IDEAS home Printed from https://ideas.repec.org/a/eee/socmed/v65y2007i11p2212-2222.html
   My bibliography  Save this article

Beyond "misunderstanding": Written information and decisions about taking part in a genetic epidemiology study

Author

Listed:
  • Dixon-Woods, Mary
  • Ashcroft, Richard E.
  • Jackson, Clare J.
  • Tobin, Martin D.
  • Kivits, Joelle
  • Burton, Paul R.
  • Samani, Nilesh J.

Abstract

Although the need to obtain "informed" consent is institutionalised as a principle of ethical practice in research, there is persistent evidence that the meanings people attribute to research tend to be substantially at variance with what might be deemed "correct". One dominant account in the ethics literature has been to treat apparent "misunderstandings" as a technical problem, to be fixed through improving the written information given to research candidates. We aimed to explore theoretically and empirically the role of written information in "informing" participants in research. We conducted a qualitative study involving semi-structured interviews with 29 unpaid healthy volunteers who took part in a genetic epidemiology study in Leicestershire, UK. Data analysis was based on the constant comparative method. We found that people may make sense of information about research, including the content of written information, in complex and unexpected ways. Many participants were unable to identify precisely the aim of the study in which they had participated, saw their participation as deriving from a moral imperative, and had understandings of issues such as feedback of DNA results that were inconsistent with what had been explained in the written information about the study. They had high levels of confidence in the organisations conducting the research, and consequently had few concerns about their participation. These findings, which suggest that some "misunderstanding" may be a persistent and incorrigible feature of people's participation in research, raise questions about the principle of informed consent and about the role of written information. These questions need to be addressed through engagement and dialogue between the research, research participants, social science, and ethics communities.

Suggested Citation

  • Dixon-Woods, Mary & Ashcroft, Richard E. & Jackson, Clare J. & Tobin, Martin D. & Kivits, Joelle & Burton, Paul R. & Samani, Nilesh J., 2007. "Beyond "misunderstanding": Written information and decisions about taking part in a genetic epidemiology study," Social Science & Medicine, Elsevier, vol. 65(11), pages 2212-2222, December.
    • Handle: RePEc:eee:socmed:v:65:y:2007:i:11:p:2212-2222
    as

    Download full text from publisher

    File URL: http://www.sciencedirect.com/science/article/pii/S0277-9536(07)00437-6
    Download Restriction: Full text for ScienceDirect subscribers only
    ---><---

    As the access to this document is restricted, you may want to search for a different version of it.

    References listed on IDEAS

    as
    1. Blaxter, Mildred, 1983. "The causes of disease : Women talking," Social Science & Medicine, Elsevier, vol. 17(2), pages 59-69, January.
    2. Dixon-Woods, Mary, 2001. "Writing wrongs? An analysis of published discourses about the use of patient information leaflets," Social Science & Medicine, Elsevier, vol. 52(9), pages 1417-1432, May.
    3. Snowdon, Claire & Garcia, Jo & Elbourne, Diana, 1997. "Making sense of randomization; responses of parents of critically ill babies to random allocation of treatment in a clinical trial," Social Science & Medicine, Elsevier, vol. 45(9), pages 1337-1355, November.
    4. Lidz, Charles W. & Appelbaum, Paul S. & Grisso, Thomas & Renaud, Michelle, 2004. "Therapeutic misconception and the appreciation of risks in clinical trials," Social Science & Medicine, Elsevier, vol. 58(9), pages 1689-1697, May.
    5. Featherstone, Katie & Donovan, Jenny L., 2002. ""Why don't they just tell me straight, why allocate it?" The struggle to make sense of participating in a randomised controlled trial," Social Science & Medicine, Elsevier, vol. 55(5), pages 709-719, September.
    6. Morris, Norma & Bàlmer, Brian, 2006. "Volunteer human subjects' understandings of their participation in a biomedical research experiment," Social Science & Medicine, Elsevier, vol. 62(4), pages 998-1008, February.
    Full references (including those not matched with items on IDEAS)

    Citations

    Citations are extracted by the CitEc Project, subscribe to its RSS feed for this item.
    as


    Cited by:

