Institutional Review Board Standard Operating Procedures

Transcription

1 Institutinal Review Bard Standard Operating Prcedures 1

2 1. Nature and Purpse f the IRB Regis University maintains a Research Prtectins Prgram under the versight f its Institutinal Official, the Assciate Prvst. The Institutinal Official cnvenes a Research Prtectins Cmmittee (RPC) that cnsists f the apprpriate fficers respnsible fr the safe and ethical cnduct f research at Regis University. This list includes, but may nt be limited t the Institutinal Animal Care and Use Cmmittee (IACUC) chair, the Institutinal Bisafety Cmmittee (IBC) chair, and the Institutinal Review Bard (IRB) chair, University Legal Cunsel, and University fficials wh have fficial versight f Envirnmental Health and Safety, risk management, and insurance. The Institutinal Official, in cnsultatin with the RPC, is respnsible fr maintaining the Institutin s assurances, reviewing the cmpliance cmmittees, and respnding t adverse events. The IRB is recgnized as a faculty gverned cmmittee perating in accrdance with this larger prgram, wh shares specific respnsibility fr the ethical and safe cnduct f research n human subjects within the brader prgram f prtectins verseen by the Institutinal Official. Regis University certifies thrugh a Federalwide Assurance that it cmplies with the rules and regulatins set frth by the Office fr Human Research Prtectins (OHRP) in the US Department f Health and Human Services regarding the cnduct f research. As a part f this assurance Regis affirms t maintain an Institutinal Review Bard (IRB), charged with the review f human subject research cnducted by the University and/r its members. In accrdance with ur University missin the University has elected t ensure prjects nt funded by the US HHS are als subject t review by the IRB, except fr where it is deemed t fall utside f the scpe f the cmmittee per its bylaws. Supprted by institutinal plicies and written prcedures, the IRB ensures that the rights and welfare f human research subjects are verseen and prtected unifrmly, regardless f persnnel changes. The IRB is guided primarily by the Cde f Federal Regulatins Title 45 part 46 (45 CFR 46), a unifrm set f regulatins infrmally knwn as the Cmmn Rule. 45 CFR 46 cntains the majrity f regulatins useful t guiding the IRB in making the mst apprpriate decisins regarding the prtectin f human subjects. In additin t the Cmmn Rule it is als expected that the IRB will be familiar with and sensitive t the regulatins utlined in The Health Insurance Prtability and Accuntability Act f 1996 (HIPAA) and the Family Educatinal Rights and Privacy Act (FERPA), alng with ther laws and regulatins applicable t specific prjects. 2. Membership and Appintment 2.1. Cmpsitin f the Bard The IRB at Regis University is cmpsed f 13 members representing the fllwing cnstituencies: One Chair drawn frm the Regis University IRB Bard f the University Tw faculty members representing each f Regis five clleges; a Chair persn and Vice-Chairpersn will be selected frm amng these members One member f the Daytn Memrial Library One nnaffiliated cmmunity member Ttal representatin n the Regis University will be 13 persns. 2

3 All Regis University IRB members will take respnsibility fr advising faculty, faculty advisrs n hw t navigate the IRB with respect t research activities that will prvide new knwledge and result in a brad disseminatin pprtunity The Regis University IRB must ensure that at least ne member n the Bard can be defined as a scientist and at least ne ther member n the Bard can be defined as a nn-scientist accrding the OHRP definitin: Scientist/Nnscientist - Members whse training, backgrund, and ccupatin wuld incline them t view scientific activities frm the standpint f smene within a behaviral r bimedical research discipline shuld be cnsidered a scientist, while members whse training, backgrund, and ccupatin wuld incline them t view research activities frm a standpint utside f any bimedical r behaviral scientific discipline shuld be cnsidered a nnscientist (Attachment B: Recmmendatin n IRB Membership and Definitin f Nn-scientist under 45 CFR 46 and 21 CFR 56) Appintment f Members IRB Bard Members IRB members are appinted by the Institutinal Official in cnsultatin with the Prvst fllwing the rules set ut in these Standard Operating Prcedures (especially sectin 3.1) and in reference t federal cde. Ranked faculty appintments are made based n dean recmmendatins in accrdance with established prcesses specific t each Cllege and the Library. These units are best suited t vet the qualificatins f ptential IRB members and cnfirm their ability t serve effectively n the cmmittee. The cmmunity member will be recmmended t the Institutinal Official by the IRB Chair and the University Cmpliance Crdinatr. Members must be qualified thrugh their experience and expertise t cmment knwledgably n and make recmmendatins regarding research n human subjects. As a bdy, the IRB must include diverse membership and members with a brad a base f backgrunds t ensure that diverse viewpints are cnsidered with respect t the rights and welfare f human subjects. Outside expertise may be cnsulted if IRB members d nt have the requisite expertise IRB Vice-Chair At the electin f a new IRB Chair all sitting bard members are invited t nminate (f selfnminate) a sitting faculty member frm the Regis University cmmunity t be Vice-Chair. Nminatins r self-nminatins fr the rle f vice chair must made in writing t the Institutinal Official by Octber 15 th. Only current IRB members will be eligible fr the rle f vice chair IRB Chair The IRB Chair will be appinted by the Institutinal Official after having served at least ne year s term as Vice Chair satisfactrily Term f Service IRB Bard Member Term Length All IRB members will serve tw-year terms. Terms begin n September 1 f the first year and end n August 31 f the secnd year. These terms are renewable s lng as ding s cmplies with established University plicies and prcesses within individual clleges and the Daytn Memrial Library. The tw members frm each cllege have terms expiring in 3

