Human Research Ethics Committee Generic Protocols and Templates Research Project Proposal (generic template)

This is a modified (expanded) version of a template used in: Iphofen, R. (2009) Ethical decision making in social research. A practical guide, London: Palgrave Macmillan pages 200 0!.
"his #empla#e ma$ %e copied and &sed for an$ research or #eaching pro'ec# s&%'ec# #o (&o#ing #he so&rce.

"his #empla#e is designed #o assis# researchers #o p&# #oge#her a pro'ec# proposal. ) good proposal sho&ld address or provide informa#ion on each of #he elemen#s o&#lined %elo*. "he amo&n# of de#ail re(&ired *ill var$ according #o #he precise research #opic and #he overall aims of #he pro'ec#. Research proposals sho&ld %e *ri##en clearl$ and in s&ch a *a$ #ha# an in#elligen# la$person can &nders#and #he principles involved. )n$ comple+ iss&es or #echnical #erminolog$ sho&ld %e clarified for #he %enefi# of research governance and e#hics revie*ers. "he pro'ec# proposal m&s# offer eno&gh informa#ion #o clarif$ #he pro'ec# aims and me#hods, %&# no# #oo m&ch &nnecessar$ or repe#i#ive ma#erial. "he proposal sho&ld demons#ra#e #ha# #he researcher f&ll$ &nders#ands #he iss&es associa#ed *i#h #he &se of #he proposed me#hods. I# sho&ld indica#e an$ ,no*n diffic&l#ies associa#ed *i#h appl$ing #hose me#hods in #he proposed se##ing. "his doc&men# can #hen %e &sed #o -c&# and pas#e. from #he relevan# fields in#o an$ o#her formal revie* forms as re(&ired. Revie ers! Criteria In *ri#ing a proposal researchers *o&ld do *ell #o remem%er #he cri#eria #ha# governance and e#hics revie*ers *ill have in mind *hen reading #he proposal. "he$ *ill %e assessing #hro&gho&# *he#her #he pro'ec# is -do a%le.. In simple #erms #he$ sho&ld %e #hin,ing: can i# %e done, does i# need #o %e done, can #his person/#hese people do i#, and can i# %e done in #he *a$ #he$ are proposing0 "he overarching e#hical (&es#ion, *hich *ill %e considered #hro&gho&# #he proposal, is: can i# %e done *i#ho&# harm #o an$ of #he people

h##p://***.open.ac.&,/research/e#hics/1)2s.sh#ml

March 2032

involved0 "he &l#ima#e '&s#ifica#ion for a pro'ec# m&s# %e: *ill i# #ell &s some#hing ne* and/or &sef&l #ha# *e didn.# alread$ ,no*0 I# is essen#ial #ha# f&ll considera#ion is given #o research e#hics and #his sho&ld %e consis#en#l$ demons#ra#ed #hro&gho&# #he research proposal. If s&%mission #o a research e#hics commi##ee (R45) is re(&ired i# sho&ld %e made clear *hich R45 *ill %e revie*ing #he proposal. 6&# e#hical considera#ions sho&ld %e em%edded in research design from #he o&#se# and clearl$ indica#ed *hen necessar$ #hro&gho&# #he pro'ec# proposal. 4#hical concerns are rela#ed #o #he principles and val&es #o %e &pheld *hils# research is %eing cond&c#ed. "he proposal m&s# sho* #hro&gho&# ho* #he researchers in#end #o pro#ec# #he righ#s, digni#$, safe#$ and *ell %eing of all ac#&al or po#en#ial research par#icipan#s #ha# incl&des -research s&%'ec#s. as *ell as #he researchers #hemselves. 7)f#er comple#ing #his proposal, go #hro&gh i# again &sing #he 84#hics Revie* 5hec,lis#9 #o ens&re ,e$ i#ems have %een a##ended #o.:

Project identification and rationale Provide: ;a s&ccinc# and clear pro'ec# #i#le 7f&ll #i#le, shor# #i#le and/ pro'ec# nic,name or acron$m:< ;a clear s#a#emen# of #he research iss&e &nder inves#iga#ion *hich; ;specifies #he 8research (&es#ion9 or (&es#ions )=> ;if appropria#e, clarifies an$ 8#es#a%le h$po#heses9. 7a shor# ini#ial s#a#emen# #ha# ma,es #he foc&s of #he research clear: ;some '&s#ifica#ion of #he need for research #o %e cond&c#ed on #his #opic 7e+plain if #he research *ill fill a gap or mee# a need i# migh# add #o ,no*ledge, deliver prod&c#ive o&#comes or add val&e for polic$ and/or prac#ice:< ;some disc&ssion of e+is#ing informa#ion on #he #opic

