HTA-2 Acquiring Materials Regulated Under the Human Tissue Act-DRAFT
SOP Number: HTA-2 Version: 1.0
Title: Acquiring Materials Regulated Under the Human Tissue Act
Purpose: To ensure that all applicable human material is sourced in compliance with The Human Tissue Act (2004), The Human Tissue (Quality and Safety for Human Application) Regulations 2007 and local rules.
Written By: Tina Dale Date: 23.02.09
Approved By: Nicholas Forsyth Date: 24.02.09
Effective Date: 24.02.09 Review Date:22.07.10
SOP History:
VERSION / AMENDMENT / CURRENT VERSION1.0 / None / 1.0
1.0 / Section 2.10 22nd July 2009 / 2.0
1. Introduction:
The 2004 Human Tissue Act requires that all establishments acquiring, storing, using or disposing of human tissues are licensed and regulated for these activities by the Human Tissue Authority (HTA). The remit of the HTA was further extended in 2007 to ensure compliance with the EU Tissues and Cells Directive. In the UK this is via The Human Tissue (Quality and Safety for Human Application) Regulations 2007. These regulations are relevant to material that has come from a human body which consists of or includes human cells and is intended for human application. Institutions licensed by the HTA should comply with the HTA Codes of Practice and, where the material is intended for human application, the Directions issued regarding the 2007 Regulations.
*ISTM is currently licensed to undertake research and storage of human materials, if the desired use falls outside these categories please contact Dr N.R. Forsyth for further information.
Please note: There are no facilities within the Keele Laboratories for handling samples with a high probability of infection risk including, but not limited to IV drug users, homosexuals, some tattooed individuals, known HIV positive individuals and known hepatitis patients. Do not attempt to procure this type of material. If such samples are received contact a senior member of staff who will dispose of the material safely.
If CJD samples are to be received please contact the relevant head of department or Consultant Microbiologist (Dr Gray or Dr Orendi) for advice before handling.
2. Procedure:
2.1 Prior to undertaking any study obtain Independent Peer Review (IPR) as per local rules by completing the IPR form, see Appendix A. For guidance contact the individuals below as appropriate.
Keele University contact: University Hospital North Staffordshire (UHNS)
contact:
Nicola Leighton Dr Darren Clement
Research Governance Officer R&D Manager
Office of Research and Enterprise Guy Hilton Research Centre
Dorothy Hodgkin Building Thornburrow Drive
Room DH1:13 Hartshill
Keele University Stoke-on-Trent
Staffordshire Staffordshire
ST5 5BG ST4 7QB
Tel: 01782 583306 Tel: 01782 554839
E-mail: E-mail:
2.2 Following Successful IPR obtain approval from the NHS Research Ethics Committee and Local Research Ethics Committee (LREC). The application form is available at www.nresform.org.uk. Guidance on completing these applications should also be sought from the above contacts as appropriate.
2.3 Following successful applications for IPR and LREC tissue samples may be procured. Where consent is being sought directly by the investigators or on behalf of the investigators signed consent forms must be obtained for all samples, these must be stored securely by the Chief Investigator of the study in a locked, metal filing cabinet, or on a password protected device. Completed consent forms must be made available for inspection upon request by any Secretariat-approved internal or external auditing body.
2.4 Tissue samples obtained from non-hospital sources such as licensed tissue banks will have established consent procedures. If using Bank materials LREC approval must still be sought however consent documentation need not be held by the Chief Investigator. Documentation from the Bank ensuring that consent was correctly obtained will be required. If material is being obtained from commercial sources a clear ethical statement should be obtained confirming that the materials were sourced using methods that meet the regulatory requirements of the HTA.
2.5 Any work to be carried out using human embryonic stem cells (hESC) must be approved by the UK Stem Cell Bank (UKSCB). All hESC should be sourced from the UKSCB. If cells are not soured from the UKSCB then Approval to Import should be sought from the UKSCB.
2.6 Where it is necessary to have Material Transfer Agreements (MTA), Material Use Licenses (MUL), Memoranda of Understanding (MOU) or other agreements the guidance of the Office of Research and Enterprise must be sought.
Research and Enterprise Services
Dorothy Hodgkin Building
Keele University
Staffordshire
ST5 5BG
Tel: 01782 583371
Fax: 01782 583740
http://www.keele.ac.uk/research/
2.7 All relevant material arriving on the premises must immediately be logged in the Human Tissue logbook or the Stem/Primary cell logbook located at the Guy Hilton Research Centre (GHRC) reception or by email to .