4 alternating years. In the event f member turnver, replacement members will serve ut the term f the member whm they replace. Members terms expire as scheduled regardless f sabbatical r ther University-apprved leaves. Units may pt t prvide temprary replacements fr IRB members n University-apprved sabbaticals r lng-term leave. Temprary replacement members must als meet the University s established CITI requirements fr IRB members IRB Chair Term Length The IRB Chair serves a 2 year term and is appinted after serving fr at least ne year as Vice- Chair IRB Vice-Chair Term Length The IRB Vice-Chair serves a 2 year term, at the end f which time they are invited t becme IRB Chair Recusal and Remval frm Service Members may resign frm the Bard at any time. A replacement member will be appinted fllwing the apprpriate prcesses designated abve. Members may als be remved frm IRB by the Institutinal Official based n recmmendatin frm the IRB Chair fr failure t perfrm, failure t cmplete required training, cnflict f interest r breech f ethics. 3. Expectatins f IRB Members 3.1. Training and Certificatin It will be generally expected that IRB members remain current n all aspects related t the safe and ethical cnduct f human subject research CITI Certificatin All IRB members are required t cmplete the Cllabrative Institutinal Training Initiative (CITI) mdules fr scial-behaviral and bimedical research befre they may vte n r participate in prtcl review. CITI certificatin entails apprximately 15 t 20 hurs f nline educatin and tests. CITI certificatin is cnsidered valid fr three years at which pint CITI refresher curses must be satisfactrily cmpleted. Members will nt be issued fficial appintment letters until satisfactry cmpletin f required CITI mdules is verified General Duties The scpe f the IRB is limited t that described in 45 CFR 46, namely reviewing prtcls entailing frmal human subjects research with the explicit purpse f ensuring that n harm r unnecessary risk is brn by its participants. The task f making the IRB a respected part f the institutinal cmmunity will fall primarily n the shulders f the IRB members. IRB members must maintain the IRB s reputatin fr being fair and impartial, immune frm pressure either by the institutin s administratin, the Investigatrs whse prtcls are brught befre it, r ther prfessinal and nnprfessinal surces. Members are accessible t the University cmmunity fr cnsultatin, and are practive regarding training and cmmunicatin effrts Expertise and Cmmentary 4

