RSRB GUIDANCE ON RECRUITMENT AND INFORMED CONSENT

Transcription

1 RSRB GUIDANCE ON RECRUITMENT AND INFORMED CONSENT TABLE OF CONTENTS Recruitment f Human Research Subjects thrugh Advertising Direct Advertising Advertising ver the Internet Access t Subjects Recruiting Subjects frm Other Institutins Recruiter/Receptinist Scripts & Screening Lgs Recruitment and Future Cntact Databases RSRB Watermarked Recruitment Dcuments Infrmed Cnsent Elements f Cnsent Cnsent Issues in Research Invlving Minrs Waiver f Parental Permissin Cnsent Issues in Adult Subjects with Decisinal Impairment Cnsent t Tissue Banking Cnsent t Genetic Testing & Other Genmic Research Waiver f Cnsent Waiver f Cnsent fr Deceptin Research Waiver f Dcumentatin f Cnsent Cnsent thrugh Oral Presentatin and Shrt Frm Cnsent t Expanded Access r Single Patient Use Emergency Use f Unapprved Drugs and Medical Devices Drafting the Infrmed Cnsent Dcument Initial RSRB Review f Cnsent Dcuments The Infrmed Cnsent Prcess RSRB Expectatins Onging Cnsent Issues after RSRB Apprval Strage f Signed Infrmed Cnsent Dcuments Amending Cnsent Dcuments Onging RSRB Review f Cnsent Dcuments Errrs in Obtaining & Dcumenting Infrmed Cnsent Re-cnsent f Subjects Preventative Actin Measures Appendices Appendix 1: Cnsent Dcument Sample Language Appendix 2: Frequently Asked Questins Appendix 3: Additinal Resurces Page 1 f 37

2 Recruitment f Human Research Subjects Recruitment f ptential research subjects is cnsidered the first step f the infrmed cnsent prcess. As such, each applicatin submitted t the RSRB must include a recruitment plan. The plan shuld address hw subjects will be identified, hw the study team will apprach ptential subjects and hw the recruitment material (if any) will be utilized. Alternately, if the study des nt invlve direct cntact with subjects, a recrds review fr example, the plan shuld address hw subjects will be identified, whether the study team has rutine access t data being reviewed and hw the study team will btain the data if they d nt have rutine access t it. The RSRB will review the plan t ensure that the selectin f subjects is equitable, that it prtects subject privacy and is free f cercin and undue influence. Cercin ccurs when an vert threat f harm is intentinally presented by ne persn t anther in rder t btain cmpliance. Undue influence, by cntrast, ccurs thrugh an ffer f an excessive, unwarranted, inapprpriate r imprper reward r ther verture in rder t btain cmpliance. - The Belmnt Reprt Direct Advertising All direct advertising fr study subjects (i.e., advertising that is intended t be seen r heard by prspective subjects) must be submitted t the RSRB and apprved prir t implementatin. Dcuments that shuld be submitted fr review: websites, web pstings, newspaper, radi and TV advertisements, press releases (that prvide cntact infrmatin), psters, flyers and scripts (phne/ral) that are intended fr prspective subjects. Dcuments that d nt need t be submitted fr review: cmmunicatins intended t be seen r heard nly by health prfessinals, such as "dear dctr" letters and dctrt-dctr letters (even when sliciting fr study subjects), news stries, and publicity intended fr ther audiences, such as financial page advertisements directed tward prspective investrs. The RSRB must review bth the infrmatin cntained in the advertisement, the mde f its cmmunicatin as well as ther visual effects, such as type size. This review is t cnfirm that the prcedures fr recruiting subjects are nt cercive and that the recruitment material des nt state r imply a certainty f favrable utcme r ther benefits beynd what is utlined in the cnsent dcument and the prtcl. This is especially imprtant when a study may invlve subjects wh are likely t be vulnerable t undue influence, fr example, financially cnstrained subjects. Generally, advertisements shuld be limited t the infrmatin the prspective subjects need t determine their eligibility and interest. When apprpriately wrded, the fllwing items may be included in advertisements: The name and address f the investigatr and/r research facility (e.g., University f Rchester) and the persn r ffice t cntact fr further infrmatin The purpse f the research (e.g., the cnditin under study r gal f the prject) The general criteria, in summary frm, that will be used t determine eligibility fr the study (e.g., healthy adults between the ages f x and y) The time r ther cmmitment required f the subjects A brief list f participatin benefits, if any (e.g., a n-cst health assessment). Nte: payments t subjects fr participatin are nt benefits; they are given fr incurred Page 2 f 37

3 expense fr participatin and as an incentive. Advertisements may state that subjects will be paid, but they shuld nt emphasize the payment r the amunt t be paid. Cnsider the fllwing additinal pints in drafting any advertisements: When advertisements are t be recrded fr bradcast the principal investigatr (PI) shuld request an RSRB review and apprval f the wrding f the advertisement (i.e., the script) prir t taping t avid having t re-tape due t inapprpriate wrding. The final audi/vide shuld als be submitted upn cmpletin. Advertisements fr investigatinal drug, bilgic r device studies shuld nt use terms such as new treatment r new medicatin withut explaining that the test article is experimental. Nr shuld they claim, either explicitly r implicitly, that the test article is safe/effective r equivalent/superir t any ther drug, bilgical, device r prcedure. A phrase such as yu will receive new treatments incrrectly implies that all study subjects will receive prducts f prven wrth newly apprved by the FDA. Advertisements shuld nt prmise free medical treatment when the intent is nly t say subjects will nt be charged fr taking part in the investigatin. If an investigatr decides that new r additinal advertising fr subjects are needed after the study has received RSRB apprval r if revisins t the apprved plan/materials are needed, an amendment must be submitted t the RSRB fr review and apprval prir t implementatin. Advertising ver the Internet Accrding t the FDA, RSRB review and apprval f listings f clinical trials n the internet prvide n additinal safeguard and is nt required when the system frmat limits the infrmatin prvided t basic infrmatin, such as: the title; purpse f the study; prtcl summary; basic eligibility criteria; study site lcatin(s); and hw t cntact the site fr further infrmatin. Examples f clinical trial listing services that d nt require prspective RSRB apprval include the Natinal Institute s f Health (NIH) ClinicalTrials.gv and ResearchMatch websites, the Natinal Cancer Institute's cancer clinical trial listing (Physician Data Query [PDQ]), the gvernment-spnsred AIDS Clinical Trials Infrmatin Service (ACTIS) and the University f Rchester s clinical trials listing. (Nte: Althugh RSRB apprval f the language prvided in the listing service may nt be required, as with all recruitment methds, if the listing is intended fr recruitment purpses, the use shuld be indentified in the prtcl/applicatin as such.) When the pprtunity t add additinal descriptive infrmatin is nt precluded by the data base system, RSRB review and apprval is required t assure that any additinal infrmatin des nt prmise r imply a certainty f cure r ther benefit beynd what is cntained in the prtcl and the infrmed cnsent dcument. Similarly, any ther type f recruiting cmpleted via websites, web pstings r the use f scial media shuld be submitted fr RSRB review and apprval. Access t Subjects Privacy and cnfidentiality prtectin is an additinal cncern that must be cnsidered in develping a recruitment plan and therefre nly investigatrs with rutine access t their prspective subjects (r subject recrds) may recruit these individuals directly ( rutine access meaning the investigatr already has a clinical/academic reasn t knw/review a subject s recrd). While this is particularly imprtant with studies that invlve the use f prtected health infrmatin (PHI), it is equally as imprtant in scial and behaviral research. Examples f recruitment methds that wuld be permitted: A clinician appraches patients under his/her care abut participatin a study in which the clinician is part f the study team. Page 3 f 37

