* James CookTS4 3BW, UK. T

E-mail addr

1355-1841/$ -doi:10.1016/j.j

Journal of Neonatal Nursing (2009) 15, 18e24

www.elsevier.com/jneo

An exploratory study to determine how parentsdecide whether to enrol their infants intoneonatal clinical trials

Simonne Jollye*

James Cook University Hospital, Marton Road, Middlesbrough TS4 3BW, UK

Available online 15 October 2008

KEYWORDSParents;Risks/benefits;Neonatal researchtrials;Decision making;Altruism/guilt

University Hospital, Mael.: þ44 1642 854871.ess: simone.jolly@stee

see front matter ª 200nn.2008.07.012

Abstract Neonatology is a relatively young discipline with many aspects of care asyet not investigated. Consequently parents of sick newborn babies are often ap-proached to consider enrolling their infants into clinical trials. The aim of this qual-itative study was to determine how parents decide whether to enrol their baby intosuch trials. The findings illustrate parents make their decision following a typicaljourney. Once the initial shock of having a baby admitted to the Neonatal IntensiveCare Unit (NICU) subsides, they weigh-up the risks and benefits of the trial againstthe need to protect their baby from perceived harm. Parents who chose to partic-ipate believe there was no harm to their baby. They display altruistic principlesstating they were pleased to be helping future babies. Parents who decline seethe risks to their baby as being too great. Upon reflection these parents experi-enced guilt at not participating in a trial. Parents are supportive of neonatalresearch providing they see the benefits out-weighing the risks.ª 2008 Neonatal Nurses Association. Published by Elsevier Ltd. All rights reserved.

Introduction

Health Care Professionals (HCP) are only too awareof the need for high quality neonatal research asa means of improving both quality as well asoutcome for newborn babies (Morley et al., 2005).However, it is unknown if parents share thisinsight. Singhal et al. (2002) write there is a gap in

rton Road, Middlesbrough

s.nhs.uk

8 Neonatal Nurses Association

the literature surrounding parental attitudes toneonatal research. Authors including Stenson et al.(2004), Hoehn et al. (2005) and Morley et al. (2005)state that there is limited data availabledescribing how parents experience the researchprocess. Chappuy et al. (2006) also agree statingmuch of the current literature is focussed on‘‘informed consent’’ rather than parental under-standing and attitudes towards research.

The literature suggests the vast majority ofparents who are approached for neonatal researchwill consent (Snowdon et al., 1997; Campbell

. Published by Elsevier Ltd. All rights reserved.

HOW DO PARENTS DECIDE WHETHER TO ENROL THEIRINFANTS INTO NEONATAL RESEARCH TRIALS?

Emotional turmoil of baby being admitted to the NICU.Effect of this when first approached about clinical trials.

How parents decide whether to enrol their infants into neonatal clinical trials 19

et al., 1998; Burgess et al., 2003; Morley et al.,2005). These authors acknowledge parents expe-rience guilt, stress and anxiety in making thedecision to enrol their infants into trials. However,they do not convey how parents made their deci-sion knowing they experience such emotions.

Many publications explain why some parentsreadily agree to participate in neonatal studies.Parents express altruistic views as being a reasonfor enrolling their infants into research (Hoehnet al., 2005; Gammelgaard et al., 2006). They alsoview entering into research as a morale obligationto the NICU and society (Mason and Allmark, 2000).However, there is a dearth of information on theopposing side of the discussion as to why someparents decline to participate. Research by Masonand Allmark (2000) and Hoehn et al. (2005)discovered some parents believe the risk of a trialto be too great, whilst other parents displayinherent anti-experimentation beliefs. Otherparents chose not to enrol in research as they didnot like the attitude of the clinician whoapproached them. These authors acknowledgemore research needs to be conducted within thisarea.

Clinical trials play an essential role in ensuringneonatal practice is evidence based. Chappuyet al. (2006) acknowledge little is known about theunderstanding of parents and the process by whichthey make their decisions to enrol their child intotrials. In order to help address this gap in theliterature this study aimed to explore the thoughtsand feelings of parents in their decision makingprocess in either choosing or declining to partici-pate in neonatal clinical trials.

Gradual understanding & acceptance of the situation.Prepared to think about clinical trials.