5 All members f the IRB are expected t prvide guidance, expertise, and advice regarding the ptential risks and impacts f prpsed research prjects. It is expected that members will d their best t limit their advice t areas f prpsals within their wn general expertise. Thus, a scientific member will refrain frm prviding extensive cmmentary n nn-science merits f prpsals, while nn-scientific members ught t refrain frm cmmenting extensively n the scientific merits f prpsals. The Cmmunity Member is expected t prvide input regarding their knwledge abut the lcal cmmunity and be willing t discuss issues and research frm that perspective. The cmmunity member is expected t participate in full-bard reviews and may be assigned a limited number f ther reviews. If any member feels additinal specific expertise is required t ensure a thughtful review r decisin, they are expected t frmally declare such needs t the Chair, prir t a full bard review, s that additinal experts can be brught it withut disrupting the timeline f the review prcess Specific Duties f IRB Members Full Bard Review and Mnthly Meeting The IRB is scheduled t meet nce a mnth as a full bard during the academic year (fall and spring semesters). Members are expected t actively participate in these meetings in persn r via phne unless they are n sabbatical. Meetings will be scheduled as needed during the summer semester t address prtcls requiring full bard review. Members are expected t have read and analyzed necessary dcuments prir t meetings. During meetings members are expected t participate in discussin in a respectful and knwledgeable manner. All IRB members are expected t actively participate in IRB meetings, IRB reviews as assigned, and peridic IRB training as needed. Ad hc meetings may be called at the discretin f the chair r vice-chair Cllege Representatin IRB members are expected t serve as pints f cntact fr faculty and students engaged in human subject research within their respective units. Members prvide advice fr researchers r review services fr research prjects invlving human subjects (45CFR46.101(b) exempt categries). Thrugh practive training and cmmunicatin, members are als respnsible fr ensuring a general level f cnversancy regarding the purpse f the IRB and the definitin f human subject research within their respective units Reviews In additin t participating in full bard reviews, IRB members will peridically be tasked with cnducting exempt and expedited reviews as defined in sectin Reprting Adverse Events Members are expected t reprt adverse events t the IRB Chair within 24 hurs f learning abut them. The Chair will then infrm the Administrative Institutinal Officer in the Prvst s Office f Regis University. The HHS regulatins at 45 CFR part 46 d nt define r use the term adverse event, nr is there a cmmn definitin f this term acrss gvernment and nn-gvernment entities. In this guidance dcument, the term adverse event in general is used very bradly and includes any event meeting the fllwing definitin: 5

6 Any untward r unfavrable medical ccurrence in a human subject, including any abnrmal sign (fr example, abnrmal physical exam r labratry finding), symptm, r disease, temprally assciated with the subject s participatin in the research, whether r nt cnsidered related t the subject s participatin in the research (mdified frm the definitin f adverse events in the 1996 Internatinal Cnference n Harmnizatin E-6 Guidelines fr Gd Clinical Practice).Adverse events encmpass bth physical and psychlgical harms. They ccur mst cmmnly in the cntext f bimedical research, althugh n ccasin, they can ccur in the cntext f scial and behaviral research. In the cntext f multicenter clinical trials, adverse events can be characterized as either internal adverse events r external adverse events. Frm the perspective f ne particular institutin engaged in a multicenter clinical trial, internal adverse events are thse adverse events experienced by subjects enrlled by the investigatr(s) at that institutin, whereas external adverse events are thse adverse events experienced by subjects enrlled by investigatrs at ther institutins engaged in the clinical trial. In the cntext f a single-center clinical trial, all adverse events wuld be cnsidered internal adverse events. In the case f an internal adverse event at a particular institutin, an investigatr at that institutin typically becmes aware f the event directly frm the subject, anther cllabrating investigatr at the same institutin, r the subject s healthcare prvider. In the case f external adverse events, the investigatrs at all participating institutins learn f such events via reprts that are distributed by the spnsr r crdinating center f the multicenter clinical trials. At many institutins, reprts f external adverse events represent the majrity f adverse event reprts currently being submitted by investigatrs t IRBs Duties f IRB Chair and Vice-Chair Chair full bard reviews The IRB chair is expected t facilitate and cnduct the business f the full bard. It is als the duty f the IRB chair t review any minutes taken during the meeting and t slicit feedback frm the members. The IRB Chair and IRB Vice-Chair will require members wh may have a cnflict f interest t leave the rm during deliberatin and vting. The IRB Chair acts as a tie-breaking vte if necessary. The Chair establishes meeting agendas in cnsultatin with the Vice Chair and University Cmpliance Crdinatr. The IRB Vice-Chair perfrms Chair duties in the absence f the Chair Adverse Events IRB Chair is respnsible fr ntifying the I/O immediately when a serius adverse event ccurs. Serius adverse events are defined by OHRP as any event that: Results in death; is life-threatening (places the subject at immediate risk f death frm the event as it ccurred); Results in inpatient hspitalizatin r prlngatin f existing hspitalizatin; Results in a persistent r significant disability/incapacity; Results in a cngenital anmaly/birth defect; r based upn apprpriate medical judgment, may jepardize the subject s health and may require medical r surgical interventin t prevent ne f the ther utcmes listed in this definitin. (OHRP Guidance n UPs and AEs, Jan. 15, 2007) 6