    1. Wade, Julia & Donovan, Jenny L. & Athene Lane, J. & Neal, David E. & Hamdy, Freddie C., 2009. "It's not just what you say, it's also how you say it: Opening the 'black box' of informed consent appointments in randomised controlled trials," Social Science & Medicine, Elsevier, vol. 68(11), pages 2018-2028, June.
    2. Putniņa, Aivita, 2013. "Bioethics and power: Informed consent procedures in post-socialist Latvia," Social Science & Medicine, Elsevier, vol. 98(C), pages 340-344.
    3. Hallowell, Nina & Cooke, Sarah & Crawford, Gill & Lucassen, Anneke & Parker, Michael, 2009. "Distinguishing research from clinical care in cancer genetics: Theoretical justifications and practical strategies," Social Science & Medicine, Elsevier, vol. 68(11), pages 2010-2017, June.
    4. Mwale, Shadreck, 2020. "‘Becoming-with’ a repeat healthy volunteer: Managing and negotiating trust among repeat healthy volunteers in commercial clinical drug trials," Social Science & Medicine, Elsevier, vol. 245(C).
    5. Sarradon-Eck, Aline & Sakoyan, Juliette & Desclaux, Alice & Mancini, Julien & Genre, Dominique & Julian-Reynier, Claire, 2012. ""They should take time": Disclosure of clinical trial results as part of a social relationship," Social Science & Medicine, Elsevier, vol. 75(5), pages 873-882.
    6. Elizabeth R. Eisenhauer & Alan R. Tait & Soo Young Rieh & Cynthia M. Arslanian-Engoren, 2019. "Participants’ Understanding of Informed Consent for Biobanking: A Systematic Review," Clinical Nursing Research, , vol. 28(1), pages 30-51, January.
    7. Dixon-Woods, Mary & Tarrant, Carolyn, 2009. "Why do people cooperate with medical research? Findings from three studies," Social Science & Medicine, Elsevier, vol. 68(12), pages 2215-2222, June.
    8. Abhyankar, Purva & Velikova, Galina & Summers, Barbara & Bekker, Hilary L., 2016. "Identifying components in consent information needed to support informed decision making about trial participation: An interview study with women managing cancer," Social Science & Medicine, Elsevier, vol. 161(C), pages 83-91.

