treatment and there is not enough time for translation, RSRB can approve the one-time use of a short form

22 Enrollment of Non-English Speaking Subjects Short Form: Template(s) available on-line Translated into the subject s language Adult witness who is fluent in both English and the subject s language will witness the oral presentation (witness must be unaffiliated with the research and it is best if the witness is a professional) The translator should not be the witness because they are engaged in the process not a witness to it

23 Enrollment of Non-English Speaking Subjects Signatures Translated short form: Subject Witness English consent form: Witness Person Obtaining Consent Subject receives signed copies of both documents Original copies are maintained by the study team

24 50 Drugs, Devices and Biologics ADD Click ADD button to add a drug to the application. The drug profile page will appear as a separate page.

25 ROSS Drug Profile

26 ROSS Drug Profile Is this drug being used as labeled (i.e. an FDA "approved use")? Is the drug given in the study consistent with the FDA approved package insert? Indication Dose Route of Administration Population NOT how it is used in clinical care, but how it is approved on the package insert

27 ROSS Drug Profile

28 ROSS Drug Profile Is this Drug or Biologic FDA approved for this indication? Indication = the reason to prescribe a drug Example #1 Drug approved to treat colon cancer at 10 mg/day Study using this drug in ovarian cancer at 20 mg/day Answer = NO Example #2 Drug approved to treat asthma at 30 mg/day for 10 days Study using this drug in asthma at 60 mg/day for 5 days Answer = YES but still not being used as labeled

29 Example #1 FDA Approval = colon cancer at 10 mg/day Study = ovarian cancer at 20 mg/day ANSWER IS NO ANSWER IS NO

30 Example #2 FDA Approval = asthma at 30 mg/day for 10 days ANSWER IS NO Study = asthma at 60 mg/day for 5 days ANSWER IS YES

31 ROSS Drug Profile

32 ROSS Drug Profile Is this Drug or Biologic exempt from the FDA IND/BBIND requirements? (all must apply) i. Not intended to change labeling; ii. Not intended to support a change in advertising; iii. Study will not significantly increase risk or decrease the acceptability of risk due to a change in the: Route of administration Dose Population Other factor; iv.conducted d in compliance with the requirements for institutional review and informed consent; and v. Conducted in compliance with the requirements of 312.7

33 ROSS Drug Profile

34 ROSS Drug Profile Describe plans for the control of the investigational drug: Where the drug is stored Pharmacy Locked cabinet in locked office Who has access to the study drug Drug accountability (Investigational Drug Service template forms) Upload a copy of the most recent package insert or Investigator Brochure All are available on the internet Go to the company s webpage

35 Questions