7 The IRB Chair and Vice-Chair may review adverse events which are nt serius in nature and recmmend apprpriate sanctins t the Institutinal Official, wh will cnvene the Research Prtectin Cmmittee fr review, discussin, mdificatin, and/r apprval f recmmended sanctins Representatin n Research Prtectins Cmmittee The IRB Chair represents the IRB n the Research Prtectin Cmmittee, which versees all research activities at Regis University. Cmmittee fr review, discussin, mdificatin, and/r apprval f recmmended sanctins Perfrmance Review and Evaluatin f Members The IRB Chair, in cnsultatin with the IRB Vice-Chair, reviews and evaluates the attendance, preparatin, perfrmance and cntributins f IRB members at least annually, and as cncerns merit. The chair and vice chair meet with the Institutinal Official in May f each year (r as situatins merit) t share these findings Cnfidentiality All IRB members are expected t maintain cnfidentiality with respect t IRB discussins and reviews. 4. IRB Practices and Prcedures 4.1. Full Bard Review One time per mnth the full bard will be scheduled t meet in rder t discuss prpsed prtcls requiring full bard review. The fllwing categries f research require Cmmittee review: 1. Studies fr which the level f risk is determined by the IRB Chair t be greater than minimal. 2. All spnsred and nn-spnsred-driven Clinical Trials (investigatinal drug r device) subject t FDA regulatins. 3. Studies that invlve the intentinal deceptin f subjects, such that misleading r untruthful infrmatin will be prvided t participants. 4. Studies that invlve sensitive, vulnerable, r prtected ppulatins (such as children, elderly, prisners, r cgnitively disabled individuals). 5. Studies that plan t use prcedures that are persnally intrusive, stressful, r ptentially traumatic (stress can be physical, psychlgical, scial, financial r legal). Any prpsed research nt qualifying fr Exempt status r Expedited review requires a Full Review, in which a majrity f IRB members review and vte n the prpsal. These typically invlve prjects that place human subjects at mre than minimal risk, r that invlve sensitive tpics r vulnerable ppulatins such as prisners, terminally ill patients, children, veterans, cgnitively impaired persns, r ecnmically disadvantaged persns. The meeting is run by the IRB chair, wh establishes an agenda, and ensures relevant materials are circulated t the bard in advance. Full-bard reviews will be assigned a lead reviewer by the IRB Chair and/r Vice-Chair and discussed during the scheduled mnthly meeting. In many cases, the Chair r Vice-Chair will 7

8 assume the rle as the lead reviewer fr full-bard studies. All IRB members are expected t review full-bard prtcls and prvide apprpriate feedback befre and during the IRB meeting. Vtes taken during a full bard meeting are cnsidered binding, if qurum is present, and will be recrded in the minutes Qurum A qurum is attained when six members are present, f which at least ne member has scientific expertise and anther has nn-scientific expertise. This definitin f a qurum meets the federal definitin f a qurum, and exceeds it by ne member. The IRB may review prtcls if a qurum is nt present. The IRB may nt vte withut a qurum present. Presence may be defined as physical presence in a meeting r full participatin via phne r virtual attendance. des nt cnstitute presence. The University Cmpliance Crdinatr is respnsible fr mnitring qurum, and ntifying the chair if qurum is lst due t member recusal fr any reasn. The chair must then suspend vting activity until qurum is re-established (45 CFR Part 46 Sec. 108 (b)) Exempt and Expedited Reviews Exempt Frm Review Research may be exempt frm review when human participants cnfrm t ne f the categries frm sectin (b) f 45 CFR 46 that suggest the activities will invlve minimal r n risk. Prjects will nt be given Exempt status if they include any degree f deceptin, invlve mre than very minimal risk t participants, invlve sensitive infrmatin, r include prtected classes r vulnerable ppulatins. Please nte that researchers must always engage in practices that ensure privacy and that minimize the risks t participants, regardless f the level f review. All f the rights and prtectins affrded t human subjects in research are required in Exempt status cases. Exempt Reviews invlve a member f the IRB bard certifying that the prtcl is indeed exempt frm further discussin by the bard. Prtcls suitable fr an exemptin will be assigned t a bard member in gd standing fr review by the IRB chair utside f the mnthly IRB meeting Expedited Review A prpsal that des nt fulfill the criteria fr Exempt status may underg an Expedited review if it invlves n mre than minimal risk t the participants and meets ther standards, such as nt including prtected classes r vulnerable ppulatins, and nt using intentinal deceptin. Expedited review may als be used when minr changes are prpsed t an apprved research prject during the perid fr which apprval is authrized. Prtcls suitable fr an exemptin will be assigned t a bard member in gd standing fr review by the IRB chair utside f the mnthly IRB meeting Cntinuatins and Extensin Requests Unless there are cncerns with the study, prtcl cntinuatin/extensin requests will be reviewed by the University Cmpliance Crdinatr wh is authrized t extend the date. Items cncern will be referred t the IRB Chair. 8

