lack of ethical review/approval

Carrying out experimental research that has not been approved by an appropriate ethical review body (such as a Research Ethics Committee or Institutional Review Board) despite such approval being required

NB: Some types of data collection, such as routine audit, which may result in publication, do not require ethical review. Lack of review/approval does not necessarily indicate that the research was unethical but simply that the appropriate safeguards/approval processes have not been applied. See also guidelines of differences between research and audit

Search results

  1. Lack of ethical approval and not reporting experimental evidence

    11-25 In May 2011 a letter from the Vice-Rector for Personnel of a reputable university was sent to the editor mentioning that two articles published in the journal contained two statements not supported by documented evidence. The two ...

  2. Data fabrication, lack of ethical approval, withdrawal of paper and publication in another journal

    11-05 This query refers to a clinical trial comparing two forms of treatment which has since been published in another journal. ...

  3. Ethical approval

    10-36 We have received an article on health care access and availability in prisons of country XX. In the first version of the manuscript there was no mention of ethics approval. On request, the revised version included a statement that ...

  4. Questionable ethics related to clinical trial raised by peer-reviewer

    10-34 You can listen to the podcast of this case from the menu on the right ...

  5. 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 ...

  6. 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 ...

  7. 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 ...

  8. Incorrect allegations from the head of an institute?

    07-41 After a number of appeals and revisions, and having satisfied ourselves about the results being “too good to be true”, we eventually accepted a paper. In September 2007, we received a letter from the head of the institute (and also ...

  9. 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 ...

  10. 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 ...

  11. 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 ...

  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. 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 ...

  14. Studies where there is no research ethics committee, or where committees disagree as to the need for approval

    07-15 The editor of this journal, in common with other journals, requires that, where appropriate, studies published should have been approved by the relevant ethics committee. In some cases researchers have reported to the editor that ...

  15. 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 ...

  16. 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 ...

  17. 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 ...

  18. Ethics approval for audit 2

    06-16 A group in a developed country performed an audit of pregnancy and its outcome in a group of 250 women with congenital heart disease. There were four maternal deaths of women in the series. It was decided to write up the audit. The ...

  19. 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 ...

  20. 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 ...

  21. 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 ...

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

    98-17 The allegations of fraud  ...

  23. Ethics, institutional review and studies from private practice

    05-24 A manuscript was submitted to our journal regarding a chart review of a novel treatment of a musculoskeletal disease, done at a private clinic in a western country. The patients had given informed consent for the novel treatment, ...

  24. 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 ...

  25. 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 ...

  26. “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.) ...

  27. Ethical approval procedural lapse

    05-06 An observational study submitted to an institutional journal was sent for peer review. The authors were invited to submit a revision six months later. They did so, but had not responded fully to the reviewers' points, so they ...

  28. 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 ...

  29. 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. ...

  30. 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 ...

  31. 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 ...

  32. 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 ...

  33. Obtaining consent for a study of people with severe learning disabilities

    04-17 A paper was submitted which reported a study of observing people with severe learning disabilities and their interactions with staff on a locked hospital ward. The journal was keen to consider the paper further, but had concerns ...

  34. 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 ...

  35. 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. ...

  36. 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, ...

  37. Plagiarism and possible fraud

    03-16 The authors of a paper published in another journal wrote to the editor of Journal A, complaining of apparent blatant plagiarism of their work by N et al. , whose paper had been published in the journal earlier in the year. ...