CIR Blood Resource OVERVIEW Use of healthy donor human blood New ethics protocol from 2016

Transcription

1 University of Edinburgh / MRC Centre for Inflammation Research November 2015 CIR Blood Resource OVERVIEW Use of healthy donor human blood New ethics protocol from 2016

2 KEY CHANGES FROM 2016 New ethics protocol (previous project no longer valid from end 2015): THE ROLE OF INFLAMMATION IN HUMAN IMMUNITY AMREC Reference number 15-HV-013 BLOOD BANK Apply to CIR Blood Resource Management Committee for: Individual project authorisation within AMREC 15-HV-013 Individual researcher authorisation (for all working with blood or products) Phlebotomist authorisation (to be covered by University insurance) Rigorous detailed record keeping required for all use, storage and destruction of samples and products auditable. Sharing samples only with approved researchers on authorised projects and record details, but can be used with external collaborators / at external sites. CIR Blood Resource (

3 MANAGEMENT COMMITTEE Dr Donald J. Davidson: MRC Senior Research Fellow Prof Adriano Rossi: Chair of Respiratory and Inflammation Pharmacology Dr Sarah Walmsley: Wellcome Trust Senior Clinical Fellow and Honorary Consultant in Respiratory Medicine Dr Sharon Hannah: CIR Centre Manager Additional experts will be co-opted as required to review specific applications where the members of Committee feel that additional expertise is necessary. The Committee will meet to review application on the first Friday of every month. ADMINISTRATION Sonia Rafferty ( ) (or Ms Sheila Marshall ( ) or Ms Ruth MacInnes ( )) MRC/ University of Edinburgh Centre for Inflammation Research The Queen's Medical Research Institute 47 Little France Crescent Edinburgh EH16 4TJ

4 Applying for a project - 1 WHO? All group leaders who want members of their group to work with healthy human blood under AMREC 15-HV-013 after 31st Dec Not restricted to CIR. HOW? Sonia.Rafferty@ed.ac.uk, or get the forms from WHAT FORMS? Complete: Project application to use CIR blood resource Read: CIR 15-HR-013 Research Protocol Read: CIR 15-HR-013 Information Sheet Read: CIR 15-HR-013 Consent form Read: PI s responsibility form Read: Researcher s responsibility form WHEN? By 1 st Dec 2016 for 1 st Jan 2016 requested start Anytime thereafter, >2 weeks before next Committee meeting (see website)

5 Applying for a project - 2 WHAT INFORMATION IS REQUIRED? See form Project application to use CIR blood resource 2 4 side A4 max. Group leader s information Project title Project overview Experimental Summary (studies, cells need, use on / of site & collaborators) Start and end (or rolling) dates Funding (if applicable) Use of results (dissemination, commercialisation) Sample storage plan

6 Applying for a project - 3 WHAT IS COVERED? Read CIR 15-HR-013 Research Protocol See AIMS in research protocol See examples of methodologies in research protocol e.g.: isolated cells / products or whole blood response of the cells to a range of naturally-occurring and synthetic chemical and biological stimuli, to represent normal biological signals and conditions, infectious and toxic hazards, and potential therapeutics. Assessments : morphological and structural characterisation by microscopy and flow cytometry, functional assays (e.g. phagocytosis assays, calcium flux assays, the generation of reactive oxygen species, migration/chemotaxis assays, degranulation assays, and coagulation assays), cell cell interaction studies, studies examining the expression and production of specific mrna and protein products by RT-PCR, ELISA, western immunoblotting or flow cytometry, assessment of DNA to establish the prevalence of specific genetic polymorphisms; toxicity and haemolysis assays, and cell death/survival assays. Samples will be used for genetic analysis (in a linked-anonymised and non-diagnostic manner), may be used in animal models (e.g. donor blood cells being injected into mouse models to evaluate the inflammatory response to cells in different stages of programmed cell death) and may be used in research related to reproductive biology. Stem cells will not be made from these samples Samples be used in cloning experiments No diagnostic tests will be performed on the blood samples. Participants will not be informed of the results of any studies specifically relating to their sample. No commercial product will be generated using the blood samples and the sample material will not be sold. Data presented and published will not be attributable to individual participants.