Contemplating clinical trial.

Risks Benefits

Decision making process.

No harm perceived to babyYes to research

Perceived harm to babyNo to research

Altruistic views“Feel good factor”

Feel guilty for notbeing in trials

Figure 1 Illustrating the journey parents experience intheir decision making process.

Methodology

A qualitative research design was adopted for thisstudy. This allowed parents the opportunity toexplore their thoughts and feelings in choosing ordeclining to enrol their baby into clinical trials. Apurposeful sample was selected from parents whohad been approached for clinical trials. Theseparents had either chosen or declined to partici-pate. Seven families were interviewed. For theduration of this study the NICU was involved inthree non-urgent clinical trials. These werea ventilation trial comparing two modes of CPAPventilation, a blood transfusion trial comparinga single infusion to a divided dose 24 h apart andan immunoglobulin trial comparing this witha placebo. Data was collected in the form of semi-structured interviews two months after the babywas discharged home. These recorded interviews

were transcribed and analysed using an opencoding mechanism similar to that described byCresswell (1998).

Ethical approval was sought from the Universityof Northumbria, The R&D department at the localhospital and the LREC committee. Parentalconsent was obtained prior to conducting theinterviews.

Findings

In analyzing the data it emerged that parentsundertook a journey in their decision makingprocess. This journey is illustrated in Fig 1 and willbe discussed in detail.

Emotional turmoil of having baby admittedto NICU & effect of this when firstapproached about research

Emotions parents experienced when their babywas admitted to the NICU include shock, anxiety,guilt and fear. Parents recognised that they hada complete lack of understanding of the situationand were unsure what the future held. Parentswere not prepared for what to expect when theyfirst saw their baby finding the machines and noise

20 S. Jollye

very frightening. Upon reflection all parents wouldhave liked a tour of the NICU prior to delivery.Parents who had been visited by a member of theNICU team did not remember anyone mentioningthe NICU was involved in research. In hind sightthey thought this might be beneficial.

When clinical trials were first mentioned toparents they were shocked to be approached atsuch an emotional time.

‘‘You just think Oh God something else, anotherthing to have to think about when you’ve got thislittle baby and all you can think about is if he’sgoing to be OK’’

(Interview E: Mother)

Parents found it disconcerting they were beingasked to make a decision regarding enrolling theirbaby in a clinical trial. Parents stated they did notfully understand what was happening and wereconcerned that they had to make a decision whenthey were trying to grasp the reality of the situation.

‘‘You know I can’t believe we are being asked tomake a decision (about research) you know wedon’t know what is going on.’’

(Interview B: Father)

Parents’ initial views were confusion about whythey were being asked to make these decisions atsuch an emotional time.

Gradual understanding and acceptance ofsituation. Prepared to think aboutclinical trials

Within a few days parents experienced a gradualacceptance of the situation. Relationships withstaff began to form resulting in parents askingmore questions. It was at this time parents beganto think about the research trials in more detail.Some parents acknowledged they were worriedabout involving their baby in research due to theirinterpretation of the word ‘‘research’’.

‘‘. you say the word ‘‘research’’ and you hearthat many things about things that go wrong.’’

(Interview B: Mother)

Parents demonstrated a clear understanding ofthe research process. They could describe thetrials they were approached for in detail andremembered being given written information andhad the opportunity to ask questions. Parentsknew they could withdraw from the trial at anystage. One area parents were unsure aboutinvolved follow-up once the trial was completed.

‘‘with our consent they were testing but I do notknow if Daniel would get checked up. I’m notsure.’’ (anxious tone)

(Interview A: Mother)

All parents thought the clinician approachingthem about a trial was courteous and proficientstating the more confident the researcher was intheir approach the happier they were. Parentspreferred to be approached for a trial in the NICUin front of their baby. Parents who wereapproached on labour ward found this frightening.Their initial reaction was that something musthave happened to their baby and that is why theDoctors want to enrol them into a trial. Once thesituation had been clarified the parents were ableto consider the trial. When parents had graspedthe concept of the clinical trial they began toweigh-up the risks and benefits to their baby.