9 Prtcl mdificatins will als be initially screened by the University Cmpliance Crdinatr. If there are n significant changes t the study (e.g., additin f new persnnel), the mdificatin can be reviewed and apprved by the University Cmpliance Crdinatr. Studies which have significant alteratins may receive additinal IRB review which can ptentially include a full-bard review even if full-bard review was nt initially cnducted. Study clsures will als be reviewed fr adverse r unexpected results by the University Cmpliance Crdinatr. In cases with unexpected r adverse results, the University Cmpliance Crdinatr will refer thse studies t the IRB Chair and Vice-Chair, and will immediately ntify the Institutinal Official. OHRP defines unexpected adverse event as fllws: Any adverse event ccurring in ne r mre subjects participating in a research prtcl, the nature, severity, r frequency f which is nt cnsistent with either: 1. the knwn r freseeable risk f adverse events assciated with the prcedures invlved in the research that are described in (a) the prtcl-related dcuments, such as the IRB-apprved research prtcl, any applicable investigatr brchure, and the current IRB-apprved infrmed cnsent dcument, and (b) ther relevant surces f infrmatin, such as prduct labeling and package inserts; r 2. the expected natural prgressin f any underlying disease, disrder, r cnditin f the subject(s) experiencing the adverse event and the subject s predispsing risk factr prfile fr the adverse event. (Mdified frm the definitin f unexpected adverse drug experience in FDA regulatins at 21 CFR (a).) 4.4. Annual Reprt The IRB shall submit an annual reprt t the Institutinal Official regarding its activities fr the year and anticipated areas f cncern. The Institutinal Official shall make the final reprt available t the Research Prtectin Cmmittee and ther parties as apprpriate 4.5. Changes t IRB Operating Prcedures Members will be instructed in the general perating prcedures f the IRB fllwing their frmal appintment. These prcedures can als be fund in instructinal dcuments maintained by the Center fr Schlarship and Research Engagement. If members desire a change be made t any f the standard perating prcedures, frms, and systems emplyed by the IRB, they may recmmend them t the Chair and Vice Chair. The Chair and Vice Chair will then assess the utility and benefit f such request and may bring recmmendatins t the IRB fr a vte n implementatin int practice. 5. Administrative Supprt The Center fr Schlarship and Research Engagement (CSRE) prvides administrative supprt fr the Human Research Prtectin Prgram and the IRB. The primary pint f cntact fr all administrative supprt is the University Cmpliance Crdinatr Screening prtcls fr applicability t IRB review The University Cmpliance Crdinatr is authrized t cnduct a limited pre-screening f all prtcls t check fr apprpriate CITI certificatin, any required faculty advisr apprval, incmplete frms, and whether the prject adheres t the federal definitin f human subject research. 9

