Informed consent,parental awareness,and reasons for participating in a randomised controlled study

BACKGROUND—The informed consent procedure plays a central role in randomised controlled trials but has only been explored in a few studies on children.
AIM—To assess the quality of the informed consent process in a paediatric setting.
METHODS—A questionnaire was sent to parents who volunteered their child (230 children) for a randomised, double blind, placebo controlled trial of ibuprofen syrup to prevent recurrent febrile seizures.
RESULTS—181 (79%) parents responded. On average, 73% of parents were aware of the major study characteristics. A few had difficulty understanding the information provided. Major factors in parents granting approval were the contribution to clinical science (51%) and benefit to the child (32%). Sociodemographic status did not influence initial participation but west European origin of the father was associated with willingness to participate in future trials. 89% of participants felt positive about the informed consent procedure; however, 25% stated that they felt obliged to participate. Although their reasons for granting approval and their evaluation of the informed consent procedure did not differ, relatively more were hesitant about participating in future. Parents appreciated the investigator being on call 24 hours a day (38%) and the extra medical care and information provided (37%) as advantages of participation. Disadvantages were mainly the time consuming aspects and the work involved (23%).
CONCLUSIONS—Parents'' understanding of trial characteristics might be improved by designing less difficult informed consent forms and by the investigator giving extra attention and information to non-west European parents. Adequate measures should be taken to avoid parents feeling obliged to participate, rather than giving true informed consent.

     

What motivates British parents to consent for research? A questionnaire study

Background

Informed consent is the backbone of a clinical trial. In children this is given by their parents. There have been many studies in the neonatal population but little is known about the views of the parents of infants and young children from within the United Kingdom. The objectives of this study were to assess what motivates parents to consent to a randomised clinical trial (RCT), their feelings on consent and participation and the factors that would influence their decision to take part in a future study.

Methods

The setting was a multi-centre randomised but non-blinded equivalence trial of oral versus intravenous (IV) treatment for community acquired pneumonia in previously well children aged 6 months to 16 years in the UK (PIVOT Study). Parents were sent a postal questionnaire at the end of the study which included open and closed-ended questions. Fishers Exact Test was used to analyse associations in non parametric categorical data.

Results

243 children were recruited into the PIVOT study. Of a possible 235, 136 questionnaires were returned (response rate 59%). Of those questionnaires returned; 98% of parents remembered consenting, 95% felt they were given enough time to make their decision and 96% felt they received enough information. Major reasons for participation were benefit to other children in the future 31%, contribution to science 27%, benefit to their own child 18%. Most parents (85%) did not feel obliged to participate. 62% felt there was an advantage to taking part and 18% felt there was a disadvantage. 91% of parents said they would take part in a similar study in the future, stating influences on their decision being benefit to their own child (91%) and benefit to all children (89%).

Conclusion

The major motivation in parents consenting for their previously well child to participate in an RCT of therapy for an acute medical illness was to increase medical knowledge in the future. Most saw an advantage in taking part in the trial and did not feel obliged to participate.     

Parental experiences of the informed consent process in randomized clinical trials—A Nordic study

Background

Randomized clinical trials (RCTs) are an essential part of improving acute lymphoblastic leukemia (ALL) treatment. This population-based questionnaire study investigated parents’ experiences of the informed consent process in the RCTs within the Nordic NOPHO (Nordic Society of Paediatric Haematology and Oncology) ALL2008 trial.

Procedure

Parents in Sweden, Denmark, and Finland whose child was alive and in first remission after end of therapy and who were asked to participate in any RCT in the ALL2008 protocol, were asked to complete 15 questions/items regarding their experience of the RCT consent process.

Results

A total of 483 parents of 279 children met the inclusion criteria and answered the study questionnaire. Most (91%) agreed/strongly agreed to having received sufficient information to make a well-informed decision, felt confidence in the study design (86%), and thought that the process was satisfactory (86%). Those who did not consent reported a generally more negative experience of the process. More than a third of all parents and over half of parents who had refused participation felt that it was burdensome to decide. Most parents (66%) in general, and one-third of those with children 8 years or older, reported that their child was not involved in the process.

Conclusions

Parents were in general satisfied with the informed consent process, although many parents, particularly those who refused participation, reported it as burdensome to make the decision concerning RCT. Fewer than expected of the school-aged children were involved in the decision process, which calls for attention on how children are included in the consent procedure in clinical trials.     