2.8 If primary cells are further recovered from the human tissue, record these in the Stem/Primary cells logbook and if all remaining tissue material was discarded mark as disposed of in the human tissue logbook.
2.9 All tissue samples must be fully labelled, details should include time and place of isolation, tissue type, tissue treatment post-isolation e.g. stored on ice, snap frozen in liquid nitrogen etc. Records must be kept clearly detailing the location of tissues at all times. Records should include origin, storage location, use and final destination if applicable.
2.10 Materials must be stored in designated rooms as described in the logbook. Materials intended for human application must be stored separately.
3. References:
http://www.hta.gov.uk/guidance/codes_of_practice.cfm
http://www.hta.gov.uk/guidance/licensing_guidance/expected_standards_directions.cfm
Appendix A
Research Protocol Outline Form
(supplement to the LREC form)
The research protocol should be completed as concisely as possible and it should address the following points as applicable. Please state clearly if any section is not applicable to your project. The majority of the sections are the same as the LREC form. The boxes can be expanded and your text can be ‘cut and pasted’ from the LREC form. For convenience we have indicated the relevant LREC question references that map to this form.
PLEASE NOTE THAT THE INDEPENDENT PEER REVIEW COMMITTEE IS NOT LINKED OR A SUB-COMMITTEE OF THE LOCAL RESEARCH ETHICS COMMITTEE (LREC).
1 STUDY TEAM AND RESEARCH MANAGEMENT (moved from the bottom of the form)
Name of Principal Investigator (C2 of Ethics form):
Current post:
Contact postal address:
Contact telephone number:
Contact e-mail address:
Other members of the study team (please specify names, current post and their role in this study) (A66 and C3 of Ethics form):
Name:
Current post:
Organisation:
Role in the study:
Name:
Current post:
Organisation:
Role in the study:
Name:
Current post:
Organisation:
Role in the study:
Name:
Current post:
Organisation:
Role in the study:
Name:
Current post:
Organisation:
Role in the study:
If more than 5, please use a separate sheet
Institute/Research Centre/Programme/Department name:
Name of Research Director:
2 PROJECT IDENTIFIER
Full title of research project (A1 of Ethics form):
Key Words:
Short title:
3 WHAT IS THE PRINCIPAL RESEARCH QUESTION/OBJECTIVE? Provide a clear account of the purpose of your investigation, including primary and secondary objectives (A7, A8, A48 and A49 of Ethics form):
4 SCIENTIFIC BACKGROUND. What is the scientific justification for the research? What is the background? Why is this an area of importance? Has similar research on this topic been done before? Have all existing sources of evidence, especially systematic reviews been fully considered? What new information will it provide (A9, A46 and A47 of Ethics form)? (Should be no longer than 1 A4 page in length).
5 STUDY TYPE
Research methodology (strike through as many as are appropriate)
Randomised controlled trial Yes / No
Controlled trial without randomisation Yes / No
Case control study Yes / No
Cross-sectional study Yes / No
Quasi-experimental Yes / No
Before and after study Yes / No
Survey Yes / No
Cross-over study Yes / No
Qualitative Yes / No
Cohort Yes / No
Observational Yes / No
Other Yes / No
If other, give details:
Is the research being undertaken as part of an educational course or degree? Yes / No
If YES give details including:
Name and level of course/degree
Name of educational establishment
Name of Supervisor
DETAILED PLAN OF INVESTIGATION
(you may wish to use the following headings as a guide – please use separate sheets of paper) (Should be no more than 2 A4 pages in length)
Summary of the study (Give a brief synopsis/summary of methods and overview of the planned research. A flow chart or diagram should be attached where appropriate. It should be clear exactly what will happen to the research participant, how many times and in what order) (A10 of Ethics form):
Study population
Inclusion criteria (What inclusion criteria will be used to select participants/patient records/tissue or bodily samples (list cases and controls separately if appropriate?)) (A22 of Ethics form):
Exclusion criteria (If you are excluding participants on the basis of age, sex or ethnicity please explain why) (A23 of Ethics form):
Will the study involve the recruitment of human research participants? Yes / No
Study Setting (Name and Description of Centres) (A56, C9 and C10 of Ethics form):
How will potential research participants in the study be identified, approached and recruited? (Give details for cases and controls separately if appropriate, describe sampling methodology and randomisation procedures) (A20 of Ethics form):
Will informed consent be obtained from the research participants? Yes / No
(Give details of who will obtain consent, how it will be done, and of any particular steps other than an information sheet taken to provide information e.g. video, interactive media. Please attach a copy of the consent form. If consent is not to be obtained, please explain why not) (A26 of Ethics form):
