protection of subjects (human)

Search results

1. The ethics of drug/medication use evaluation audit cycles and publication of the results

   10-11 We are seeking guidance on the ethical issues surrounding drug/medicine use evaluation (DUE or MUE) audit cycles, particularly with respect to the publication of findings but also perhaps with regard to the conduct of these audits ...

2. 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 ...

3. 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 ...

4. 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 ...

5. 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 ...

6. Researchers give an experimental therapy to patients based on a laboratory study published in our journal

   07-31 We published a paper in the journal which reported on microarray expression profiling of cell lines from a specific type of cancer (not named here, to preserve anonymity). That paper suggested that a particular compound might ...

7. Is ethics approval required?

   07-24 The journal received a paper on an imaging technique which reported changes in a normal healthy volunteer. No adverse events were experienced. This study demonstrated the feasibility and safety of the imaging studies in a ...

8. 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 ...

9. HIV testing without offering treatment to affected individuals

   07-16 A team of Western researchers carried out a longitudinal study of pregnant nomadic tribeswomen in Africa between 2002 and 2003. They took blood samples during and after pregnancy to test for a specific disease. Those who tested ...

10. Effect of the British Human Tissue Acts on biological monitoring

    07-14 Biological monitoring is a common procedure in assessing the dose of contaminants from a workplace atmosphere.  It may include measuring a contaminant, such as lead in blood, or a resulting metabolic product, such as mandelic acid ...

11. 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 ...

12. Ethical approval for a study

    06-35 We had a presubmission enquiry from a group regarding a paper reporting what seemed to be an uncontrolled trial in infertile women who were given soft tissue physical therapy. The authors wanted to know if we would be interested in ...

13. A case of scientific misconduct?

    06-31 We had a paper submitted reporting results of a randomized trial. The trial seemed to look at immune responses in lung fluid in participants receiving either a particular vaccine or placebo. We got a copy of the trial protocol ...

14. 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 ...

15. 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 ...

16. 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 ...

17. No control group, arbitrary dosage, undiagnosed condition

    05-12 In summary, we have a case series, with no control group, of patients with different conditions treated for an undiagnosed underlying condition with an arbitrarily prescribed dosage of a drug which is not registered for treating ...

18. 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 ...

19. Ethical approval and fabrication of results

    04-37 A group of authors, based in private practice, submitted three manuscripts to Journal A and one to Journal B. All the manuscripts described the application and effectiveness of a spinal manipulation technique. ...

20. 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 ...

21. 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 ...

22. 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 ...

23. Possible malpractice revealed in a case report

    04-19 We received a case report describing the diagnosis and treatment of a middle-aged woman who presented to a gastroenterology service in England with weight loss and a right iliac fossa mass. The authors did a barium swallow, ...

24. Lack of ethics committee approval?

    04-18 An editor received a paper and requested details of ethical approval from the authors. The authors replied that they had approached the ethics committee about carrying out a more extensive study than the one submitted, for which ...

25. 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 ...

26. CV study: was ethics approval and consent required?

    04-07 A submitted paper detailing the negative experiences of overseas doctors applying for a training post in a district general hospital was poorly presented and scientifically weak, but on a topic of great interest and importance. ...

27. Going public on potential fraud

    03-20 A research article published some time ago detailed an invasive test. The authors obtained informed consent from the patients, but did not seek ethics committee approval. Subsequently, the journal published correspondence from X, ...