APPLICANT'S CHECKLIST

Transcription

1 APPLICANT'S CHECKLIST Research tissue bank (or other research biobank) REC Ref: Title of Tissue Bank: Applicant's Name: Name of Designated Individual: Please complete this checklist and send it with your application Except where stated, send ONE hard copy of each document to the REC office by the agreed submission date. Check that the lock code appears on each page of the application form before sending the hard copy. ALL accompanying documents must bear version numbers and dates (except where stated). Documents marked as mandatory must be submitted in all cases for the application to be valid. Other documents should be submitted if relevant to the application. When collating please do NOT staple documents as they will need to be photocopied. Document Enclosed? Date Version Office use Covering letter on headed paper Application form Mandatory Protocol for management of the tissue bank Summary of research programme(s) Participant information sheet (PIS) Participant consent form Relative information sheet Relative consent form Human Tissue Authority licence NHS REC Application Form Version 5.3 1

2 WELCOME TO THE NHS RESEARCH ETHICS COMMITTEE APPLICATION FORM An application form specific to your project will be created from the answers you give to the following questions. 1. Is your project an audit or service evaluation? 2. Select one research category from the list below: Clinical trials of investigational medicinal products Clinical investigations or other studies of medical devices Other clinical trial or clinical investigation Research administering questionnaires/interviews for quantitative analysis, or using mixed quantitative/qualitative methodology Research involving qualitative methods only Research limited to working with human tissue samples and/or data Research tissue bank If your work does not fit any of these categories, select the option below: Other research 2a. In which part of the United Kingdom is the bank established? England, Wales or Northern Ireland Scotland Questions 3 6 disabled. NHS REC Application Form Version 5.3 2

3 NHS Research Ethics Committee Research tissue bank (or other research biobank) Short title and version number: (maximum 70 characters) Name of NHS Research Ethics Committee to which application for ethical review is being made: REC reference number: (For office use) Submission date: Preliminary checklist Completion of this checklist will determine which questions in the form are not relevant to your application as well as providing the REC with a convenient summary of the activities of the Bank. Tick all activities to be undertaken by the establishment (i.e. the legal entity responsible for storage of the tissue/data): Existing holding of stored tissue (any "relevant material" as defined by the Human Tissue Act and held prior to 1 September 2006) Removal, collection and storage of tissue from the living Collection and storage of surplus tissue from the living Collection and storage of samples from the deceased Collection and storage of other biological material Collection of new data from the living Arranging the collection of new tissue samples or data by collaborator(s) Sponsoring or conducting research projects using the tissue samples or data Releasing tissue samples or data to other researchers with no involvement of the establishment in sponsoring or conducting the research Collection and storage of tissue, other biological material or data from adults (aged 16 or over) without the capacity to consent for themselves NHS REC Application Form Version 5.3 3

4 A. Administrative information A1. Title of the tissue bank A2. Name and address of the establishment (i.e. the legal entity responsible for storage of the tissue/data) Organisation: Address: Postcode: Telephone: Fax: A3. Contact point within this organisation for purposes of the application Title: Forename/Initials: Surname: Work Address: Postcode: Telephone: Fax: Mobile: E mail: A4. Does the establishment hold a licence from the Human Tissue Authority for the storage of tissue? Please enclose copy of licence if available. Licence application pending A5. Give the name of the "designated individual" for purposes of licensing by the Human Tissue Authority. Title: Forename/Initials: Surname: Work Address: Postcode: Telephone: Fax: Mobile: E mail: NHS REC Application Form Version 5.3 4

5 A6. Has this tissue bank previously been the subject of an application for ethical review? If Yes, was the application approved? Name of Research Ethics Committee: Date of decision: REC reference number: NHS REC Application Form Version 5.3 5

6 B. Purpose of the Bank B1. Describe the types of tissue sample, other biological material or data to be collected/stored from the living. B2. Describe the types of tissue sample, other biological material or data to be collected from the deceased. B3. Will the samples or data be linked to identifiable donors? Will further data be accrued from donors in future? Please give details. B4. How is it intended to make beneficial use of the samples or data in research? Summarise the overall policy of the bank/establishment for use of the samples or data, including release to other researchers or research organisations NHS REC Application Form Version 5.3 6

7 C. Use of samples or data in future research C1 C8 apply where the bank/establishment will be sponsoring or conducting its own research using the samples or data. Answer in relation to this research programme. (C9 C20 apply where the bank will be releasing tissue and data to other researchers.) C1. Do you wish to seek generic ethical approval for research projects sponsored or conducted by the bank/establishment using the stored tissue/data, under conditions agreed with the REC, without requirement for researchers to apply individually to the REC for approval? If Yes, C2 C8 will be enabled. If No, C2 C8 will be disabled. Researchers will be required to apply individually to obtain ethical approval. C2. What types of research will be undertaken and in what field(s) of biomedicine? C3. What types of test or analysis will be carried out on the samples or data? C4. Will the research involve the analysis of human DNA in the samples? C5. Is it possible that the research could produce findings of clinical significance for individuals? (This may include relatives as well as donors.) C6. Where research data is clinically significant for individuals, will arrangements be made to notify the individuals concerned? If No, please justify. If Yes, say what arrangements will be made and give details of the support or counselling service. C7. Will the samples be used in animal research? If Yes, please give details: C8. Will the samples be used in research into termination of pregnancy or reproductive cloning? If Yes, please give details: NHS REC Application Form Version 5.3 7