Participation in research: informed consent, motivation and influence

OBJECTIVE: To investigate the process and quality of informed consent, motivation and influence in parents who were invited to enroll their baby in a research project. METHODOLOGY: A mixed quantitative/qualitative questionnaire was sent to a cohort invited to participate in a physiological research project on sudden infant death syndrome (SIDS) at the Dunedin Public Hospital, Dunedin, New Zealand. Separate questionnaires were used for parents who participated (94) and those who declined to participate (103). Response rates were 69% and 47%, respectively. RESULTS: All consenting parents felt they understood the purpose and procedure of the study. The majority (90%) thought the information about the study was very good; 6.5% felt more detail was required. Eighty-five per cent found the verbal explanation the most useful source of information. All participated for altruistic reasons such as to aid SIDS research. Although 27% had concerns about safety of the tests, after the tests all responders felt happy with the safety of the tests. Inconvenience was the main reason (53%) for declining to participate. Twenty-eight per cent of declining parents were concerned about the safety of the tests. CONCLUSION: Of those who responded to the questionnaire, the process for obtaining informed consent in the SIDS studies was satisfactory. Parents' motives for participating were mostly altruistic. The role of recall bias and selection bias may make the implications of this study unclear.     

Parental consent in paediatric clinical research.

AIMS: To assess parental understanding and memorisation of the information given when seeking for consent to their child's participation to clinical research, and to identify the factors of significant influence on parents' decision making process. METHODS: Sixty eight parents who had been approached for enrolling their child in a clinical oncology or HIV study were asked to complete an interview. Their understanding was measured by a score which included items required to obtain a valid consent according to French legislation. RESULTS: Items that were best understood by parents were the aims of the study (75%), the risks (70%), the potential benefits to their child (83%), the potential benefits to other children (70%), the right to withdraw (73%), and voluntariness (84%). Items that were least understood were the procedures (44%), the possibility of alternative treatments (53%), and the duration of participation (39%). Less than 10% of the parents had understood all these points. Ten parents (15%) did not remember that they had signed up for a research protocol. Thirty three parents (48%) reported no difficulty in making their decision. Twenty four parents (38%) declared that they made their decision together with the investigator; 26 (41%) let the physician decide. Fifty four parents (78%) felt that the level of information given was satisfactory. CONCLUSION: There was an apparent discrepancy between parents' evaluation of the adequacy of the information delivered and evaluation of their understanding and memorisation. The majority of parents preferred that the physician take as much responsibility as possible in the decision making process.     

Proxy informed consent in pediatric research: a review

This paper is aimed at discussing the issue of proxy consent for medical research with children carried out in the context of developed countries. First, requirements for valid informed consent are reviewed, and differences with clinical practice highlighted. In the second part the findings from empirical studies, and implications for improving the consent process, are discussed. Perceived benefit for their child is the most important factor motivating parents to grant consent, but also a desire to contribute to medical research and benefit others are frequently mentioned. Abstract concepts such as randomization are more difficult to grasp and remember than practical issues. The type and style of the consent-seeking process (quality of the information, physician's attitude, allocated time, readability of consent forms) have an influence on how the invitation to participate is received. Rather than as a one-sided delivery of information, consent should be viewed as a continuous, two-way communication process developing in a context of transparency and partnership between the investigator and potential research subjects.     

Neonatal research: the parental perspective

OBJECTIVES: To investigate the recollections of parents consenting for their infants to be research subjects and determine their views about the need for consent. SUBJECTS: Parents of 154 sick newborn infants enrolled in a randomised trial in the early neonatal period. All parents had given written consent and received printed information. METHODS: A questionnaire and accompanying letter was sent to the parental home 18 months later. Non-responders were sent a further questionnaire and letter. RESULTS: Response rate was 64% (99/154). Some respondents (12%) did not remember being asked to consent to their baby joining a study, and a further 6% were unsure. Most of the respondents (79%) were happy, 13% neutral, and 8% unhappy with their decision to give consent. None felt heavy pressure to agree. Entering the trial caused 24% of respondents to feel more anxious, 56% neutral, and 20% less anxious about their baby. Most of the respondents (83%) would be unhappy to forgo the consent process for trials passed by the institutional ethics committee. CONCLUSIONS: A significant proportion of parents who give written consent for a trial in the early neonatal period do not later remember having done so. Parents who have had experience of neonatal research would be unhappy for their baby to be enrolled in a study that had ethics committee approval without their consent being obtained.     