Subject/Patient participation
(Provide details of what research participants will do e.g. treatment intervention, completion of a questionnaire, participate in an in-depth interview; provide details of how the research procedures or intervention will be administered (include duration and audit details); provide details of any risks to the participant and safeguards to be put in place) (A12 and A13 of Ethics form):
Follow-up (Provide details of follow-up procedures and time points, if appropriate)
Outcome Measures (if appropriate)
Primary Outcome (A48 of Ethics form):
Secondary Outcome (A49 of Ethics form):
DATA ANALYSIS
(include power calculations, if applicable)
Has the size of the study been informed by a formal statistical power calculation? Yes / No
If YES indicate the basis upon which this was done, covering the areas shown, and giving sufficient information to allow the replication of the calculation (A51 of Ethics form):
If NO, explain how the size of the study was determined and why a formal sample size calculation is not required:
Describe methods of analysis (identifying specific procedures in the case of statistical analysis or analytical methods in the case of qualitative research) (A53 of Ethics form):
Has a statistician or an advisor for qualitative research given an opinion about the statistical or methodological aspects and design of the research? (A52 of Ethics form) Yes / No
If YES, give the name and contact details:
If NO, then give reason why not:
Where will the analysis of the data from the study take place and by whom will it be undertaken? (A41 of Ethics form)
STUDY TIMETABLE
Start date:
End date:
Duration (Years and Months):
Completion date for data collection:
Proposed reporting/publication dates:
Has funding for this project been secured? Yes / Currently being sought / No*
*Please delete as appropriate
If yes or being sought, where from?
Funding details
This section is covered on the COREC form so the information is no longer requested by the Peer Review Committee.
EVIDENCE OF SCIENTIFIC REVIEW
(only applications with NO evidence of independent peer review need to be submitted)
DETAILS OF PEER REVIEW REQUIREMENTS(to be completed by the Principal Investigator)
Name of Funder:
Name of Sponsor:
I confirm that the information submitted in this proposal is complete and correct and this project will be conducted in accordance with Research Governance requirements
SIGNED …………………………………………………….. (Principal Investigator’s signature)
STATUS of STUDY (please indicate which)
(to be completed by the Principal Investigator)
Student Project / Pre-pilot/Pilot study / Full study
PROPOSED INDEPENDENT REVIEWERS
(to be completed by the Principal Investigator)
For projects that have not been externally reviewed. Provide names and e-mail addresses. The Committee member reviewing the project may choose to send the project to one of your external reviewers, together with an external reviewer of their own choice.
For student/pilot research projects:-
Applicants are requested to provide the names of three external reviewers, as for full projects. These projects will normally only be reviewed by the Board. However, a judgment will be made by a Committee member if the project requires external peer review.
Name:
E-mail:
Organisation:
Relationship between applicant and reviewer:
2) Name:
E-mail:
Organisation:
Relationship between applicant and reviewer:
3) Name:
E-mail:
Organisation:
Relationship between applicant and reviewer:
STUDENT PROJECTS
(Student projects will be normally reviewed by the Board only and a judgment made if they need to be sent for external review)
Supervisor’s name and institutional address
Degree type, and institution (if different from supervisor’s)
Educational value of the project
Potential risks and safeguards
Supervision arrangements
I can confirm that this project will be supervised in line with Research Governance Requirements / Supervisor signature …………………………………
Status of Supervisor ………………………………….
Principal Investigator to obtain the authorised signatures
ORGANISATION / ORGANISATION / AUTHORISING SIGNATURE
Having discussed this proposal with the applicant, I confirm that the research fits within the scientific programmes of the University / NHS Trust
If it is a joint project between the University and the NHS Trust, or involves both the University and the Trust, signatures must be obtained from BOTH organisations. / University Institute Director/Programme Director/Head of Department
OR
NHS Trust R&D Director/Manager or Research Governance Manager
I confirm that I have read this application and agree that if approved it:
will meet Research Governance requirements
be accommodated & administered in the University / NHS Trust
If it is a joint project between the University and the NHS Trust, or involves both the University and the Trust signatures must be obtained from BOTH organisations. / University Institute Director/Programme Director/Head of Department
OR
NHS Trust Clinical Director/Directorate Manager or Research Governance Manager
Once completed and the appropriate signatures have been obtained:-