Consent For First Trimester Screening

  • Research type

    Research Study

  • Full title

    Do women have sufficient understanding of the process and implications of the first trimester combined screening test to give informed consent?

  • IRAS ID

    229835

  • Contact name

    Helen White

  • Contact email

    Helen.White@bcu.ac.uk

  • Sponsor organisation

    Faculty of Health, Education and Life Sciences of Birmingham City University

  • Duration of Study in the UK

    0 years, 8 months, 31 days

  • Research summary

    Do women have sufficient understanding of the process and implications of the first trimester combined screening test to give informed consent?

    The proposal is a piece of primary qualitative research. The aim is to determine whether pregnant women who attend for first trimester screening have enough knowledge and understanding of the procedure and potential results to be giving truly informed consent. Evidence from practice suggests that some women may embark on the the screening process without a full understanding of either the process, the potential findings or the implications of results. Garcia et al (2012)* explain that as screening is a part of customary antenatal care women may deal with it without consideration of its significance. If this is the case there are implications for practice regarding informed consent. The findings of the proposal will help to guide possible changes to practice regarding how and when women are prepared for the offer of first trimester screening.
    The researcher is a Midwife-Sonographer working in the area in which the study is proposed. I have personally observed situations which suggest that women had consented for tests which they did not understand the purpose, process or potential outcomes of. I consider myself to be in a good position to influence any necessary changes to practice.

    Data will be collected via a semi-structured questionnaire consisting of both closed and open questions as well as some multiple choice options. The questions have been designed to ascertain how much information the participants know about the screening test in order to ascertain whether they are giving informed consent.

    A questionnaire has been selected rather than interviews in order to recruit a larger sample size and collect large amounts of information in a shorter period of time.

    Using a questionnaire ensures that exactly the same questions are asked of each participant and allows that the research can still be carried out in the absence of the researcher, if necessary, without minimal effect on validity or reliability.

    * for full reference please refer to Research Proposal.

  • REC name

    West Midlands - Solihull Research Ethics Committee

  • REC reference

    17/WM/0403

  • Date of REC Opinion

    11 Jan 2018

  • REC opinion

    Further Information Favourable Opinion