    Most related items

    These are the items that most often cite the same works as this one and are cited by the same works as this one.
    1. Morris, Norma & Bàlmer, Brian, 2006. "Volunteer human subjects' understandings of their participation in a biomedical research experiment," Social Science & Medicine, Elsevier, vol. 62(4), pages 998-1008, February.
    2. Hallowell, Nina & Cooke, Sarah & Crawford, Gill & Lucassen, Anneke & Parker, Michael, 2009. "Distinguishing research from clinical care in cancer genetics: Theoretical justifications and practical strategies," Social Science & Medicine, Elsevier, vol. 68(11), pages 2010-2017, June.
    3. Lawton, Julia & Jenkins, Nicholas & Darbyshire, Julie & Farmer, Andrew & Holman, Rury & Hallowell, Nina, 2012. "Understanding the outcomes of multi-centre clinical trials: A qualitative study of health professional experiences and views," Social Science & Medicine, Elsevier, vol. 74(4), pages 574-581.
    4. Sarradon-Eck, Aline & Sakoyan, Juliette & Desclaux, Alice & Mancini, Julien & Genre, Dominique & Julian-Reynier, Claire, 2012. ""They should take time": Disclosure of clinical trial results as part of a social relationship," Social Science & Medicine, Elsevier, vol. 75(5), pages 873-882.
    5. Snowdon, Claire & Elbourne, Diana & Garcia, Jo, 2006. ""It was a snap decision": Parental and professional perspectives on the speed of decisions about participation in perinatal randomised controlled trials," Social Science & Medicine, Elsevier, vol. 62(9), pages 2279-2290, May.
    6. Fisher, Jill A., 2008. "Practicing research ethics: Private-sector physicians & pharmaceutical clinical trials," Social Science & Medicine, Elsevier, vol. 66(12), pages 2495-2505, June.
    7. Lawton, Julia & Peel, Elizabeth & Parry, Odette & Araoz, Gonzalo & Douglas, Margaret, 2005. "Lay perceptions of type 2 diabetes in Scotland: bringing health services back in," Social Science & Medicine, Elsevier, vol. 60(7), pages 1423-1435, April.
    8. Garthwaite, Kayleigh & Bambra, Clare, 2017. "“How the other half live”: Lay perspectives on health inequalities in an age of austerity," Social Science & Medicine, Elsevier, vol. 187(C), pages 268-275.
    9. Ben Butlin & Keith Laws & Rebecca Read & Matthew D Broome & Shivani Sharma, 2019. "Concepts of mental disorders in the United Kingdom: Similarities and differences between the lay public and psychiatrists," International Journal of Social Psychiatry, , vol. 65(6), pages 507-514, September.
    10. Scott, Clare & Walker, Jan & White, Peter & Lewith, George, 2011. "Forging convictions: The effects of active participation in a clinical trial," Social Science & Medicine, Elsevier, vol. 72(12), pages 2041-2048, June.
    11. Ajit K. Dalal, 2000. "Living with a Chronic Disease: Healing and Psychological Adjustment in Indian Society," Psychology and Developing Societies, , vol. 12(1), pages 67-81, March.
    12. Kinderman, Peter & Setzu, Erika & Lobban, Fiona & Salmon, Peter, 2006. "Illness beliefs in schizophrenia," Social Science & Medicine, Elsevier, vol. 63(7), pages 1900-1911, October.
    13. Skea, Zoë C. & Entwistle, Vikki A. & Watt, Ian & Russell, Elizabeth, 2008. "'Avoiding harm to others' considerations in relation to parental measles, mumps and rubella (MMR) vaccination discussions - An analysis of an online chat forum," Social Science & Medicine, Elsevier, vol. 67(9), pages 1382-1390, November.
    14. Hicks, Alison, 2022. "The missing link: Towards an integrated health and information literacy research agenda," Social Science & Medicine, Elsevier, vol. 292(C).
    15. Murphy, Elizabeth & Dingwall, Robert, 2007. "Informed consent, anticipatory regulation and ethnographic practice," Social Science & Medicine, Elsevier, vol. 65(11), pages 2223-2234, December.
    16. Nancy Santesso & Gian Paolo Morgano & Susan M. Jack & R. Brian Haynes & Sophie Hill & Shaun Treweek & Holger J. Schünemann, 2016. "Dissemination of Clinical Practice Guidelines," Medical Decision Making, , vol. 36(6), pages 692-702, August.
    17. Wolters, Anna & de Wert, Guido & van Schayck, Onno & Horstman, Klasien, 2014. "Constructing a trial as a personal lifestyle change project: Participants' experiences in a clinical study for nicotine vaccination," Social Science & Medicine, Elsevier, vol. 104(C), pages 116-123.
    18. Elberse, Janneke Elisabeth & Pittens, Carina Anna Cornelia Maria & de Cock Buning, Tjard & Broerse, Jacqueline Elisabeth Willy, 2012. "Patient involvement in a scientific advisory process: Setting the research agenda for medical products," Health Policy, Elsevier, vol. 107(2), pages 231-242.
    19. Madden, Sue & Sim, Julius, 2006. "Creating meaning in fibromyalgia syndrome," Social Science & Medicine, Elsevier, vol. 63(11), pages 2962-2973, December.
    20. Hodgins, Margaret & Millar, Michelle & M Barry, Margaret, 2006. ""...it's all the same no matter how much fruit or vegetables or fresh air we get": Traveller women's perceptions of illness causation and health inequalities," Social Science & Medicine, Elsevier, vol. 62(8), pages 1978-1990, April.

    Corrections

    All material on this site has been provided by the respective publishers and authors. You can help correct errors and omissions. When requesting a correction, please mention this item's handle: RePEc:eee:socmed:v:65:y:2007:i:11:p:2212-2222. See general information about how to correct material in RePEc.

    If you have authored this item and are not yet registered with RePEc, we encourage you to do it here. This allows to link your profile to this item. It also allows you to accept potential citations to this item that we are uncertain about.

    If CitEc recognized a bibliographic reference but did not link an item in RePEc to it, you can help with this form .

    If you know of missing items citing this one, you can help us creating those links by adding the relevant references in the same way as above, for each refering item. If you are a registered author of this item, you may also want to check the "citations" tab in your RePEc Author Service profile, as there may be some citations waiting for confirmation.

    For technical questions regarding this item, or to correct its authors, title, abstract, bibliographic or download information, contact: Catherine Liu (email available below). General contact details of provider: http://www.elsevier.com/wps/find/journaldescription.cws_home/315/description#description .

    Please note that corrections may take a couple of weeks to filter through the various RePEc services.

    IDEAS is a RePEc service. RePEc uses bibliographic data supplied by the respective publishers.