school of sport & exercise sciences faculty of science hta accreditation training presented by...
TRANSCRIPT
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School of Sport & Exercise SciencesFACULTY OF SCIENCE
HTA Accreditation Training
Presented by
Monica Barclay
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School of Sport & Exercise SciencesFACULTY OF SCIENCE
Resources• PowerPoint presentation slides
Supporting material – can be found from the following locations:
• RSO homepage: http://www.ljmu.ac.uk/RGSO/93042.htm• Faculty of Science webpage:• https://
share.ljmu.ac.uk/dept/sps/ResInstSES/HTA%20documents/Forms/AllItems.aspx
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School of Sport & Exercise SciencesFACULTY OF SCIENCE
• Human Tissue Act (2004) (HT Act)• Human Tissue Authority (HTA)• LJMU HTA licence
• Human Tissue: includes muscle, saliva, blood and other bodily fluids
• Accreditation training - essential
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School of Sport & Exercise SciencesFACULTY OF SCIENCE
HTA licence
Designated Individual (DI): Prof Peter Wheeler. Legal responsibility:• that suitable practices are used in
undertaking the licensed activity • that the other persons who work under the
licence are suitable • and that the conditions of the licence are
complied with.
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School of Sport & Exercise SciencesFACULTY OF SCIENCE
HTA licencePersons Designated• Andy Young (LJMU, Director of Research)• Unknown (Research Officer and HTA licence tissue coordinator)• Denise Philip (Research Officer)• Cathy Montgomery (Reader in Psychology: Natural Sciences
and Psychology (NSP)• Isabelle De Groote (Senior Lecturer: Natural Sciences and
Psychology (NSP) • Gordon Lowe (Reader in Biomedical Sciences: Pharmacy and
Biomolecular Sciences (PBS)• Aly Leigh (Head of Faculty Operations)• Monica Barclay (Training coordinator)• Dr Dave Harriss (undergraduate major project Module Leader,
Chair of the School REC & Deputy Chair of UREC).
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School of Sport & Exercise SciencesFACULTY OF SCIENCE
HTA Accreditation
• Section 1. Steps of the research process – to abide by the HTA licence & HT Act
• Section 2. What if…• Section 3. Spot checks/ auditing
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School of Sport & Exercise SciencesFACULTY OF SCIENCE
Section 1. Steps of the research process – to abide by the HTA licence & HT Act
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School of Sport & Exercise SciencesFACULTY OF SCIENCE
Step 1. Undertake HT Act accreditation training
• Recorded• Ethics
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School of Sport & Exercise SciencesFACULTY OF SCIENCE
Step 2. Complete a HT act risk assessment form
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School of Sport & Exercise SciencesFACULTY OF SCIENCE
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School of Sport & Exercise SciencesFACULTY OF SCIENCE
In addition to the general risk assessment form
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School of Sport & Exercise SciencesFACULTY OF SCIENCE
• Students – supervisor to check• Review if necessary
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School of Sport & Exercise SciencesFACULTY OF SCIENCE
Step 4. Deliver a copy of the ethics approval confirmation letter to the
tissue coordinator
• A project file in the ProCuro database will be set up for you.
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School of Sport & Exercise SciencesFACULTY OF SCIENCE
Step 5. Seek subject consent
• Consent is the central focus of the legislation and carrying out the collection, use and storage of human tissue without the necessary consent is an offence.
• All documentation must be clearly and fully completed
• Fully informed consent must be sought and be demonstrated to have been obtained.
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School of Sport & Exercise SciencesFACULTY OF SCIENCE
• Participant information – oral and written
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School of Sport & Exercise SciencesFACULTY OF SCIENCE
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School of Sport & Exercise SciencesFACULTY OF SCIENCE
Template!
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School of Sport & Exercise SciencesFACULTY OF SCIENCE
Template!
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School of Sport & Exercise SciencesFACULTY OF SCIENCE
• The participant must be allowed sufficient time to ask questions and consult with family or friends prior to giving consent.
• The researcher must make themselves accessible to the potential subject in order to answer any question or discuss the research procedures
• Consent must be freely and voluntarily given with no coercion
• Once a participant has given consent he/she is free to withdraw consent without giving a reason. The decision to withdraw will not prejudice the participants’ legal rights
• The participant information sheet and consent form should be in duplicate – one copy is given to the participant and one is retained by the researcher.
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School of Sport & Exercise SciencesFACULTY OF SCIENCE
If written consent cannot be given (this must be ethically approved)
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School of Sport & Exercise SciencesFACULTY OF SCIENCE
• All original participant information sheets and consent forms must be delivered to the tissue coordinator BEFORE any tissue samples are collected. Participant information sheets and consent form will be stored centrally in the project file, which is located in the office of the person responsible for the HT Act (which is within the laboratory).
• In exceptional circumstances, consent forms may be delivered to the tissue coordinator after tissue has been collected – for example in the case of collecting samples outside of the laboratory. However, this must be approved by the tissue coordinator prior to subject recruitment.
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School of Sport & Exercise SciencesFACULTY OF SCIENCE
Step 6. Sample code
U 13SEC017a 001 P 1/1
• Staff, Post-graduate or Undergraduate• 13SEC017 = Ethics number• more than one study per application will be denoted as a, b, c, etc• 001 = subject code• Then the type of sample is noted i.e. Plasma, Serum,
Muscle or Saliva. • The final part represents the sample time point and can be
decided by the researcher e.g. 1/1 – Trial 1, first sample (more than one sample per time point will be denoted as a, b, c, etc.).
