NYU SoM IRB Policies & Procedures for Human Subjects Research Protection. Institutional Review Board Human Research Protection Program

Transcription

1 NYU SM IRB Plicies & Prcedures fr Human Subjects Research Prtectin Institutinal Review Bard Human Research Prtectin Prgram

2 NYU SM IRB HRPP Plicies & Prcedures fr Human Subjects Research Prtectin 1. Revisin Histry Prepared by NYU Schl f Medicine Institutinal Review Bard (IRB) Revised January 31, 2008 Revised March 31, 2009 Revised March 15, 2010 Revised June 11, 2010 Revised August 20, 2010 Revised December 28, 2010 Revised March 1, 2011 Revised Octber 13, 2011 Revised June 5, 2012 Revised April 7, 2014 revised (s)10.6 Revised August 1, 2015 AAHRPP updated requirements made Revised January 1, 2016 replaced numbering fr all chapters/sectins Revised January 21, 2016 Dept. f Defense language included new sectin 9.7 Revised May 5, 2016 Revised Octber 12, 2016 updated s7.2 t reflect electrnic system update Revised Nvember 28th minr update t s15.1 Principal Investigatr (staff allwed t be PI) IRB plicies and prcedures irb-inf@nyumc.rg page 2 f 143

3 NYU SM IRB HRPP Plicies & Prcedures fr Human Subjects Research Prtectin Table f Cntents 1. Revisin Histry 2 2. Missin Intrductin Ethical Principles: The Belmnt Reprt... 9 Respect fr Persns: Vluntary Participatin and Infrmed Cnsent... 9 Beneficence: The Risk-Benefit Rati... 9 Justice: The Fair Selectin f Research Subjects Sharing Research Risks Sharing Research Benefits Definitins Institutinal Authrity Assurance f Cmpliance Regulatry Cmpliance NYU SM Institutinal Review Bard Authrity f the IRB Jurisdictin f the IRB IRB Relatinship with Other HRPP Units Relatinships with Other Institutins Rles and Respnsibilities Institutinal Official Directr f the IRB Institutinal Review Bard (IRB) Office f Legal Cunsel Chairpersns f the IRB Vice Chairs f the IRB Subcmmittees f the IRB The Principal Investigatr Department Chairs Other Regulatry Units f the HRPP Prtcl-Specific Crdinatin IRB Operatins IRB Administrative Staff Selectin, Supervisin and Evaluatin f IRB Supprting Staff Resurces fr the IRB Cnduct f Quality Assurance/Quality Imprvement Activities fr IRB Operatins IRB Membership Cmpsitin f the IRB Appintment f Members t the IRB Alternate Members Use f Cnsultants (Outside Reviewers) Duties f IRB Members Attendance Requirements Training / Onging Educatin f Chair and IRB Members in Regulatins, Prcedures Orientatin Initial Educatin Staff Training Liability Cverage fr IRB Members Review f IRB Member Perfrmance Reprting and Investigatin f Allegatins f Undue Influence IRB Recrds IRB Recrds IRB Study Files Minutes f an IRB Meeting Membership Rsters Dcumentatin f Exemptins Dcumentatin f Expedited Reviews IRB plicies and prcedures irb-inf@nyumc.rg page 3 f 143

4 NYU SM IRB HRPP Plicies & Prcedures fr Human Subjects Research Prtectin 7.7. Access t IRB Recrds Recrds Retentin Requirements Written Plicies and Prcedures IRB Review Prcess Human Subjects Research Determinatin Exempt Research Limitatins n Research Subjects; Vulnerable Ppulatins Categries f Research Permissible fr Exemptin FDA Exemptins Hw t Submit an Exemptin Applicatin Additinal Prtectins Expedited Review f Research Categries f Research Eligible fr Expedited Review Hw t Submit an Expedited Review Infrming the IRB Cnvened IRB Meetings Schedule f IRB Meetings Qurum Pre-Meeting Distributin f Dcuments Meeting Prcedures Guests Primary Reviewers Review Prcess Submitting Electrnically t the IRB (esubmissin) esubmissin Cntingency Prcess IRB Office Pre-review In-Persn Cnsultatins Materials Received by the IRB fr the Initial Review f Research IRB Member Cnflicts f Interest Pssible IRB Actins Taken by Vte Appeals Determinatin f Risk Perid f Apprval Review Mre Often Than Annually Independent Verificatin Regarding Material Changes Cnsent Mnitring Significant New Findings Other Cmmittee Apprvals Reprting IRB Actins Cntinuing Review f Active Prtcls Apprval Perid Cntinuing Review Prcess Expedited Cntinuing Review Lapse in IRB Apprval Mdificatin f an Apprved Prtcl Expedited Review f Prtcl Mdificatins Full Bard Review f Prtcl Mdificatins Clsure f Studies Unanticipated Prblems Definitins Reprting IRB Review Further Review/Apprval f IRB Actins by Others within the Institutin Appeal f IRB Decisins Spnsred Research Cntracts IRB Fee Plicy and Schedule The Rights f Research Subjects IRB Plicy Review Prcess Criteria fr IRB Apprval f Research Risk/Benefit Assessment Scientific Merit Other Cnsideratins Selectin f Subjects is Equitable Recruitment f Subjects Infrmed Cnsent IRB plicies and prcedures irb-inf@nyumc.rg page 4 f 143

