Factors That Influence Women’sDecisions About Whether to Participate

in Research: An Exploratory Study

Lisa Baker, DipHeMid Studies, RM, RGN, Tina Lavender, PhD, MSC, RM, RGN, andDouglas Tincello, BSc, MD, MRCOG

ABSTRACT: Background: Women are increasingly being asked to consider participating inmedical research. We sought to investigate views of women who participated in and declinedto participate in a study that was part of a program of maternity care research. Methods: Anexploratory study using focus group interviews and semistructured interviews was conducted.A purposive sample of 17 postnatal women who had participated in research, from a hospitalin the North West of England, were interviewed. An open coding mechanism to identifyemergent themes was used for the analysis of data. Results: Of women who had not declinedto participate in any research, the following themes were identified: altruism versus self-protection, enhanced versus inferior care, professional guidance versus self-direction, andwelcome versus unacceptable methodology. Of women who had participated in some researchbut declined to participate in other research, the following themes were identified: feelingdisempowered by the process, inability to believe equipoise existed, and practical incon-venience. Conclusions: These findings suggest that although health care researchers adoptan individualistic approach to care, they may fail to adopt a similar approach within research.What is important and acceptable to women needs to be ascertained to develop appropriateresearch strategies. This plan will ensure that research is carried out to the highest ethicalstandard, which may increase recruitment rates. (BIRTH 32:1 March 2005)

Conducting research within maternity services hasbecome the accepted norm in many units in theUnitedKingdom.However, although long-termbenefitsforwomenandbabies areobvious, the short-term impacton the experience of participants remains unknown.As adirect response to complaints received from womenabout research in the maternity services, the Associationfor Improvements in Maternity Services proposed aResearch Charter (1). The concept of research “with

women” not “on women” (2) is an important principle,but one that is relatively new to the maternity field andhas not yet been fully developed in practice.Studies that have explored and reported the views of

maternity research participants (3–6) are encouraging,and some were conducted of women partaking inone specific maternity trial (3,5–7). Women participatein research for many reasons, the most frequentof which are altruism (8), feeling special (4), andadditional human contact (3). Nevertheless, little isknown about women’s feelings about nonexperimentalresearch (invasive and noninvasive); their acceptanceof being asked to participate in multiple studies;their views of timing and manner of beingapproached to participate; and reasons for declining.Additional evidence on this subject is anecdotal(9,10), and although it raises awareness of researchissues that are important to women, such informalcontributions are unlikely to change researchpractice.

Lisa Baker is a Midwifery Research Coordinator at the LiverpoolWomen’s Hospital, Liverpool; Tina Lavender is a Professor ofMidwifery and Women’s Health at the University of CentralLancashire, Preston; Douglas Tincello is a Senior Lecturer at theUniversity of Leicester, Leicester, England.

Address correspondence to Tina Lavender, Department of MidwiferyStudies, University of Central Lancashire, Preston, PR12HE, UnitedKingdom.

� 2005 Blackwell Publishing, Inc.

60 BIRTH 32:1 March 2005

We therefore concluded that investigations whichexamine maternity patients’ participation in researchis specific to one particular study, is anecdotal, or isunexplored. The void in the literature, local concernsthat women were being “over-researched,” and adesire to improve research practice led us to embarkon a program of research exploring different per-spectives of research participation. The aim was toexplore the views of women who had consented toparticipate in a variety of research studies within thestudy hospital during the course of their pregnancy.

Methods

In an attempt to provide a multilayered, more validpicture, triangulation of data collection methods wasused (11). This program included an exploration ofparticipants’ views toward research, which is thetopic of this report. The program also comprised alongitudinal survey of women’s views before and afteraccessing maternity services (data not reported).Permission to undertake the study was secured fromthe Trust and Local Research Ethics Committee.