10 Persns requesting a decisin regarding whether research r schlarly activity is subject t the University s Human Research Prtectin Prgram, and thus requires IRB apprval, must cnsult with the University Cmpliance Crdinatr. Decisins will be made in cnsultatin with the IRB Chair based n the fllwing factrs: (1) whether r nt the activity invlves human subjects, (2) whether the activity meets OHRP s definitin f research and (3) the degree t which Regis University persnnel, designees r students will be engaged in the research activity. The University Cmpliance Crdinatr r the IRB will respnd t written requests with a written determinatin. All crrespndence and a cpy f the determinatin ntificatin will be kept n file. CSRE, acting fr the IRB, shall maintain minutes f all meetings and shall recrd their findings and recmmendatins as part f these minutes. The University Cmpliance Crdinatr must maintain valid CITI certificatin and is expected t cmplete the same CITI curses as ther IRB members. 6. Prcedures fr Review, Revisin and Apprval f these Standard Operating Prcedures (SOP) These SOP and all plicies, prcesses, and prcedures described herein (hereafter SOP ) will be reviewed n less than three years frm the date f apprval as described in this plicy. Reviews may als ccur as needed in rder t maintain cmpliance with federal regulatins and Regis University plicies and prcedures, r as requested by the IRB Chair r Institutinal Official. The review date is determined as three years frm the last date f apprval by the Regis University Research Prtectin Cmmittee, which shall nt ccur withut prir review and apprval by the Institutinal Official and Prvst The IRB Chair must ensure that current IRB members have pprtunity t review and cmment any time IRB bylaws are reviewed. The review and apprval f these bylaws is dcumented by the University s Cmpliance Crdinatr, wh recrds the plicy and prcedure, the date apprved (e.g. mm/dd/yyyy and the member(s) respnsible fr apprval). In all cases, the effective date f bylaw revisins is the same as the date f RPC apprval. Any changes t the bylaws will be filed by the University Cmpliance Crdinatr and circulated t all current members. 7. Health Insurance Prtability and Accuntability Act (HIPAA) 1996 All IRB Members and Staff must cmply with the HIPAA regulatins f cnfidentiality. The HIPAA privacy rule prtects individually identifiable health infrmatin frm disclsure withut authrizatin unless there are special circumstances, accrding t HHS. Patients als have the right t access their medical recrds fr a small fee pursuant t the privacy rule. The HIPAA security rule sets natinwide standards fr cvered entities t prtect individually identifiable health infrmatin frm disclsure and was enacted in light f medical field's shift t string medical recrds electrnically, explains HHS. HIPAA requires cvered entities t ntify affected individuals when their health infrmatin has been disclsed withut authrizatin, ntes HHS. Cvered entities must als ntify the secretary f HHS f any breaches f patient health infrmatin. If the privacy breach affects mre than 500 individuals, the cvered entity must ntify the media. 10

11 The Office f Civil Rights fr HHS enfrces HIPAA and is respnsible fr investigating cmplaints. Fines fr HIPAA vilatins range frm $100 t $50,000 per vilatin, up t $1.5 millin fr vilatins f a single prvisin, accrding t TrueVault. The U.S. Department f Justice may seek criminal penalties fr egregius vilatins. HIPPA Website: 8. Family Educatinal Rights and Privacy Act (FERPA) All IRB Members and Staff must cmply with the FERPA regulatins f cnfidentiality. The Family Educatinal Rights and Privacy Act (FERPA) (20 U.S.C. 1232g; 34 CFR Part 99) is a Federal law that prtects the privacy f student educatin recrds. The law applies t all schls that receive funds under an applicable prgram f the U.S. Department f Educatin. FERPA gives parents certain rights with respect t their children's educatin recrds. These rights transfer t the student when he r she reaches the age f 18 r attends a schl beynd the high schl level. Students t whm the rights have transferred are "eligible students." Parents r eligible students have the right t inspect and review the student's educatin recrds maintained by the schl. Schls are nt required t prvide cpies f recrds unless, fr reasns such as great distance, it is impssible fr parents r eligible students t review the recrds. Schls may charge a fee fr cpies. Parents r eligible students have the right t request that a schl crrect recrds which they believe t be inaccurate r misleading. If the schl decides nt t amend the recrd, the parent r eligible student then has the right t a frmal hearing. After the hearing, if the schl still decides nt t amend the recrd, the parent r eligible student has the right t place a statement with the recrd setting frth his r her view abut the cntested infrmatin. Generally, schls must have written permissin frm the parent r eligible student in rder t release any infrmatin frm a student's educatin recrd. Hwever, FERPA allws schls t disclse thse recrds, withut cnsent, t the fllwing parties r under the fllwing cnditins (34 CFR 99.31): Schl fficials with legitimate educatinal interest; Other schls t which a student is transferring; Specified fficials fr audit r evaluatin purpses; Apprpriate parties in cnnectin with financial aid t a student; Organizatins cnducting certain studies fr r n behalf f the schl; Accrediting rganizatins; T cmply with a judicial rder r lawfully issued subpena; Apprpriate fficials in cases f health and safety emergencies; and State and lcal authrities, within a juvenile justice system, pursuant t specific State law. Schls may disclse, withut cnsent, "directry" infrmatin such as a student's name, address, telephne number, date and place f birth, hnrs and awards, and dates f 11

12 attendance. Hwever, schls must tell parents and eligible students abut directry infrmatin and allw parents and eligible students a reasnable amunt f time t request that the schl nt disclse directry infrmatin abut them. Schls must ntify parents and eligible students annually f their rights under FERPA. The actual means f ntificatin (special letter, inclusin in a PTA bulletin, student handbk, r newspaper article) is left t the discretin f each schl. FERPA Website: Ratified by the Regis University Institutinal Review Bard (IRB) n March 12, Vincent C. Wincelwicz, IRB Chair 12