Sign on the dotted line: parental consent

The issue of informed consent in paediatric surgery has always been contentious. Despite the fact that taking consent is one of the most frequently performed tasks of a surgeon, it is rarely audited. Indeed, there are few studies looking at the consent process in adult practice and fewer in the paediatric setting. The aim of this study was, therefore, to determine parental understanding, recall, attitudes and opinion of the consent process in a busy paediatric day surgery unit. A prospective study was conducted using a questionnaire consisting of 20 questions. These were handed out to the parents of all children undergoing one of four procedures: circumcision, prepuceplasty, orchidopexy and herniotomy over a 3-month-period. Completed questionnaires were collected and analysed. One hundred and sixty-one parents were asked to complete the questionnaire. Ninety-three were collected, a response rate of 58%, 87% believed consent was taken by the performing surgeon, 15% felt the consent process was rushed, but 91% thought the right amount of detail was given. Ninety-seven percent of parents believed that the consent form was a legal necessity and 72% believed that a child in Scotland had to be aged 16 or over to sign the consent form. Interestingly, 23% of parents were unsure if signing the consent form meant that they could not claim compensation if anything went wrong. Ninety-one percent recalled the procedure being explained in the outpatient clinic, but 22% did not remember potential complications being discussed. The amount parents recalled of potential complications varied. Seventy percent felt that a leaflet about the procedure prior to attending the unit would be helpful. In conclusion consent is an extremely important part of our practice. This study highlights some of the common parental misconceptions and limitations of the process. Parents appear satisfied and consenting for procedures is overall performed well. Some areas could be improved and more research is required in this area.     

Children's consent and paediatric research: is it appropriate for healthy children to be the decision-makers in clinical research?

AIM: To determine the appropriateness of asking healthy children to make a decision regarding participation in a research study. METHODS: Participants constituted a group of children taking part in a follow-up to a vaccine study which involved a blood test to look at the persistence of antibodies. Information about the study was given to each child and following venepuncture an oral questionnaire was completed to establish understanding of the vaccine study. Parental views concerning their child's ability to make a decision regarding research participation were also sought. RESULTS: 73 children participated overall. Following venepuncture 59% (n = 43) had grasped some aspect of the reasoning behind venepuncture with 33% (n = 24) unclear. The majority of parents (n = 55) and a substantial number of children (n = 28) believed that the parent should make the decision about study participation, although it is clear that a significant minority of parents thought it is right to involve the child in that process. CONCLUSION: New guidance about the requirements for informed consent involving children in research is needed, which can respect the autonomy of the child and the role of the parent, while recognising the limited capacity of some children to understand age-appropriate information.     

Guidelines for informed consent in biomedical research involving paediatric populations as research participants

To promote and protect the best interests of children involved in biomedical research, paediatricians have to ensure that participating minors and their parents/legal representatives have understood and assented/consented to the research. Therefore guidelines providing child-specific guidance that are compatible with other international guidelines on informed consent are laid down. Special regard is paid to the willingness to participate and the social and cultural background of the patients, the legal conditions of the countries, the capacity of the child to understand and give his/her informed assent, the adequate communication with the child and the parents, the respect of the will of the patient, the understandable written informed consent of legal representatives and to the evaluation of the informed consent/assent process by competent ethics committees.     

Informed consent in pediatric practice

Informed consent is a communication process of providing the patient/parents/guardians with relevant information regarding the treatment and the diagnosis, so that they can make informed decisions. The process of informed consent in pediatric patients is not well understood. The amount of information to be disclosed in an informed consent is a matter of debate. There are four basic elements to the content of informed consent form: nature of procedure, risks, benefits and alternatives. The article delineates the essential elements and legal implications of informed consent in pediatric practice.     

Presence of both parents during consent process in non‐therapeutic neonatal research increases positive response

Aim: To investigate factors that influenced parental consent/non‐consent in a non‐therapeutic electroencephalogram (EEG) study in healthy newborns. Methods: Parents of healthy newborns were approached to participate in a neonatal EEG study within 36 h of birth. The rationale and risks/benefits of the study were explained. Any concerns were discussed, and detailed information about the EEG study was provided in the consent form. In the case of refusing/withdrawing consent, an informal interview was used to investigate the reasons, which were subsequently analysed and grouped according to the four principles of the consent process. Results: A total of 123 parents were included in the study. Parental consent was obtained in 72/123 (59%) cases, 10/123 (8%) parents subsequently withdrew their consent and 41/123 (33%) parents refused to participate in the study. Consent was more likely if both parents were present (p < 0.0001). When the mothers were approached alone, obtaining consent was significantly more difficult within the first 6 hours of delivery, compared to a later approach (37% vs. 67% respectively; p = 0.009). Refusals were classified into issues of voluntariness (7%), informed choice (10%), understanding (54%) and competence (29%). Conclusion: Parents of healthy newborns demonstrated a positive attitude towards non‐therapeutic neonatal research with maximal consent occurring when both parents were present. Parental perception of harm was the main reason for declining consent.     

