This is a controlled documentAny printed versions of this document will be classed

as uncontrolledHuman Tissue Act

SOP – Consenting Healthy Participants

SOP Reference: SOP/HTA/04

Version Number V 3.0 Date: 16/03/2015

Effective Date: Review by: 15/03/2017

Author:Dr Teresa KnappDesignation:Designated IndividualSchool of Life SciencesAuthor:Dr Natalie ChaplinDesignation:Tissue Bank ManagerBrighton & Sussex Medical School

Signature Date

Authorised By:University of Sussex, HTA Coordination Group

Version Date Reason for Change2.0 30/01/2013 Addition of form field check

box missing in V13.0 16/03/2015 Incorporation of donation for

future use facility

1. PurposeThis standard operating procedure defines the consent process that must be followed in order to obtain samples for use within research projects covered by HTA license 12119. The overriding principles are documented in separate SOP/HTA/03, a related document which refers to consenting for samples to be acquired from patients.

2. IntroductionUniversity of Sussex aims to collect high quality tissue and data whilst working to the highest ethical standards. In order to protect the rights of the public and to ensure the integrity and validity of all research that may be carried out on banked tissue samples, appropriate consent must be obtained and recorded. These records must be maintained to ensure that all samples can be linked back to the

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donor as required. Donors will only be recruited if they have provided written informed consent and this consent has been freely given.

3.0 Approval of Consent ProcessAll healthy donor Information Sheets and Consent procedures must be submitted with an application to the local research ethics committee, and a favourable opinion must be granted prior to their use. Specimens can only be donated as part of an ethically approved project.

4.0 TrainingAny person taking consent must be trained in accordance with HTA standards or equivalent eg BPS standards. A list of staff/student competencies and training log will be maintained.

5.0 Consent when future unspecified use is intendedCurrently, specimens can only be donated by individuals as part of a REC-approved specific research project. If it is anticipated that samples acquired as part of such a project will not be used fully during the initial project, researchers may ask participants to consent for the continued storage of specimens and their potential ‘secondary use’ for broadly defined areas of ethically approved research at a later date.There will therefore be two parts to the consent process for patients who donate samples for future unspecified use:

Firstly the patient information sheet and consent form for the specific research project to be conducted will be given to the patient. These will be designated Part A of the PIS and Part A of the consent form.

Secondly, the patient will be presented with the patient information sheet “Donation of samples to research tissue bank” and consent form “Consent: Donation of samples to research tissue bank.” These will be designated Part B. Guidance is given as to the information that should be included in these documents in HTA/PIS/001 (“Donation of tissue samples to research tissue bank”) and HTA/Consent/001 (“Consent: Donation of tissue samples to research tissue bank”).

Alternatively, if the PI decides that one consent form is required, they will need to incorporate the necessary paragraphs from the Consent form and PIS for ‘Donation of samples to research tissue bank. This hybrid consent form and PIS will then have to be approved by the relevant University Ethics Committee.

When researchers are making an ethics application for the specific research study both Parts A and B of the PIS and Consent form should be approved by the Research Ethics Committee.

BSMSAlthough samples will broadly been viewed as part of the BSMS Research Tissue Bank, the PI initially collecting will retain custodianship of the samples, consent

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forms and associated data. A discussion with the BSMS Research HTA licence DI, prior to initiating the process for tissue banking, will be required.

All BSMS samples MUST be logged into the tissue tracking database, FreezerPro.

6.0 Consent procedure1. Volunteer is approached by trained researcher and given the donation

information sheet, the contents of the sheet should be verbally explained to the donor.

2. Ensure the volunteer fully understands the information sheet before consenting

3. If it is anticipated that samples acquired as part of such a project will not be used fully during the initial project, researchers may ask participants to consent for the continued storage of specimens and their potential ‘secondary use’ for broadly defined areas of ethically approved research at a later date.

4. Once the donor has agreed, they are given the consent form which they read at their leisure and sign. The donor must NOT be pressurized into signing on the spot.

5. The consent form is then numbered according to the system employed by the principal investigator and retained securely by the principal investigator.

6. The researcher then takes the sample, logs it onto Tissue database and assigns a unique identifier

7. The storage coordinates will be logged into the Tissue database.8. The consenting pathways are kept current by reporting any necessary

change in procedure.

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