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School of Sport & Exercise SciencesFACULTY OF SCIENCE
Step 7 Sample tracking
• label with the sample code. • Record details of the sample in the Procuro
database• When recording ANY data from the sample
the sample code MUST be used (DO NOT record the subjects name or initials on any data collection sheets).
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School of Sport & Exercise SciencesFACULTY OF SCIENCE
Step 8. Disposal of human tissue
• Clinical waste - use the appropriate laboratory bin so that the samples can be disposed of by incineration
• Details of disposal must be recorded in the database
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School of Sport & Exercise SciencesFACULTY OF SCIENCE
Section 2. What to do in specific situations
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School of Sport & Exercise SciencesFACULTY OF SCIENCE
1. The subject wishes to withdraw consent?
• inform the tissue coordinator immediately. This information will be noted on the subject details database and all of the subject’s samples destroyed so that no further analysis can be conducted on the subject’s sample. This is recorded on the sample tracking database
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School of Sport & Exercise SciencesFACULTY OF SCIENCE
2. Samples are transferred to or from LJMU.
• If samples are transferred to or from other establishments, then either the other establishment MUST have a HTA licence or the research project MUST be approved by the NRES.
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School of Sport & Exercise SciencesFACULTY OF SCIENCE
guidance
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School of Sport & Exercise SciencesFACULTY OF SCIENCE
Deliver to the tissue coordinator
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School of Sport & Exercise SciencesFACULTY OF SCIENCE
• Where LJMU receive samples from another institution a copy of the original subject consent forms must be delivered to the tissue coordinator. Samples and consent forms MUST be sent separately.
• Where LJMU are distributing samples to collaborating institutions a copy of the original subject consent forms must be delivered to the collaborating institutions. Samples and consent forms MUST be sent separately.
• A list of the sample codes included for transport is signed by the principle investigator and then checked by the receiving establishment.
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School of Sport & Exercise SciencesFACULTY OF SCIENCE
3. You experience equipment failure
• Record in the equipment failure log located in the laboratory technicians’ office
• If the integrity of your samples are compromised then an adverse events form needs to be completed and submitted to the person in laboratory responsible for the HT Act
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School of Sport & Exercise SciencesFACULTY OF SCIENCE
4. The subject wishes to make a complaint• Deliver to the tissue
coordinator – investigate – report to DI
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School of Sport & Exercise SciencesFACULTY OF SCIENCE
5. There is an emergency?.
dial 2222.
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School of Sport & Exercise SciencesFACULTY OF SCIENCE
6. You experience an adverse event• An adverse event is any event that:
– caused harm or had the potential to cause harm to staff, visitors, researchers or research participants
– led to or had the potential to lead to a breach of security of the premises and the contents contained therein
– caused harm or had the potential to cause harm to stored human tissue (including loss)
– contravene, or had the potential to contravene subject consent or confidentiality
– gave rise to an internal inquiry
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School of Sport & Exercise SciencesFACULTY OF SCIENCE
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School of Sport & Exercise SciencesFACULTY OF SCIENCE
• The DI or Person[s] Delegated may immediately suspend a project and take remedial or disciplinary action as deemed necessary.
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School of Sport & Exercise SciencesFACULTY OF SCIENCE
Section 3. spot checks/auditing• Spot checks will be undertaken on a weekly or monthly
basis by the person[s] designated dependent upon the research activity within the laboratories.
• Internal auditing will take place every three months by the person[s] designated (prior to the School Management Team meeting).
• Results of spot checks/audits will be reported to the DI and discussed at School Management Team meetings.
• All adverse events identified from spot checks/audits will be processed as detailed in section 2 part 6.
• Independent audits will be conducted annually and reported to the School Management Team.
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School of Sport & Exercise SciencesFACULTY OF SCIENCE
What now?1. Please complete the HTA
accreditation training record of attendance and give it to me
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Use of Pro-Curo database for storing samples in -80 freezer according to laboratory protocols.
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Select your name from the drop down menu. You will need to change your password the first time you log on.Your default password is your name as you see it in the log on box. The system will prompt you to change it to something more memorable.
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To access the -80 freezer in LSB you will need to book out the freezer key from the tissue coordinator. The time you book the key out will be recorded. You will notice on the front of the freezer is a tachograph (still to be installed) which records the temperature of the freezer 24/7. The temperature of the freezer MUST NEVER rise above -70. Therefore it is your responsibility whilst you have the key booked out to control the temperature of the freezer by keeping the time the door is open to a minimum. The doors to the freezer room must be kept closed at all times to ensure the temperature within the room is also controlled.
VERY IMPORTANT INFORMATION
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Once you have logged onto Pro-Curo you should identify a free space within freezer to store your samples, then locate the corresponding space within the database.
Select the corresponding location within the database to ensure the location is free, the key to the locations is on the front of the freezer.
Here I have selected HTA Freezer 2, Shelf 1, Rack 1, Box 1.
You will have already have informed consent forms for each of your subjects, you should assign subject codes for each subject and make a note of the subject code on each form. The forms will then be handed into the technicians office.
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Select a new sample
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Select your project from the drop down list, only YOUR projects will be visible.
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Then choose : sample type, project code, subject number
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Fill in information about your sample code and select storage date
And add
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Once you no longer store the samples, they MUST be disposed of
Highlight the samples and select dispose
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If your reason for disposal is not available ask one of the pro-curo administrators to add it for you.
You can never delete anything from the database.
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When asked if you want to print a label, select no then go to techs office they will print the labels for you. You are now ready to start collecting samples.The database will not let anyone else enter data into the locations you have selected.
To export the data to excel, highlight the samples you want to export. Right click on the mouse and Export grid
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Everything you do in the database is recorded.
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Thank You
Any Questions??