5 NYU SM IRB HRPP Plicies & Prcedures fr Human Subjects Research Prtectin 9.4. Data Safety Mnitring Privacy and Cnfidentiality Definitins Privacy Cnfidentiality Vulnerable Ppulatins Special Requirements fr Research Funded by the Department f Defense Minimal Risk [DDI , enclsure 3, para 6b] Military Persnnel as Subjects and Undue Influence [DDI , enclsure 3, para 7e1] Educatin and Training [DDI , enclsure 3, para 5] Appintment f a Research Mnitr [DDI , enclsure 3, para 8] Additinal prtectins fr pregnant wmen, prisners, and children (Subparts B, C and D f 45 CFR 46) [DDI , enclsure 3 para 7] Limitatin f Waivers and Exceptins frm Infrmed Cnsent - [DDI , enclsure 3, paras 9 and 13] Limitatins n Cmpensatin fr U.S. Military Persnnel - [DDI , para 11; Dual Cmpensatin Act and 24 U.S.C. 30] Requirement fr Reprting [DDI , enclsure 3, para 4b4] Recrdkeeping Requirements - [DDI , para 15] Classified research - [DDI , enclsure 3, para 13] Additinal Requirements fr DD Spnsred Research Respnsibilities Infrmed Cnsent Infrmed Cnsent Prcess Definitins Basic Requirements Basic Elements f Infrmed Cnsent Subject Withdrawal r Terminatin Waiver f Infrmed Cnsent Dcumentatin f Infrmed Cnsent (Signed Cnsent) Waiver f Dcumentatin f Infrmed Cnsent (Waiver f Signed Cnsent) Review and Apprval f the Infrmed Cnsent Frm Parental Permissin and Assent Surrgate Cnsent Cnsent and Language Barriers Use f Interpreters in the Cnsent Prcess Braille Cnsent Oral Cnsent Vulnerable Ppulatins PI Respnsibilities IRB Respnsibilities Initial Review f Research Prpsal Cntinuing Review and Mnitring Research Invlving Children Definitins Allwable Categries Parental Permissin and Assent The Assent Frm Children wh are Wards Research Invlving Pregnant Wmen, Human Fetuses and Nenates Definitins Research Invlving Pregnant Wmen r Fetuses Research Invlving Nenates Research Invlving, After Delivery, the Placenta, the Dead Fetus r Fetal Material Research Nt Otherwise Apprvable Research Invlving Prisners Definitins Purpse Applicability Cmpsitin f the IRB Additinal Duties f the IRB Certificatin t HHS Incarceratin f Enrlled Subjects Requirements f the Prisner Representative Applicability Waiver fr Epidemilgy Research IRB plicies and prcedures irb-inf@nyumc.rg page 5 f 143

6 NYU SM IRB HRPP Plicies & Prcedures fr Human Subjects Research Prtectin Persns wh Lack Capacity t Prvide Infrmed Cnsent fr Research and Surrgate Cnsent General Requirements fr Surrgate Cnsent Apprval Criteria fr Research Invlving Surrgate Cnsent Additinal Safeguards IRB Cmpsitin Required Submissins t IRB Determinatin f Decisin-Making Capacity Legally Authrized Representatives Ntificatin and Assent f Subjects Wh Lack Capacity Additinal Cnsideratins Cmplaints, Nn-Cmpliance and Suspensin r Terminatin f IRB Apprval f Research Cmplaints Nn-Cmpliance Definitins IRB Review f Allegatins f Nn-Cmpliance Review f Findings f Nn-Cmpliance Inquiry Prcedures Final Review Additinal Actins Suspensin r Terminatin Investigatr Hld Prtectin f Currently Enrlled Participants Reprting Reprting t Regulatry Agencies and Institutinal Officials Investigatinal Drugs & Devices in Research Definitins FDA Exemptins IND/IDE Requirements Investigatr-Spnsrs Respnsibilities Investigatr IRB Emergency Use Emergency Exemptin frm Prspective IRB Apprval Emergency Waiver f Infrmed Cnsent Expanded Access f Investigatinal Drugs Treatment IND Emergency Waiver f IND Waiver f Infrmed Cnsent fr Planned Emergency Research Expanded Access f Investigatinal Devices Humanitarian Use Devices (HUD) Investigatr Respnsibilities Investigatr Classificatins Prtcl Develpment Changes t Apprved Research Cntinuing Review after Prtcl Apprval Required Reprts t the IRB Unanticipated Prblems Submissin f Reprts Cmplaints, Nn-Cmpliance and Prtcl Deviatins Exceptins Deviatins Reprting & Review Prgress Reprts Investigatr-Required Recrd Keeping Training & Onging Educatin f Principal Investigatr and Research Team Investigatr Cnflict f Interest Definitins Individual Cnflicts f Interest Institutinal Cnflict f Interest Subject Recruitment IRB plicies and prcedures irb-inf@nyumc.rg page 6 f 143

7 NYU SM IRB HRPP Plicies & Prcedures fr Human Subjects Research Prtectin Recruitment Incentives Payment t Subjects Investigatr Cncerns Health Insurance Prtability and Accuntability Act (HIPAA) Definitins Histrical Backgrund Effects f HIPAA n Research Research under HIPAA Waiver f Authrizatin fr Use r Disclsure f Prtected Health Infrmatin in Research Review Preparatry t Research Research n Prtected Health Infrmatin f Decedents Limited Data Sets with a Data Use Agreement Transitin Prvisins HIPAA and Dcument Requirements Patient Rights and Research HIPAA and Existing Studies Waivers t HIPAA Cnsent Frm Special Tpics Certificate f Cnfidentiality Statutry Basis fr Prtectin Limitatins Applicatin Prcedures Mandatry Reprting NYU SM Students and Emplyees as Subjects Oral Histry Genetic Studies Privacy and Cnfidentiality Diagnstic Status and Types f Tests Federal vs. State Law Recruitment fr Individual r Pedigree Studies Summary Research Invlving Cded Private Infrmatin r Bilgical Specimens Wh Shuld Determine Whether Cded Private Infrmatin r Specimens Cnstitutes Human subjects research Case Reprts Requiring IRB Review Definitins Internatinal Research Mnitring f Apprved Internatinal Research Embrynic Stem Cell Research Cmmunity Based Research IRB plicies and prcedures irb-inf@nyumc.rg page 7 f 143