Contemplating the research trial e risksand benefits

The most significant theme that emerged from thisstudy was the parents’ perceptions of the risks andbenefits of the research trial(s). Once parents hadevaluated these they were able to make theirdecisions. The most important issue was theresearch must not harm their baby and hencewanted to protect them.

‘‘it (research) should not hurt the baby should it?And they should not get any problems.’’

(Interview D: Mother)

All parents discussed the risks and benefits foreach trial they were approached for.

Ventilation trialIn order for babies to be randomised into this trialthey must have improved sufficiently on theircurrent ventilation. Parents expressed this trial didnot cause them great concern as their babies wereprogressing well. They were aware their babieswould need some form of respiratory support andthought there was no great harm to their baby witheither arm of the trial.

‘‘.there wasn’t anything that would harm Poppyso we decided you know, we would be quite happywith that (trial).’’

(Interview C: Mother)

Parents saw their baby benefiting from thisstudy as their condition continued to improve. Thisreassured them they had made the right decision.Parents admitted they had no preconceived

How parents decide whether to enrol their infants into neonatal clinical trials 21

knowledge about neonatal ventilation and there-fore were happy to put their trust in Doctors andconsent to the trial.

‘‘Really it was a case of thinking we’ll just put thetrust in you.(Doctors)’’

(Interview D: Mother)

A couple of parents expressed concern overissues of randomisation. One set of parentsdecided to consent to the ventilation trial but ifthey were not randomised to what they perceivedas the ‘‘right’’ arm they had already made a deci-sion to withdraw from the trial. Some parentsexpressed concerns about whether the resultsfrom the research would illustrate that the armtheir baby was randomised into was the leasteffective.

‘‘.what if Anna is put on (one arm of trial) andthings didn’t work out as well.would it have madea difference if Anna had the other type.?’’

(Interview G: Father)

Generally there were few concerns expressedabout this trial from all parents. They acknowl-edged the study was mentioned to them at a timewhen their baby was improving and hence found iteasier to consent.

Blood transfusion trialMost parents who were approached about theblood transfusion trial experienced anxiety indeciding whether to participate. They saw thistrial as having more risks than the ventilation trialas they had more knowledge about blood trans-fusions than neonatal ventilation.

‘‘(ventilation trial) you think you know absolutelynothing about it where as with the blood you havea preconceived idea.I think that is the hardestbecause then you put together what you haveheard and a little about what you know.’’

(Interview A: Mother)

Parents found it harder to make a decision iftheir baby was unwell as they thought there was anincreased risk of harm by being in the trial. Theyacknowledged they were influenced by externalfactors including the connotations of havinga blood transfusion. The need for a blood trans-fusion was perceived by many parents as the babybeing unwell.

‘‘You associate a blood transfusion with someonebeing sick, really sick.’’

(Interview F: Mother)

Parents expressed concerns about their infantbeing exposed to a potential risk of developing aninfection if they were randomised to receiving theblood transfusion in two doses. The need toprotect their baby from an infection caused manyparents great anxiety.

Immunoglobulin trialParents were approached for this trial at a timewhen their baby was becoming unwell with a sus-pected or proven sepsis. One major issue parentsexpressed with this trial was the need to thinkabout research at such a time. Most parents chosenot to be involved in the immunoglobulin trial asthey were worried the trial would harm their baby.Parents worried if they participated and theirbaby’s condition deteriorated if would be theirfault for enrolling the baby in the trial.

‘‘if anything did happen you think ‘‘Oh God is itbecause I entered Lucy into that research.?’’(anxious tone)

(Interview B: Mother)

Whilst weighing-up the risks and benefits of theimmunoglobulin trial parents voiced concernsabout having to make a decision when their babywas unwell. Most parents chose not to participatein this study as they worried that being in the trialmight make their baby worse.

Decision making process

It emerged in this study parents would watch andlisten to what is happening to other infants in theNICU. Many parents stated if they saw a babyenrolled into a trial they had been approachedabout they would observe that baby and may evenchoose to discuss the trial with the parents.

‘‘Really it’s a case of its best asking other peoplearound who have been through it as well.’’

(Interview A: Mother)

Apart from discussing the trials amongst them-selves most parents discussed the trials with familyand/or friends. It became evident the immediatefamily were reluctant to make a decision or offeran opinion. However, they were supportive ofparents in the decisions they made.