Study Sample

The study was conducted in an inner city hospital inthe North West of England, where approximately6,000 women give birth annually. The study hospitalis a university teaching institution that has a strongresearch awareness and culture. Whereas every effortis made to ensure that women are not overburdenedwith research, on occasion a woman may beapproached to participate in 4 or 5 studies.All women who had an appointment to book for

maternity care at the hospital during one randommonth were provided with information about theresearch. From a cohort of women who completedquestionnaires at two time points (n=132), a pur-posive sample was obtained of women who had partici-pated in research. From this sample, women who haddeclined to participate in some research were alsoidentified. Volunteering women were included ifthey had given birth to a live baby, had participatedin a study during this maternity experience, and werenot having their baby adopted. The number of parti-cipants was not predetermined.

Procedure

Women who had participated in the larger study hadreceived written and verbal information in theantenatal period before completing two question-naires. On the second questionnaire they indicatedwhether they would consent to be interviewed at

between 6 to 12 weeks after childbirth. Focus groups,conducted in the hospital, were arranged with parti-cipants who had not declined to participate in anyresearch, and individual interviews in the partici-pant’s home were arranged with those who haddeclined.A semistructured approach was used, the interview

schedule being compiled from the current literatureand debates generated from local and national mid-wifery forums. All interviews were audiotaped, andcontemporaneous field notes kept. On completion ofeach interview the facilitator gave a verbal summaryof the main points to ensure authenticity of interpre-tation.The audiotapes were transcribed verbatim, using

pseudonyms, and a qualitative software packageWinMax Pro (12) assisted with data organization.Analysis used an open coding mechanism to identifyemergent themes. Two researchers (LB, TL) viewedthe responses, from which they independently gener-ated themes to minimize interpreter bias. Data werethen collated and individually discussed until a con-sensus was reached.

Results

Of the 132 women who met the eligibility criteria, 43volunteered to participate in the exploratory part ofthe study. Of this group, 37 had participated inresearch and consented to join focus groups, which12 women attended. Six of the 43 women had bothparticipated in and declined to participate inresearch, and consented to individual interviews,which 5 women attended. Reasons for nonattendanceincluded bereavement, bad weather, personal orfamily illness, and unknown. The total number ofparticipants was 17 women.

Focus Group Participants

Focus group participants included women who hadparticipated in research and not declined to partici-pate in any studies (n=12). Four focus groups werefacilitated, each comprising 2 to 5 participants. Eightwomen were married, 2 women were co-habiting, and2 were single, and all women were between 6 and 10weeks postpartum. Women lived in a variety of areas,as was evident from the range of underprivileged areascores (13). All women were white British, and one-half were primiparas with various levels of education.The median age of participants was 32.5 years (range17–40 yr). The median number of studies in whichthey had participated was 2 (range 1–4), containinga combination of observational and experimentaldesigns.

BIRTH 32:1 March 2005 61

The themes generated reflected the opposing dilem-mas that women faced when considering researchparticipation. They included altruism versus self-protection, enhanced versus inferior care, professionalguidance versus self—direction, and welcome versusunacceptable methodology.

Altruism versus Self-protection

Some women wanted to “give something back to thehospital” to show their “gratitude by helping.” Manyindicated that they wished to assist in improvingmaternity care despite acknowledging that they per-sonally had little or nothing to gain.Women were clearly aware of specific practice

implications of research, which gave them some moti-vation to participate. For example, Carol said:

Research should take place for advancement . . . . Look how

we have come from the dark ages. Our mothers used to

labor on their backs, yeah, and have an enema and shave

(laugh). It’s (research) needed to move care forward.

However, some womenwere reluctant to consider parti-cipation in some research that they believed wouldthreaten the emotional or physical well-being of them-selves or their baby. Although study women had parti-cipated in several qualitative studies that hadencouraged them to express their views, they recognizedthat this would be inappropriate for some women. Oneparticipant who related research to a previous negativechildbirth experience clearly was unable to disassociateaspects of the research with that of the care.