8 NYU SM IRB HRPP Plicies & Prcedures fr Human Subjects Research Prtectin 2. Missin NYU Schl f Medicine ( NYU SM ) fsters a research envirnment that prmtes respect fr the rights and welfare f individuals recruited fr, r participating in, research cnducted by r under the auspices f NYU SM. In the review and cnduct f research, actins by NYU SM will be guided by the Principles set frth in the Ethical Principles and Guidelines fr the Prtectin f Human Subjects f Research (ften referred t as the Belmnt Reprt ), and will be perfrmed in accrdance with the Department f Health and Human Services ( DHHS ) plicies and regulatins at 45 CFR 46 (als knwn as the Cmmn Rule ), and als the Fd and Drug Administratin ( FDA ) plicies and regulatins at 21 CFR 50 and 21 CFR 56, as applicable. All f these principles stress such factrs as, inter alia, respect fr persns, beneficence and justice. The actins f NYU SM will als cnfrm t all ther applicable federal, state, and lcal laws and regulatins. In rder t effectively cnduct research, NYU SM maintains a Human Research Prtectin Prgram ( HRPP ) which includes five Institutinal Review Bards ( IRB ), which nt nly review research prtcls invlving human subjects, but als evaluate bth risk against and prtectin fr thse subjects. The missin f the IRB is t: safeguard and prmte the health and welfare f human research subjects by ensuring that their rights, safety and well-being are prtected determine and certify that all prjects reviewed by the IRB cnfrm t the plicies and prcedures set frth in this dcument, including all applicable regulatins regarding the health, welfare, safety, rights, and privileges f human subjects prvide timely and high quality educatin, review and mnitring f human research prjects facilitate excellence in human subjects research The IRB includes mechanisms t: establish a frmal prcess t mnitr, evaluate and cntinually imprve the prtectin f human research participants dedicate resurces sufficient t d s exercise versight f research prtectin educate investigatrs and research staff abut their ethical respnsibility t prtect research participants assist the investigatrs in cmplying with federal and state regulatins. when apprpriate, intervene in research and respnd directly t cncerns f research participants 2.1. Intrductin The NYU SM Plicies and Prcedures fr Human Subjects Research Prtectin details nt nly the plicies and regulatins gverning research with human subjects, but als the prcedures fr submitting research prpsals fr review by the NYU SM IRB. These plicies and prcedures apply t all research invlving human subjects if NYU SM faculty, staff, students, r facilities are invlved, regardless f spnsrship and/r perfrmance site, whether dmestic r freign. NYU SM is guided by the ethical principles regarding all research invlving humans, as set frth in the Reprt f the Natinal Cmmissin fr the Prtectin f Human Subjects f Bimedical and Behaviral Research: Ethical Principles and Guidelines fr the Prtectin f Human Subjects f Research, (Natinal Cmmissins fr the Prtectin f Human Subjects f Bimedical and Behaviral Research, April 1979). IRB plicies and prcedures irb-inf@nyumc.rg page 8 f 143

9 NYU SM IRB HRPP Plicies & Prcedures fr Human Subjects Research Prtectin 2.2. Ethical Principles: The Belmnt Reprt It is the duty f NYU SM IRB t review and make decisins n all prtcls fr research invlving human subjects. The tw principal respnsibilities f the IRB are (1) the prtectin f research subjects frm undue risk and (2) the prtectin f research subjects frm deprivatin f persnal rights and dignity. This prtectin is best assured by cnsideratin f three principles as set frth in the Belmnt Reprt, which are the tuchstnes f ethical research: that vluntary participatin by the subjects, indicated by free and infrmed cnsent, is assured; that an apprpriate balance exists between the ptential benefits f the research t the subject r t sciety and the risks assumed by the subject; and that there are fair prcedures and utcmes in the selectin f research subjects. These principles are referred t as Respect fr Persns, Beneficence, and Justice. Respect fr Persns: Vluntary Participatin and Infrmed Cnsent One f the mst imprtant elements in any research invlving human research subjects is the assurance f vluntary infrmed cnsent. Any persn wh is t be a research subject, whether designed fr his/her wn direct benefit r fr the advancement f scientific knwledge in general, must understand as cmpletely as pssible what the study entails and the ptential risks and benefits f the study. The persn must give his/her cnsent freely, withut pressure r inapprpriate inducement. The IRB at NYU SM strives t ensure vluntary infrmed cnsent f research subjects thrugh a careful review f the recruitment and cnsent prcess, and a further review f the details f the cnsent frm and/r any ther materials t be viewed by subjects. The infrmed cnsent cncept is further extended t thse studies in which the subjects are nt able t give persnal cnsent fr themselves. In this situatin, the cnsent dcument is addressed t thse wh have been designated respnsible fr the research subject s wellbeing (e.g., parent f a child). The IRB s cncern is t verify that the cnsent prcess and dcument are likely t assist these persns in making an infrmed decisin as t the best interests f the research subject. The capacity fr truly infrmed and vluntary participatin in research varies widely amng study ppulatins. At ne extreme there may be ample understanding and manifest freedm frm cercin; at the ther, there may be degrees f understanding and freedm that affect the cnsent f ptential subjects. The IRB must exercise special care when cnsidering subjects whse ability t give free and infrmed cnsent may be cmprmised in any way. Beneficence: The Risk-Benefit Rati The IRB is charged with deciding, fr any prpsed activity that falls under its jurisdictin, whether: The risks t the subject are s utweighed by the sum f the benefit t the subject and the imprtance f the knwledge t be gained as t warrant a decisin t allw the subject t accept (thse) risks. (Federal Register, May 30, 1974) The assessment f the risk/benefit relatin is a cmplex task. There are risks f injury r discmfrt t the individual that can be physical, psychlgical, financial, and/ r scial. Cnversely, there may be ptential benefits t the individual, t a grup t which the individual belngs, and/r t sciety. During the review f applicatins, the IRB must carefully assess the types and degrees f bth risks and benefits fr a given subject ppulatin, as well as the investigatr s cmmunicatin f these risks and benefits t the subject in the cnsent prcess and cnsent frm. While the IRB is nt charged with reviewing scientific design per se, it must ccasinally d s in rder t assess the risk/benefit rati. If a study design seems inadequate in attainment f the stated aim f the investigatin, then n benefit can be anticipated frm cnducting the study. Thus, there wuld be n justificatin fr placing any research IRB plicies and prcedures irb-inf@nyumc.rg page 9 f 143