‘‘You were asking (your) parents what do you thinkwe should do, nobody really wanted to committhemselves to giving an answer.’’

(Interview B: Mother)

Some parents found it difficult to make theirdecision and worried whether it was the right

22 S. Jollye

decision. At times parents did not want to makea decision at all. Some parents wanted the Doctorsto decide for them whilst other parents wantedmore support from family and friends in the deci-sion making process.

‘‘Sometimes you do want somebody to take thatresponsibility away from you.’’ (quiet pause)

(Interview F: Mother)

All parents stated they made a joint decisionregarding participating in clinical trials. However,this study concludes many mothers tend to makethe final decision. Though parents would discussthe trials together the final decision was often leftto the mothers.

‘‘He just said ‘‘I don’t know you are going to haveto make the decision.’’

(Interview F: Mother)

The mothers to whom this happened found itdifficult and upsetting as they constantly worriedabout the consequences of their actions.

‘‘He sort of put it straight to me and that upset mea little bit as I was thinking I’m making this deci-sion and what if it’s wrong?’’

(Interview B: Mother)

Many parents stated they felt great anxiety andguilt about enrolling their baby into researchwhich lasted for the duration of the trial. Theyexperienced a sense of relief when the researchwas complete.

Consent to research as no perceivedharm to baby

Parents who chose to participate in researchdeveloped an altruistic view by seeing themselvesas helping babies of the future. They acknowledgeprevious parents who had been involved inresearch had helped their baby and thereforewanted to show their appreciation by helpingfuture babies.

‘‘We thought well obviously they (parents) had tomake these decisions in the past which has obvi-ously given Daniel the care that he’s had.’’

(Interview E: Mother)

Parent’s recognised research was necessary toprogress neonatal care and upon reflection werepleased to have participated. When asked ifthey would have wanted to be involved in moretrials all but one set of parents said they would

be happy providing they saw a benefit to thetrial and there was no perceived harm to theirbaby.

Parents who had chosen to participate in clin-ical trials displayed an overwhelming sense ofsatisfaction to have been involved in the trial(s).This has given them a sense of pride and wellbeing.

‘‘If we’ve helped now for something in the futurethen you’ve done your bit e you know what Imean? (laughs)’’

(Interview G: Mother)

No to research as perceived harm to baby

Though parents recognise the need for researchsome chose not to participate in certain trials asthey saw the risks out-weighing the benefits. Theydid not want their baby to endure what theyperceived as further suffering and worried if theirbaby deteriorated it would be their fault forenrolling the baby in the trial. On reflection theseparents experienced guilt at reaching thisdecision.

‘‘If circumstances were different.we probablywould have thought more about putting Joshua inthe (immunoglobulin trial) because they have to dothese things to develop.’’

(Interview F: Mother)

Parents gave many reasons for not participatingin research including they would have liked moretime to time to think about the trial, particularly iftheir baby was unwell. They stated that if they hadknown about the trial before their baby was unwellthey may have considered participating as theywould have been more prepared.

‘‘Maybe if we had been told about the bloodtransfusion side of it a little bit earlier we mighthave been able to get our heads round it.’’

(Interview B: Mother)

Though parents stated they did not feel pres-sured into enrolling in a trial they experiencedguilt upon reflection for not participating and inhindsight wondered whether they should haveparticipated.

Discussion

The findings of this study illustrate parents expe-rience a journey in their decision making process

How parents decide whether to enrol their infants into neonatal clinical trials 23

(see Fig. 1). This journey is not evident in thecurrent literature, however, many of the emergingthemes are documented.

The emotional turmoil that parents experiencewhen their infant is first admitted to the NICU is wellrecognised. Nicklin and Spencer (2004) state parentsare in an emotional turmoil for the first 48 h of theirbaby’s admission and hence experience difficultiesin coming to terms with the situation. This studyreflects this as parents spoke of not understandingthe situation they were in for up to a week. Singhalet al. (2002) write parents are so stressed when theirinfant is admitted to the NICU they cannot makeimportant decisions regarding their baby’s care. Thiswas evident when parents were questioning whythey were being approached about research andwhy they had to make decisions at such a stressfultime. Snowdon et al. (2005) discovered similarfindings stating when research was first introducedto some parents they experienced overwhelmingfear and anxiety about being involved in a trial.