You know, I just want to put it all behind me, I don’t really

want to participate, and it brings back too many memor-

ies . . . . Yeah, it’s like a whole package if there are any bad

things, you just try and block it out. (Cathy)

As expected, all participants wished to protect theirbabies from potential harm associated with research.Although they were happy to consent for the baby’sparticipation in noninvasive studies, they were extre-mely cautious about participation in studies invol-ving what they perceived to be hurtful or harmfulprocedures, such as venipuncture or administrationof drugs. Before making decisions on behalf of theirbabies, women suggested that they had to weigh theperceived benefits versus risks:

I think if they had to do something medical like giving

blood or, well then I might be a bit like, you know, should

I put him through all that? (Rebecca)

Some women expressed disdain toward womenwho had declined participation in research. In parti-cular, they implied that those wishing to access theservice have some responsibility to contribute to thegeneration of new knowledge:

Oh, I see. They (decliners) want us to do all the hard work

and reap the benefits of the research. Good isn’t it? It

doesn’t take long to fill in a questionnaire. That’s selfish.

(Mary)

Enhanced versus Inferior Care

Women had different views related to the impact ofresearch on their care. Some women thought thatresearch enhanced their personal experience, whereasothers thought it had the potential of a more negativeeffect. For some, being approached to participate inresearch made them feel “special” and valued. How-ever, concerns were raised that research participationcan make an individual feel vulnerable:

If I go into research, what will happen? Will I be used as a

guinea pig, will it affect what will happen, and will my care

not be as good? (Donna)

Concerns were also expressed about the potentialretribution if they chose not to participate or to with-draw from any study:

Am I going to get the standard of care that you can expect?

And if I decide suddenly that I don’t want to do this because

I don’t feel up to it, is it going to be, like, ‘she wouldn’t do

this, you know, we’re not going to help you out’? You know

you think all kinds. (Shirley)

Furthermore, some women were worried that thecare to which they were allocated within a studymight be an inferior standard of care comparedwith that received by others. It was important towomen that care among women was equitable:

I think people will think that it will affect their standard of

care and, you know, will get second class care because they

are being tested, so they may think that may cause problems

when they are in labor, for example . . . I think it is impor-

tant that you do not feel like your care is really different

from everybody else’s. It is when you’re in a roller coaster

going along and you feel that you’re totally out of control

and . . . you could feel very angry. (Donna)

This perception also demonstrated that consenting toparticipate in research could lead to lack of controland feelings of anger.

Guided versus Self-directed Decisions

A woman’s decision to participate was either self-directed or made with guidance from her partner,health professional, or researcher. When researchhad no obvious impact on the baby, women appearedmore able to reach an autonomous decision aboutparticipation:

It’s a personal choice isn’t it? They (researchers) don’t put

your arm up your back and say you have got to do it. If you

don’t want to, you just say no. (Cathy)

62 BIRTH 32:1 March 2005

Some women had an opposing view, suggestingthat they did not want to choose whether or not toparticipate in research, and would feel relieved if theonus were removed from them. Interestingly, somewomen believed that research should be incorporatedinto routine care.

I don’t even think that you need to mention it (research). I

think you should just do it. I think you should just intro-

duce research as part of the normal regime. (Ruth)

Yes, I think so, too. I think it’s just making some really

simple intervention complicated by going into it all . . . . Just

do it, and the women would know no different. (Alison)

Women’s decision-making process differed whenconsidering whether to consent for research thathad an impact on their baby. In these instances,they were much more inclined to involve their part-ner. For some couples a unanimous decision had tobe reached, which was particularly pertinent whenconsidering studies that involved invasive procedures:

I wouldn’t just participate in it, but when it is down to the

baby, if it was anything other than behavior or something

like that, if it was invasive, then I would involve him.

(Rebecca)

Welcome versus Unacceptable Methodology

Women discussed several methodological issues,some favorably and others less favorably. The mainissues were the number of studies they wereapproached to participate in, timing of approach toparticipate, manner and status of the researcher andmethod of communicating research information, andstudy design. Some women suggested a limit to theamount of research they should be asked about; forexample, Donna said:

I think if you feel, if you were asked to be doing, involved in

too many things, well I feel then you would say, just let me

get on with it, I’ve had enough! And then you might get very

negative, feeling down and depressed.