10 NYU SM IRB HRPP Plicies & Prcedures fr Human Subjects Research Prtectin subject at risk, hwever minimal. Therefre, the design f the study must be sund, and the nature and likelihd f all risks and benefits must be made clear in any applicatin t the IRB. Justice: The Fair Selectin f Research Subjects Bth the risks and the ptential benefits f research shuld be spread fairly amng ptential research subjects and research subject grups. Study design and selectin f subjects shuld avid bias fr r against particular grup based n such factrs a gender, sexual rientatin, sciecnmic status, immigratin status, race, r scial grup. Sharing Research Risks The guiding principle in the ethical selectin f research subject grups is that any risks f the research shuld fall upn the grups wh might benefit frm the research. If the results f a risky prtcl might benefit the general ppulatin, it wuld be unethical t fcus subject recruitment n vulnerable r disadvantaged grups (e.g., institutinalized peple r prisners; patients at free clinics primarily patrnized by peple unable t affrd ther medical care) simply because this ppulatin is easily accessible r can be persuaded t participate. Further, an undue share f research risks shuld nt burden grups already burdened by ther factrs. Rather, attempts shuld be made t include a fair sampling f the ppulatins wh might benefit frm the study. When research invlves persns whse autnmy is cmprmised, it is expected that the research bear sme direct relatinship t the cnditins r circumstances f the research subject ppulatin. In additin, grups fully able t cnsider the research risks and infrmed cnsent prcess shuld be cnsidered fr selectin in a study prir t invlvement f the mre vulnerable ppulatins. Fr example, investigatinal drugs are typically tested in adults prir t being tested in children. Certain investigatinal drugs and prcedures may be tested in healthy vlunteers prir t being tested in patients. Sharing Research Benefits In recent years, increasing attentin has been paid t the rights f varius grups t be included in research. Thrugh advcacy grups, many patients have cme t insist n having access t experimental treatments, as these experimental treatments may ptentially prvide the best medical care available. In additin, researchers, ethicists and public fficials have recgnized that because many clinical trials fcus primarily n white middle-class research subject grups, the results f certain trials were f questinable value fr members f ther scial, racial, sexual, and ethnic grups. As a result, bth the Natinal Institutes f Health and the FDA nw require that a study design include as brad a range f research subjects as feasible, and further that the data be analyzed t uncver respnses that differ between grups. Fr example, where wmen f child-bearing ptential, pregnant and nursing wmen were previusly rutinely excluded frm new drug trials, it is nw required that, whenever pssible, these wmen be asked t make their wn chices after being fully infrmed f the risks f the research. 3. Definitins Ag e n t Agents include all individuals perfrming institutinally designated activities r exercising institutinally delegated authrity r respnsibility. C m m n Rul e The Cmmn Rule refers t the Federal Plicy fr the Prtectin f Human Subjects adpted by a number f federal agencies. Althugh the Cmmn Rule is cdified by each agency separately, the text IRB plicies and prcedures irb-inf@nyumc.rg page 10 f 143

11 NYU SM IRB HRPP Plicies & Prcedures fr Human Subjects Research Prtectin is identical t DHHS regulatins in 45 CFR 46 Subpart A. Fr the purpses f this dcument, references t the Cmmn Rule will cite the DHHS regulatins. H u m a n s u b je c t s r e s e a r c h Fr the purpses f this plicy human subjects research is defined as any activity that either Meets the DHHS definitin f research and invlves human subjects as defined by DHHS; r Meets the FDA definitin f research and invlves human subjects as defined by FDA. R e s e a r c h (as defined by DHHS regulatins) a systematic investigatin, including research develpment, testing and evaluatin, designed t develp r cntribute t generalizable knwledge. Generalizable knwledge means that (1) cnclusins are drawn frm particular instances and (2) the infrmatin frm the investigatin is t be disseminated. A systematic investigatin is defined as a methdical planned inquiry t btain r ascertain facts. Activities that meet this definitin f research may be funded r unfunded, r may be cnducted as a cmpnent f anther prgram nt usually cnsidered research. Fr example, demnstratin and service prgrams may include evaluatin cmpnents, which cnstitute research activities under this definitin. Research as defined by FDA regulatins is any experiment that invlves a test article and ne r mre human subjects and that either is subject t requirements fr prir submissin t the Fd and Drug Administratin under Sectin 505(i) r 520(g) f the act, r is nt subject t requirements fr prir submissin t the Fd and Drug Administratin under these Sectins f the act, but the results f which are intended t be submitted later t, r held fr inspectin by, the Fd and Drug Administratin as part f an applicatin fr a research r marketing permit. An experiment, as defined in 21 CFR 312, includes any use f a drug ther than the use f a marketed (apprved) drug in the curse f medical practice, and as defined in 21 CFR 812, includes any activity that evaluates the safety r effectiveness f a medical device. The terms research, clinical research, clinical study, study, and clinical investigatin are synnymus fr purpses f FDA regulatins. [21 CFR 50.3(c), 21 CFR (c)] Experiments that must meet the requirements fr prir submissin t the Fd and Drug Administratin under sectin 505(i) f the Federal Fd, Drug, and Csmetic Act means any use f a drug ther than the use f an apprved drug in the curse f medical practice. [21 CFR 312.3(b)] Experiments that must meet the requirements fr prir submissin t the Fd and Drug Administratin under sectin 520(g) f the Federal Fd, Drug, and Csmetic Act means any activity that evaluates the safety r effectiveness f a device. [21 CFR 812.2(a)] Any activity in which results are being submitted t r held fr inspectin by FDA as part f an applicatin fr a research r marketing permit is cnsidered t be FDA-regulated research. [21 CFR 50.3(c), 21 CFR (c)] H u m a n Su b je c t (as defined by DHHS regulatins) a living individual abut whm an investigatr (whether prfessinal r student) cnducting research btains: data thrugh interventin* r interactin** with the individual, r identifiable*** private infrmatin Human Subject as defined by FDA regulatins: IRB plicies and prcedures irb-inf@nyumc.rg page 11 f 143