Parental consent in paediatric clinical research

Aims

To assess parental understanding and memorisation of the information given when seeking for consent to their child''s participation to clinical research, and to identify the factors of significant influence on parents'' decision making process.

Methods

Sixty eight parents who had been approached for enrolling their child in a clinical oncology or HIV study were asked to complete an interview. Their understanding was measured by a score which included items required to obtain a valid consent according to French legislation.

Results

Items that were best understood by parents were the aims of the study (75%), the risks (70%), the potential benefits to their child (83%), the potential benefits to other children (70%), the right to withdraw (73%), and voluntariness (84%). Items that were least understood were the procedures (44%), the possibility of alternative treatments (53%), and the duration of participation (39%). Less than 10% of the parents had understood all these points. Ten parents (15%) did not remember that they had signed up for a research protocol. Thirty three parents (48%) reported no difficulty in making their decision. Twenty four parents (38%) declared that they made their decision together with the investigator; 26 (41%) let the physician decide. Fifty four parents (78%) felt that the level of information given was satisfactory.

Conclusion

There was an apparent discrepancy between parents'' evaluation of the adequacy of the information delivered and evaluation of their understanding and memorisation. The majority of parents preferred that the physician take as much responsibility as possible in the decision making process.     

Pediatric autopsy and informed parental consent]

AIM: In French legal terminology, the definition of autopsy is "organs'withholding". This phrase is ambiguous, meaning both removing the organs for their macroscopic exam and their retention for subsequent histology. The autopsy of a child requires an informed consent from both parents. The issue is that the pathologist who performs the autopsy is not the one who delivers the information and gets the parents' consent: therefore, he does not know what they were told and what they actually agreed upon. MATERIALS AND METHODS: A questionnaire was sent to 3 groups of paediatricians (N=891) to approach their knowledge regarding autopsy. RESULTS: Among 362 paediatricians who answered the questionnaire, 57.2% never attended an autopsy and procedures were badly known. They did not know whether or not organs, were systematically sampled especially brain. Regarding the possibility of conservation of organs, a majority thought that one should not solely answer to parents'queries (63.8%) but rather that one should point out every possibility, without giving the ins and outs (60.8%). The majority favoured organs retention and use for research. CONCLUSION: We make 3 suggestions: to register autopsy in the Natioanal Securite Sociale nomenclature, to establish information and consent forms for organs'removal, retention and disposal, and to offer parents the possibility of an interview with the pathologist before and/or after the autopsy, in association with the paediatrician.     

Patients', parents', and oncologists' perceptions of informed consent for bone marrow transplantation

Bone marrow transplantation (BMT) is gaining increasing acceptance as a therapeutic treatment modality and is being offered to patients even in the early stages of disease in the presence of minimal debilitating symptoms. Despite this, little is known regarding patients' and physicians' perceptions of the process in which informed consent for this controversial and potentially lethal procedure is obtained. Thirty-nine adult BMT patients and the parents of 61 children undergoing BMT and each of their physicians completed a questionnaire concerning their perceptions of the discussion in which consent for BMT was obtained and their evaluation of the consent document. In addition, the factors influencing patients' and parents' decision to accept BMT and the nature and amount of BMT information retained by patients and parents were assessed. The results indicate that on the whole patients and parents evaluated the BMT consultation and consent document favorably, were motivated by their trust in the physician and their belief in BMT as a cure, retained information regarding major points of informed consent from both the consent document and physician discussion, and had considerable difficulty with recall of the specific toxic side effects associated with BMT. Physicians' perceptions, on the other hand, reflected a less positive view of the extent to which patients and parents were actively involved in the consent process and the readability of the consent document. Perceptions of the informed consent process on the part of oncologist-investigators and patients which could impede the goals of informed consent and implications for facilitating the process are discussed.     