4 A scial wrker wh is nt part f the study team appraches his/her clients abut participatin in a study and, if the client agrees, prvides the study team the client s cntact infrmatin fr fllw up. A prfessr wh is nt part f the study team annunces a new study that is being cmpleted within department during ne f his/her classes. Interested subjects are prvided the study team s cntact infrmatin. A daycare directr wh is nt part f the study team mails IRB apprved letters t parents f children attending the daycare. Included in the letter is the study team s cntact infrmatin fr parents t cntact directly. When principal investigatrs wish t recruit subjects frm ppulatins with which they d nt have rutine access (e.g., the patients f ther physicians r students at a different schl district) t a research study, they may nt cntact these ptential subjects directly (i.e., n cld calls ). The fllwing prcedure is t be used: The PI prvides a written descriptin f the prject t the persn having access and a relatinship (e.g., the treating physician) with ptential subjects, explaining that he/she wuld like t recruit subjects fr research. The persn with access makes the prject descriptin available s that ptential subjects have the pprtunity t cnsider whether r nt they may wish t get mre infrmatin abut participatin. Ptential subjects can chse t cntact the PI either by phne r in writing (e.g., returning a pstcard prvided in a mailing r calling the phne number prvided n an advertisement) t gain further infrmatin and cntinue t cnsider the prject. Recruiting Subjects frm Other Institutins When recruiting subjects frm ther institutins, IRB apprval frm that institutin s IRB is required. If the institutin des nt have an IRB, a letter f cperatin will need t be submitted. Fr example, if students will be recruited thrugh a lcal schl, dcumentatin f the schl district s apprval must be submitted t the RSRB prir t initiating any study activities at the schl. Recruiter/Receptinist Scripts & Screening Lgs The first cntact prspective study subjects make is ften with a recruiter/receptinist wh fllws a script t determine basic eligibility fr the specific study. The investigatr shuld assure the prcedures adequately prtect the rights and welfare f the prspective subjects. In sme cases persnal and sensitive infrmatin is gathered abut the individual. The RSRB shuld have assurance that the infrmatin gathered during recruitment will be apprpriately handled. A simple statement such as "cnfidentiality will be maintained" des nt adequately infrm the RSRB f the prcedures that will be used t prtect cnfidentiality. The acceptability f the prcedures wuld depend n the sensitivity f the data gathered, including persnal, medical and financial infrmatin. Examples f issues fr RSRB review: What happens t persnal infrmatin if the caller ends the interview, declines participatin, is fund t be ineligible r simply hangs up? Are names f nneligible subjects maintained in case they wuld qualify fr anther study? Are paper cpies f recrds shredded? If an utside recruitment cmpany is being utilized, will the infrmatin gathered be used fr ther purpses r sld t thers? Similarly, these same issues must be taken int cnsideratin when screening lgs will be utilized. Generally, this infrmatin shuld be cllected in a de-identified frmat (e.g., nting that ptential subject 1 declined due t the time cmmitment t participate r that subject 2 was nt eligible because their bdy mass index was t high). If the infrmatin being cllected n the screening lg is identifiable (e.g., a name r a date f service will be cllected), additinal Page 4 f 37

5 prtectins must be put in place. A limited data set and data use agreement r waiver f HIPAA authrizatin fr these subjects may need t be included with the RSRB applicatin. Recruitment and Future Cntact Databases Under University plicy, databases established slely fr research purpses require RSRB review and apprval. Therefre separate apprval fr the creatin f any recruitment r future cntact databases may be required. Required: Subject cntact infrmatin will be cllected and pled with ther study subjects participating in ther studies fr future cntact. The database may include subjects wh have participated in previus/current research studies as well as individuals wh have nt yet participated in research but wuld like t in the future. (Fr example, multiple studies enrlling subjects with a specific disease are prvided future cntact ptins in each individual study s cnsent frm. All subjects that prvide permissin are entered int ne cmmn database.) Nt required: Subject cntact infrmatin will be cllected fr use in a single study r sub-study within the same RSRB applicatin. (Fr example, subjects enrlling in ne study are prvided future cntact ptins at the end f the study s cnsent frm fr the purpses f lng term fllw-up and ptential enrllment in related sub-studies. All subjects that prvide permissin are entered int ne database specific t that ne study.) Prtcls fr any recruitment/future cntact shuld address hw the database will be used, what infrmatin will be maintained in the database, wh cntrls the database and wh has access t the database. Please cntact yur RSRB specialist fr mre infrmatin. Any study that will use a recruitment/future cntact database fr the purpses f identifying ptential subjects will need t describe the database in their submissin and prvide an explanatin f hw the database will be used. Depending n the nature f the database, yu may need t verify that an investigatr has access (is listed as study persnnel) n the database (e.g., with department r disease specific databases apprved within the institutin). Other databases such as SONA r Mechanical Turk where users register and chse what studies t participate in dn t necessarily require such access permissin but still need t be indentified as a recruitment tl in the submissin. Please cntact yur RSRB specialist fr mre infrmatin. RSRB Watermarked Recruitment Dcuments Upn apprval, the RSRB expects that nly RSRB watermarked recruitment dcuments will be used. Only the mst recently apprved versin f the recruitment dcument shuld be used and, when applicable, they must be printed n department letterhead. Exceptins t this may be permissible under certain circumstances (fr example, if a frm letter has been apprved and it is nt pssible t enter persnalized names/addresses n the watermarked versin). Please cntact yur RSRB specialist if these circumstances arise. Infrmed Cnsent Infrmed cnsent is a basic ethical bligatin fr researchers and is required by federal regulatin. Infrmed cnsent is nt a frm. It is a prcess f infrmatin exchange that takes place between the prspective/enrlled subject and the investigatr, befre, during and smetimes after the research interventin r interactin. Thus, the infrmed cnsent prcess is nt a single event, but cntinues as the study prgresses. Subjects shuld feel free t ask questins at any time. The amunt f infrmatin that needs t be presented bth in writing (i.e., Page 5 f 37