12 NYU SM IRB HRPP Plicies & Prcedures fr Human Subjects Research Prtectin An individual wh is r becmes a subject in research, either as a recipient f the test article r as a cntrl. A subject may be either a healthy human r a patient. In the case f a medical device, a human subject/participant is als means a human n whse specimen an investigatinal device is used. *Interventin includes bth physical prcedures by which data are gathered (fr example, venipuncture) and manipulatins f the subject r the subject's envirnment that are perfrmed fr research purpses. **Interactin includes cmmunicatin r interpersnal cntact between investigatr and subject. ***Private infrmatin includes infrmatin abut behavir that ccurs in a cntext in which an individual can reasnably expect that n bservatin r recrding is taking place, and infrmatin which has been prvided fr specific purpses by an individual and which the individual can reasnably expect will nt be made public (fr example, a medical recrd). Private infrmatin must be individually identifiable (i.e., the identity f the subject is r may readily be ascertained by the investigatr r assciated with the infrmatin) in rder fr btaining the infrmatin t cnstitute research invlving human subjects. E n g a g e m e n t Institutins are cnsidered engaged in a research prject when the invlvement f their emplyees r agents in that prject includes any f the fllwing: Interventin fr research purpses with any human subjects f the research by perfrming invasive r nninvasive prcedures. Interventin fr research purpses with any human subject f the research by manipulating the envirnment. Interactin fr research purpses with any human subject f the research. Obtaining the infrmed cnsent f human subjects fr the research. Obtaining fr research purpses identifiable private infrmatin r identifiable bilgical specimens frm any surce fr the research. In general, btaining identifiable private infrmatin r identifiable specimens includes, but is nt limited t: bserving r recrding private behavir; using, studying, r analyzing fr research purpses identifiable private infrmatin r identifiable specimens prvided by anther institutin; and using, studying, r analyzing fr research purpses identifiable private infrmatin r identifiable specimens already in the pssessin f the investigatrs. I n s t i t u t i n a l O f f i c i a l (IO) The IO is respnsible fr ensuring that the NYU SM IRB has the resurces and supprt necessary t cmply with all federal regulatins and guidelines that gvern human subjects research. The IO is legally authrized t represent the institutin, is the signatry fficial fr all assurances regarding the cnduct f human subjects research n behalf f NYU SM, and versees all bligatins f all such assurances. I RB An Institutinal Review Bard established in accrd with and fr the purpses expressed in this plicy. I RB Ap p r v a l The determinatin f the IRB that the research has been reviewed and may be cnducted at an institutin within the cnstraints set frth by the IRB and by ther institutinal and legal requirements. IRB plicies and prcedures irb-inf@nyumc.rg page 12 f 143

13 NYU SM IRB HRPP Plicies & Prcedures fr Human Subjects Research Prtectin M i n i m a l Ri s k Risk fr which the prbability and magnitude f harm r discmfrt anticipated in the research are nt greater in and f themselves than thse rdinarily encuntered in daily life r during the perfrmance f rutine physical r psychlgical examinatins r tests. C e r t i f i c a t i n The fficial ntificatin by the institutin t the supprting Department r Agency, in accrdance with the requirements f this plicy, that a research prject r activity invlving human subjects has been reviewed and apprved by an IRB in accrdance with an apprved assurance. R e s e a r c h u n d e r t h e Au s p i c e s f t h e O r g a n i z a t i n Research under the auspices f the rganizatin means research cnducted at this institutin, cnducted by r under the directin f any emplyee r agent f this institutin (including students) in cnnectin with his r her institutinal respnsibilities, cnducted by r under the directin f any emplyee r agent f this institutin using any prperty r facility f this institutin, r invlving the use f this institutin's nn-public infrmatin t identify r cntact human subjects. T e s t Ar t i c l e Test articles cvered under the FDA regulatins include: Human Drugs the primary intended use f the prduct is achieved thrugh chemical actin r by being metablized by the bdy. A drug is defined as a substance recgnized by an fficial pharmacpeia r frmulary; A substance intended fr use in the diagnsis, cure, mitigatin, treatment, r preventin f disease; A substance (ther than fd) intended t affect the structure r any functin f the bdy; A substance intended fr use as a cmpnent f a medicine but nt a device r a cmpnent, part r accessry f a device. Medical Devices A device is an instrument, apparatus, implement, machine, cntrivance, implant, in vitr reagent, r ther similar r related article, including a cmpnent part, r accessry which is: recgnized in the fficial Natinal Frmulary, r the United States Pharmacpeia, r any supplement t them; intended fr use in the diagnsis f disease r ther cnditins, r in the cure, mitigatin, treatment, r preventin f disease, in man r ther animals; r intended t affect the structure r any functin f the bdy f man r ther animals, and which des nt achieve any f its primary intended purpses thrugh chemical actin within r n the bdy f man r ther animals and which is nt dependent upn being metablized fr the achievement f any f its primary intended purpses htm Bilgical Prducts include a wide range f prducts such as vaccines, bld and bld cmpnents, allergenics, smatic cells, gene therapy, tissues, and recmbinant therapeutic prteins. Bilgics can be cmpsed f sugars, prteins, r nucleic acids r cmplex cmbinatins f these substances, r may be living entities such as cells and tissues. Bilgics are islated frm a variety f natural surces human, animal, r micrrganism and may be prduced by bitechnlgy methds and ther cutting-edge technlgies. Gene-based and cellular bilgics, fr example, ften are at the frefrnt f bimedical research, and may be used t treat a variety f medical cnditins fr which n ther treatments are available. Fd Additives In its bradest sense, a fd additive is any substance added t fd. Legally, the term refers t any substance the intended use f which results r may reasnably be expected t result directly r indirectly in its becming a cmpnent r therwise affecting the characteristics f any fd. This definitin includes any substance used in the prductin, prcessing, treatment, packaging, transprtatin r strage f fd. Clr Additives A clr additive is any dye, pigment r substance which when added r applied t a fd, drug r IRB plicies and prcedures irb-inf@nyumc.rg page 13 f 143

