Human Research Protection Program Investigating Reports of Research Non-compliance at MMC

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1 Human Research Prtectin Prgram Investigating Reprts f Research Nn-cmpliance at MMC SOP- I.5.D, II.2.F, II.2.G A-II.2.F, II.2.G 1. POLICY 1.1 Definitins Nn-cmpliance Failure n the part f a PI r any member f a research team t adhere t the terms f IRB apprval, r Failure t abide by applicable laws r regulatins r MMC plicies, including failure t submit research fr IRB review and apprval prir t implementing the research Minr nn-cmpliance is nn-cmpliance that des nt impact subjects rights and welfare, safety f subjects, the willingness f subjects t participate in the study, r the integrity f the study data. Examples f minr nn-cmpliance include, but are nt limited t, islated incidences f the fllwing: Missing riginal signed and dated cnsent frm (nly a phtcpy is available) Failure t fllw the apprved study prcedure that, in the pinin f the IRB, des nt affect subject safety r data integrity: Study prcedure cnducted ut f sequence Omitting an apprved prtin f the prtcl Study visit cnducted utside the required timeframe, if n risk t the subject is incurred Failure f the subject t return study medicatin Serius nncmpliance is an actin r missin, nncmpliant with federal regulatins r IRB plicy, taken by an investigatr r faculty, staff, students, and thers invlved in human research, that in the judgment f the IRB, increased risks fr r cmprmising the rights and welfare f a research participant(s) r thers Cntinuing nncmpliance describes a pattern f repeated actins r missins taken by an investigatr r faculty, staff, students, and thers invlved in human research that indicate a deficiency in the ability r willingness f an investigatr, r faculty, staff, students t cmply with federal regulatins, IRB plicy, r determinatins r requirements f the IRB Reprt f nn-cmpliance is a ntificatin t the Research Cmpliance Office, IRB members, the Research Cmpliance Officer and/r the Institutinal Official (IO). Reprts f nn-cmpliance may cme frm a variety f surces, including: Self reprt frm the research team, thrugh a New Infrmatin Frm filed with the IRB Page 1 f 6 SOP # RR 406 Effective Date 01/15/2014 Supersedes 08/25/2013

2 Discvery by the IRB during nging review (serius adverse event reprting r cntinuing review), Discvery during an internal audit, Discvery during mnitring r audit by an external entity, Allegatin frm a prfessinal clleague r IRB member Cmplaint frm a research subject, subjects family, PI, IRB Member r member f public. 1.2 Initial Evaluatin When a reprt r allegatin f nn-cmpliance is received, the Research Cmpliance Office is ntified.. The Research Cmpliance Staff evaluates whether the reprt represents an imminent threat f harm t subjects r thers If there is an indicatin f imminent threat f harm, the Research Cmpliance Staff ntifies the IRB Chair. The Chair determines whether immediate suspensin is warranted. The Chair may cnsult with the Research Cmpliance Officer. In the Chair s absence, the IO r Research Cmpliance Officer can suspend a study n an urgent basis. Fllwing the Plicy fr Respnding t Allegatins f Scientific r Other Schlarly Miscnduct the team will determine if the allegatin is based in fact When a study is suspended, the Chair r Research Cmpliance Officer ntifies the IO. The Chair r the IO ntifies the investigatr by phne call and in writing The IO ntifies federal authrities f the suspensin. The IO files a preliminary reprt within five wrking days. The reprt is filed as described belw in sectin The Chair wrks with investigatr t prvide fr cntinued safety and welfare fr subjects. Depending n the nature f the nncmpliance and the subjects best interests, they may be cntinued n an investigatinal drug, transferred t clinical care, placed under additinal safety mnitring, r prvided with ther prtective measures When a study is suspended, the Research Cmpliance Officer crdinates an investigatin t gather further infrmatin, at the directin f the Chair and the IO The IRB is ntified f and reviews the suspensin at its next meeting If the initial evaluatin des nt indicate imminent threat f harm, the Research Cmpliance Staff evaluates the reprt t determine whether it is minr nncmpliance. If the reprt meets the definitin f minr nn-cmpliance, the reprt is evaluated by the IRB staff. If it is minr, IRB staff examines past reprts t see if there is a pattern f behavir that may indicate cntinuing nncmpliance. If the staff determines that a cntinuing nn-cmpliance investigatin is nt warranted, the staff develps a crrective actin plan that is cmmunicated t the investigatr t prevent similar cases f nncmpliance frm ccurring in the future. If a crrective actin plan is nt warranted, the reprt is placed in the file with n further actin. The reprt is Page 2 f 6 SOP # RR 406 Effective Date 01/15/2014 Supersedes 08/25/2013