6 the cnsent dcument and related materials) and rally is directly related t the risk that the study presents and the cmplexity f the research prcedures. The manner and cntext in which infrmatin is cnveyed is as imprtant as the infrmatin itself. There must be n cercin r undue influence. Subjects must have sufficient time t decide and shuld be allwed t cnsult with family and/r thers if needed. The purpse f a cnsent frm is t prvide a written surce f infrmatin and a place t dcument that a subject s cnsent has been given befre the start f the study. Cnsent frms must be signed and dated by the subject (r the subject s authrized representative) befre any research prcedures may begin. The frm is imprtant because it serves as a baseline f infrmatin fr initial presentatin, a reference surce during the study, and dcumentatin f vluntary participatin. The cmplete riginal signed cnsent frm is retained in the investigatr s study recrds and a cpy is given t the subject. Cpies may be placed in the subject s recrds (e.g., medical chart r schl recrds) if apprpriate. The study plan/prtcl needs t utline the cnsent prcess. It shuld describe wh will btain cnsent and hw the prcess f infrmed cnsent will prmte thughtful decisin-making by subjects. Steps taken t determine cmprehensin and t minimize undue influence shuld be explained, especially when the study will include vulnerable ppulatins such as children and the terminally ill. If any (r all) subjects will nt be capable f prviding cnsent, the study plan/prtcl needs t describe the prcess used t btain permissin f authrized representatives. If an auditr-witness and/r translatr are t be used, the prtcl shuld explain their functin, identify when they are required as well as wh qualifies t act as an auditr/witness/translatr. Nte that the use f family members as translatrs is generally nt apprpriate because f ethical cncerns abut the accurate relay f infrmatin. The prtcl shuld als explain hw cnsent will be dcumented and hw the frms will be stred. Subjects are cnsidered t be enrlled in a study nce they have given cnsent. In studies where a screening/selectin prcess is needed, it may be necessary t btain a separate cnsent fr the screening in additin t the study cnsent. In either case, the prcess shuld be clearly described in the prtcl. NOTE: Only RSRB-apprved investigatrs, c-investigatrs and sub-investigatrs may btain cnsent. Everyne btaining cnsent at UR must be trained thrugh the HSPP/EPRP prgram and listed n the RSRB applicatin. Elements f Cnsent Althugh each research study invlving human subjects is unique, the federal regulatins and the RSRB require that all cnsent frms cntain the fllwing infrmatin elements: An intrductin, including a statement that the study invlves research An explanatin f the purpse(s) f the research Descriptin f study prcedures (identifying bth standard f care prcedures and any that are experimental) Expected duratin f subject invlvement A descriptin f any reasnably freseeable risks r discmfrts f participatin Benefits f participatin t the subject r thers Apprpriate alternatives r curse f treatment that might be advantageus t the subject (nt applicable if the nly alternative is nn-participatin) UR standard wrding fr cmpensatin fr injury (fr studies invlving greater than minimal risk) Cnfidentiality f Recrds statement (and, if applicable, HIPAA authrizatin) Page 6 f 37

7 FDA-required statement that infrmatin abut the trial has been, r will be, entered int a databank that is publicly accessible at (fr applicable trials nly; t determine if this applies t yur study see: fact-sheet.pdf). Fr questins r help with registratin cntact the CTSI s Office f Regulatry Supprt. Cntact persns (fr questins abut the research, research-related injury and subject rights) Statement that participatin is vluntary Statement that subjects will receive a signed cpy f the cnsent Federal regulatins and/r the RSRB require several ther elements f infrmatin if they apply t the study and are imprtant fr subject t knw. These additinal elements mst ften apply t FDA-regulated studies. Additinal elements include: A statement that the particular treatment r prcedure may invlve risks t the subject that are currently unfreseeable Include fr research invlving investigatinal r marketed drugs r devices fr which txicities are nt well-studied in humans (e.g., phase 1 studies). A statement that, if the participant is r becmes pregnant r fathers a child, the particular treatment r prcedure might invlve risks t the embry r fetus, which are currently unfreseeable Include fr research invlving investigatinal r marketed drugs r devices fr which effects t a fetus are unknwn. Anticipated circumstances under which the subject s participatin may be terminated by the investigatr withut regard t the subject s wishes (e.g., side effects f a study drug are t severe r the spnsr terminates the study) Payments (incentives and/r expense reimbursements if any) Additinal csts t participate (e.g., hspitalizatin, cst f testing r transprtatin t and frm the research site) Cnsequences f withdrawal and prcedures fr withdrawal that prtect the subject s safety Include if any adverse health r welfare effects may be anticipated (e.g., the need t taper a drug treatment), r whether additinal tests may be needed t help ensure the safety f the subject after withdrawal. Remember that the cnsequences f withdrawal are nt intended t cerce the subject int cntinuing t take part. Statement that subjects will be infrmed f new findings that may relate t their willingness t take part (e.g., if findings f a data & safety mnitring bard raise safety cncerns r new txicities develp) Number f subjects (if this pses a risk t privacy, fr example, r t prvide the subject the risk expsure/cntext in which the study takes place) Prbability f randm assignment t placeb r experimental arm (e.g., ne in tw, like flipping a cin; r, ne in fur like drawing numbers frm a hat) Statement f the entity spnsring the study Cnflict f interest statement(s) if applicable (bth investigatr and University) Cnsent Issues in Research Invlving Minrs In all research invlving human subjects, the agreement t participate is an essential prtectin f their rights and welfare. Children, by definitin, cannt give legal cnsent (per New Yrk State, children are thse persns under the age f 18). Therefre, a cmbinatin f assent (agreement) f the child subject and permissin f the parent r legal guardian is generally deemed an adequate substitute. If either the parent refuses permissin r the child subject refuses assent, the child cannt be enrlled. Page 7 f 37