Renal transplantation in children: psychological and donation-related aspects from the parental perspective

Parent(s) accompanying their 18 children to the annual medical follow-up after renal transplantation were interviewed by a child psychiatric social worker. Thirteen of the children had received their grafts from one of their parents, two from other relatives, and three from cadaveric donors. The aims of this interview were to study the decision-making process regarding donation, and the consequences, reflections, and psychological reactions from the parental perspective. Although most parents reported improved psychosocial functioning of the family, many parents also reported significant psychological distress, in many cases complicated by unemployment related to the care of the child. Most parent donors reported that the relationship with their child had improved. For most parents, the decision about the donation seemed to have been a matter of course. However, the process may have induced suffering in those parents who had felt obliged to donate. Thus, questions regarding donation must be approached in a professional and non-judgmental manner when parents are informed about the preconditions of transplantation. The present results indicate a need of psychosocial support for all families during the transplantation process. Therefore, a psychologist and a social worker have been included in the pediatric nephrology team at our unit. The donors also require further information concerning the operative details as well as in regard to the post-operative pain.     

First information and support provided to parents of children with Down syndrome in Sweden: clinical goals and parental experiences

When parents are informed that their newborn child has Down syndrome (DS), they often respond with a traumatic crisis reaction. The aims of this study were to assess the clinical goals regarding the first information and support provided to parents of newborn children with DS at the Swedish paediatric departments, and to analyse the parents' experiences of how they were first informed and treated. Data were collected during 1992-1993 from all of the 51 departments of paediatrics in Sweden. Information on the parents' experiences, collected retrospectively in 1996, was based on recollection by 165 parents of 86 children with DS born between 1989 and 1993 at 10 of the paediatric departments considered representative for Sweden. Seventy-five percent of the families were informed about the diagnosis within 24 h post partum. Some parents felt they were informed too late, and a few parents that they were told too soon. Half of the parents were satisfied with the timing. About 70% of the parents considered the information insufficient and 60% felt that they had been unsupported. Seventy percent would have liked more frequent information. Parental criticisms concerning the way in which the information was provided were that they received too much negative information about DS and that both the communication skills and the basic knowledge of DS on the part of the professionals could have been better. Conclusion: The Swedish paediatric departments fall short of their reported strong clinical goals regarding the initial information in Sweden, and improvements in this area are desirable.     

Parent responses to participation in genetic screening for diabetes risk

Screening for type 1 diabetes (T1DM) risk in newborns has little negative emotional impact on mothers. In this study, the impact on the mother and the father was evaluated both in the general population and in families with diabetes. All parents with a newborn in Skane, Sweden, were invited to a screening for T1DM risk in their children (the Diabetes Prediction in Skane (DiPiS)). Blood was obtained at delivery from the mother and the child. When the child was 2 months old, parents gave written consent and filled out questionnaires, but were not informed about the genetic risk. Of the 10 538 invited families, 6831 (64.8%) consented and 806 (7.7%) declined participation. Five questions addressing both parents were filled out by 6676 (63.4%) mothers and 6099 (57.8%) fathers. In 146/6676 (2.2%) families, one family member had diabetes (D-families). Participation in DiPiS did not affect most parents and the majority was satisfied with the information. The majority of parents (28.9%) were reassured and only 1.1% (140/12,670) reported increased worries because of participation, compared to 2.8% of the mothers in D-families. Parents in D-families more often ascribed diabetes risk to their child as well as the risk being higher. Mothers and fathers differed in their answers on four of the five study questions, with mothers being more satisfied with the information, reporting more knowledge of diabetes, estimating lower risk of their child to get diabetes, but reporting more worries of possible future chronic disease in the child. Parents with lower education, being born abroad, or being younger who reported worries of chronic disease in the child were also reassured by participation in the study. These results confirm that screening for T1DM risk in newborns does not create worries in most parents, but stress that fathers differ from mothers in opinions and reactions, that parents' reactions are affected by diabetes in the family, and that demographic factors might be important for the parents' reports.     

Strafbarkeit der Zirkumzision von Jungen

Surgeons and urologists (usually pediatric) are often confronted with the request to perform circumcision on a boy from parents or guardians in the absence of a medical indication. This review highlights the importance of refraining from such procedures to avoid being the possible addressee of a civil law claim or even being accused in a lawsuit a some later point. The attending physician who performs a circumcision without medical indication on a minor male incurs a penalty according to § 223 para. 1 of the German Criminal Code, even in the case where the parent or guardian of the child has signed the informed consent to that procedure. In the absence of power of approval over the compromised legally protected interest of the child (physical inviolacy), the consent is invalid. The present article discusses not only the current German legal status, but also examines in depth the arguments often put forward to support the legitimacy of male circumcision (treatment of phimosis, disease prevention, religion).