Research governance frame work for health and social care / Department of Health.

  • Great Britain. Department of Health.
Date:
2001
Catalogue details

Licence: Open Government Licence

Credit: Research governance frame work for health and social care / Department of Health. Source: Wellcome Collection.

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    oO pate of OTe ge Who do I report an adverse event to? Any worrying reaction must be reported immediately to the patient's GP. Any adverse drug reaction, as well as reporting it to the patient's GP, must be reported to the drug manufacturer, the Medicines Control Agency, the Trial Steering Committee, the Research Ethics Committee and the Data Monitoring Committee. The Steering Committee will decide whether or not to notify the sponsor. I am concerned that the staff in the university labs are not following appropriate health and safety rules. What do I do? You should raise this concern through the university's local health and safety systems. I want to go on a training course, who should I talk to? The university as your employer is responsible for your training. To whom do I talk about my suspicion that a university colleague is fabricating data? The university as employer has primary responsibility. You should use the university's local system for dealing with suspected misconduct. The sponsor also has an interest. You should keep them informed, particularly if you have any concerns following your approach to the university. They have powers to withdraw funding. You could also consider consulting other organisations such as the General Medical Council with authority to regulate the conduct of the person concerned. I think we could improve the design of this study. What do I do? You should discuss this with the Trial Steering Committee. If they agree, you will need to draw up a revised protocol and submit it through both ethical review and the MRC’s scientific review system. You should not implement changes to a protocol without these formal agreements. I think I have generated some important intellectual property. What should I do? Ownership of intellectual property will be addressed in your University’s contract of employment with you and in their contract with the sponsor. There may also be an agreement between the university and the NHS locally. You need to report the findings to the University’s responsible officer, who will advise you on the procedures to be followed. 23