The Impact of the Study on the Trials Team

Chapter

Abstract

I interviewed the Chair of the Ethics Committee, a data coordinator and a principal investigator on the study to explore the impact of the study on them. The Ethics Committee used their standard evaluation criteria for evaluating randomized clinical trials. The major ethical issue was the blinding of the participants to the intervention within the study which could also require risk management. The data coordinator was concerned that she didn’t receive all of the information she would have desired about the study and found it difficult to respond to the detailed questions participants asked. She didn’t have any objection to blinded or randomized studies as such, but was reacting to her perception of the need to blind the study team. The principal investigator, an atheist, was excited at being a part of the design and analysis of a “creative” study. However, as she became aware of the controversy surrounding other such studies and the personal discussions with investigators in related fields she became concerned about her involvement compromising her future career and declined the responsibility of authorship. Knowing the impact of a study on those involved informs the approach to future studies.

Keywords

Placebo Rofecoxib 

References

  1. 1.
    Byrd RC (1988) Positive Therapeutic Effects of Intercessory Prayer in a coronary care unit population. South Med J 81:826–829CrossRefGoogle Scholar
  2. 2.
    Canada AL, Murphy PE, Fitchett G, Peterman AH, Schover LR (2008) A 3-component model for the FACIT-Sp. Psychooncology 17:908–916CrossRefGoogle Scholar
  3. 3.
    Cohen J (1998) Statistical power analysis for the behavioral sciences, 2nd edn. Hillsdale, Lawrence Erlbaum Associates, New JerseyGoogle Scholar
  4. 4.
    Dossey L (1993) Healing words: the power of prayer and the practice of medicine. Harper, San FranciscoGoogle Scholar
  5. 5.
    Harris W, Gowda M, Kolb J, Strychacz C, Vacek J, Jones P et al (1999) A randomized, controlled trial of the effects of remote intercessory prayer on outcomes I patients admitted to the coronary care unit. Arch Intern Med 159:2273–2278CrossRefGoogle Scholar
  6. 6.
    Leibovici L (2001) Effects of remote retroactive intercessory prayer on outcomes in patients with bloodstream infection: randomised controlled trial. BMJ 323:1450–1451CrossRefGoogle Scholar
  7. 7.
    Moher D, Hopewell S, Schulz KF (2010) CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomized trials. BMJ 340:c869. doi: 10.1136/bmj.c869 CrossRefGoogle Scholar
  8. 8.
    National Health and Medical Research Council (2007) National Statement on Ethical Conduct in Human Research. http://www.nhmrc.gov.au/_files_nhmrc/publications/attachments/e72.pdf. Accessed Jan 2012.
  9. 9.
    O’Laoire S (1977) An experimental study of the effects of distant, intercessory prayer on self-esteem, anxiety, and depression. Altern Ther Health Med 3:38–53Google Scholar
  10. 10.
    Parkinson L, Doljagore X, Gibson R (2011) An observational study of the discrediting of COX-2 NSAIDs in Australia: Vioxx or class effect? BMC Public Health 11:892. doi: 10.1186/1471-2458-11-892 CrossRefGoogle Scholar
  11. 11.
    Reed C (2004) Mass deception. Focus The Australian Doctor Magazine Nov: 22–29Google Scholar
  12. 12.
    Seipp CA, Chang AE, Schilling DJ et al (1980) In search of an effective antiemetic: a nursing staff participates in marijuana research. Cancer Nurs 3:271–276CrossRefGoogle Scholar
  13. 13.
    Tan H, Wilson A, Olver I, Barton C (2010) Recruiting patients for a large qualitative study: some ethical considerations and staff dilemmas. Explore 6:159–165CrossRefGoogle Scholar

Copyright information

© Springer Science+Business Media New York 2013

Authors and Affiliations

  1. 1.Cancer Council AustraliaSydneyAustralia

Personalised recommendations