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7a# #his s#age a %rief o&#line of #he c&rren# s#a#e of ,no*ledge f&r#her '&s#ifica#ion of #he need for #his research and *hich *ill %e e+panded la#er in #he f&ll pro#ocol:< ;an e+plana#ion of an$ secondar$ research #ha# can/sho&ld %e cond&c#ed 7a %rief s#a#emen# of des, research or s$s#ema#ic li#era#&re revie* #ha# ma$ %e re(&ired:< ;a ra#ionale for cond&c#ing primar$ research 7*h$ ne* primar$ research is re(&ired:< ;an e+plana#ion of *h$ #he research needs #o %e cond&c#ed in #he chosen se##ing(s) 7in par#ic&lar, *h$ #he proposed s&%'ec#s and/or se##ing are needed for #his research:.

Project personnel and colla"orators "his sec#ion com%ines #he need for clear lines of responsi%ili#$ and acco&n#a%ili#$ #oge#her *i#h a (&ic, reference so&rce for all #hose involved in #he pro'ec#. I# also clarifies *ho is doing *ha# and *he#her #he$ can demons#ra#e #he compe#encies necessar$ #o accomplishing #he research goal. Provide: ;#he name and con#ac# de#ails of #he Principal Inves#iga#or (PI)< ;#he names and con#ac# de#ails of all research assis#an#s/colla%ora#ors/par#ners in #he pro'ec#< ;a clear indica#ion of #he research roles of all #hose involved in #he pro'ec# 7#he #as,s/role alloca#ed #o each named individ&al:< ;%rief, #arge#ed 5@s for PI, s&pervisor(s) and an$ colla%ora#ing researchers and par#ners< an indica#ion of all researchers. e+perience or e+#ra #raining if re(&ired 75@s help indica#e an$ -#rac, record. of relevan# e+perience in #he field< ac,no*ledge an$ gaps in compe#ence (especiall$ for novice researchers) and ho* #hese *ill %e me#:< Iphofen/Oates (v.2) 0?.0?.09 A

;a clarifica#ion of an$ advice or cons&l#a#ion #ha# has %een &nder#a,en on pro'ec# design s&ch as peer revie* of #he me#hodolog$< ;names of sponsor and/or s&pervisor(s) 7#his ma$ %e a formal re(&iremen# for research governance:< ;an$ s#a#emen# rela#ing #o research s&%'ec#s. (service &sers, s#aff, carers e#c.) par#icipa#ion in #he design of #he pro'ec#. 7ma,ing clear #heir precise #as,s/role: Research Protocol ) f&ll research pro#ocol m&s# %e provided e+plaining ho* and *h$ #he research is #o %e cond&c#ed. "he pro#ocol sho&ld con#ain: Literature review ;an ade(&a#e revie* of #he e+is#ing li#era#&re or previo&s research ;clarifica#ion of *he#her #he proposed s#&d$ replica#es prior *or, )=>/BR ;d&plica#es *or, done else*here;)=>/BR ;con#ains an elemen# of originali#$. Methodology ;an o&#line of and a ra#ionale for #he research design or approach #a,en< ;de#ails of #he research me#hod(s) #o %e emplo$ed and an$ com%ina#ions of #echni(&es or me#hods (e.g. a social s&rve$ emplo$ing a self comple#ion (&es#ionnaire)< ;i# sho&ld %e clearl$ indica#ed #ha# #he iss&es associa#ed *i#h #he &se of #he me#hods %eing advoca#ed are f&ll$ &nders#ood< ;an$ diffic&l#ies associa#ed *i#h #he &se of #he me#hod(s) proposed are addressed %$ #he prospec#ive researcher< ;de#ails for an$ research ins#r&men#s/meas&ring devices #o %e emplo$ed (e.g. (&es#ionnaires copies of *hich need #o %e appended #o #he proposal< pre valida#ed and relia%ili#$ #es#ed ins#r&men#s offer a degree of sec&ri#$ for #he val&e of #he research #o %e cond&c#ed and i#s compara#ive po#en#ial)< Iphofen/Oates (v.2) 0?.0?.09 !