However, others were disappointed when they werenot approached to participate in research for whichthey were eligible:

I was in theatre and was asked if I had consented to a cord

blood study, which I hadn’t. I couldn’t take part because I

hadn’t consented. I would have liked to take part. They

missed a golden opportunity. (Carol)

The timing and manner of approach, and methodof communication were believed to be important.Women preferred written and verbal information,given in a conducive environment, before decidingon research participation:

It would be easier if it (approach to participate) was in a

more relaxed setting, sort of, where you have got a lot more

control, where it is a more relaxed situation, and perhaps

you are given something that is written, and you also have it

explained, and you are allowed to ask questions, and then

with a person who isn’t confrontational. (Shirley)

However, some women acknowledged the difficul-ties faced by researchers wishing to conduct intrapar-tum studies:

But I think that is what the difficulty is, because labor is

only a set amount of time, and if you want to do research in

that set amount of time, at the end of the day, you have got

to ask them in that time. (Shirley)

Some women thought that the professional ap-proach, status, and manner were important factorsin determining whether or not they consideredresearch participation:

I think some people may be more nervous of a doctor . . . but

not nervous . . . I mean, perhaps feel, if you are talking about

pressurized, they might feel a bit more from a doctor than a

nurse. But I think that it would be that person not the

position of the person—someone may feel more intimidated

by different professions, but in general, it would be more the

individual rather than what the profession was. (Donna)

Some women implied that they were more impressedand perhaps more likely to take part if the obstetricconsultant approached them:

I think speaking with the consultant always puts the profes-

sional edge on it . . . . it was nice that he bothered. (Lesley)

Some women did not like the concept of randomi-zation due to the element of chance, which theythought to be “flippant,” and detrimental to care.No participants welcomed the potential use of mate-rial incentives to encourage participation, stating, “Itis more like a bribe.” They thought that incentivesmight entice participation for the wrong reasons andcould make it difficult to withdraw if desired.

Individual Interview Participants

Individual interview participants included womenwho had participated in research and declined toparticipate in another study (n=5). Three womenin this group were married and 2 were single. Allwomen were between 6 and 10 weeks postpartum.Women lived in a variety of areas, as was evidentfrom the range of underprivileged area scores (12).All women were British (4 white, 1 black); 3 wereprimiparas, and all had education below graduatelevel. The median age was 28 years (range 19–35 yr).The median number of studies in which they hadparticipated was 2 (range 1–2), combining observa-tional and experimental designs. All had declined onestudy.

BIRTH 32:1 March 2005 63

Women were generally positive about research inwhich they had taken part, and themes were consist-ent with those of the women who participated in thefocus groups. The additional themes that emergedrelated to reasons for declining certain studies, feelingdisempowered by the process, inability to believeequipoise existed, and practical inconvenience.

Feeling Disempowered by the Process

Women discussed the process of research as being akey factor in deciding whether or not to participate.Disempowerment was perceived by women to haveoccurred through lack of an individualized approach,timing of the approach, and the vulnerability theprocess made them feel.

Lack of individualized approach. Although all thewomen talked about participating in research foraltruistic reasons, they wanted their individual situa-tions acknowledged when being asked to participate.For example, Jane said:

I think they have to understand that at the time you are not

really thinking of next year when somebody else is having a

baby, but you’re thinking of right now and you and your

baby . . . they have got to understand that you are stressed

out.

When discussing asking women about research duringlabor, participants were unanimous, saying the“approach should be individualized.” For example,Nicola said:

I don’t think there’s sort of a right or wrong way of doing it

personally . . . but they [researchers] must understand that

we are all different and should take this into account.

Interestingly, women compared the research with thecare they received.

It was weird really, because when the midwife talked to me

about my health she was chatty and caring, but when she

talked about the research it was like I was another number.

