Topic outline
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Ethics - What are they & why do we need them?
•Ethics are the moral principles that govern a person's behaviour, or how an activity is conducted. Ethics in research determine the standards that you work to and your code of conduct whilst carrying out your research work.•–Legal responsibility to ensure that ethical review has been carried out.•Adherence to any research licences.•Evidence adherence to Health and Safety Law and any associated legislation.•Doing things to people without their consent (even if it is in the name of science) could be classed as an assault under common law.•Insurance.•–Research institutions will not allow research on human participants to take place unless it has undergone ethical review.–Publishing houses will not publish work with human participants that has not undergone ethical review.Does my project need ethical clearance?
•Discuss your project with your supervisor.•Do an ethics awareness form in the first instance with your supervisor.••Give you an awareness of the ethics process, and where your project sits within this.•It is likely that if you are working with human (biological) samples your supervisor has already submitted the ethics application on your behalf.–Applications &associated processes are lengthy•Ask your supervisor about the ethics reference and make a note of this. This is evidence that the project you are working on has undergone ethical review.••It is important to remember there are different ethics pathways depending on the type of work that you will be doing.••Ethics application submitted via an electronic system.–LEON (Loughborough Ethics Online)It is helpful to be aware that ethics applications can be designated as low, medium or high risk
Notification from Karen Coopman ( May 2022)
Following on from the last HTA training session and some of the questions that have been coming through I just thought I would send out a quick reminder to all of you in the CBE.
Ethics: ALL projects should have an ethics checklist or quick test completed as a minimum but you may need to complete a full application depending on the nature of your work (e.g. working with a cell line or blood that has been commercially sourced is likely to be a checklist as not working with human participants but you still need to complete this check). Do also remember to do a new checklist or update if your project changes over the course of e.g. your PhD. The checklist and info about the application can be found here: https://www.lboro.ac.uk/internal/research-ethics-integrity/research-ethics/project-need-ethical-review/. The pink box on the right hand side will also take you to an FAQ style section “ethical review” on what to do if working with e.g. military applications or animal tissues.
HTA: remember to speak to your Departmental Quality Manager, Carolyn, or persons designate, Rob if you have any questions about whether the material you are working with is or isn’t HTA relevant. If you are working with HTA relevant material you should already have completed your University HTA training with myself and Donna and had local training from Carolyn but if you need a refresher on e.g. Procuro, please don’t hesitate to reach out. Compliance with our licence is incredibly important and we need everyone to do their bit – so logging material into and out of Procuro, completing paperwork and so forth.
MTAs: If you are bringing ANY material into or out of the CBE from another Institution (UK or globally) or industrial partner, whether it is a biologic, chemical, HTA or non HTA, an MTA must be in place. See here for details of the forms (https://www.lboro.ac.uk/research/support/collaboration/) but in brief, you will need to complete a checklist first which provides either myself (HTA) or Julie Turner (non HTA bio +chemicals) information about what you are bringing in/out, why, where to, paperwork in place (e.g. ethics, consent) etc. Once we sign this off you can then ask for the legal part, the MTA itself to be drawn up (this will cover ownership, IP, etc).
Some scenarios:
I am buying a cell line from ATCC directly: complete ethics, a biological risk assessments and SOP008.1 Management & control of Incoming Biological Material form with certificate of analysis attached when it arrives.
I am buying a HTA relevant material commercially (e.g. blood, PBMCs): complete ethics done, biological risk assessments and CBE AAT Authorisation to Acquire or Transfer HTA Material HTA form. Once the material arrives, log in Procuro and ensure it has a unique identifier ,complete the CBE ARF Acquisition & Receipt of HTA Material Form and attach a copy of the accompanying paperwork/shipping information. Ensure your HTA training is up to date and evidenced in your training file.
I am working with the University of Nottingham and they want to send me a genetically modified cell line they created: complete ethics, a bio and GMO risk assessment and MTA (checklist to Julie Turner) and complete paperwork as per SOP008.1 Management & control of Incoming Biological Material form with any certificate of analysis attached.
I am planning to work with animal tissues (whole organs or biopsies): notify Julie Turner as soon as possible - we may not have the appropriate licence in place (the animal by-product licence is very nuanced!) and application can take some time so the sooner you inform her, the better as work cannot start until this is in place. Alongside, you will need to complete your ethics, biological risk assessment and so forth as with other materials entering the CBE.
I am already working with human material that was commercially sourced but did not complete an ethics checklist: you cannot apply for ethical approval retrospectively but will need to complete your ethical review asap using links above.