Focus Group Guidelines. A. Designing a Focus Group Protocol

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1 Fcus Grup Guidelines This dcument prvides guidelines fr hw t design fcus grup prtcls and hw t describe fcus grups in the cnsent frm. Fcus grup studies are cmmnly used in scial and behaviral research t bring ut insights and understandings that regular questinnaires r individual interviews may nt ffer. Engaging in this type f research, frm an IRB perspective, requires certain cnsideratins and safeguards t prtect participants. The fllwing are sme guidelines t help investigatrs as they are designing a fcus grup prtcl that cnsiders the rights and welfare f the subjects. A. Designing a Fcus Grup Prtcl The prtcl shuld include the fllwing infrmatin under the apprpriate sectin-objectives, Abut the Subjects, Risks t Participants, etc. Addressing these questins in the prtcl dcument can help the IRB efficiently and effectively review the research prtcl t determine risk t subject and level f categry review. OBJECTIVES sectin: What are the main tpics r ideas that will be discussed during the fcus grup? The nature f fcus grups is usually designed t remain pen-ended and allw free discussin regarding a particular tpic. Hwever, the IRB needs t knw the main fcal pints f the discussin in rder t assess risk t subject and ensure that discussin tpics t d nt deviate frm the prpsed research plan. What is the main gal r aim f this study? Is there a scientific r qualitative reasn fr designing the study as a fcus grup (instead f individual interviews)? ABOUT THE SUBJECTS sectin: Hw many subjects per fcus grup? Prvide nly a range/estimatin. Being t specific may narrw yur flexibility in structuring the grups. Hwever, a maximum number f subjects fr the verall study must be described, and shuld nt be exceeded withut prir IRB apprval. What are the inclusin/exclusin criteria fr this study? What is the general descriptin f the subject ppulatin? What is the subject age range fr the study? RECRUITMENT METHODS sectin: Hw will yu be recruiting subjects (i.e. phne call, , send recruitment letter, advertisement, etc.)? Page 1 f 6

2 What is the rigin f the cntact infrmatin (e.g., address, address, phne number r name)? Des the infrmatin cme frm a database r registry? D yu have permissin t access this database r registry? If s, please submit a letter which grants this authrizatin. Are yu cllabrating with a fundatin r gvernment prgram that already has a list f prspective subjects? Will yu be ding a secndary data analysis in rder identify ptential subjects? Will this data cme frm a publicly available data surce? If s, please attach a cpy f the catalg/website page indicating where the data can be lcated. Wh will be cntacting the prspective subjects? Remember, recruitment is part f the cnsenting prcess; therefre, CITI training is required fr thse invlved in subject recruitment. What is yur target recruitment number? Will advertisements be used as a recruitment tl? If s, please visit the IRB website under Inf Sheets fr IRB guidance n Advertising and Recruitment PROCEDURES sectin: Hw many fcus grups will yu have? Where will the fcus grup sessin be lcated? The sessin shuld be held in an area that will be cmfrtable fr the subjects t interact and discuss the research tpics. The lcatin shuld als be secure and private as the infrmatin being discussed by the subjects can be cnsidered sensitive and persnal. Hlding a fcus grup sessin in pen r high traffic areas may nt nly discurage subjects frm talking but als cause ptential harm t subjects. Here, harm is nt physical but rather a ptential injury t a persn s reputatin r cnfidentiality (r als knwn as infrmatinal risk). Duratin f the discussin: Hw lng will the fcus grup sessin be? Will the fcus grup sessin be a ne-time visit? Or, will there be mre than ne fcus grup sessin? What will be the prcedure fllwed during the fcus grup? Will there be a break ffered t the subjects? Will the subjects have t fill ut a demgraphic sheet r any type f survey prir t r after the fcus grup discussin? Page 2 f 6

3 If set questins are being used t facilitate the fcus grup discussin, these shuld be attached fr review with yur submissin. Otherwise, a general utline f the tpics and prmpts shuld be prvided. If discussing sensitive tpics, have a cunselr r trained individual in the rm r readily available during the discussin. Train the mderatr t handle an emtinal crisis r respnse. Will the grup discussin be recrded? If s, this shuld nt nly be mentined t the subject in the cnsent frm but als prir t the recrding actually beginning. Will the subjects be cmpensated fr their time and effrt? CONSENT PROCESS sectin: When will the subjects be cnsented? A week r an hur befre the fcus grup discussin? Just befre the sessin begins? Be clear and specific. Wh will cnsent the subjects (e.g. investigatr r mderatr)? DATA MANAGEMENT sectin: If fcus grup sessins are recrded, hw will yu ensure subject cnfidentiality? Limiting the types f identifiers can minimize the risk f identificatin. Remind subjects nt t use their last names. Keep recrdings in a secure and lcked area with access limited t designated researchers. Destry recrdings after data analysis r cmpletin f the study. RISKS TO PARTICIPANTS sectin: Risk in terms f human subject research may nt always invlve physical harm. Rather and usually the case in scial behaviral research, risk t subjects may invlve infrmatinal r emtinal risk. Investigatrs must cnsider the risks that maybe assciated with the fcus grup study as they are designing their prtcl. These risks shuld be mentined in the prtcl, cnsent frm and, if applicable, briefly in a cver letter (used in lieu f infrmed cnsent). Infrmatinal risk invlves the prbability f breach f cnfidentiality r lss f privacy. Accidental disclsure f research infrmatin (e.g. respnses, data, identifiers, etc.) allws fr subject identificatin utside f the research study. This culd reasnably place the subjects at risk f criminal r civil liability r be damaging t the subjects' financial standing, emplyability, r reputatin. Emtinal risk can be assciated with a study if the fcus grup discussin invlves a sensitive research tpic that can trigger an unwanted emtinal respnse (e.g. sexual, child r spusal Page 3 f 6

