RESEARCH REGISTRATION CHECKLIST

This checklist MUST be completed and signed by the Chief Investigator, student supervisor and/or student for all research projects that are undertaken at the University of Bristol (UoB) involving human participants, their tissue and/or data.Please refer to guidance notes whichare available at

PROJECT TITLE:

Start date: // End date: // Full Economic Costing Code:

1. Clinical Trial Regulations:Does the research project involve the investigation of the safety or efficacy of a medicine/foodstuff/placebo or a trial of a medical device in humans (includes healthy volunteers and patients)? / Yes
see note 1 / No
2. Research Governance Framework: Does the research project involve:
2a. patients, clients or carers of an NHS Trust or Social Care organisation or health related research involving prisoners? and/or
2b. staff or premises of an NHS Trust or Social Care organisation?
(please tick all that apply) / Yes
Yes
see note 2 / No
No
3. Human Tissue Act: Does the research involve the procurement, import, use and/or storage of human tissue? / Yes
see note 3 / No
4. Student qualification: Is this a student project?
If so, what level of qualification? / Yes
see note 4 / No
5. Insurance and Indemnity:
5a. For ALL research, does the research fall into any of the following categories?
Drug/medical device studies; clinically invasive procedures; children under 5; pregnant women; cohorts of more than 5000 participants; conception/contraception studies; trials undertaken outside the UK; genetic engineering; research into Hepatitis, HIV/AIDS, CJD.
5b. If you have answered ‘YES’ to questions 1, 2a, 2b or 3 you need a letter from our Insurance Officer to apply for NHS ethics and/or R&D approval. Specimen insurance answers are available at Have you applied/will you apply for an insurance letter? / Yes
Yes
see note 5 / No
No
6. Funder: Who is funding this research?
Approximate level of funding
Peer review undertaken, provide details if not funder / see note 6
7. Ethical review:
7a. You will need ethics approval from an NHS Research Ethics Committee if you have answered ‘YES’ to questions 1, 2a or 3 (except 2b, research solely involving staff or premises). Have you applied/will you apply for this?
7b. You will need Faculty, School or Departmental ethics approval if you have answered ‘YES’ to question 2b (your study only involves NHS staff/premises) or the study has ethical implications in accordance with UoB ethics policy. Have you applied/will you apply for this? / Yes
Yes
see note 7 / No
No
8. Sponsorship: You will need a Research Sponsor if you have answered ‘YES’ to questions 1, 2a, 2b or 3.
8a. Would you like the University of Bristol to be the Sponsor for the project?
8b. Is another Organisation acting as Sponsor?
Please give details and attach a letter confirming sponsorship / Yes
Yes
see note 8 / No
No
Responsibilities
  • It is your responsibility to ensure that you and all other staff and students having access to NHS patients, NHS patient identifiable data, children, vulnerable adults have the appropriate access clearances e.g. NHS research passport, letter of access, DBS/CRB checks.
/ see note 9

Declaration

As the Chief Investigator/student supervisor/student I confirm that the answers provided on page 1 are true and that, where appropriate to the nature of my research, I will abide by the following government legislation, NHS and UoB policies in the management, conduct and administration of this research project:

  • The Human Tissue Act 2004
  • The Mental Capacity Act 2005
  • The Data Protection Act 1998 and, in the case of medical research, the Caldicott Principles
  • The Research Governance Framework for Health and Social Care (2005) as amended
  • The terms and conditions of the approval of the relevant ethics committee(s)
  • NHS Research & Development approval terms from all NHS Trusts directly responsible for the care of the research participants
  • The Medicines for Human Use (Clinical Trials) Regulations 2004
  • Home Office licences (if the research involves animals)
  • UoBResearch Governance and IntegrityPolicy
  • UoB Ethics of Research Policy and Procedure
  • All other appropriate UoB policies and guidance.

In addition by signing below I confirm the following:

~ The dignity, rights, safety and well being of any research participants will be given priority at all times.

~ Adequate and accurate records will be maintained and made available for audit/monitoring as required.

~ The findings from the research will be open to critical review and appropriately disseminated.

~ In the event that any approvals are withdrawn, the project will be suspended until all approvals are once again in place. The UoB research governance team will be notified of this activity.

~I will notify the UoB research governance team of any amendments to the project prior to submission for approval.

~ All members of the research team are informed of their obligations in meeting the above commitments. They will be suitably qualified and adequately supervised to undertake their roles in the research.

I understand that it will be a disciplinary offence to commence any research participant recruitment until all the necessary approvals are received.

Chief Investigator (this could be UoB staff or a student working towards a PhD, MD or equivalent)

Name:

Dept:

Date:

Student Supervisor (complete if a student is named as the Chief Investigator)

Name:

Dept:

Date:

Student (name any students working towards an undergraduate or masters degree on this study)

Name:

Qualification:

(seenote 10 for further information)

How to submit

1. Complete the form overleaf and ensure above named parties approve the content

2. Complete the declaration (no signature needed)

3. The Chief Investigatoronly should e-mail (or post) the following from their University e-mail accountto

  • completed form
  • protocol / research summary
  • NHS ethics application (if applicable)
  • Letter confirming Faculty ethics approval (if applicable)
  • R&D Trust approvals (if available)

Please allow at least 10 working days for your application for sponsorship to be processed.

Version 10, 29.07.14