8 As part f the review prcess, the RSRB will determine whether adequate prvisins are made fr sliciting bth the permissin f each child s parent r legal guardian and the assent f the child. In sme cases, the RSRB may find that the permissin f ne parent is sufficient. While this is typically based n the risk level assigned t the study, ther factrs regarding the nature f the study may be cnsidered. In cases where bth parent signatures are required, per federal regulatins, bth parents must give permissin unless ne parent is deceased, unknwn, incmpetent, r nt reasnably available, r when nly ne parent has legal respnsibility fr the care and custdy f the child (45 CFR [b]). Nte that the RSRB des nt cnsider parents wh are unavailable due t scheduling cnflicts t be nt reasnably available. In determining whether children are capable f assenting, the RSRB will take int accunt the ages, maturity and psychlgical state f the children invlved. The judgment may be made fr all children invlved in the research under a particular prtcl, r fr each child, as the RSRB deems apprpriate. Infrmatin must be presented in a language and frmat that is understandable t the child. The child shuld have an understanding f the research prcedures and it shuld be clear that their participatin is vluntary. In lng-term studies where subjects are enrlled as children, but wh will turn 18 while they are actively participating in the study, prvisins must be made fr btaining their cnsent as adults after their 18 th birthdays. NOTE: One f the main gals f assent in studies is t let children knw that they are nt required t take part in the research, even if their parents say it is kay. An exceptin t the assent mechanism can be made if the RSRB determines that either f the fllwing is true: The capability f sme r all f the children is s limited that they cannt reasnably be cnsulted. The interventin r prcedure invlved in the research hlds ut a prspect f direct benefit that is imprtant t the health r well being f the children and is available nly in the cntext f the research (e.g., children with life-threatening illnesses wh are entered int pen-label treatment prtcls). In these cases, the permissin f the parent is sufficient, but the understanding f the child subjects is still desirable. Assent in the sense f agreement is nt sught frm the child subject because if he/she des nt agree, the parent s wishes will prevail. It wuld be disingenuus t ask fr agreement when negative respnses will be ignred. The nn-agreement f the child, especially in lder children (e.g., 17) may be ethically trublesme. The University medical center ffers a Clinical Ethics Cnsultatin Service that may be helpful t subjects, families and staff. It is imprtant t nte that the permissin f caregivers and/r service prviders is nt sufficient t cnduct research with children. Only parents and legal guardians have that authrity and respnsibility. Fr children wh are in fster care r are wards f the state, permissin must be btained frm an individual wh is authrized under state/lcal law t cnsent n the child s behalf. With these cases, it is imprtant t ensure that permissin is being sught frm the apprpriate individual(s) and that dcumentatin f this authrity be maintained with the signed permissin frm. Schl principals, teachers, clinic persnnel, etc., d nt have the authrity t give blanket permissin fr their students/patients/clients t participate in research. In classrm research, it must be made clear that the research is nt part f the regular educatinal prgram and that the student s grades r standing will nt be affected by nt participating. Page 8 f 37

9 Signature requirements fr the child-subject s assent and the parents permissin depend upn the nature f the research. In mst cases, parent permissin shuld be dcumented n a signed permissin frm that fllws the guidelines fr cnsent frms. Fr assent, the federal regulatins d nt specify any specific elements that shuld be included in a frm, nr d they prvide guidance n signatures. Typically, the RSRB requires the use f an assent frm fr adlescents t sign and an assent script fr yunger children t dcument presentatin f the infrmatin and the subject s ral agreement. Refer t the RSRB s Assent Dcument Templates fr suggested elements t include in these frms. Table 1 belw summarizes the University s permissin and assent dcumentatin requirements. Waiver f Parental Permissin The University f Rchester requires the permissin f parents fr research that invlves subjects under the age f 18. There are fur exceptins t this general plicy which may be requested by investigatrs: 1) N-risk r minimal-risk research with lder adlescents (e.g., annymus surveys in high schl students) 2) Purely bservatinal studies (n interventin) f public behavir (e.g., classrm activities) 3) Studies f existing data and 4) Research with subjects under the age f 18 in thse circumstances where New Yrk Law expressly gives children the right t seek certain types f medical treatment withut parental cnsent. Depending n the nature f the study, the RSRB may require that the study team identify a research subject advcate wh is independent frm the study and available fr cnsultatin with research subjects as needed thrughut the curse f the study. NOTE: Except fr studies invlving existing data, waiver f parental permissin must be reviewed and apprved by the Senir Assciate Dean fr Clinical Research, as a cnditin fr RSRB apprval. Table 1: Summary f RSRB Permissin / Assent Guidelines Subject Age Range Dcument Type(s) Ntes 7 and under Parent Permissin N assent script r frm required 8-12 years Parent Permissin + Assent Script Age-apprpriate Oral Permits subject t pt ut if parent(s) pt in Signature f subject nt required (but shuld dcument subject s name) Dcumentatin f persn btaining assent years Parent Permissin + Assent Frm Age-apprpriate Written Permits subject t pt ut if parent(s) pt in Signature f subject and persn btaining assent required Page 9 f 37

10 18 years and lder Cnsent frm When a child reaches 18 while participating in a study, the apprpriate cnsent prcess shuld be cnducted fr the nw adult subject t cnsent t participate in the research fr him/herself. Under 18: RSRB Determines Assent Nt Required Under 18: Waiver f Parental Permissin Parent Permissin Assent Frm N assent script r frm required Understanding f the child subject is still desirable N parent permissin frm required Appintment f advcate may be required ** Nte that the ages ranges prvided abve fr btaining assent frm a child are nly guidelines. The ages, maturity and psychlgical state f the children invlved shuld be taken int cnsideratin when determining whether and hw t btain assent. Cnsent Issues in Adult Subjects with Decisinal Impairment The University has develped a plicy delineating the cnsent prcess fr adult subjects with decisinal incapacity. T review the cmplete plicy, see Appendix 1 f the RSRB Investigatr Guidance. Under this plicy, the RSRB may apprve enrllment int research with permissin given by an authrized representative fr: 1) Research nt invlving greater than minimal risk 2) Research invlving greater than minimal risk, but presenting the prspect f direct benefit t the individual subjects r 3) Research invlving a minr increase ver minimal risk, with n prspect f direct benefit t individual subjects, but may prduce knwledge abut the subjects disrder r cnditin. (Nte: this categry requires additinal apprval by the Senir Assciate Dean fr Clinical Research and ntificatin t URMC risk management ffice). Telephne permissin by an authrized representative - While the FDA allws investigatrs t btain permissin by telephne frm a legally authrized representative, such practice presents ethical difficulties. The FDA s psitin is as fllws: A verbal [ral] apprval des nt satisfy the 21 CFR (c) requirement fr a signed cnsent dcument, as utlined in 21 CFR 50.27(a). Hwever, it is acceptable t send the infrmed cnsent dcument t the legally authrized representative (LAR) by facsimile and cnduct the cnsent interview by telephne when the LAR can read the cnsent as it is discussed. If the LAR agrees, he/she can sign the cnsent and return the signed dcument t the clinical investigatr by facsimile. RSRB apprval f this prcess f btaining permissin will be limited t a case-by-case basis. Investigatrs wishing t btain permissin by telephne must clearly justify its ratinale in the prtcl. Cnsent t Tissue Banking Bilgical specimens include: bld & bld prducts, saliva, cells r tissue frm any part f the human bdy, bdily prducts such as hair, sweat, breast milk, urine, etc. Studies invlving the cllectin f bilgical specimens frm research subjects require written infrmed cnsent frm each dnr-subject. Cnsent may be prvided either as stand-alne dcument fr studies where Page 10 f 37