As parents gradually accepted their situationthey were prepared to start thinking aboutresearch trials. The current literature illustratesmany parents understand the concept of clinicaltrials. However, Mason and Allmark (2000), Burgesset al. (2003) and Stenson et al. (2004) foundbetween 10 and 25% of parents did not fullyunderstand the research process. Within this studyparents clearly demonstrated their understandingof research, however, were unsure about follow-up procedures. This is similar to Chappuy et al.(2006) who found parents had a poor under-standing of the duration of follow-up as part ofa clinical trial. In order to rectify this problema greater emphasis on follow-up both verbally andwritten should be given to parents.

Once parents had grasped the concept of thetrial they weighed up the risks and benefits prior tomaking their decision. This finding is echoed in thecurrent literature with many authors alluding tothis concept. As with this study Tait et al. (2002)state parents rated the risks and benefits to theirchild as the two most important items they neededto understand before making a decision aboutenrolling them in a clinical trial.

Within this study parents expressed an over-whelming need to protect their infant fromperceived harm particularly when their baby wasunwell. Snowdon et al. (2005) discovered parentswho declined to participate in neonatal researchwere doing so out of a need to protect their baby.Singhal et al. (2002) similarly discovered thatparents want to be involved in research but wouldalways act to protect their baby from perceivedharm.

Parents in this study stated they jointly madetheir decision about being involved in a clinicaltrial. However, upon reflection some mothersdivulged the final decision was theirs alone. This issimilar to research by Burgess et al. (2003) whonote more mothers than fathers make the finaldecision regarding research. Snowdon et al. (2005)discovered the final decision making is aimed atthe mother of the baby. This has implications forclinical practice as HCP approaching parentsshould focus on both parents with the emphasisbeing the family agree upon the final decisiontogether. In single parent families it maybe usefulto ascertain who is supporting the mother and withher consent also discuss the trials with the supportperson.

Some parents spoke about observing otherbabies who were enrolled in trials and discussingthis with their parents. There is no evidence in thecurrent literature of this practice. This is an areafor further exploration as it became evident in thisstudy the higher the number of parents in a trialthe more likely other parents would be to enrol inthe same study. This has implications for practiceas parents may be influenced by other parents intheir decision making process rather then theinformation provided.

Within this study many parents expressedaltruistic principles as to why they chose toparticipate in a clinical trial. Burgess et al. (2003)found parents enrolled in trials knowing thatprevious parents had enrolled their babies intoresearch. These parents wanted to contribute tofuture neonatal care like their predecessors.Hoehn et al. (2005) discovered that an altruisticview to helping future babies was the main reasonwhy over 50% of parents chose to participate inneonatal research. Gammelgaard et al. (2006) alsodiscovered parents were motivated by altruism asa reason for enrolling their child into clinical trials.Parents who choose not to participate in researchexperience guilt at not participating in a study.This is similar to work published by Mason andAllmark (2000) and Singhal et al. (2002) who stateparents experience guilt at not participating ina clinical trial. This is an area for more research tounderstand why parents experience such guilt.

Conclusion

This study concludes parents make their decisionsregarding participation in a clinical trial byfollowing a typical journey. They weigh-up therisks and benefits of the trial against a need toprotect their baby from perceived harm. In

24 S. Jollye

reaching their decision parents will discuss thetrial amongst themselves, with their family andother families on the NICU who already havea baby enrolled into clinical trials. Parents whochose to participate believed there was no greatharm to their baby and displayed altruistic views instating they were pleased to be helping futurebabies. Parents who declined to participate ina trial saw the risks as being too great for theirbaby. Upon reflection they experienced guilt atreaching this decision. However, this was a smallstudy in one NICU hence more studies arerequired. Overall parents were supportive ofneonatal research and recognised the need forstudies to be conducted to advance neonatal care.

Acknowledgements

I would like to thank Drager UK for awarding mea Neonatal Nursing Scholarship in 2006 to help fundthis research. I would like to thank my colleaguesfor their help support and encouragement whilst Iwas undertaking the study and finally I would liketo thank the parents who selflessly gave up theirtime for me.

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