;de#ails of an$ %aseline and o&#come meas&res #ha# *ill %e #a,en< Participants ;f&ll e+plana#ion of da#a collec#ion proced&res *hich se#s o&# in de#ail: ;an$ sampling s#ra#eg$, ;an e+plana#ion and '&s#ifica#ion for #he sample siCe if sampling of a pop&la#ion is #o %e cond&c#ed, ;an$ calc&la%le po*er and effec# siCes if appropria#e, ;#he ra#ionale for an$ p&rposive or #heore#ical sampling provided. ;an e+plana#ion of ho* research s&%'ec#s migh# %e s$s#ema#icall$ e+cl&ded from par#icipa#ion/selec#ion dependen# on sampling s#ra#eg$ or considera#ions for minimising an#icipa#ed harm #o #hem, #heir gro&p and/or #heir comm&ni#$< ;f&ll e+plana#ion of #he proced&re for ga#hering/collec#ing da#a< ;f&ll e+plana#ion of proced&res for anon$mising da#a and/or #he main#enance of confiden#iali#$ if #his is proposed< Data Storage and Protection ;f&ll e+plana#ion of #he proced&re for s#oring da#a and *he#her #he da#a *ill %e re#ained or archived for secondar$ anal$sis. If da#a is #o %e disposed of de#ails m&s# %e given for ho* and *hen #his *ill happen. ...an ass&rance #ha# #he proposed pro'ec# is complian# *i#h #he >a#a Pro#ec#ion )c#, and ho* #ha# ass&rance can %e g&aran#eed. ;a f&ll e+plana#ion of #he da#a anal$sis proced&res #ha# *ill %e emplo$ed. D&ch as: ;if (&ali#a#ive da#a anal$sis is #o %e emplo$ed an o&#line of #he proced&re for coding/ca#egorising da#a and if and ho* an$ da#a red&c#ion *ill #a,e place< ;if (&an#i#a#ive da#a anal$sis is #o %e emplo$ed, an o&#line of #he proced&re for gro&ping, colla#ing and s#a#is#icall$ #es#ing da#a rela#ionships specif$ing #he #es#s #o %e &sed< ;an o&#line of #he &se of an$ comp&#er assis#ed da#a anal$sis (e.g. DPDD< =@ivo) and ho* and *h$ s&ch me#hods are #o %e applied.

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;some evidence of a%ili#$ #o an#icipa#e an$ po#en#ial so&rces of %ias #ha# co&ld compromise #he rigo&r and/or #he o%'ec#ivi#$ of #he pro'ec#. Dome de#ail a%o&# ho* #hese pro%lems migh# %e addressed if #he$ arise. ;an assessmen# of an$ po#en#ial for harm #o individ&als, gro&ps or socie#$ and ho* #his migh# %e addressed. "he #$pes of harm #o %e assessed migh# incl&de: ps$chological, ph$sical, social, economic and legal< and considera#ion m&s# %e given as #o *he#her #he harm accr&es from par#icipa#ion or s$s#ema#ic e+cl&sion from par#icipa#ion. Dome indica#ion of ho* an#icipa#ed harms migh# %e addressed sho&ld %e s&pplied #oge#her *i#h a proced&re for handling an$ complain#s. ;an assessmen# of #he po#en#ial -v&lnera%ili#$. of mem%ers of #he research pop&la#ion and ho* #his migh# %e addressed< Project imeta!le ;a clear o&#line of #he pro'ec# #ime#a%le no#ing ,e$ s#ages in #he pro'ec# s&ch as: ;an#icipa#ed s#ar# and comple#ion da#es< ;period of des, research and li#era#&re revie*ing< ;an$ pilo# *or, or feasi%ili#$ s#&d$< ;#he se(&encing of in#erven#ions, %aseline, o&#come and eval&a#ion meas&res< ;#he period se# aside for da#a anal$sis and prod&c#ion of repor#s< ;an$ an#icipa#ed o%s#acles #o comple#ing on sched&le. 7Inser# F)="" and/or P4R" char#s or, a# leas#, a simple #a%&la#ed #ime#a%le *i#h #he a%ove i#ems incl&ded sho*ing a*areness of #he an#icipa#ed #ime needed #o accomplish #he given #as,s.:

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Research #enefits ;an o&#line of #he an#icipa#ed %enefi#s of cond&c#ing #he research. "hese co&ld %e %enefi#s #o research s&%'ec#s/par#icipan#s, clien#s, service &sers, s#aff, governmen# (local and na#ional), #he research si#e, #he researcher(s) and/or #he research organisa#ion. ;an e+plana#ion of an$ gro&nds for generalising #he research findings %e$ond #he immedia#e research si#e, organisa#ion or s&%'ec# gro&p/pop&la#ion ca#egor$ %eing s#&died e.g. regionall$, across #he HI, and/or in#erna#ionall$< ;an o&#line of all in#ended forms of dissemina#ion for #he research findings #o incl&de: ;an in#ernal research repor# for f&nders/commissioners< ;a p&%lic repor# (#arge# n&m%ers and a&dience specified)< ;press release #o local/na#ional media< ;an assessed research disser#a#ion or #hesis< ;conference/seminar presen#a#ions (local/na#ional/in#erna#ional)< ;a self p&%lished research repor#< ;scholarl$/professional 'o&rnals. ;an o&#line of an$ an#icipa#ed limi#a#ions #o #he p&%lic availa%ili#$ of #he pro'ec#.s findings. ;clarifica#ion if research s&%'ec#s (services &sers, clien#s, s#aff, carers e#c.) *ill %e involved in dissemina#ion/implemen#a#ion of research findings in an$ *a$< if no# an e+plana#ion of *h$ #heir incl&sion is no# necessar$ and/or &n'&s#ified< or if #he$ are #o %e involved a ra#ionale for *h$ #his *o&ld %e of %enefi#. ;an o&#line of ho* #he research findings migh# help deliver %e##er services, prod&c#s or offer some improved val&e for mone$<

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;some considera#ion of *he#her #he research *ill %e of direc# %enefi# #o #he research si#e in *hich i# is %eing cond&c#ed in #he form of: ;helping develop local research s,ills< ;con#ri%&#ing #o #he research infras#r&c#&re in #he organisa#ion< ;providing a %asis for f&r#her research and developmen#< ;res&l# in *a$s in *hich managemen# and professionals can improve service/prod&c# deliver$. ;a disc&ssion of #he feasi%ili#$ of implemen#ing an$ findings in #he research si#e, local comm&ni#$, more generall$ or o#her services.

$imiting Research Ris%s ;an o&#line of an$ ris,s #o researcher(s), s&%'ec#s, organisa#ions or #he pro'ec# as a *hole #ha# can %e an#icipa#ed< ;de#ails of an$ ris,s #o an$ colla%ora#ing social services gro&p from permi##ing #he pro'ec# #o %e cond&c#ed (#his incl&des #he governance revie*ing commi##eeK)< ;a comple#ed ris, assessmen# form (append a comple#ed 8Pro'ec# Ris, )ssessmen# Ma#ri+9)< ;a specifica#ion of #he s$s#em for recording and repor#ing an$ serio&s adverse even#s< ;a specifica#ion of #he indemni#$/ins&rance provision sec&red agains# an$ non negligen# harm. (5opies of cer#ifica#es sho&ld %e appended.) ;a specifica#ion of #he means *here%$ s&%'ec#s (clien#s, service &sers, s#aff, mem%ers of #he p&%lic e#c.) *ill %e informed of #he na#&re of #he pro'ec# and precisel$ ho* #he s#&d$ *ill %e descri%ed #o po#en#ial par#icipan#s (s&ch as in Iphofen/Oates (v.2) 0?.0?.09 ?

#he form of informa#ion leafle#s and/or informa#ion le##ers< or sched&led/scrip#ed oral descrip#ions< copies of #hese sho&ld %e appended #o #he proposal). ;an o&#line of #he pro#ocol for o%#aining par#icipan#s. consen# #o ga#hering da#a and #o an$ f&r#her archiving or secondar$ da#a anal$sis (s&ch as consen# forms< again copies sho&ld %e appended). 75onsen# can %e gained in a varie#$ of *a$s depending &pon research design so i# need no# %e in #he form of a *ri##en, signed and *i#nessed consen# form if s&ch a proced&re is deemed #hrea#ening or in#imida#ing #o par#icipan#s or inhi%i#ive of a valid me#hodolog$.: ;specifica#ion of ho* #he par#icipan#s *ill %e given 8#ime #o #hin,9 a%o&# *he#her #he$ *ish #o par#icipa#e< and ho*, if #he$ *ish #o discon#in&e par#icipa#ion, #his *ill %e facili#a#ed.