11 the sle purpse f the study is t bank the tissue fr future research r it may be included in a cnsent dcument where the tissue bank is nly part f a study with several ther prcedures (fr example, an investigatinal drug study banking leftver bld frm samples prvided a several time pints thrughut the curse f the study). If the later methd is used, the cnsent dcument can be written in a manner that either A) presents the banking as an ptinal part f the study (e.g., prviding checkbxes t indicate the subject s permissin/refusal); r B) advises subjects that the specimens will be banked as part f their participatin (nte that in this manner, enrllment will then be limited t nly thse agreeing t participate in bth the primary study and the tissue bank). The cnsent dcument describing the tissue banking shuld include: The purpse fr string the tissue, including the type f research that will be cnducted with the specimens Where the specimen will be stred Wh will have access t the specimens and the cnditins (if any) under which they will be released t investigatrs utside the riginal study team Hw lng the specimens will be stred and whether they will be destryed at any time pint Prcedures fr prtecting the privacy f subjects and maintaining cnfidentiality. Keep the fllwing descriptrs in mind: Identified Samples = samples stred with an identifier Single Cded Samples = samples stred withut any identifiers but a key between the identifiers and the cde n the sample is kept Duble Cded Samples = samples stred withut any identifiers but the cde n the sample links t a cded key; a secnd key, maintained elsewhere, links the first cde t the identifiers Annymised Samples = samples that are initially single r duble cded but the key t the linking cdes has been destryed Annymus Samples = samples with which identifiers were never cllected r labeled Whether r nt subjects wuld be re-cntacted (r given the ptin t be re-cntacted) regarding the banked specimens Wh subjects shuld cntact in the event they decide t withdraw their specimens and what will be dne with withdrawn specimens Whether the results f any future testing will be prvided t subjects Any risks/benefits and csts t subjects fr banking Cnsent t Genetic Testing & Other Genetic Research Genetic testing presents additinal risk beynd the risks related t btaining a bilgical specimen and maintaining cnfidentiality. The results f a genetic test have the ptential t drastically change an individual s life and therefre additinal prtectins must be cnsidered. Sectin 79-L f the New Yrk State Civil Rights Law defines genetic testing and requires additinal prtectins pertaining t genetic testing research. The regulatin states that written cnsent must be btained prir t perfrming a genetic test and has additinal prvisins fr cmpleting the tests. Studies that may nt necessarily be ding genetic testing as defined by NYS law but may be ding ther genetic research (e.g., gene expressin) shuld als cnsider the fllwing items in drafting their infrmed cnsent dcuments (and prtcls). A general descriptin f the test including a general descriptin f the disease r cnditin being tested. The research purpse/use f the test and whether test results will be given t subjects. Referral fr prfessinal genetic cunseling prir t signing the cnsent frm. Page 11 f 37

12 Whether/when samples will be destryed r stred (if s, explain). A descriptin f the prcedures t prtect data cnfidentiality. A statement f the right t withdraw cnsent t use f tissue fr future use and hw that can be initiated by the subject. A descriptin f the special risks genetic testing may pse. Waiver f Cnsent The federal Cmmn Rule regulatins permit an alteratin t sme r all f the elements f infrmed cnsent r a cmplete waiver f cnsent fr research subjects prvided the fllwing criteria are met (nte that a waiver f cnsent is nt permitted fr FDA-regulated research): 1) The research is t be cnducted by r under the apprval f state r lcal gvernment fficials and is designed t study: Public benefit r service prgrams; Prcedures fr btaining benefits r services under thse prgrams; Pssible changes in r alternatives t thse prgrams r prcedures; r Pssible changes in methds r levels f payment fr benefits r services under thse prgrams; And the research culd nt practicably be carried ut withut the waiver r alteratin. And the research is nt subject t FDA regulatin. OR 2) The research meets all f the fllwing criteria: The research invlves n mre than minimal risk t the subjects The waiver r alteratin will nt adversely affect the rights and welfare f the subjects The research culd nt practicably be carried ut withut the waiver r alteratin and Whenever apprpriate, the subjects will be prvided with additinal pertinent infrmatin after participatin. Waiver f Cnsent fr Deceptin Research The RSRB recgnizes that sme therwise ethically acceptable scial/psychlgical research cannt be cnducted with a cmplete descriptin f its purpse; s sme infrmatin must be temprarily withheld. Because subjects cannt truly cnsent withut full infrmatin, the infrmed cnsent prcess is altered fr apprved studies invlving deceptin. In applicatins and study plans, investigatrs using deceptin shuld address the fllwing pints: Cnsideratin f the scientific value and validity f the research Cnsideratin f the cmparative efficacy f alternative prcedures Assurances that deceptin wuld nt influence subjects willingness t participate Prvisin f prcedures fr remving any harm thrugh debriefing Assurances that the deceptin des nt create inapprpriate invasins f privacy Prcedures fr data handling when subjects decline t give cnsent t the use f their infrmatin NOTE: Because deceptin research invlves a waiver/alteratin f cnsent, and the waiver/alteratin may nly be granted t studies invlving minimal risk, deceptin studies may invlve n greater than minimal risk. Page 12 f 37

13 Prir t data cllectin, subjects must have an pprtunity t read and respnd t infrmatin cntained in a Cnsent t Prcedures. This dcument shuld reveal as much as pssible abut the study and shuld include, at minimum, clear statements f: Study title Investigatr names, department, and cntacts What subjects will be asked t d Any risks assciated with thse activities Any payment r ther reward fr subject participatin Unqualified pprtunity t withdraw at any time withut penalty Extensin f the pprtunity t ask questins and get answers Signature and date f the subject and persn btaining cnsent (unless the study qualifies fr a waiver f dcumentatin f cnsent). Nte that the Cnsent t Prcedures itself shuld nt be used as part f the deceptin and therefre shuld nt include untruthful infrmatin. Any missing infrmatin shuld nt put the subject at increased risk f harm r discmfrt. At the cnclusin f participatin, it is imprtant that subjects be advised that deceptin has ccurred, and be given the pprtunity t withdraw r cnsent t have the data used. Subjects must have an pprtunity t read and respnd t additinal infrmatin entitled, Cnsent t Data Use (see belw), which will cntain, at minimum, clear statements f: Study title Investigatr names, department and cntacts Full disclsure f the deceptin Unqualified pprtunity t withdraw the data cllected withut penalty In additin, the fllwing must be included: A statement nting that a frm f deceptin was used in the study. A statement regarding data use, e.g., I give my permissin fr the investigatrs t use the data I prvided in this study. If I d nt give my permissin, I understand that the data I prvided will be destryed. Refer t the Cnsent t Data Use and Cnsent t Prcedures fund n the RSRB web site and the sample language prvided in Appendix 1 belw fr additinal guidance. Waiver f Dcumentatin f Cnsent The RSRB may als permit investigatrs t waive the requirement that the subject r the subject s authrized representative sign a written cnsent frm if it finds either: That the research presents n mre than minimal risk f harm t subjects and invlves n prcedures fr which written cnsent is nrmally required utside the research cntext r, That the nly recrd linking the subject and the research is the cnsent dcument and the principal risk is ptential harm frm breach f cnfidentiality (nte that this waiver f dcumentatin f cnsent is nt permitted fr FDA-regulated research). When it cnsiders waiving the requirement t btain written dcumentatin f the cnsent prcess, the RSRB may require the investigatr t prvide subjects with a written descriptin f the study. Refer t the cnsent frm templates fr an example f such an infrmatin sheet t prvide t subjects as well as Appendix 1 belw fr sample language. Cnsent thrugh Oral Presentatin and Shrt Frm Page 13 f 37