14 NYU SM IRB HRPP Plicies & Prcedures fr Human Subjects Research Prtectin csmetic, r t the human bdy, is capable (alne r thrugh reactins with ther substances) f imparting clr. Fds including dietary supplements, that bear a nutrient cntent claim r a health claim Infant Frmulas 4. Institutinal Authrity The NYU SM Human Research Prtectin Prgram perates under the authrity f this plicy. The perating prcedures in this dcument gvern the cnduct and review f all human research cnducted under the auspices f the institutin. This plicy is made available t all investigatrs and research staff by being psted n the IRB website ( The Vice Dean fr Science f NYU SM designates the individual wh serves as the Institutinal Official ( IO ) fr the purpse f carrying ut NYU SM HRPP. Further, the Vice Dean fr Science identifies, as necessary, ther individuals t whm respnsibility is delegated fr administrative versight f the individual cmpnents f the HRPP. The NYU SM IRB, which reprts t the Vice Dean fr Science r his/her delegate, has jurisdictin ver all human subjects research cnducted under the auspices f the institutin. All human subjects research at the fllwing institutins r cmpnents are cnsidered research activity f NYU SM and are subject t these plicies: NYU SM, including all institutes and faculty grup practices thereunder; all hspitals within the NYU Hspitals Center, including Tisch Hspital, NYU Hspital fr Jint Diseases, and NYU Lutheran Medical Center. The NYU SM IRB als certain human subjects research at ther institutins in accrdance with IRB authrizatin agreements, including NYU Cllege f Dentistry and Nursing, NYU Lutheran Family Health Centers, Bellevue Hspital Center, and the Department f Veteran s Affairs New Yrk Harbr Healthcare System Assurance f Cmpliance NYU SM hlds a federal-wide assurance (FWA), The FWA is an assurance f cmpliance with the federal regulatins fr the prtectin f human subjects in federally-funded research. The FWA is apprved by the HHS Office f Human Research Prtectins ( OHRP ), thereby permitting ther departments and agencies that have adpted the Federal Plicy fr the Prtectin f Human Subjects t rely upn the FWA fr the research that they cnduct r supprt. Under this plicy, NYU SM maintains these same standards fr all human subjects research regardless f funding status Regulatry Cmpliance The IRB is respnsible fr ensuring cmpliance with institutinal plicies and applicable law in its review and versight f human subjects research. All human subjects research under the ausprices f NYU SM must be cnducted in accrdance with this plicy, the Cmmn Rule, 21 CFR 50 and 56 (as applicable), and applicable state and lcal law in the jurisdictin where the research is cnducted. Such laws culd include Article 24-A f the New Yrk State Public Health Law fund at The IRB vluntarily applies the Internatinal Cnference n Harmnizatin ( ICH ) Gd Clinical Practices ( GCP ) Guidelines (smetimes referred t as ICH-GCP r E6 ) nly t the extent that they are cmpatible with FDA and DHHS regulatins. IRB plicies and prcedures irb-inf@nyumc.rg page 14 f 143

15 NYU SM IRB HRPP Plicies & Prcedures fr Human Subjects Research Prtectin 5. NYU SM Institutinal Review Bard The NYU SM IRB is an administrative bdy established t prtect the rights and welfare f human research subjects recruited t participate in research activities cnducted under the auspices f this institutin. There are five Institutinal Review Bards that functin identically, have equivalent expertise and review all human subjects research cnducted at NYU SM r ther rganizatins r studies under its jurisdictin. The IO, the IRB Directr and the Chairs f the IRB review the activity f the IRB n at least an annual basis and make a determinatin as t the apprpriate number f review bards and meetings that are needed fr the institutin Authrity f the IRB The IRB at the NYU SM reviews and has the authrity t apprve, require mdificatins in, r disapprve all research activities cnducted under the auspices f NYU SM. The IRB als has the authrity t suspend, place restrictins n, r terminate apprvals f research activities that fall within its jurisdictin that are nt being cnducted in accrdance with IRB requirements, r that have been assciated with unexpected serius harm t subjects. The IRB ensures that apprpriate safeguards exist t prtect the rights and welfare f research subjects [45 CFR ]. In fulfilling these respnsibilities, the IRB reviews all research dcuments and activities that bear directly n the rights and welfare f the subjects f prpsed research. Examples f IRB review dcumentatin include, inter alia: prtcls, cnsent/assent dcument(s) and, fr studies cnducted under the Investigatinal New Drug ( IND ) regulatins, the investigatr's brchure(s), tests, surveys, questinnaires and similar measures, and recruiting dcuments. Befre any human subject becmes invlved in research at NYU SM, an IRB will prperly cnsider: risks t the subject and thers anticipated benefits t the subject and thers imprtance f the knwledge that may reasnably be expected t result frm the study infrmed cnsent prcess t be emplyed The IRB has the authrity t suspend, place restrictins upn, r terminate apprval f research activities that fall within its jurisdictin that: are nt being cnducted in accrdance with IRB requirements, r that have been assciated with serius harm t subjects The IRB has the authrity t bserve (r delegate a third party t bserve) the cnsent prcess and the research if the IRB deems this necessary Jurisdictin f the IRB The IRB jurisdictin extends t all research (funded and unfunded) invlving human subjects cnducted at NYU SM, as well as research cnducted elsewhere by NYU SM faculty, staff, and students, excluding research where invlvement f human subjects falls within ne r mre exempt categries (see Categries f Research Permissible fr Exemptin). If an IRB chair, member, r staff persn believes the IRB t have been unduly influenced by any party, a cnfidential reprt shall be made t the Institutinal Official wh can determine apprpriate crrective actin. IRB plicies and prcedures irb-inf@nyumc.rg page 15 f 143

