IRB GUIDELINE 4 Parental Consent and Child Assent

Transcription

1 IRB GUIDELINE 4 Parental Cnsent and Child Assent Institutinal Review Bard (IRB) Divisin f Research Office f Animal Welfare and Research Integrity Rm 130 Dysn Building Tallahassee, Flrida irb@famu.edu Research cncerned with sensitive issues and invlving the participatin f children is becming mre cmmn. Federal law defines "children" as persns wh have nt attained the legal age fr cnsent t treatments r prcedures invlved in the research, under the applicable law f the jurisdictin in which the research will be cnducted. Under Flrida law, persns under the age f eighteen (18) generally meet this definitin f "children", with the exceptins nted belw. As a result, permissin f the child's parent(s) r guardian(s) must generally be btained prir t the participatin f that child in research. The fllwing exceptins t the general rule apply, where a persn under the age f 18 des nt meet the federal definitin f "child" and may prvide legally effective cnsent t participate in research if either: 1. The research invlves the prvisin f medical care r treatment, (including care r treatment deemed t be experimental) AND the persn: a. has graduated frm high schl, r b. is married, r c. is r has been pregnant. 2. The persn is an emancipated minr. If an emancipated minr prvides cnsent fr him r herself, the curt rder must be cpied and included in the research recrds with the cnsent dcument. Federal regulatins that gvern research with children include 45 CFR 46, Subpart D and Subpart D f the FDA regulatins. Such research ften presents difficult questins related t the prtectin f human participants. The purpse f these guidelines is t help researchers plan prcedures and prepare prpsals that can be apprved by the Institutinal Review Bard (IRB). RISKS Research n health and scial issues ften invlves requesting sensitive infrmatin frm participants, sme f whm may be children. The prcedures fr cllecting and handling such data ften d pse risks t the participants. These risks may include sme r all f the fllwing: 1. Vilatin f Privacy: Cllectin f data cncerning at-risk r scially questinable behavir (fr example, questins abut substance use r sexual activity) is viewed by many individuals as vilatins f privacy. Page 1 f 7 Versin /19/09 This frm is available electrnically at

2 2. Legal Risks: Data cncerning illegal behavirs may place individuals at risk f legal actin, if (a) names can be linked t particular respnses r bservatins and (b) the research has nt received specific legal prtectin (e.g., by Certificate f Cnfidentiality). 3. Psychscial Stress and Related Risks: Prcedures that raise sensitive issues may generate stress fr participants. Fr example, questins abut at-risk behavirs may cause students t feel stress related t their self-image r cntribute t perceived peer pressure. 4. Scial Relatins: Because relevant questins ften request infrmatin abut the behavir, r relatins with, family members, peers, r authrities, sme prcedures may pse a risk t thse relatins if cnfidentiality is nt adequately safeguarded. In additin t these risks, which may be applicable t either child r adult participants, research invlving child participants may als pse risks t parents r ther family members. In particular, research sliciting infrmatin abut at-risk behavirs f family members may place thse individuals at legal risk. Furthermre, sme parents may feel that their right t determine the activities f their children is vilated if signed parental cnsent is nt btained. PROTECTION In general, prtectin frm these risks may be achieved by (a) ensuring the cnfidentiality f infrmatin btained abut participants, (b) prviding access t r infrmatin abut resurces fr cping with psychscial stress caused by the research prcedures, and (c) ensuring that the prcedures meet the principles f vluntary participatin and infrmed cnsent. Guidelines fr achieving this prtectin include: 1. Cnfidentiality and Annymity: Infrmatin is cnsidered cnfidential when nly the investigatr has access t the identity f the individual abut whm infrmatin is btained. Infrmatin btained frm individual participants must be kept cnfidential frm public scrutiny, frm parents and peers, and frm legal and schl authrities. This is mst easily accmplished by cllecting data in a manner that insures annymity. Infrmatin is cnsidered annymus when names r ther identifying infrmatin abut individual participants can at n pint be assciated with bservatins r with respnses t a survey r ther data cllectin instruments. Hwever, annymity is nt always cmpatible with research gals (fr example, when data cllected frm the same individual at different times must be linked fr analysis). In these cases, prcedures fr prtecting cnfidentiality must be fully spelled ut. When infrmatin that might put participants at legal risk is t be cllected, it is the investigatr's respnsibility t btain and dcument specific legal prtectin (e.g., by Certificate f Cnfidentiality btained frm a gvernmental agency). 2. Psychscial Stress: The prcedures needed t help participants cpe with psychscial stress that may arise frm participating in research will vary depending n the exact nature f the research. If such prcedures are required, it will typically be sufficient t prvide participants with infrmatin abut resurces (e.g., cunselrs) available t them. In cases in which mre severe stress seems likely, it may be necessary t ensure that smene qualified t handle such stress be present during data cllectin. 3. Vluntary Participatin and Infrmed Cnsent: These are basic ethical principles fr cnducting research with human participants. Participants must be infrmed that participatin is vluntary, that answers t specific questins may be withheld withut penalty, and that they may withdraw frm the research at any time. Because research f this Page 2 f 7 Versin /19/09 This frm is available electrnically at