14 When investigatrs anticipate enrlling subjects wh d nt speak English, the RSRB requires that a translated versin f the entire cnsent frm and any ther applicable study dcuments (e.g., surveys, drug cmpliance diaries r ther study measures) be submitted fr review and apprval. In the event that a nn-english-speaking subject presents unexpectedly, the ethical requirement fr cmplete infrmatin disclsure using a full translated cnsent frm remains. Therefre, the default assumptin is that the investigatr will submit an amendment with the full translated dcument and btain RSRB apprval befre enrlling the subject. The investigatr must als determine if the lack f English prficiency will negatively affect the subject s ability t participate in the study, i.e., understand and fllw directins and be able t reprt prblems. In sme special circumstances, usually because necessary clinical care/treatment is part f the research and the subject must be enrlled befre a full translatin can be develped and apprved, the RSRB may apprve the use f a shrt frm cnsent dcument. If this ccurs, cmplete the fllwing: Submit an amendment request t the RSRB Include a shrt-frm written cnsent dcument that states, in the subject s language (see the RSRB s Shrt Frm Cnsent Template): The title f the study That the cnsent infrmatin fr the research study was presented rally t the subject r the subject s authrized representative The presentatin included the purpses, risks, benefits and alternatives (if any) f participatin That participatin is vluntary. The subject des nt have t take part and can withdraw at any time That the subject was given a cpy f the full English versin f the cnsent frm and a cpy f the shrt frm The name, signature line and date fr the subject The attestatin, signature line and date fr the witness (nte that the witness must als sign the English cnsent frm with the persn btaining cnsent) Ensure that the fllwing issues have been addressed: The shrt frm cnsent states that the elements f disclsure required by regulatins have been presented rally t the subject r the subject s authrized representative. The full English versin f the cnsent frm embdies the basic and required additinal elements f disclsure. There will be an adult witness t the ral presentatin wh is cnversant in bth English and the language f the subject (the witness must be unaffiliated with the research and it is best if the witness is a fluent prfessinal). The translatr shuld nt be the same persn as the witness. The subject r the subject s authrized representative will sign and date the translated shrt-frm cnsent dcument. The witness will sign bth the translated shrt-frm and the full English versin. The persn actually btaining cnsent will sign a cpy f the full English versin. Cpies f the translated shrt-frm and the full English versin will be given t the subject r the authrized representative. Bth the riginal signed translated shrt-frm and the signed full English versin are t be kept in the research recrds with ther signed cnsent frms. If the study team anticipates any additinal nn-english speaking subjects, a translated versin f the entire cnsent dcument shuld be submitted fr RSRB review. Page 14 f 37

15 Translated versins f the shrt-frm are included with the cnsent templates. Use the English versin t translate as necessary. Cnsent t Expanded Access r Single Patient Use Spnsrs and/r investigatrs may ccasinally request RSRB review and apprval f prtcls using investigatinal drugs r devices (i.e., unapprved) in the clinical treatment f a patient(s). This mechanism prvides seriusly ill patients access t experimental drugs and devices when there are n satisfactry alternatives. Prspective RSRB apprval review is required and clinicians must cmply with the regulatins pertaining t infrmed cnsent. Althugh this is still cnsidered research under FDA regulatins, cnsent wrding fr these activities differs frm ther research, in the fllwing ways: The use f patient (vs. subject ) and dctr r treating physician (vs. investigatr ) is permitted. Research is replaced with treatment r treatment use. The cmpensatin fr injury sectin is deleted (unless the spnsr makes prvisin fr such cmpensatin). The cnsent frm must clearly indicate that the treatment use is experimental/ investigatinal and has nt yet been apprved by the FDA. Refer t the RSRB s Cnsent Template Cnsent Frm fr Treatment fr additinal guidance. Emergency Use f Unapprved Drugs and Medical Devices Emergency use is defined as the use f an investigatinal drug, bilgical prduct r medical device (i.e., unapprved) with a human subject in a life-threatening situatin in which n standard acceptable treatment is available [21 CFR (d)]. This des nt include ff-label uses f apprved medical prducts in the practice f medicine (nte, ff-label use in a research cntext still requires RSRB review and apprval). In these types f emergency-use situatins, while a waiver f prir RSRB review may be permissible, waivers f ther human subject prtectins, such as btaining infrmed cnsent, may nt apply. Prir t initiating the prcedure, the clinician/investigatr must btain infrmed cnsent f the patient r the patient s authrized representative. In a medical emergency, it may nt be pssible t btain infrmed cnsent. If bth the clinician/investigatr and a physician wh is nt therwise participating in the emergency treatment certify all f the fllwing in writing, prir cnsent may be waived n a case-by-case basis: 1) The subject is cnfrnted by a life-threatening situatin necessitating the use f the test article. 2) Infrmed cnsent cannt be btained frm the subject because f an inability t cmmunicate with, r btain legally effective cnsent frm the subject. 3) Time is nt sufficient t btain cnsent frm the subject s authrized representative; and 4) There is n alternative methd f apprved r generally recgnized therapy that prvides an equal r greater likelihd f saving the subject s life. If immediate use f the test article is, in the clinician/investigatr s pinin, required t preserve the subject s life, and if time is nt sufficient t btain an independent physician s determinatin that the fur cnditins abve apply, the clinician/investigatr shuld make the determinatin and, within five wrking days after the use f the article, have the determinatin reviewed and evaluated in writing by a physician wh is nt participating in the clinical investigatin. The subject and/r the subject s authrized representative must be ntified f the use f the experimental prcedure. Cnsent t cntinue shuld be btained fr emergency use/prcedures requiring cntinued/repeat administratin. Page 15 f 37