4 abuse, alchlism, teen pregnancy, sexuality, STDs, etc.). Emtin is relative and varies frm persn t persn. An investigatr cannt assume they will nt encunter this pssibility. In sensitive fcus grup discussins, investigatrs shuld cnsider their subjects experiences, culture and envirnmental setting as well as hw a subject might react in public (a rm full f ther peple). What services r cunsel will yu ffer in case the fcus grup discussin triggers an emtinal respnse frm a subject? This ften ccurs with sensitive tpics and an investigatr must be prepared t manage this type f harm (emtinal). Have a crisis htline number r the cntact infrmatin fr ther cunseling services available t subjects in case an emtinal respnse ccurs after the discussin ends. Nte that in a fcus grup setting, even if all participants are reminded nt t share the infrmatin discussed in the fcus grup, it is always a pssibility that sme may breach this trust. Cmplete cnfidentiality must never be guaranteed t subjects in a fcus grup. PROVISIONS TO PROTECT THE PRIVACY INTERESTES OF PARTICIPANTS sectin: Sensitive infrmatin can be revealed during fcus grup discussin. What measures will yu take t ensure the discussin will remain private and cnfidential? Remind subjects that the infrmatin discussed during the fcus grup needs t remain cnfidential. B. Waiver f Infrmed Cnsent/Dcumentatin in Fcus Grup Settings The type f risk level (minimal r mre than minimal) can dictate whether an infrmed cnsent dcument r a waiver f written cnsent is needed. Federal regulatins define minimal risk t be the prbability and magnitude f harm r discmfrt anticipated in the research are nt greater in and f themselves than thse rdinarily encuntered in daily life r during the perfrmance f rutine physical r psychlgical examinatins r tests. The required elements f infrmed cnsent can be fund n the IRB website under the Inf Sheets tab. See the Infrmed Cnsent and Assent dcument. T qualify fr a waiver r alteratin f Infrmed Cnsent, the fllwing requirements must be met [45 CFR (d)]: (1) The research presents n mre than minimal risk t subjects (2) The waiver will nt adversely affect the rights and welfare f the subjects (3) The research culd nt practicably be carried ut withut the waiver; and (4) Whenever apprpriate, the subjects will be prvided with additinal pertinent infrmatin after they have participated in the study Page 4 f 6

5 It is imprtant t nte that numbers (1), (2), (3) and (4) must all apply and must be cited as justificatin fr waiver f infrmed cnsent. Number (4) is particularly imprtant in Scial Behaviral Research, fr example, in the fllwing types f situatins: There may be new infrmatin as a result f a survey r fcus grup that wuld be relevant t the subjects. The purpse f the research may require elements f deceptin, in rder t btain a natural respnse that the subject wuld nt display if thse elements f deceptin were disclsed prir t the exercise. Hwever, after the cmpletin f the study, pertinent infrmatin must be disclsed t the subject. See the IRB website under Inf Sheets fr guidance n Research Invlving Deceptin. Subjects may be underging sme mderatr r investigatr manipulatin t elicit emtinal respnses. An investigatr wh qualifies fr an alteratin f federal required elements f cnsent must still disclse t subjects pertinent study infrmatin. This cnsent can be in frm f a recruitment/cver letter, which includes: (1) A brief explanatin f the study (2) The prcedures (3) Highlight the risks (breach f cnfidentiality r emtinal respnse) assciated with the study (4) Optin t withdraw (5) Vluntary participatin (6) Measures t maintain cnfidentiality, and (7) Apprpriate cntact infrmatin (Principal Investigatr and IRB Office). If a research study qualifies fr a waiver f infrmed cnsent, CU-Bulder requires an investigatr t have an ral r written script cntaining cre infrmatin abut the research study. This script must be submitted fr review as an attachment in era. Investigatrs must frmally request a waiver f infrmed cnsent in the prtcl dcument/efrm and receive apprval frm the IRB. This request must als include a justificatin explaining the need fr a waiver f infrmed cnsent r dcumentatin C. Infrmed Cnsent in Fcus Grup Settings Use the Cnsent Frm Template, Infrmed Cnsent Guidance, and Language Resurce Text available n the IRB website. All cnsent statements shuld be cnsistent with the prcedures and risks described in the prtcl. Be sure t include the fllwing as it applies: CONFIDENTIALITY sectin: Page 5 f 6

6 Fr minimal risk fcus grup research: The researchers will try t maintain cnfidentiality f the data. Hwever, the nature f fcus grups means that we cannt guarantee cnfidentiality. Please respect the privacy f the ther participants and nt repeat what is said in the fcus grup t thers. Fr research that is greater than minimal risk it may be necessary t include a statement f nndisclsure that participants wuld agree t in the infrmed cnsent. This shuld be added t the Signing the Cnsent Frm sectin f the Infrmed Cnsent template available n the IRB website.. Example: Nn-Disclsure Statement: I agree t maintain the cnfidentiality f the infrmatin discussed by all participants and researchers during the fcus grup sessin. If yu cannt agree t the abve stipulatin please see the researcher(s) as yu may be ineligible t participate in this study. Risk and Discmfrts sectin: Sme f the questins the researchers ask yu may be upsetting r make yu uncmfrtable. If yu d nt wish t answer a questin, yu can skip it and g t the next questin. If yu d nt wish t participate yu can stp. Page 6 f 6