(Cheryl)

Timing of approach. Participants were all approachedat different times, according to the nature of theresearch they were asked to consider. However, it wasclear from all their responses that researchinvestigators did not appear to consider the woman’ssituation before presenting them with researchinformation. For example, Ann was approached withinminutes of a vaginal examination, which she felt was“an inappropriate time.” Cheryl was approachedbefore having her labor induced, and said:

That just sort of added to the fear. If I’d known exactly

what was going on, I might have been able to say, well, yes,

I will take part in the research. But it was sort of additional

pressure put on me at the time when I felt I didn’t really

need it.

Jane said:

At the time I was actually in premature labor, and the

doctor came and said “well . . . we think you should have

the steroids.” and someone in the back end [of the] room

was going “What about the study? What about the study?”

And I was, like, with drips and in pain and panicking, and

everything was up in the air, and you’ve got somebody

saying “Well, this study is going on,” and I was just going

“I just don’t want to know!”

Vulnerability. Another issue was the vulnerability feltby women when asked to participate. The relation-ship of the researcher also being the caregiver couldleave women feeling powerless. For example, Cherylsaid:

It wasn’t so much that I felt that when I was asked about

research a second time, it was inappropriate. It was more to

do with the feelings I had and the comments that were made

by the doctor . . . and because of that I was nearly in

tears. . . . This person has just made these comments indicat-

ing that they have got ultimate power over me.

Cheryl felt “humiliated,” and although was able todecline participation, it is unsettling to know that todo so she believed it necessary to be “strong” and“assertive.” Jane’s account clearly demonstrated theemotional impact that can occur when being asked bya caregiver to participate in research:

I said “no” . . . but the midwife wasn’t pleased. And the

doctor came in when she was there, and she said “and the

lady’s declined the study!” And in the end my husband said

“Look, she’s said no. She’s given her reasons and that’s it.”

Nicola, however, who had developed a good rela-tionship with the midwives during her antenatalinpatient stay, thought that this enabled her todecline more easily:

I got quite friendly with all the midwives . . . so I wasn’t

frightened to say no . . .

Diane believed that it was less acceptable to beasked to participate by a researcher external to thehospital:

If you were approached by somebody who actually worked

at the hospital then I think you would feel more legitimate

towards research for care . . . if it was somebody totally out-

side I don’t think that would be appropriate really.

Inability to Believe Equipoise Existed

When considering trial participation, women clearlyhad to have a strong belief that the evidence was inequipoise before they considered taking part. If thewomen thought that one treatment was potentially

64 BIRTH 32:1 March 2005

superior to another, they would decline participation.One woman, for example, had given birth previouslyto a healthy preterm baby, and therefore declinedparticipation in a trial of single versus multiplesteroids:

I had the steroid injections with Camille, and she was born

at 26 weeks . . . she was less than 24 hours on the ventilator,

and they did say to me at the time “we think the steroid

injections have really boosted her system.” (Jane)

Nicola and Cheryl talked at about “weighing upthe risks and benefits,” stating that if they were askedto take part in a study where they believed one treat-ment to be more harmful than the other, they woulddecline. Diane reinforced this when she said:

It’s really difficult [deciding whether to participate]. . . . The

decision is not that easy because you always think that one

way is better than another, and if it’s left to chance, you

might get the worst treatment.

Practical Inconvenience

Although women appeared prepared to give upsome of their own time, properly resourced studies,which enabled expenses to be reimbursed,were viewed more favorably. Diane, for example,was making regular trips to a hospital for progressassessments as part of her participation, andwas grateful that “they pay for a taxi . . . ” This wasreinforced by Nicola, who said “I wouldn’t take partin any study that meant I had to traipse up to thehospital for blood tests. It’s hard to get out with ababy.” Ann said “My partner does a college course,so I would have to take into consideration things likethat, the practical things.”