16 NYU SM IRB HRPP Plicies & Prcedures fr Human Subjects Research Prtectin 5.3. IRB Relatinship with Other HRPP Units The IRB functins independently f, but in crdinatin with, ther institutinal regulatry cmmittees. The IRB, hwever, makes independent determinatins regarding apprval r disapprval f a prtcl based upn whether r nt human subjects are adequately prtected. The IRB retains review jurisdictin ver all research invlving human subjects cnducted, supprted, r therwise subject t regulatin by any federal department r agency that adpted the human subjects regulatins. Research previusly reviewed and apprved by the IRB may be subject t review and disapprval by fficials f the institutin. Hwever, fficials f the institutin have n authrity t apprve research previusly disapprved by the IRB Relatinships with Other Institutins NYU SM may chse, n a case-by-case basis, t prvide human research prtectin versight fr unaffiliated institutins. In prviding such versight, a frmal relatinship must be established between NYU SM and the unaffiliated institutin thrugh a written agreement. This agreement must be executed prir t NYU SM s acceptance f any human research prpsals frm the unaffiliated institutin. When NYU SM reviews research cnducted at an unaffiliated institutin, the particular characteristics f the unaffiliated institutin s lcal research cntext must be cnsidered, either (1) thrugh prir knwledge f the unaffiliated institutin s lcal research cntext, r (2) thrugh subsequent review by apprpriate designated institutinal fficials, such as the Chairpersn and/r ther IRB members. When NYU SM is the crdinating center fr a multi-center prtcl, the study chair r equivalent at NYUSM shall submit the prtcl and ther study dcuments t the NYU SM IRB fr review and apprval, unless such prtcl relies n an external IRB in accrdance with a written agreement. The NYU SM IRB will require that study chair r equivalent ensure that each participating site receive apprval frm an IRB with jurisdictin ver that site prir t initiatin f the research at that site. At the time f initial review, the IRB will assess the prcedures fr disseminatin f prtcl infrmatin t all participating sites. NYU SM may als chse, n a case-by-case basis, t cede r share its IRB versight respnsibilities t an external IRB. A frmal relatinship between NYU SM and the external IRB must be established thrugh a written agreement. When NYU SM relies n anther IRB, the IRB Directr will review the plicies and prcedures f the IRB t ensure that they meet NYU SM standards. If the ther IRB is accredited by AAHRPP, then it will be assumed that the NYU SM standards are being met prvided all lcal cntext and institutinal requirements are cnsidered. In the cnduct f cperative research prjects, NYU SM acknwledges that each institutin is respnsible fr safeguarding the rights and welfare f human subjects, and further fr ensuring cmpliance with the applicable federal regulatins. When a cperative agreement exists, NYU SM may enter int a jint review arrangement, rely n the review f anther qualified IRB, r make similar arrangements fr aviding duplicatin f effrt. When an investigatr plans t cnduct research at sites external t the NYU SM and the site s IRB plans t defer review t the NYU SM s IRB, arrangements must be made fr the NYU SOM s IRB t be the IRB f recrd fr the prject and arrangements must be made fr cmmunicatin between the IRB and the site. When NYU SM is the crdinating center fr a multi-center prtcl, the IRB will require that NYU SM ensure that IRB apprval has been btained at each participating site prir t initiatin f the research at that site. At the time f initial review, the IRB will assess the prcedures fr disseminatin f IRB plicies and prcedures irb-inf@nyumc.rg page 16 f 143

17 NYU SM IRB HRPP Plicies & Prcedures fr Human Subjects Research Prtectin prtcl infrmatin t all participating sites. Assessment f prtcl infrmatin includes, inter alia, unanticipated prblems invlving risks t participants, prtcl mdificatins and interim findings. NYU SM faculty may submit certain research t external IRBs such as BRANY and NCI Central IRB, as permitted by IRB guidance dcuments and in accrdance with written agreements with such external IRBs. The VAMC IRB reviews research cnducted by NYU SM faculty that invlves participants slely recruited at the VAMC 5.5. Rles and Respnsibilities Institutinal Official The ultimate respnsibility f the IRB resides with the Institutinal Official (IO). The IO is respnsible fr ensuring the IRB has the resurces and supprt necessary t cmply with all institutinal plicies and with regulatins and guidelines that gvern human subjects research. The IO signs all assurances regarding human subjects research t gvernmental versight agencies. The IO als hlds ultimate respnsibility fr versight ver the: Institutinal Review Bard (IRB); cnduct f research cnducted by all IRB investigatrs; Directr f the IRB The Directr f the IRB (Directr) reprts t the Vice Dean fr Science r his/her delegate, and is respnsible fr: develping, managing and evaluating plicies and prcedures that ensure cmpliance with all regulatins gverning human subjects research. This includes mnitring changes in regulatins and plicies that relate t human research prtectin and verseeing all aspects f the IRB prgram advising the IO n matters regarding research at IRB implementing the institutin s IRB plicy assuring the IRB members are apprpriately knwledgeable t review research in accrdance with ethical standards and applicable regulatins assuring that all investigatrs are apprpriately knwledgeable t cnduct research in accrdance with ethical standards and applicable regulatins the develpment and implementatin f an educatinal plan fr IRB members, staff and investigatrs submitting, implementing and maintaining an apprved FWA thrugh the IO t the Department f Health and Human Services Office f Human Research Prtectin (OHRP) managing the finances f the IRB assisting investigatrs in their effrts t carry ut NYU SM s research missin. develping and implementing needed imprvements and ensuring fllw-up f actins, as apprpriate, fr the purpse f managing risk in the research prgram develping training requirements as required and as apprpriate fr investigatrs, subcmmittee members and research staff, and ensuring that training is cmpleted n a timely basis serving as the primary cntact at IRB fr the Office fr Human Research Prtectins (OHRP) f the U.S. Department f Health and Human Services and ther federal regulatry agencies day-t-day respnsibility fr the peratin f the IRB ffice, including supervisin f IRB staff respnding t faculty, student and staff questins wrking clsely with the Chairs f the IRB and n the develpment f plicy and prcedures, as well as rganizing and dcumenting the review prcess The Directr is a vting member f the IRB. IRB plicies and prcedures irb-inf@nyumc.rg page 17 f 143

