Research & Development Website
Research activity involves many different individuals and management functions within the organisation. It is therefore essential that the responsibilities of the Trust management structure as well as researchers, healthcare professionals and other members of staff are clearly defined. An overview of these responsibilities is provided here:
| Back to Research Governance Page |
Responsibilities of Directorate Research Leads & Guidance for their Role:
Each Directorate has at least one research lead who takes responsibility for the management of research activity within their area and their role is crucially important in supporting the Trust's R&D agenda. The Research Lead is an active researcher or is involved in research management and a cross-section of disciplines is represented. The key elements of their role are to:
-
Provide Directorate managerial sign-off of all proposed research projects which includes agreement for the use of resources and assessing whether the project fits with the local research strategy.
-
Ensure projects are peer-reviewed where necessary
-
Chair the Directorate's Research Committee (where one already exists or is convened) and developing a Directorate research strategy which complements the LTHT/UoL research strategy
-
Act as a contact for matters relating to intellectual property and its management
Intellectual Property - Guidance for Directorate Research Leads
-
Attend the Research Forum and represent the interests of their Directorate within this group and share good practice with other members of the forum
- Contribute to the resolution of issues relating to specific research projects, e.g. issues raised through the R&D audit process or via the Research Ethics Committees.
| Back to Research Governance Page |
What are your Responsibilities of as a Chief Investigator?
The principal investigator is the person designated as taking
overall responsibility within the team of researchers for the design, conduct
and reporting of the study. They are accountable to their employing organisation,
the host organisation/s (if different to the employing organisation) and the
sponsor of the research for the conduct of the study.
Chief investigators must have suitable experience and expertise in the design
and conduct of research.
Their responsibility is to ensure that:
- The dignity, rights, safety and well-being of participants are given priority at all times by the research team
- The research has received research ethics committee and Trust managerial (local and R&D) approval before commencing.
- Healthcare staff are suitably informed about the research their patients are taking part in.
- Each member of the research team is qualified by education, training and experience to discharge his/her role in the study.
- Students and new researchers must have adequate supervision, support and training.
- The research follows the protocol approved by the relevant research ethics committee. Any proposed changes or amendments to or deviations from the protocol must be submitted for approval to the research ethics committee, the research sponsor and any other appropriate body.
- Arrangements should be made for the appropriate archiving of data when the research has finished (records must normally be kept for 15 years).
- Procedures are in place to ensure collection of high quality, accurate data and the integrity and confidentiality of data during processing and storage.
- Clear arrangements are in place for the management of financial and other resources provided for the study, including management of intellectual property arising from the work.
- Reports on the progress and outcomes of the work are produced on time and to an acceptable standard.
- The findings from the work are exposed to critical review through the accepted scientific and professional channels.
- Findings are disseminated promptly and fed back as appropriate to research participants.
- Any adverse events/adverse drug reactions or suspected misconduct are reported.
- All data and documentation associated with the study are available for
audit at the request of the appropriate auditing authority.
| Back to Research Governance Page |
What are your responsibilities as a Researcher?
Researchers bear the day-to-day responsibility for the conduct of research. They are responsible for:
- Ensuring that the dignity, rights, safety and well-being of participants at all times
- ensuring that any research they undertake follows the agreed protocol
- ensuring that patients receive appropriate high quality care while involved in research
- protecting the integrity and confidentiality of clinical and other records and data generated by the research
- ensuring they aware of their responsibilities under the Health and Safety Act both in respect of themselves and of other participants in research
- reporting any failures in any of the above, adverse drug reactions and other potential harmful events or suspected research misconduct through the appropriate systems
Professional Integrity in Researchtegrity in Research
The University of Leeds have produced
a document outlining the principles of professional integrity in research.
These guidelines can be accessed by clicking
here
| Back to Research Governance Page |
What are your responsibilities as an Employee?
All healthcare professionals, even if not involved in research, have a responsibility for the safety of their patients participating in research.
Before agreeing that patients be approached to take part in a study you should ensure that the research has been approved by the Trust and the appropriate research ethics committee.
If you are unsure if the project has received appropriate Management or Ethical approval, contact the R&D Department.
Staff should report any concerns about the way informed consent is obtained or how the study is to be carried out to the R&D Department or Directorate Research Lead.
| Back to Research Governance Page |