Discussion and Conclusions

This study explored the views of a group of womenwho had participated in research during their mater-nity experience. Importantly, the cohort of womenhad been exposed to both positive and negativeexperiences of research within the same pregnancy.This factor alone highlighted the fact that women arenot just “for” or “against” research. Their researchdecisions are much more complex, considered, andrationalized.Unlike earlier research, which suggested that people

with altruistic motives were most likely to participate(5), it was just one of many factors in this study. Theprocess of recruitment and practical issues, such asself-commitment and expense, were pivotal in awoman’s decision to participate in research.Interestingly, women commented that being part

of research could enhance their own childbirth

experience. They felt proud that they had contributedand important that their views were acknowledged. Adegree of vulnerability was recognized, however, andthe term “guinea pig” was referred to frequently, in aderogatory manner. Furthermore, participants wereconcerned that in some instances contributing toresearch might result in their receiving an inferiorstandard of care.When there was little impact on the baby, women

made their own decisions about participation, and jointdecisions with their partner were only made whenthe baby was involved. Surprisingly, some womenpreferred to be directed by the health care professionalor researcher about participation, in contrast withconforming to the concept of informed consentadvocated in the Declaration of Helsinki (14).Importantly, women debated the number of times

they should be approached to participate inresearch—an issue regularly debated in professionalforums and ethics committees. With an internationalmaternity agenda for more evidence-based practice,there is a concern that women are being overexposedto research. Although a consensus was not reached,in this study, with respect to the acceptable numberof times women should be asked to participate,women recognized the potential to be overburdened.However, they agreed that each woman should betreated individually; for example, one woman wasdisappointed that she was not asked to participatein multiple studies, which can pose a dilemma forhealth care researchers.Perhaps, as suggested by participants, the actual

approach to participate has more influence than theresearch per se. Timing, manner, status, and methodof communication were the important elements thataffected decision-making. Participants believed thatrandomization might deter some women from parti-cipating in research, since they might dislike theelement of chance and lack of control that theyassociated with this study design.Women clearly wanted the person who was asking

them to adopt an individualized approach and tohave a sensitive awareness of the woman’s maternitycontext. Timing of the approach was particularlyimportant. It appeared that in an attempt to standar-dize research process, the fundamental issue of anindividualized experience was sometimes forgotten.Women drew parallels between the approach to careand the approach to research. Individualization hasbeen the philosophy underpinning maternity care formany years (15), and it should be equally applied toresearch instead of seeking to find standardized for-mats for recruitment. This approach supports theview that the clinician should decide on the suitabilityof a potential research candidate. Given that some

BIRTH 32:1 March 2005 65

women felt a degree of vulnerability whenapproached by their clinician, however, a more sen-sitive approach needs to be adopted. This poses achallenge to researchers, who have been encouragedto standardize research practice (16).When asked to consider trial participation, women

in this study grappled with deciding whether onetreatment was more preferable than another. Giventhat trials should only be conducted when the evi-dence is in equipoise, perhaps study information wasinadequate for these women, thus making the deci-sion to participate difficult. Women’s input in thedevelopment of information is particularly useful,since they can assist with presenting risks and benefitsin an acceptable way. When delivering such informa-tion, the researcher has an obligation to consider thefact that women also carry a responsibility for theirbaby (17). In our study this was a major factor influ-encing women’s decisions.Despite methodological rigor, our study had sev-

eral limitations. The sample size was disappointinglysmall, and we acknowledge that those who failed toattend may have had views different from those whoattended. Because of the nature of the study, it wasdecided not to pursue these women further. Thewomen had participated in various studies of differ-ent designs that provided views on a range of issues.Although the sample was derived from a single site,which limits generalizability and the ability to makedirect comparisons, on verbal presentation ofresponses, strong resonance with other women fromdifferent settings was evident. It was not possible tovalidate any facts supplied by the women, for exam-ple, how they were approached. Interviews with staffand observations of interactions between women andresearchers or caregivers would add further dimen-sions to this work. Similar confirmatory research inother settings with different populations would beuseful.This study provides a useful insight into maternity

research as viewed by women, despite some metho-dological shortcomings. Researchers should considerconcerns highlighted by this study as they endeavorto enhance the experience for women. Listening towomen’s views not only ensures that the research iscarried out in an ethical and acceptable manner; but

it may actually enhance recruitment rates and reduceattrition rates.

Acknowledgments

The authors wish to thank the 17 women who gaveup their precious time to participate in this study.

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