18 NYU SM IRB HRPP Plicies & Prcedures fr Human Subjects Research Prtectin Institutinal Review Bard (IRB) The IRB currently has five Bards appinted by the Institutinal Official (IO). These Bards prspectively review and make decisins cncerning all human subjects research cnducted at NYU facilities by its emplyees r agents, r under its auspices. The IRB is respnsible fr the prtectin f rights and welfare f human research subjects under the auspices f the rganizatin. It discharges this duty by cmplying with all applicable requirements f law, the FWA and institutinal plicies. Office f Legal Cunsel The IRB relies n the cunsel f the NYU Langne Medical Center Office f Legal Cunsel fr the interpretatin f applicable law in the jurisdictin(s) where the research is cnducted. When there are any cnflicts between legal requirements, the Office f Legal Cunsel will determine the apprpriate reslutin. Chairpersns f the IRB The Vice Dean fr Science, in crdinatin with the IO and the IRB Directr, will appint a Chair and Vice Chair f each IRB t serve fr renewable three-year terms. Any change in appintment, including reappintment r remval, requires written ntificatin. The IRB Chairs shuld be highly respected individuals at NYU SM wh are fully capable f managing the IRB and the matters brught befre it with fairness and impartiality. Mrever, the IRB Chairs must endeavr t be immune t pressure frm the institutin's administratin, the investigatrs whse prtcls are brught befre him/ her, and ther prfessinal and nnprfessinal surces. The IRB Chairs are respnsible fr cnducting cnvened IRB meetings. The IRB Chairs may designate ther IRB members (including but nt limited t the Vice Chair r IRB Directr) t perfrm duties, as apprpriate, fr review, signature authrity, and ther functins f the IRB Chairs. The IRB Chairs will advise the IO and the IRB Directr abut IRB member perfrmance and cmpetence. Vice Chairs f the IRB A Vice Chair serves as the Chair f the IRB in the absence f the Chair, and maintains the same qualificatins, authrity, and duties as the IRB Chair. Subcmmittees f the IRB The IRB Chairs, in crdinatin with the IRB Directr, may establish subcmmittees cnsisting f ne r mre IRB members. Duties f a subcmmittee may include the fllwing: Serve as designees by an IRB Chair fr the expedited review f new r cntinuing prtcls, and/ r mdificatins f cntinuing prtcls. The subcmmittee must be experienced (in terms f senirity n the IRB), and must be matched as clsely as pssible with their field f expertise t the study. Review and apprve revisins f prtcls previusly given prvisinal apprval ( Cnditinal Apprval ) by the cnvened IRB. Cnduct an inquiry int allegatins f nn-cmpliance. The subcmmittee is given a charge by the IRB, which can include any r all f the fllwing: review f prtcl(s) in questin review f FDA audit reprt f the investigatr, if apprpriate IRB plicies and prcedures irb-inf@nyumc.rg page 18 f 143

19 NYU SM IRB HRPP Plicies & Prcedures fr Human Subjects Research Prtectin review f any relevant dcumentatin, including, inter alia, cnsent dcuments, case reprt frms, and a subject's investigatinal and/ r medical files, as the dcumentatin relates t the investigatr's executin f her/ his study invlving human subjects interview f apprpriate persnnel if necessary preparatin f either a written r ral reprt f the findings, which is presented t the full IRB at its next meeting recmmend actins if apprpriate Cnduct n-site review. Determinatin f the review interval and the need fr additinal supervisin and/ r participatin is made by the IRB n a prtcl-by-prtcl basis. Fr example, an n-site review by an IRB subcmmittee might ccur in a particularly risky research study, r apprval might be subject t an audit f study perfrmance where an investigatr recently had a prtcl suspended by the IRB due t regulatry cncerns. The Principal Investigatr The Principal Investigatr is the ultimate prtectr f the human subjects wh participate in research, and is ultimately respnsible fr all research cnducted under his/her versight. The Principal Investigatr is expected t abide by the highest ethical standards and fr develping a prtcl that incrprates the principles f the Belmnt Reprt. He/she is expected t cnduct research in accrdance with the apprved research prtcl and t versee all aspects f the research by prviding apprpriate training and supervisin f study staff, including but nt limited t versight f the infrmed cnsent prcess. All subjects must give infrmed cnsent and the Principal Investigatr must establish and maintain an pen line f cmmunicatin with all research subjects within his/her respnsibility. In additin t cmplying with all the plicies and standards f the gverning regulatry bdies, the Principal Investigatr must cmply with institutinal and administrative requirements, including but nt limited t that f the IRB, fr cnducting research. The Principal Investigatr is respnsible fr ensuring that all research staff cmpletes apprpriate training and must btain all required apprvals prir t initiating research. When investigatinal drugs r devices are used, the Principal Investigatr is respnsible fr prviding written prcedures fr their strage, security, dispensing and dispsal. The Principal Investigatr must be qualified, licensed and credentialed fr all aspects f the research under his versight, r therwise delegate such respnsibilities t a member f the study team with the requisite qualificatins, licenses r credentials. The IRB shall require a licensed physician t be n the study team fr any human subjects research requiring an interventin. Department Chairs Department chairs are respnsible fr ensuring that the Principal Investigatr (PI) is qualified by training and experience t cnduct the prpsed research. In additin, department chairs are respnsible fr ensuring that the Principal Investigatr has sufficient resurces and facilities t cnduct the prpsed research. Fr each prtcl submitted t the IRB fr apprval, the department chair must certify that s/he accepts respnsibility fr assuring adherence t the federal and state regulatins and institutinal plicies gverning the prtectin f human subjects f research, including applicable institutinal credentialing requirements. Department chairs are required t review all prpsals befre they are submitted t the IRB fr review. The signature f the Department chair indicates that the study is fund t be scientifically sund, can reasnably be expected t answer the prpsed questin, and that the department will cmmit resurces required t cnduct the research in a way that will prtect the right and welfare f participants. Such resurces include but are nt necessarily limited t persnnel, space, equipment and time. IRB plicies and prcedures irb-inf@nyumc.rg page 19 f 143