Research Integrity & Ethics. Rowena Lamb Cultures of Integrity Coordinator

Transcription

1 Research Integrity & Ethics Rowena Lamb Cultures of Integrity Coordinator

2 UCL Statement on Research Integrity Applies to all staff and students at UCL Sets out the standards all those involved with research at or in collaboration with UCL are expected to adhere to. Adopts the concordat s four elements as Principles of Integrity: Honesty Rigour Transparency and open communication Care and respect

3 Research Integrity Research at all levels Not just focussing on PhD and above Process is the same Crossing disciplines Every researcher Every discipline Details vary but the framework remains the same Whole research life-cycle Every day Encompasses all stages of research Part of your everyday work

4 Research Integrity Website UCL Statement on Research Integrity Research Data Management Research Collaboration Research Data Management Declaration of Interest Data Protection Research Funding Ethics Freedom of Information Research Ethics Intellectual Property Mentoring Information Security Publication & Authorship Open Access Peer Review Training News & Updates. Mailing List

5 Why is ethics review required? Ethics review is about heightening risk awareness not about preventing potentially high risk research. Protecting the researcher and also those being researched. Ethics review is about encouraging researchers to think through potential ethical challenges. Put yourself in the participant s shoes. UCL s Principles of Integrity; Honesty, Rigour, Transparency and open communication, Care and respect.

6 Which ethics committee should I apply to? Social Care Research Ethics Review (SCREC) Social care research funded by the Department of Health. Ministry of Defence Research Ethics Committee (MoDREC) Human participant research undertaken, funded or sponsored by the MOD. NHS Research Ethics Review Research involving NHS patients and carers, invasive research involving prisoners or adults lacking capacity, a Clinical Trial of an Investigational Medicinal Product or human tissue.

7 Institute of Education Research Ethics Committee All research projects by staff, students or visitors which collect or use data from human participants including secondary data analysis, systematic reviews and pilot studies, are required to gain ethical approval before data collection begins.

8 UCL Research Ethics Committee All research proposals involving living human participants and the collection and/or study of data derived from living human participants undertaken by UCL staff or students on the UCL premises or elsewhere requires ethical approval. Unless, research falls into the 6 exemption catagories

9 Is it research? Within the definition of research, the following are not considered to be 'research' and would be exempt: Quality assurance Performance reviews and testing within normal education requirements Literary or artistic criticism Audit projects Service evaluation

10 Is my research exempt? Six exemption categories: 1. Research that relies exclusively on publicly available information. 2. Research involving anonymised records and data sets that exist in the public domain. 3. Taste and food quality evaluation and consumer acceptance studies.

11 Is my research exempt? 4. Research involving the use of educational tests/ survey/interview procedures on human participants in the public arena. 5. Research involving the use of non-sensitive, completely anonymous educational tests/survey/interview procedures on participants not defined as vulnerable and participation will not induce psychological stress or anxiety. 6. Purely observational studies of people in public places.

12 Research Conducted Overseas (to include the rest of Europe) The following approvals are required for research conducted overseas: For exempt studies local ethics approval required in the study country(ies). For studies conducted solely overseas UCL REC and local ethics approval required in the study country(ies). For studies conducted in the UK involving NHS patients and overseas triple review required UCL REC, HRA for patient element & local ethics approval in the study country(ies).

13 How to apply? Visit the UCL REC website at: ethics.grad.ucl.ac.uk Check application submission deadlines and meeting dates if you need to apply for full committee review. Register personal and project details on ethics database. Download the ethics application form and appendices for completion. Before submission ensure that the application form has been signed by both your supervisor and your Head of Department.

14 How to apply? The following checks/registrations should be conducted as part of the application process as appropriate: Formal sponsorship review required if conducting a Clinical Trial in a Developing Country register in UCL Interventional Clinical Trials Portal (if required) Disclosure and Barring Service Check (if required) UCL Data Protection registration (if required) Risk Assessment (required) Insurance application (if required) Travel Insurance application required for studies conducted overseas only.

15 Type of review required There are 2 types of review: Expedited review by the REC Chair for low risk studies on an ad hoc basis Full committee review for high risk studies

16 Using pre-collected data Things to consider: What restrictions are in place for usage or access? What consent is in place and what does it cover? What was the data originally collected for: How does this match with your research aims? Does this raise ethical considerations; impact upon participants/communities, etc? Trust - Put yourself in the participant s shoes.

17 Further Guidance Research Ethics Helen Dougal, UCL Research Ethics Administrator ethics.grad.ucl.ac.uk Research Integrity Rowena Lamb, Cultures of Integrity Coordinator