Research Matters. April 7 th 2015

Transcription

1 Research Matters April 7 th 2015

2 Grants Federally-Negtiated Hspital Rate ( ) FINAL RATE (09/01/ /31/2013) Indirect Cst Rate: 63.50% On-Site, 30.00% Off-Site PROVISIONAL RATE (01/01/ /31/2015) Indirect Cst Rate: 63.50% On-Site, 30.00% Off-Site Fringe Benefits: 34.40% Grant Applicatin Internal Deadlines All FINAL dcuments must be received by FH Grants 5 business days frm the applicatin due date (r frm the prime applicant s need by date if FH is a subrecipient) New Bigraphical Sketch Frmat Required fr applicatins submitted fr due dates n r after May 25, 2015.

3 Investigatr Frum 2015 Pst Live Training Update The institutinal requirement has been added t IRB website under Training Requirments tab Directins - Lg int NetLearning Directins - Uplad Transcript int IRBNet Nn-attendees Cmplete the institutinal requirement by April 17, 2015 Cnsequence Research Services will nt accept new research studies after April 17, New investigatrs Required t cmplete the training prir t being added t a study team

4 Refresher n Reprtable New Infrmatin & Mving Frward Reprtable New Infrmatin Frm current vs. new Minr Deviatin Lg Prtcl deviatin due t the actin r inactin f the investigatr r research team Written Reprts f study mnitrs N lnger required after rllut f new P/P s. What d I Reprt?

5 Reprtable New Infrmatin What D I reprt? Cnt. Prtcl deviatin due t the actin r inactin f the investigatr r research team. Real-time mnitring t help yur team and ur teams identify gaps. Cllabrative effrt t reach End Result End Result = Enduring cmpliance and prtecting human subjects. Why reprt deviatins that are ne ff s and nt significant in terms f risks? Let s review sme examples!

6 Reprtable New Infrmatin, What D I reprt? Cnt. NEEDS Reprted: Prtcl deviatin due t the actin r inactin f the investigatr r research team 2 sets f bld pressures t be btained at study visit, nly ne was btained due t versight Bld draw btained utside f prtcl-defined time windw Cnsent frm nt prperly signed Researcher administered wrng test Failed t infrm participant f next appintment which results in nshw These ne-ffs smetimes becme habits that raise red flags In mst cases, will NOT NEED Reprted Participant lst appintment card and never shwed Lab misplaced/drpped tube with bld cllectin Participant refused t answer questinnaire PI t discern if these errrs placed the subject at risk. IF NOT, dn t reprt.

7 Reprtable New Infrmatin, What d I Reprt? Cnt. Prtcl deviatin due t actin r inactin f the investigatr r research team Needs Reprted: **Enrllment f a participant utside f inclusin criteria** **BOTH FDA and HHS regulatins state that n changes may be implemented withut prir IRB review and apprval except where necessary t eliminate an apparent hazard.** Submit the intent t enrll ut side f inclusin/exclusin fr IRB review and apprval prir t initiating.

8 Reprtable New Infrmatin, What d I Reprt? Cnt. Written Reprts f study mnitrs Typically acknwledged Reviewed/tracked Just submit the reprt. N need t include a respnse r explanatin NOTE: If the mnitr reprt indicates an issue that wuld be defined as Reprtable t FH IRB and nt previusly reprted, yu must reprt the issue(s)- describe incident and crrective actin plan.

9 IRB Reminders IRBNet access Please ensure that mre than ne(1) persn has FULL access t each study Delegatin Lgs Reminder t update if/when names change

10 Dcumentatin f the Infrmed Cnsent Prcess Christina Jacksn Cmpliance & Educatin ORA Respnsible Cnduct in Research

11 What d the Federal Regulatins Say? The case histry fr each individual shall dcument that infrmed cnsent was btained prir t participatin in the study. FDA 21 CFR (b) Dcument either the time IC was btained and the time that the study prcedures began, r simply include a statement in yur dcumentatin, such as; n study prcedures began prir t btaining infrmed cnsent. The FDA states, The case histry shuld cntain dcumentatin f the infrmed cnsent prcess. The dcument itself is nt enugh, the IC prcess must be dcumented as well.

12 What d the Federal Regulatins Say? 21 CFR (a): infrmed cnsent shall be dcumented by the use f a written cnsent frm apprved by the IRB and signed and dated by the subject r the subject s legally authrized representative at the time f cnsent. A cpy shall be given t the persn signing the frm. The subject r LAR must date their wn signature (n ne shuld enter the date fr them). Dcument that a cpy was given t the subject.

13 Dcumentatin f IC What shuld be Included? FDA guidance and infrmatin sheets describe a best practice f including additinal infrmatin (ther than the requirements we just reviewed) in the dcumentatin f the IC prcess. Sme f the additinal infrmatin includes: Ptential risks and benefits were explained Inclusin and exclusin criteria were reviewed The subject was given adequate time t review the IC dcument The subjects questins were answered t their satisfactin The subject verbalized understanding

14 Infrmed Cnsent Dcumentatin Best Frmats Best Practice is t include a cntextual statement in the dcumentatin regarding exactly hw and when the cnsenting prcess ccurred. This is best accmplished by utilizing ne f the fllwing methds: Infrmed Cnsent Dcumentatin Checklist Writing r typing a narrative statement (may be entered as a timed event in the EMR) If utilizing an IC checklist, it is best t add cmment lines t add additinal infrmatin unique t each cnsenting cnversatin in rder t individualize it. Narrative statements may be entered in a prgress nte, the EMR, r ther apprpriate surce.

15 IC Narrative Example The patient meets initial inclusin/exclusin criteria at this time. The study was explained including ptential risks/benefits, alternative treatments, and the patient understd. He/she was given adequate time t review the IC and all questins were answered t his/her satisfactin. The patient wishes t participate and signed the IC prir t any study related activities being initiated. The subject was given a cpy f the signed IC.

16 IC Dcumentatin 16 Checklist Example

17 Case Studies REMINDER: Reprt minimally necessary infrmatin abut demgraphics, past medical histry, etc. If the infrmatin is nt relevant t the case study, cnsider mitting it frm the case study Case studies must be reviewed and certificatin prvided that the study is deidentified per HIPAA requirements OR Patient can give authrizatin fr Case Study (Authrizatin frm n ORA Website, Case Study Tab)

18 Educatinal Platfrm Update ORA cnducted feedback sessins with 9 separate grups t ensure that the cntent f the Research Onbarding Training materials will be cmprehensive but tailred t each grup f researchers (i.e. Directrs, Regulatry, Vlunteers, etc. Thanks t all wh participated! We meet with Research Leadership this week t get sign-ff t set this prject in mtin. Next steps: Determine the highest pririty mdules needed. Set timeline t develp the first wave f mdules.

19 All Rads Lead t Rme

20 ORA Annuncements COI Renewal Time fr mst departments April & May classes ffered: Budget Develpment: 4/8, 4/22, 5/6, 5/20 Data Cllectin: 4/9 Sample Size: 4/15 Infrmed Cnsent: 4/21 Prtcl Develpment: 4/30 Study Initiatin: 5/5 Bistatistics: 5/13 IRBnet Training and Overview: 5/14 Study Design: 5/18

21 Study Sptlight William Sensakvic, Ph.D Reductin f Pediatric X-ray Dse Using Image Prcessing

22 Research Enterprise Update frm Leadership Steven Smith Chief Scientific Officer Rb Herzg Vice President

23 THANK YOU FOR YOUR ATTENDANCE AT RESEARCH MATTERS!