School of Sport & Exercise SciencesFACULTY OF SCIENCE

HTA Accreditation Training

Presented by

Monica Barclay

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

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

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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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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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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Section 1. Steps of the research process – to abide by the HTA licence & HT Act

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Step 1. Undertake HT Act accreditation training

• Recorded• Ethics

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Step 2. Complete a HT act risk assessment form

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In addition to the general risk assessment form

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• Students – supervisor to check• Review if necessary

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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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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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• Participant information – oral and written

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Template!

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Template!

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• 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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If written consent cannot be given (this must be ethically approved)

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• 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.

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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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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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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Section 2. What to do in specific situations

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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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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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guidance

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Deliver to the tissue coordinator

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• 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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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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4. The subject wishes to make a complaint• Deliver to the tissue

coordinator – investigate – report to DI

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5. There is an emergency?.

dial 2222.

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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

• The DI or Person[s] Delegated may immediately suspend a project and take remedial or disciplinary action as deemed necessary.

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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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What now?1. Please complete the HTA

accreditation training record of attendance and give it to me

Use of Pro-Curo database for storing samples in -80 freezer according to laboratory protocols.

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.

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

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.

Select a new sample

Select your project from the drop down list, only YOUR projects will be visible.

Then choose : sample type, project code, subject number

Fill in information about your sample code and select storage date

And add

Once you no longer store the samples, they MUST be disposed of

Highlight the samples and select dispose

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.

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

Everything you do in the database is recorded.

Thank You

Any Questions??