participant consent

Failing to obtain fully informed consent from individuals taking part in research or conducting experiments in circumstances in which voluntary participation (and freedom to withdraw from a study without fear of the consequences) cannot be ensured

Search results

  1. No ethics committee approval of a study

    10-28 Our journal received a manuscript describing a comparison of two different techniques for patients in the intensive care unit. There was no information on ethics committee approval and so we asked the authors if approval was ...

  2. Ethics committee waives consent for case report, editor disagrees

    09-25 The authors wish to publish a case report that aims to characterise complex chromosomal abnormalities in a rare congenital syndrome. It describes, in detail, the clinical features of two newborn infants. When asked about consent to ...

  3. Homeoprophylactic treatment of a zoonotic disease

    09-24 This research article investigated the effect of the widespread administration of a homeoprophylactic preparation against a bacterial zoonotic disease in a developing country after a period of particularly heavy rainfall. The ...

  4. Pedigree descriptions: genotyping results for family members

    09-17 We received a paper which describes genotyping results from a large number of individuals (>50) from five unrelated families, in which family members had various blood and liver conditions. On submission we noted that the paper ...

  5. Ethics and consent in research

    09-16 A letter was sent to the chief editor of our journal in response to a recently published article in our journal. The author had serious concerns about the ethics and consent obtained as a result of this study and the follow-up by ...

  6. HIV homeopathy

    09-11 The authors carried out a study. A homeopathic treatment was given to people with HIV/AIDs. The outcome was quality of life, as measured by a questionnaire after 1 month and 18 months of treatment. Participants were selected for ...

  7. Has formal ethical approval been granted that satisfies publication criteria?

    09-08 The issue here is whether formal ethics approval has been granted in order to satisfy publication criteria. By way of some background information, a lot of screening data are collected on many athletes in many sports, both ...

  8. Should we always follow the decisions of ethics committees?

    08-12 A paper was submitted to our journal describing a study in which children received general anaesthesia for a minor operation. The authors chose to induce anaesthesia with a mask and 8% sevoflurane inhalation for 8 minutes. The aim ...

  9. Community leaders’ consent as a proxy for individual consent

    08-10 A study was submitted that reported the prevalence of an intestinal infection in a tribal community. The authors did not obtain informed individual consent for stool collection from the study participants; instead they obtained ...

  10. Retraction of article from 1994

    07-39 Professor A and professor B has been in a dispute over a certain type of treatment for over 15 years. Professor A has accused professor B of killing a patient while he was (in professor A’s view) doing research on the patient ...

  11. Sponsorship, ethical approval and consent for study done as part of an expanded access program

    07-32 We received a paper describing the results of an analysis of pathogen gene sequences from patients who had been given an investigational drug as treatment for their infection. The study had been done in Europe. One reviewer said ...

  12. A survey of doctors’ opinions, with no IRB approval or written consent

    07-23 A doctor who trained in country A took the licensing examinations in country B because he wished to work in country B. ...

  13. Unusual consent process in a vulnerable population

    07-22 A clinical trial was conducted in a low income country. The trial involved two schools. At the first school (the control school), children would receive a one-off drug treatment for a common infection (such “mass drug ...

  14. No ethics approval or informed consent?

    07-02 A thesis published by a student was submitted by his guide for publication. One of the journal editors found the research unethical and asked for confirmation of ethics committee approval. The editor received a verbal commitment ...

  15. Request for a retraction of a retraction

    06-14 In October 2000, a journal published a retraction of a February 2000 publication of a research paper. In the same issue the dean of the corresponding author’s medical school reported the findings of an investigational committee ...

  16. Ethical approval and parental consent

    06-08 A journal received a paper from a single author, attributed to a UK institution, in which 10 children were operated on using two techniques, each child having one technique to one side and one to the other side, at the same ...

  17. Ethical approval for retrospective study

    06-06 A paper reported the clinical outcomes of patients suffering from a neglected disease before and after a change in the national treatment policy which raised the threshold of one laboratory parameter before a more toxic, but more ...

  18. Allegations of scientific fraud and unethical conduct of experiments with attempts to silence the whistleblower

    98-17 The allegations of fraud  ...

  19. A case report of an experimental therapy, submitted by the patient

    05-10 We received a pre-submission enquiry about whether we were interested in publishing a case report of a novel therapy that provided “a complete cure for heart disease.” The therapy involved a “membranotrophic drug” combined with ...

  20. Sufficient consent?

    05-16 A paper was submitted which enrolled elderly nursing home patients to an experimental study of the effect of a medicinal plant on skin ulcers. Although the plant is licensed for use in other skin conditions, it does not have a ...

  21. “Medical research” using data in the public domain

    05-09 Information on competitors participating in a popular sporting activity was obtained from a website in the public domain. The authors used this data to see if the competitors' personal characteristics (height, weight etc.) ...

  22. Consent and ethics approval questioned after acceptance

    04-38 In a paper detailing a physiological study of healthy human volunteers the authors stated that ethics committee approval had been granted and that the participants had given informed consent. After peer review the paper was revised ...

  23. Interactive case report of a patient with ongoing health problems

    04-31 The case of a patient with unresolved upper abdominal pain and weight loss was written up and submitted by her family doctor to a journal that publishes interactive case reports. The intention was to present it as an unfolding ...

  24. Online trial of a new diagnostic tool

    04-22 A paper was submitted that attempted to evaluate a new tool for diagnosing an acute symptom. This symptom is one that could be linked with various medical conditions—some causing little harm and some life threatening. The ...

  25. The case of a physician in private practice offering an experimental intervention

    04-21 A physician in private practice wrote to our journal asking if we were interested in a paper discussing his experience of offering a novel intravenous therapy to his patients. He hoped we wouldn’t discriminate against him for ...

  26. Research on volunteers without informed consent or ethics committee approval

    04-12 An experiment on a volunteer in hospital was written up. The volunteer was an asthmatic who was stable at the time and given a combination of intravenous magnesium sulphate and salbutamol to observe the pharmacological effects. The ...