7 PROCESS Applying for a project - 4 Read forms and submit completed application to Sonia Rafferty Reviewed at monthly CIR Blood Resource Management Committee Respond to any queries re application Upon approval, the Projects Administrator will: Assign a Project number & add to Blood Projects Database Approve applicant as authorised researcher for that calendar year Authorisation certificate Add as researcher to that project Enable access to protected shared drive and Donor Database Provide password to Donor Database personal use only Create a project number specific Blood Sample Use Record file on the shared access drive, for that project for that calendar year. Reminder all researchers now apply to work on this project Reminder all samples must be recorded Annual review (+/- audit)

8 Applying for a project - 5 PROJECT HOLDER S RESPONSIBILITIES See PI s responsibility form Hold current calendar year authorised project approval Comply with regulations detailed on forms for AMREC 15-HV-013 Responsibility that researchers and collaborators working on this approved project are individually authorised and aware of the permission granted for this project Only share blood and components with registered users Ensure all researchers comply with local safety rules & risk assessments Report all publications and grants arising from / involving use this resource to Projects Administrator Report any adverse outcome witnessed or reported Ensure clear, auditable central project-specific records detailing every sample obtained: identification number use / storage / given away / disposal date / disposal

9 Applying to be a researcher - 1 WHO? All researchers who want to work with healthy human blood or products under AMREC 15-HV-013 after 31st Dec 2015 Not restricted to CIR Apply to work on specific authorised project(s) HOW? Sonia.Rafferty@ed.ac.uk, or get the forms from WHAT FORMS? Complete: Researcher application to use CIR blood resource Read: CIR 15-HR-013 Research Protocol Read: CIR 15-HR-013 Information Sheet Read: CIR 15-HR-013 Consent form Read: Researcher s responsibility form WHEN? Anytime after project approved (or before, for consideration after project approval).

10 PROCESS Applying to be a researcher - 2 Read forms and submit completed application(s), signed by Group leader(s) holding relevant project approval, to Sonia Rafferty Reviewed by Project Administrator after associated project is authorised Respond to any queries re application Upon approval (cced to PI), the Projects Administrator will: Add researcher to project on Blood Projects Database Approve applicant as authorised researcher for that calendar year Authorisation certificate Enable access to protected shared drive and Donor Database Provide password to Donor Database personal use only Reminder all samples must be recorded Annual review via PI approval, with password change

11 Applying to be a researcher -3 RESEARCHER S RESPONSIBILITIES See Researcher s responsibility form Hold current calendar year researcher authorisation to work on authorised project(s) Comply with regulations detailed on forms for AMREC 15-HV-013 Comply fully with CIR 15-HR-013 Research Protocol re taking, using, storing, destroying blood cells, components and data generated Only share blood and components with registered users Comply with local safety rules and risk assessments (strongly advised to be Hepatitis B vaccinated) Maintain phlebotomy room in good condition Report any adverse outcome witnessed or informed about Ensure clear, auditable central project-specific records detailing every sample obtained: identification number use / storage / given away / disposal date / disposal

12 Applying to be an external collaborator - 1 WHO? Applicable only to researchers whose involvement is strictly limited to receipt of samples to conduct assays in collaboration with authorised University of Edinburgh investigators, on an authorised project with existing project number under AMREC 15-HV-013 after 31st Dec Researchers wishing to be involved in collection of blood or processing of blood to generate cells or products, must make a full application is required HOW? Sonia.Rafferty@ed.ac.uk, or get the forms from WHAT FORMS? Complete: External Collaborator application to use CIR blood resource Read: CIR 15-HR-013 Research Protocol Read: Collaborator s responsibility form WHEN? Anytime after project approved

13 Applying to be an external collaborator 2 PROCESS Read forms and submit completed application(s), signed by collaborating Group leader(s) holding relevant project approval, to Sonia Rafferty Reviewed at monthly CIR Blood Resource Management Committee Respond to any queries re application Upon approval (cced to collaborating PI), the Projects Administrator will: Add researcher to project on Blood Projects Database Approve applicant as authorised researcher for that calendar year Authorisation certificate External collaborators do not have access to the protected shared drive and Donor Database Reminder all samples use/storage/destruction must be recorded the collaborator in the same way as internal researchers, available for audit but held independently.