8 C9 C20 apply where the bank will be releasing tissue and data to other researchers. C9. Do you wish to seek generic ethical approval on behalf of researchers who will be using tissue or data supplied by the bank, under conditions agreed with the REC, without requirement for researchers to apply individually to the REC for approval? If Yes, C10 C20 will be enabled. If No, C10 C20 will be disabled. Researchers receiving tissue or data will be required to apply individually to the REC using the REC project based application form. Go to section D. C10. What types of research will be undertaken by other individuals/organisations using the samples or data and in what field(s) of biomedicine? C11. Name any research organisations or units you plan to collaborate with. C12. Will any types of research or research organisation be excluded from receiving tissue or data? If Yes, please give details: C13. Will tissue samples be released for use in animal research? If Yes, please give details: C14. Will the samples be used in research into termination of pregnancy or reproductive cloning? If Yes, please give details: C15. What arrangements will be made to ensure that research projects using released tissue or data have been subject to appropriate scientific critique, are adequately funded and fall within the terms of any prior donor consent? C16. Will tissue or data be released: In fully anonymised form? (link to stored tissue or data is broken) In linked anonymised form? (linked to stored tissue and data but donor not identifiable to the researcher) NHS REC Application Form Version 5.3 8

9 In a form in which the donor could be identifiable to the researcher? If Yes, please justify. Projects receiving identifiable tissue or data should apply separately for ethical review. C17. Will tissue or data be released to individuals/organisations conducting research outside the UK? If Yes, please give details: C18. What will your policy be for requiring feedback of research data specific to the donor to be linked with the stored tissue/data? C19. Where returned data is clinically significant for individuals, will arrangements be made to notify the individuals concerned? If Yes, please say what arrangements will be made and give details of the support or counselling service. C20. What arrangements will be made with researchers for return or disposal of samples when studies are completed? NHS REC Application Form Version 5.3 9

10 D. Informed consent D1 D2 apply to existing holdings of tissue/data only: D1. Has informed consent already been given to use in research? If Yes, for what purposes has consent been given? Enclose a copy of the information sheet and consent form used (if available) D2. If informed consent has not been given, is it proposed to seek consent for future use in research? If Yes, please say how donors will be approached and enclose copy of information sheet (or letter) and consent form. If No, please justify. D3 applies to collections of surplus tissue from the living: D3. Is it proposed to seek consent for use of the samples in research? If Yes, please say how donors will be approached and enclose copy of information sheet (or letter) and consent form. If No, please justify. D4 applies to collections from the deceased: D4. What arrangements will be made to seek appropriate consent? Enclose copy of information sheet(s) and consent form(s). D5 D7 apply to all other tissue samples, other biological material or data collected from the living: D5. How will donors be identified and approached? Describe the involvement of collaborators. D6. Describe the arrangements for collection of samples or data. Indicate whether samples or data will be collected in the course of healthcare provision or whether additional procedures will be involved. In the case of additional procedures, what risks or burdens could arise for participants? NHS REC Application Form Version

11 D7. Describe the arrangements for taking appropriate consent for use in research. State who will be responsible for the consent process. Enclose copy of information sheet(s) and consent form(s). D8. Will any donors be from the following groups? Minors (under the age of 18) Prisoners Persons in a dependent relationship with the establishment or any collaborators Adults (aged 18 or over) without the capacity to consent for themselves If so, please justify and describe what particular arrangements will be made to ensure that appropriate consent is given or, in the case of adults with incapacity, to satisfy the criteria in the Human Tissue Act Regulations. D9. Will any financial or other incentives be offered to donors? D10. What steps will be taken where participants subsequently withdraw consent to the use of their samples or data? D11. Will PIAG approval be required for processing of identifiable patient data without consent? If Yes, has approval already been given and if so for what activities? Enclose copy of PIAG approval letter. NHS REC Application Form Version

12 E. Declaration Declaration by the applicant: 1. The information in this form is accurate to the best of my knowledge and belief and I take full responsibility for it. 2. If the application is approved I undertake to adhere to the terms of the application of which the REC has given a favourable opinion and any conditions set out by the REC in giving its opinion. 3. I undertake to seek an ethical opinion before implementing substantial amendments to the terms of the application of which the REC has given a favourable opinion. 4. I undertake to submit annual progress reports to the REC. 5. I understand that the information contained in this application, any supporting documentation and all correspondence with NHS Research Ethics Committees or their operational managers relating to the application: Will be held indefinitely by the main REC. May be disclosed to the operational managers or the appointing body for the REC in order to check that the application has been processed correctly or to investigate any complaint. May be seen by auditors appointed by the National Research Ethics Service to undertake accreditation of the REC. Will be subject to the provisions of the Freedom of Information Acts and may be disclosed in response to requests made under the Acts except where statutory exemptions apply. Optional please tick as appropriate: I would be content for members of other RECs to have access to the information in the application in confidence for training purposes. All personal identifiers and references to the establishment and other research units and collaborators would be removed. Signature:... Print Name: Date: NHS REC Application Form Version