3 type is ften cnducted in an institutinal setting where participant's presence is mandatry (e.g., the schl classrm), it is especially imprtant that prcedures fr meeting this requirement be made explicit in the prpsal. PARENTAL CONSENT A particular cncern with research f this nature is the rle f parental cnsent fr the participatin f child participants. The general requirement is that explicit parental cnsent be btained in writing fr each participant. Hwever, there are situatins in which such a cnsent prcedure is nt apprpriate. The IRB may apprve a cnsent prcedure which des nt include, r which alters, sme r all f the elements f infrmed cnsent, r waives the requirement t btain infrmed cnsent as utlined in 45 CFR (c) prvided the IRB finds and dcuments: The research r demnstratin prject is t be cnducted by r subject t the apprval f state r lcal gvernment fficials and is designed t study, evaluate r therwise examine: 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 be practicably carried ut withut the waiver r alteratin. The IRB may apprve a cnsent prcedure which des nt include, r which alters, sme r all f the elements f infrmed cnsent utlined abve, r waives the requirement t btain infrmed cnsent as utlined in 45 CFR (d) prvided the IRB finds and dcuments: The research invlves n mre than minimal risk t the participants; and The waiver r alteratin will nt adversely affect the rights and welfare f the participants; and The research culd nt practicably be carried ut withut the waiver r alteratin; and Whenever apprpriate, the participants will be prvided with additinal pertinent infrmatin after participatin; and The research is nt subject t FDA regulatin. The IRB may waive the requirement t btain a signed cnsent frm, in accrd with 45 CFR (c) when: The nly recrd linking the participant and the research wuld be the cnsent dcument and the principal risk wuld be ptential harm resulting frm a breach f cnfidentiality and the research is nt subject t FDA regulatin; r Page 3 f 7 Versin /19/09 This frm is available electrnically at

4 The research presents n mre than minimal risk f harm t participants and invlves n prcedures fr which written cnsent is nrmally required utside f the research cntext; In cases in which the dcumentatin requirement is waived, the IRB may require a script f the infrmatin r an implied infrmed cnsent frm that will be prvided during the cnsent prcess. That dcument, if requested by the IRB, is reviewed and apprved by the IRB. Researchers are reminded that the reading level f infrmed cnsent dcuments shuld be apprpriate t the typical educatinal backgrund f the research ppulatin, and that dcuments designed fr cllege students may nt be suitable fr seeking parental cnsent. Researchers shuld write these dcuments using shrt sentences and everyday language. Fr example, "vluntary participatin" may be paraphrased by "yu d nt have t d this if yu dn't want t." OBTAINING AND DOCUMENTING ASSENT FROM CHILDREN Parental cnsent is usually a prerequisite t the recruitment f human research participants wh are children. Hwever, parental cnsent cnstitutes nly half f the cnsent prcess. Assent, the agreement f a child t participate in research, is the secnd cmpnent f the infrmed cnsent prcedure fr children. The means f btaining assent frm children must be apprpriate fr the age ranges and levels f mental develpment fund within the prpsed participant pl. The Natinal Cmmissin fr the Prtectin f Human Subjects f Bimedical and Scial Science Research expects that assent be requested frm children wh are 6 years f age r lder. Hwever, fr children between the ages f 6 and 18, the apprpriate methd fr btaining assent will vary. The fllwing guidelines were prpsed during a panel discussin spnsred by the Natinal Institutes f Health: Age 6-7 A simple ral descriptin f the child's invlvement is given t the participant and verbal assent is requested. The prcedure may be dcumented n the infrmed cnsent frm by the presence f the signature f a witness. Age 8-13 A mre cmplete ral descriptin f the research (in layman's terminlgy) is given t the participant. Verbal assent is requested. The prcedure may be dcumented n the infrmed cnsent frm by the signature f a witness. Page 4 f 7 Versin /19/09 This frm is available electrnically at