Project &anagement ;an o&#line of #he lines of responsi%ili#$ involved in #he cond&c# of #he research. 7)n indica#ion of *ho is acco&n#a%le #o *hom in #he form of an organisa#ional char# *o&ld help.: ;a clear specifica#ion of #he pro'ec# 8delivera%les9 (e.g. poin#s of da#a collec#ion and anal$sis, in#erim repor#s, final *ri##en repor#) and da#es *hen #he$ are d&e 7M&s# %e consis#en# *i#h and ma#ch #he #ime#a%le incl&ded earlier.: ;evidence of #he s&ppor# of appropria#e managers or ga#e,eepers e#c. in #he research si#e< 7*ri##en le##ers of permission sho&ld %e appended #o #he proposal or some s#a#emen# of *hen and ho* s&ch permission *ill %e so&gh#: Iphofen/Oates (v.2) 0?.0?.09 9

;if #his is research co&n#ing #o*ard an ed&ca#ion (&alifica#ion #here sho&ld %e evidence of L4I approval, processing #hro&gh L4I.s governance and e#hics proced&re, in #he form of a le##er of approval incl&ding s&pervisor(s) de#ails and signa#&re(s). ;evidence of 5R6 chec,s if re(&ired for #he pro'ec# and/or researchers. regis#ra#ion *i#h #he Independen# Dafeg&arding )&#hori#$ (ID)).

#udget 'etails ) f&ll %&dge# doc&men# sho&ld de#ail #he an#icipa#ed f&ll cos#s of cond&c#ing #he research and *ho (organisa#ion or person) is ac#&all$ f&nding #he pro'ec#. ;an indica#ion of #he i#emised e+pendi#&re on s&ch #hings as: ;h&man reso&rces ;e(&ipmen# ;#ravel ;s&%sis#ence ;accommoda#ion ;comp&#er hard*are/sof#*are. ;an indica#ion of #he #ime #ha# *ill %e spen# on #he pro'ec# %$ researchers and colla%ora#ors< ;an indica#ion of #he so&rce(s) of f&nding for #he pro'ec#.

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Ethical Concerns Mhile #he &se of #he 84#hics Revie* 5hec,lis#9 helps in an#icipa#ing and declaring e#hical ris,s, #he f&ll proposal sho&ld offer clear evidence for #he follo*ing: Lo* valid consen# from par#icipan#s #o #a,e par# in #he s#&d$ *ill %e o%#ained. Lo* #he in#eres#s of and par#ic&larl$ -v&lnera%le. par#icipan#s *ill %e pro#ec#ed s&ch as #he old, $o&ng people (children &nder 3? $ears), as$l&m see,ers, prisoners, e#hnic minori#ies and #hose *i#h a disa%ili#$. In #he case of s&ch par#icipan#s special arrangemen#s ma$ have #o %e made #o ens&re valid consen# and #his ma$ en#ail #he &se of pro+ies and/or ga#e,eepers. "he proced&re #o %e adop#ed if someone discloses some#hing a%o&# #heir o*n or o#hers. criminal ac#ions and/or provides informa#ion a%o&# &nprofessional %ehavio&r. "he proced&re #o %e adop#ed if an ac#ion is &ncovered #ha# has de#rimen#al conse(&ences for individ&als, gro&ps, organisa#ions or socie#$. 1amiliari#$ *i#h e#hical g&idelines on research prod&ced %$ #he researchers. o*n relevan# professional associa#ions (e.g. Docial Research )ssocia#ion, 6ri#ish Dociological )ssocia#ion, 6ri#ish Ps$chological Docie#$, Docial Polic$ )ssocia#ion, HI 4val&a#ion Docie#$ and so on). "he medical research e#hics principles con#ained in #he Declaration o" #elsinki (&pda#ed 200?) con#ain recommenda#ions of val&e #o social research, so reference #o #heir implemen#a#ion *i#hin #he proposal *ill s#reng#hen evidence for researchers. a*areness of e#hical concerns. In similar vein #he In#erna#ional 5ommission on Leal#hcare.s Food 5linical Prac#ice g&idelines m&s# %e follo*ed if performing a clinical #rial. "he principles con#ained in #his doc&men# co&ld %e applied #o all prac#ice orien#ed s#&dies and ma$ %e of &se Iphofen/Oates (v.2) 0?.0?.09 33

#o an$ s#&d$ adop#ing an e+perimen#al design *i#h e+perimen#al and con#rol gro&ps *i#hin #he social care field as *ell as in heal#h and ma$, conse(&en#l$, %e relevan# #o a range of research in social and %ehavio&ral science. "he proposal #hro&gho&# sho&ld con#ain indica#ions of proced&res #o %e adop#ed if serio&s &nan#icipa#ed e#hical and/or me#hodological diffic&l#ies arise.

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