14 Applying to be an external collaborator -3 COLLABORATOR S RESPONSIBILITIES See Collaborator s responsibility form Hold current collaborator authorisation to work on authorised project(s) Comply with regulations detailed on forms for AMREC 15-HV-013 Comply fully with CIR 15-HR-013 Research Protocol re using, storing, destroying blood cells, components and data generated Only share blood and components with registered users Ensure clear, auditable central project-specific records detailing every sample obtained: identification number use / storage / given away / disposal date / disposal

15 Applying to be a phlebotomist - 1 WHO? Anybody planning to perform venepuncture under AMREC 15-HV-013 after 31st Dec 2015 irrespective of clinical status. WHY? To be covered by University of Edinburgh indemnity insurance HOW? Reply to from Sonia.Rafferty@ed.ac.uk (if re-authorising), or get the forms from WHAT FORMS? Complete: Phlebotomist application for CIR blood resource Read CIR 15-HR-013 Research Protocol Read CIR 15-HR-013 Information Sheet Read CIR 15-HR-013 Consent form Read Phlebotomist s responsibility form WHEN? As soon as possible to continue after 31 st Dec 2015 Anytime thereafter, >3 days before next Committee meeting (see website)

16 Applying to be a phlebotomist 2 PROCESS Read forms and submit completed application to Sonia Rafferty Applications for new phlebotomists to be signed by line manager familiar with skills and (for non-clinicians) accompanied by training records. Reviewed at monthly CIR Blood Resource Management Committee Respond to any queries re application Upon approval, the Projects Administrator will: Add applicant to approved phlebotomists list on Blood Projects Database for that calendar year Reviewed annually This only covers venepuncture not researcher use of samples

17 Applying to be a phlebotomist -3 PHLEBOTOMIST S RESPONSIBILITIES See Phlebotomist s responsibility form Be fully trained and competent in phlebotomy Hold current phlebotomist authorisation for AMREC 15-HV-013 Comply with regulations detailed on forms for AMREC 15-HV-013 Comply fully with CIR 15-HR-013 Research Protocol re venepuncture Comply with local safety rules and risk assessments (strongly advised to be Hepatitis B vaccinated) Maintain phlebotomy room in good condition Report any adverse outcome witnessed or informed about Before taking blood, phlebotomists must check that the Consent form has been signed by the donor after full explanation from the Researcher.

18 Applying to be a donor WHO? All donors must reapply to give donations of healthy human blood under AMREC 15-HV-013 after 31st Dec HOW? Respond to from Sonia.Rafferty@ed.ac.uk if renewing, or contact Sonia to volunteer. WHEN? As soon as possible. Current donors will be removed from the donor list on 31 st Dec 2015, unless they reapply. Any time thereafter, after 1 st Jan 2016

19 COLLECTING BLOOD - 1 Initial donor interaction Donors may approach the Projects Administrator after becoming aware of the project via advertising Pressure / coercion must not be applied to individuals to become involved The Projects Administrator will supply a potential donor with the Information sheets to review. Potential participants: must take a minimum of 24 hours to consider the content of the information sheet before donating blood. must pay careful attention to the self-exclusion criteria. contact the Projects Administrator if they have any questions arising from the information sheet, to be put in contact with a member of the Management Committee. are under no obligation to participate in the study, but should re-contact the Projects Administrator if they do wish to proceed as a volunteer and participate after reading the information sheet.

20 COLLECTING BLOOD - 2 Donor 2 nd contact Donors contact the Projects Administrator after reading the Information Sheet The Projects Administrator will supply a potential donor with the application form to become a donor. Upon completed application the Projects Administrator will record the participant s name, sex, date of birth and contact details in the Donor Database, in addition to any optional information provided on atopy and eosinophil levels. Donors are reviewed annually. Potential donors are now eligible to be approached by researchers after checking the Donor Database.

21 COLLECTING BLOOD - 3 Researcher finding a donor An authorised researcher, working on an approved project, will check the Donor Database to determine donors that are eligible to provide the volume of blood needed this is essential. The donor database automatically checks that donors will not exceed project limits: a) no more than 320 ml of blood donated in a 12 week period, b) no more than 8 significant donations of blood of greater than 20 ml per year, c) no more than 1.4 litres of blood donated per year. The researcher contacts the donor to arrange a time and to ask whether the donor has made any other significant (>20 ml) blood donations outside this project, for any other purpose, in the last year (not already reported to this project), so that they can confirm eligibility to donate a blood sample for at that time. If there are no other blood donations to consider a time to give blood is arranged. The researcher organises an authorised phlebotomist from the list on the Blood Projects Records on the protected shared drive.