16 Please cntact yur RSRB specialist fr mre infrmatin. Drafting the Infrmed Cnsent Dcument The infrmed cnsent dcuments are meant t act as the fundatin f the infrmatin exchange between the study team and ptential subjects. The dcument shuld prvide ptential subjects with enugh infrmatin s that they can make an infrmed decisin abut whether t participate in the study and cnsent frms shuld be written in a manner that is clear and understandable t the study ppulatin. Remember: The term understandable als pertains t the language cmmnly spken by the subject ppulatin. Investigatrs wh anticipate enrlling even ne subject wh nly speaks a language ther than English need t translate the entire cnsent frm int that language. This translatin may be dne after an English frm has been apprved, but translated frms must be apprved by the RSRB befre use. When drafting the cnsent frm, the RSRB recmmends wrking ff the templates prvided n the RSRB website. The templates prvide instructins as well as standard language fr several sectins f the dcument. They shuld als be used in cnjunctin with the sample language prvided in Appendix 1. Keep the fllwing additinal pints in mind: Infrmatin in the cnsent frm must agree with the study plan/prtcl and the RSRB applicatin. It s nt uncmmn fr prtcls t g thrugh a number f revisins befre and after they re submitted t the RSRB. Sme f these revisins may be t prtcl elements that are explained in the cnsent frm (e.g., the number/kind f tests). With each revisin, make sure the prtcl, applicatin and cnsent are cnsistent (e.g., nt 3 tests in the cnsent and 4 in the prtcl). Aim fr a 6th-8th grade reading level. Mst wrd prcessrs can generate reading level scres. Write as if yu were talking t the subject (in 2nd persn narrative, e.g., yu are being asked t ) in a cnversatinal tne nt abut the subject (in 3rd persn bjective, e.g., he/she will be asked t ). Use active rather than passive vice and keep prnun usage cnsistent thrugh the dcument. Fr example, rather than saying: A pregnancy test will be administered t yu/the subject will be given say: Yu will have a pregnancy test. D nt use, I understand that This terminlgy can be cercive, implying a level f understanding the subject may nt have. Use the term subject instead f participant r patient. Fr clinical trials, use study dctr r study investigatr instead f principal investigatr. Use the term payment instead f cmpensatin. The prject title in the cnsent frm may be the actual title n the review applicatin and grant/cntract, r, if it helps the subject understand the study, it may be simplified (as lng as it isn t incrrect r misleading). Replace scientific, medical and technical terms with lay terms. See Plain Language Resurces in Appendix 3 fr thesauruses and health literacy tlkits. Use subheadings and white space t imprve readability in lng frms. Page 16 f 37

17 Use pictures, lists, bullets, tables and charts t help clarify cmplex schedules, study designs, and prcedures. When using graphics ensure that they are easy t understand, have captins, reprduce well, are apprpriately lcated and are meaningful t the subject. List/Describe study prcedures in a lgical rder (start at the beginning; end at the end). Use cnsistent terminlgy thrughut the dcument. Spell ut all abbreviatins and acrnyms when first used. Clearly define any scientific, medical r legal wrds. Use type-fnt n smaller than Times New Rman 12 pint. Cnsent frms fr elderly subjects and thse with visual impairments may benefit frm even larger type. Keep the fnt style and size cnsistent thrughut the dcument. Try t keep wrds t 3 syllables r less. Keep sentences shrt, simple and direct. Keep paragraphs shrt, cnveying ne prcedure/risk/etc. per paragraph/bullet. Cnsider prviding a summary f highlights r supplemental quick reference guide with cnsent dcuments that are lengthy and ptentially verwhelming. Include a fter that numbers the pages (e.g., 1 f 6), identifies the RSRB study number and shws the versin date. When entering the date in the fter, manually type in the date rather than selecting Insert Date frm the fter tlbar; using Insert Date will autmatically update the fter each time the dcument is pened resulting in incrrect versin dates. When creating multiple cnsent dcuments fr ne study (e.g., an adult cnsent, authrized representative permissin, parental permissin and age-apprpriate assents) cnsider cmbining the cnsent and permissin dcuments. This can be accmplished by stating in the cnsent heading If yu are the parent f a child r the authrized representative f an adult subject wh may be enrlled in this study, the use f the wrd yu in this frm refers t the subject. Initial RSRB Review f Cnsent Dcuments Once the cnsent dcument has been submitted with the RSRB applicatin fr initial apprval, it will be reviewed by the RSRB specialist, chair and depending n the level f risk, the full bard. The dcument will be reviewed t ensure that it will be understandable t the study ppulatin and that it is cnsistent with bth the prtcl and applicatin. Any RSRB-required changes will either be described in writing r prvided directly in a tracked dcument. In reviewing tracked dcuments, be sure t review and accept each change and address any miscellaneus cmments r questins nted directly in the dcument. Once yu have made all f the necessary revisins and accepted the tracked changes, review the dcument fr any additinal grammatical r frmatting errrs. A clean, unmarked versin f the dcument shuld then be upladed int the applicatin fr cnfirmatin review by the RSRB. Nte that nly a clean versin f the revised cnsent dcument is required with new applicatins that have nt yet been apprved. Shuld yu wish t prvide a tracked cpy f the dcument, please uplad the tracked dcument with yur respnse t the chair/bard (in the ROSS system, nce yu click Submit Changes t IRBS a pp up bx will appear; uplad a cpy f the tracked dcument here as ppsed t sectin 83.1 f the applicatin). The Infrmed Cnsent Prcess It is imprtant t understand that infrmed cnsent is nt just a signature n a frm; it is a prcess f infrmatin exchange that takes place between the prspective/enrlled subject and the Page 17 f 37

18 investigatr, befre, during and smetimes after the experiment. The infrmed cnsent dcument itself is a descriptin f what shuld have been cmmunicated t ptential subjects. The prcess nt nly includes reviewing and signing the infrmed cnsent dcument but may als include: Recruitment materials Oral instructins r explanatins A questin and answer perid Assessing subject understanding Prviding adequate time fr the subject t review the frm and cnsider their participatin Prviding new findings r study updates as apprpriate thrughut the study Peridic re-affirmatin r re-cnsent as apprpriate thrughut the study As part f the review prcess, the RSRB will evaluate the cnsent prcess utlined in the study prtcl and applicatin t ensure that the prcess is adequate given the nature f the study. In develping yur cnsent prcess in yur prtcl, cnsider the fllwing: Setting: Generally speaking cnsent discussins shuld ccur in a private setting where yur cnversatin wn t be verhead by thers (this is particularly imprtant when dealing with tpics that are sensitive in nature). It s als imprtant t cnsider hw the setting may effect yur discussin. Fr example, if yu are prviding study infrmatin in a classrm setting there may be additinal elements f peer pressure and inattentiveness t deal with. Timing: The cnsent prcess shuld be cmpleted well in advance f any study interventin r prcedure t give the subject sufficient pprtunity t cnsider participatin. It may take several meetings/discussins befre the ptential subject nt nly understands the study but, fr clinical trials, the disease they may have just been diagnsed with and what their ther treatment ptins may be. Minimizing Undue Influence: Vulnerable ppulatins such as minrs and students are particularly susceptible t influence frm authrity. Cnsider hw yu can remve the intimidatin factr as apprpriate. Healthcare prvides have tremendus influence ver patients within their clinical practice. Subjects may be t trusting f their healthcare prviders and prvide cnsent withut a true understanding f what the study entails. Subjects may nt want t antagnize healthcare prviders by refusing t participate in a study. In these cases, it may be apprpriate t cnsider delegating the cnsent respnsibility t smene else n the study team. Use additinal aids (vides, brchures, etc.) t explain study prcedures and supplement the infrmatin prvided in the cnsent dcument. Ask pen-ended questins t ptential subjects t assess their understanding f the study (e.g., In yur wn wrds, tell me what the study is abut; what will happen t yu if yu decide t be in the study; what risks might yu experience; what ther ptins d yu have. ) Discuss the study in the presence f persnal advisrs (friends/family members) wh may aid in the subject s decisin making prcess. RSRB Expectatins The University s expectatins, i.e., what yu must d t cmply with the apprved cnsent prcess are utlined in the RSRB apprval letters. Expectatins cncerning cnsent are the same regardless f the risk invlved in the study. These letters state: Cnsent must be btained and dcumented in the manner apprved by the RSRB. Only cnsent frms bearing a current RSRB Apprved watermark may be used. Only the mst recently apprved versin f any cnsent r recruitment dcument may be used when btaining cnsent. Page 18 f 37