3 detailed in the Study Histry sectin f the database t easily identify similar reprts in the file. If the reprt is nt minr nn-cmpliance, r if the reprt may indicate a pattern f cntinuing nn-cmpliance, it is referred t the IRB Chair befre review by the cnvened IRB The Chair evaluates the reprt t determine whether additinal infrmatin is needed prir t IRB review. If additinal infrmatin is needed, the Directr, Research Cmpliance crdinates the investigatin. Otherwise, the reprt is placed n the agenda f the next IRB meeting Reprt f Undue Influence by IRB Members r Staff are reprted t the Office f Research Cmpliance r the Chair, IRB and reviewed by: a. The Chair, IO and Research Cmpliance Officer wh will evaluate the reprt t determine whether additinal infrmatin is needed and what actin shuld be taken. Other departments will be included as necessary (HR, Crprate Cunsel) 1.3. Evaluatin by the Cnvened IRB All IRB members receive dcumentatin assciated with the initial reprt, any additinal dcumentatin generated by the investigatin, and a cpy f the current cnsent frm. A primary reviewer is assigned as described. Primary reviewers may request cpies f the study prtcl r any ther relevant materials in the IRB files. All members have access t the cmplete file, which is maintained in the Research Cmpliance ffice. During the meeting, the primary reviewer presents the reprt t the Bard, makes an initial recmmendatin and begins the discussin After discussin, the IRB may defer the review in rder t btain mre infrmatin frm the investigatr r additinal investigatin by the Research Cmpliance Officer and the Institutinal Official wh may charge: An Investigative Cmmittee (IC) t help gather further infrmatin and make recmmendatins; The IRB must ntify the investigatr the f the pending investigatin; The IC determines what infrmatin t gather and wh t interview; The IC bases their decisins n a prepnderance f evidence; The decisins are made by a majrity vte; The investigative cmmittee carries ut their charge within 60 days. The investigative cmmittee prvides a written reprt t the IRB and the IO If the review is nt deferred, the IRB determines whether nn-cmpliance is serius r cntinuing. The determinatin is dcumented in the meeting minutes. Upn finding that the event represents serius r cntinuing nncmpliance, the IRB takes ne r mre f the fllwing actins: Require additinal training f the investigatr r research team; Require additinal supervisin f the investigatr; Page 3 f 6 SOP # RR 406 Effective Date 01/15/2014 Supersedes 08/25/2013

4 Require mdificatins t the study prtcl; Require mdificatins t the infrmed cnsent dcument; Require additinal infrmatin be prvided t past subjects; Require ntificatin f current subjects; Require that current subjects re-cnsent t participatin; Increase the frequency f cntinuing review; Mnitr the cnduct f the research; Mnitr the cnsent prcess; Suspend the study pending further infrmatin; Terminate the study. A Cmpliance and Preventative Actin (CAPA) shuld be develped and fllwed until evidence f required actins has been taken If the cnvened IRB suspends r terminated the study, the IRB will wrk with the investigatr t prvide fr cntinued safety and welfare fr subjects. Depending n the nature f the nn-cmpliance and the subjects best interests, they may be cntinued n an investigatinal drug, transferred t clinical care, placed under additinal safety mnitring, r prvided with ther prtective measures If the IRB directs mre than minr mdificatins t the prtcl r cnsent frm t address the nn-cmpliance, the changes are reviewed by the cnvened Bard. Minr changes may be reviewed by the IRB Chair r experienced member If the IRB determines the event is neither serius nr cntinuing nncmpliance, the reprt is accepted with n further actin Actin by the IO When the IRB suspends r terminates a study, the IO may take additinal actins, in cnsultatin with the department chair and senir leadership. Additinal actins may include: Limiting the research f the investigatr (by number f active prtcls r number f active participants) Withdraw r limit the privileges f the investigatr t cnduct human research Refer the matter t ther rganizatinal entities (such as General Cunsel, Risk Management, Human Resurces and Medical/Academic Affairs) When the IRB determines serius r cntinuing nn-cmpliance, suspends r terminates a study, the IO files a letter f ntificatin t federal authrities and thers within 30 days. The letter is drafted by the Research Cmpliance Officer, with final apprval by the IO. The letter f ntificatin will include: Name f the institutin Title f the research prject and/r grant prpsal in which the nncmpliance ccurred Name f the principal investigatr n the prtcl Page 4 f 6 SOP # RR 406 Effective Date 01/15/2014 Supersedes 08/25/2013

5 The IRB number assigned t the prtcl A detailed descriptin f the nncmpliance; and Actins the institutin is taking r plans t take t address the nncmpliance (including thse actins described abve in III.C.) A. The ntificatin will be sent, as applicable, t: OHRP FDA, if the study is subject t FDA regulatins Other federal agencies (if applicable) that are cnducting r funding the study Spnsr, if the study is spnsred Principal investigatr Department Chief The IRB members B. A cpy f the letter is saved in the IRB file. 2. APPLICABLE REGULATIONS AND GUIDELINES 45 CFR CFR Guidance fr Addressing Nn-cmpliance: Guidelines fr Department and Practices 3. ATTACHMENTS RR 406-A Nn-cmpliance Determinatin Decisin Tree RR 406-B Cmpliance and Preventative Actin (CAPA) Template Wrd Versin 4. PROCEDURES EMPLOYED TO IMPLEMENT THIS POLICY Wh Task Tl Research Cmpliance Officer r Chairpersn Research Cmpliance Staff/Cmpliance Officer Reprts nn-cmpliance r unanticipated prblems t the IO Wrk with Cmpliance Officer and Chair t determine if this represents nn-cmpliance and it needs t be further reprted. Prvides IRB members with infrmatin fr review f actin. Crdinates the investigative cmmittee, if applicable Suspends r terminates study, if necessary Enters infrmatin int Study Histry Develps and versees the Cmpliance Actin Plan Nn-cmpliance Flw chart CAPA Frm Page 5 f 6 SOP # RR 406 Effective Date 01/15/2014 Supersedes 08/25/2013

6 Chair and IO Chair, Cmpliance Officer and IO Investigative Cmmittee Chair and IO cmmunicate with the investigatr. Determines if subjects are in imminent threat f harm and suspends investigatr r halts the study is necessary. Charge an Investigative Cmmittee, if necessary. Develps necessary ntificatins Reviews and make determinatin f actins. Prvides written reprt f recmmendatins within 60 days. Page 6 f 6 SOP # RR 406 Effective Date 01/15/2014 Supersedes 08/25/2013

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