22 COLLECTING BLOOD - 4 Other blood donations If the potential donor reports other blood donations outside this project, the researcher must complete the form Additional blood donations with this donor and give this form to the Projects Administrator (Sonia Rafferty). This donor must not be asked to give blood until the Projects Administrator has been able to update the donor records with the information from the Additional blood donations form and the Donor database re-checked for eligibility.

23 COLLECTING BLOOD - 5 Final checks Before the sample is taken, the researcher will ensure that the participant: has read, and taken a minimum of 24 hours to consider, the content of the most recent version of the Information Sheet, is able to give informed consent (on the basis of being at least 16 years old, in a fit mental state, is sufficiently able to read and comprehend English to understand the Information sheet) and has carefully observed the self-exclusion criteria (note that no explanation will be sought where an individual selfexcludes). has an opportunity to ask any questions arising from the information sheet, and receives satisfactory answers, after which they still wish to participate, has informed the researcher of any other recent blood donations, which have been taken into account in considering the maximum donation limits and recorded in the digital donor database This is the basis of the consent form questions This applies to every occasion of blood donation, where repeat donation occurs.

24 COLLECTING BLOOD - 6 Consenting Before the sample is taken, the researcher will assist the donor in completing the consent form: The participant will read and sign the consent form (CIR 15-HV-013 Consent Form). A photocopy is made for the donor. After copying the lower section is completed, signed by the researcher and phlebotomist and an anonymization sticker attached. If any there is any doubt about the ability of the donor to fully understand the Information sheet and Consent form, then that donor must not be consented and the issue must be reported to the Projects Administrator. These forms can be made available on tape, in Braille, large print and various computer formats and other languages upon request to the Projects Administrator. This applies to every occasion of blood donation, where repeat donation occurs. Forms must be given to the Projects Administrator (Sonia Rafferty) the same day, to enable updating of the Donor Database.

25 COLLECTING BLOOD - 7 Anonymisation stickers Affix and complete anonymisation code AFTER photocopying code/gender/age category/year collected e.g. X1b6 / M / 4 / 2014 Sticker is added after copying the consent form for the donor Code is already on the sticker Researcher adds gender (M/F) Age category number (see consent form) Year of collection Sample must now only be referred to by this full code and donor information must not be recorded elsewhere (e.g. lab book).

26 COLLECTING BLOOD - 8 Taking blood Performed in dedicated blood collection room in Level 2 of the Queen s Medical Research Institute Performed by trained authorised phlebotomist. Wear appropriate personal protective equipment: Gloves strongly recommended. Comply with risk assessment. Donor reclining until phlebotomist assured that bleeding has stopped. Donor given snack and drink. Any adverse events to be reported to the Projects Administrator. Donor has no further obligation to any project on this study, and will have no feedback. However, the opportunity to volunteer again in the future will remain (subject to having their availability checked on the donor database as above, having examined the self-exclusion criteria again, and having reviewed the most recent information sheet).

27 COLLECTING BLOOD - 9 Sharing blood Blood /cells / components must only be shared with researchers holding a current authorisation on a specified project. This must be confirmed. The specific details of what sample was given, how much, who to (including project number) must be recorded. Once blood / cells / components have been given to another researcher on another project, that is recorded as the end point for that bit of the sample for the researcher giving the sample. The researcher / group receiving sample is then responsible for recording use / storage / destruction of the sample on their project specific records on the protected shared drive. Sharing components of samples with external collaborators must be preceded by application using the External collaborator application for CIR blood resource. CIR Blood Resource Freecycle will be available on the protected shared drive to enable planning of future sharing.

28 COLLECTING BLOOD - 10 Sharing blood - CIR Blood Resource Freecycle

29 RECORD KEEPING - 1 Most sample used / destroyed within days weeks Some cells / components (serum, DNA, RNA) banked, in the storage spaces on any authorised Group Leader. Banked samples may be stored by for as long as is scientifically justified and defined in each individual authorised project. Samples must be destroyed within the approved time frame for their authorised project (note that the year of collection forms part of the sample ID number to help in this process). Detailed, fully auditable, project specific records must be maintained for each authorised project.

30 RECORD KEEPING - 2 Project specific Blood Sample Use Record Excel sheet in protected shared drive One record per project One tab per blood sample (taken by your group or given by another) Update as stored samples used/destroyed/sent to collaborators etc. A random selection of blood donations will be audited each year internally and our records may be subject to external audit.

31 QUESTIONS?