19 Principal Investigatrs are respnsible fr maintaining all apprved pages f the signed cnsent frms fr at least 3 years after the research is cmpleted and clsed in the RSRB files (6 years after the research is cmpleted if HIPAA authrizatin is required), r fr a lnger term if required by FDA regulatins r ther cntractual agreements. Cnsent frms/recruitment letters must be printed n department letterhead. Practically speaking, what des this mean? Hw Cnsent is Obtained: The RSRB expects that yu will btain cnsent in the manner indicated in yur applicatin and prtcl, and that, if yu want t change the prcedure, yu will get the RSRB apprval by means f an amendment request. Here are sme examples: If the study eligibility criteria state that subjects must be able t cnsent fr themselves, a relative r friend cannt sign the cnsent n behalf f the subject. If the applicatin and prtcl indicate that nly English-speaking subjects will be enrlled, cnsent cannt be btained frm an individual wh desn t speak English. If the study invlves tw different ppulatins and tw separate cnsent dcuments fr each ppulatin patients with illness and healthy cntrls, fr example the prper cnsent fr each specific subject ppulatin must be used. This is particularly imprtant when different subject ppulatins underg different study interventins r prcedures. If the prtcl states that the Principal Investigatr will btain cnsent and n ther persnnel are listed, then nly the Principal Investigatr may sign cnsent dcuments as the persn btaining cnsent. Hw Cnsent is Dcumented (Signed): Here are sme guidelines that will help ensure prper dcumentatin f cnsent: Unless dcumentatin f the subject s signature has been waived by the RSRB, make sure the cnsent frm is signed and dated. Signatures are required frm the subject (r subject s representative) and rutinely frm the persn btaining cnsent (which is ften, but nt always, the investigatr). Generally speaking, the persn btaining cnsent shuld sign the frm n the same day as the subject. Signature dates separated by days may prmpt auditrs and the RSRB t questin the cnsent prcess. If yu anticipate that the signature dates f the subject and persn btaining cnsent will cnsistently be different fr example, if yu re btaining written cnsent via mail after a telephne discussin this shuld be described in the prtcl. Make sure the first page f the cnsent dcument is n department letterhead. It is recmmended that cnsent/recruitment dcuments be submitted t the RSRB n electrnic letterhead; hwever if this is nt pssible, the first page f the watermarked dcument shuld be printed n letterhead upn apprval. Make sure that any checkbxes n the frm (e.g., indicating interest in additinal testing r future studies) are cmpleted. Make sure that any witness signature blcks are cmpleted. Generally speaking, it is expected that nly individuals unaffiliated with the research will act as witnesses. If a witness is ptinal r required nly in certain circumstances, this shuld be clarified in the prtcl. Remember that anyne btaining cnsent must have cmpleted the University s research ethics training and must be apprved by the RSRB (listed in sectins r 85.1 f the applicatin). If any additinal individuals will btain cnsent, submit an amendment t the RSRB requesting that they be added t the study persnnel befre they start btaining cnsent. Page 19 f 37

20 The RSRB expects that the riginal cpy f the signed cnsent be maintained in the study file and that a cmplete cpy f the cnsent frm will be prvided t the subject. Failure t keep these recrds may lead auditrs/rsrb t questin whether valid cnsent was btained. T help ensure cnfidentiality, stre the cnsent frms in a secure way (in a lcked file cabinet, fr example). DON T sign r date the cnsent frm fr the subject (r the subject s representative). Signed cnsent dcuments shuld be reviewed by the persn btaining cnsent prir t prviding a cpy t the subject t ensure that it is cmplete. DON T use a signature stamp in place f an riginal signature fr the persn btaining cnsent. DON T white ut, crss ut r therwise change any part f the RSRB-apprved cnsent frm. Any revisins t the cnsent frm must be submitted as an amendment fr RSRB review and apprval. It is acceptable fr the persn btaining cnsent t use the back f frms/ther white space t nte questins the subject r family members asked, etc. as a way t dcument the cnsent cnversatin. Cnsider dcumenting the prcess fr each subject in the prgress nte/case histry. While federal guidelines d nt specify that further dcumentatin is required beynd that f signing/dating the cnsent frm, FDA regulatins specific t clinical trials cnducted under an Investigatinal New Drug Applicatin state that the case histry fr each individual shall dcument that infrmed cnsent was btained prir t participatin in the study (21CFR312.62[b]). Therefre, althugh cntextual dcumentatin f hw and when the cnsent prcess ccurs is nt required fr all studies, it is recmmended as best practice. Dcumentatin f any re-cnsent as described belw shuld als be include in the study file. Using the Current RSRB-Watermarked Cnsent: The RSRB places a watermark n each page f every cnsent dcument it apprves indicating the study number and expiratin date. Pints t cnsider: The watermarked cnsent is the versin the RSRB apprved and the nly ne the University recgnizes as valid. T lcate the watermarked dcuments: Lg int ROSS and click n the Applicatins tab; Lcate the study under the Active heading and click n the name f the study t cntinue; On the hrizntal tlbar at the bttm f the screen, click n the Dcuments tab; Scrll dwn t lcate yur apprved & watermarked cnsent and recruitment dcuments. Make sure the date n the cnsent frm is current. Review the dcument befre presenting it t the ptential subject. If the watermark indicates the study expired 1/15/12, fr example, and the cnsent prcess is taking place n 3/20/12, valid cnsent wn t be btained. Remember that, each time the cnsent frm is amended r the study is renewed, a new watermark is applied. In additin t the study apprval expiratin date, the new watermark will bear the date f the amendment s r cntinuing review s apprval. It s this versin yu ll need t use. Keep ne cpy f the previus versin in the study file, but thrw ut any unsigned cpies t help ensure that nly the current cpies are available t the study staff and presented t ptential subjects. If the cnsent frms are kept in mre than ne lcatin, make sure all have been updated with the current versin. Page 20 f 37