5 Abve age 13 Written assent shuld be requested frm bth parent and child, using age-apprpriate and backgrund-apprpriate dcuments. Althugh age is used as the primary criteria in determining an apprpriate means f btaining assent, factrs such as literacy and mental develpment must als be cnsidered. The need fr flexibility in the methds fr btaining assent frm children is universally recgnized. Because a single methd f btaining assent may nt be apprpriate fr all ptential participants, investigatrs may need t be prepared t use different appraches with different participants. As in any cnsent prcess, the primary cncern is that the participant is able t understand the explanatin that is presented. The need fr a witness t dcument verbal assent prcedures is dependent upn the cmplexity f the research and the risks t the participant. NOTE: A parent r guardian may nt be the witness fr a child's verbal assent dcument. The IRB assesses the ptential risks and benefits fr each research prpsal, and the prvisins fr permissin and assent, t determine if an activity satisfies the cnditins fr a categry f research permitted in children, as specified in DHHS 45 CFR , , and , and FDA 21 CFR 50.51, 50.52, 50.53, and The research categries are described belw. Research that des nt invlve greater than minimal risk may be apprved if the IRB finds that adequate prvisins are made fr sliciting the assent f the children and the permissin f their parents r guardians (45 CFR and 21 CFR 50.51). Fr such research the IRB determines whether adequate prvisins t slicit the permissin f each child's parents r guardian unless ne parent is deceased, unknwn, incmpetent, r nt reasnably available, r unless nly ne parent has legal respnsibility fr the care and custdy f the child is made. Where parental permissin is t be btained, the IRB may find that the permissin f ne parent is sufficient. Research invlving greater than minimal risk, but presenting the prspect f direct benefit t an individual participant, r a mnitring prcedure that is likely t Page 5 f 7 Versin /19/09 This frm is available electrnically at

6 cntribute t the participant's well-being, may be apprved if the IRB finds that (45 CFR and 21 CFR 50.52): the risk is justified by the anticipated benefit t the participant; the relatinship f anticipated benefit t risk is at least as favrable as that presented by available alternative appraches; and adequate prvisins are made fr sliciting the assent f the children and permissin f their parents r guardians. Fr such research the IRB determines whether adequate prvisins t slicit the permissin f each child's parents r guardian, unless ne parent is deceased, unknwn, incmpetent, r nt reasnably available, r unless nly ne parent has legal respnsibility fr the care and custdy f the child, is made. Where parental permissin is t be btained, the IRB may find that the permissin f ne parent is sufficient. Research invlving greater than minimal risk with n prspect f direct benefit t individual participants, but likely t yield generalizable knwledge abut the participant's disrder r cnditin, may be apprved if the IRB finds that (45 CFR and 21 CFR 50.53): the risk represents a minr increase ver minimal risk; the interventin r prcedure presents experiences t participants that are reasnably cmmensurate with thse inherent in their actual r expected medical, dental, psychlgical, scial, r educatinal situatins; the interventin r prcedure is likely t yield generalizable knwledge abut the participant's disrder r cnditin which is f vital imprtance fr the understanding r ameliratin f the participant's disrder r cnditin; and adequate prvisins are made fr sliciting assent f the children and permissin f their parents r guardians. Fr such research, the IRB requires the permissin f bth parents, unless ne parent is deceased, unknwn, incmpetent, r nt reasnably available, r unless nly ne parent has legal respnsibility fr the care and custdy f the child. Research that is nt therwise apprvable which presents an pprtunity t understand, prevent, r alleviate a serius prblem affecting the health r welfare f children may be apprved if the IRB and the Secretary f the Department f Health and Human Services (DHHS), after cnsultatin with a panel f experts in pertinent disciplines and fllwing an pprtunity fr public review and cmment, find that: the research in fact satisfies ne f the abve three cnditins (45 CFR and 21 CFR 50.54); r Page 6 f 7 Versin /19/09 This frm is available electrnically at

7 the research presents a reasnable pprtunity t further the understanding, preventin, r alleviatin f a serius prblem affecting the health r welfare f children; the research will be cnducted in accrdance with sund ethical principles; and adequate prvisins are made fr sliciting the assent f children and the permissin f their parents r guardians. Fr such research, the IRB requires the permissin f bth parents, unless ne parent is deceased, unknwn, incmpetent, r nt reasnably available, r unless nly ne parent has legal respnsibility fr the care and custdy f the child. If the IRB has determined that the permissin f bth parents is required, permissin granted by ne parent will nevertheless be sufficient if the ther parent is deceased, unknwn, incmpetent, nt reasnably available r if the parent granting permissin has legal respnsibility fr the care and custdy f the child. In rder t establish that nly ne parent has legal respnsibility fr care and custdy f a child, an rder issued by a curt frm the state in which such parent resides must grant sle custdy f the child t such parent. A cpy f the curt rder shuld be retained with the dcumentatin f the parent's permissin. Page 7 f 7 Versin /19/09 This frm is available electrnically at