FORM FRM4657/1
Effective: 28/03/13
NHS BLOOD AND TRANSPLANT
ORGAN DONATION AND TRANSPLANTATION:
Researcher Responsibilities MOU
Outline and Agreement of Responsibilities of those Involved in the Facilitation of
Organs or Tissues from a Deceased Organ Donor Being Used in Approved
Research Studies
1.
Introduction
NHS Blood and Transplant Organ Donation and Transplantation (NHSBT ODT) has the
responsibility to support all appropriately approved research provided that such activity
does not adversely impact on organ donation, retrieval and transplantation.
Support for such activity may be provided by the SN-ODs seeking appropriate consent/
authorisation from the families of deceased donors or facilitating the removal and
transport of organs and tissues.
For the purposes of this document reference ‘organs and tissues’ in relation to their
removal for research purposes refers to all ‘relevant material’ as described in the
Human Tissue Act 2004..
2.
Purpose of document
The purpose of this document is to clarify the process involved and the responsibilities
of those involved in such research following approval by NHSBT.
3.
Process for approval
All research proposals affecting organ donation and transplantation supported by
NHSBT and its employees must be approved by NHSBT and this is delegated to the
Organ Donation and Transplantation Clinical Audit and Risk Effectiveness group
(ODTCARE). This process is described in MPD1029 ODT Research Approval Process.
The approval process is underpinned by the principles of research governance which
are outlined in Policy161 Research Governance. The approval process focussed on the
potential impact on donation and transplantation and does not provide an ethical or
scientific review All projects approved by ODT are recorded in a Research Register and
evidence of research ethics and local R&D/ Management approval has to be provided
by the prospective researcher.
4.
Responsibilities
This covers the responsibilities of three groups of personnel who may be asked to
facilitate retrieval of tissue or organs:
A. Researchers
The researchers are responsible for:
Prior to the Research Commencing
 Providing a clear protocol which should include:
 The purpose of the research
 The inclusion and exclusion criteria for the donation
(Template Version 07/10/08)
Cross-Referenced in Primary Document: MPD1029
Page 1 of 4
FORM FRM4657/1
Effective: 28/03/13
NHS BLOOD AND TRANSPLANT
ORGAN DONATION AND TRANSPLANTATION:
Researcher Responsibilities MOU
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What specific samples/material is required
A start date and finish date and/or number of samples required.
A single phone number for the SNOD to alert the research team that an
appropriately consented sample is available
The packaging arrangements
The transport arrangements
Ensuring that the SN-ODs have been provided with and understand the
research protocol and can obtain consent.
Ensuring that the research has all the appropriate approval (including Research
Ethics Committee and Trust/Hospital approval).
Ensuring there are trained, qualified and competent personnel who can lawfully
retrieve the tissue/organs.
Ensuring that the legal requirements are fulfilled for handling, storing and
disposing of donated material.
Ensuring, when appropriate, that the costs incurred by NHSBT will be refunded.
Providing feedback/updates on the research and at completion of the study to
NHSBT and the SN-OD teams involved. The requirements for this will be
determined on a project by project basis.
Removal of Organs /Tissues for Research Purposes
Ensuring that the removal of organs/tissues under the local removal licence
complies with the local governance arrangements as agreed with the local
Designated Individual.
England, Wales and Northern Ireland - Ensuring the removal of organs or tissues
for research is carried out in a premises licensed by the Human Tissue Authority
for this purpose if taken from deceased donors and that local governance
arrangements are followed ensuring this activity is recorded and reported to the
local Designated Individual (DI) responsible for this licence. Note: for Scotland
there are no licensing requirements for the removal of material for research.
At the Retrieval:
 Ensuring that any samples are collected in a timely manner from an agreed
location, by an approved courier and delivered to an appropriate location to
ensure traceability of the donated material.
 Ensuring the tissue/organs are packaged and transported appropriately as
clearly outlined in the research proposal/guidance documentation provided to the
SN-OD team(s) involved.
(Template Version 07/10/08)
Cross-Referenced in Primary Document: MPD1029
Page 2 of 4
FORM FRM4657/1
Effective: 28/03/13
NHS BLOOD AND TRANSPLANT
ORGAN DONATION AND TRANSPLANTATION:
Researcher Responsibilities MOU
B. SN-ODs
The SN-OD is responsible for:
 Obtaining valid consent/authorisation from the appropriate person under the
relevant legislation (Human Tissue Act 2004 or Human Tissue Act (Scotland)
2006. whilst working within the NHSBT procedures for Consent/Authorisation.
 Liaising with the National Organ Retrieval Service Team to ensure that the team
is aware of the proposed removal of organs or tissue for research purposes and
that this will not adversley effect organ or tissue donation for clinical purposes.
 Recording the consent/authorisation as detailed in the NHSBT
Consent/Authorisation procedures.
 Informing the researcher that consent/authorisation has been given.
 Ensuring any organ retrieved for transplant purposes and subsequently deemed
unsuitable, has been offered to the appropriate transplant centres before being
considered for research
C. Retrieval Personnel
The retrieval personnel are responsible for ensuring that:
 Any removal of organs/tissue for research does not interfere with the retrieval for
transplantation.
 Appropriate consent/authorisation has been obtained.
 The retrieval takes place in a licensed premises (not required in Scotland) and in
accordance with all current regulations.
 Agreeing with the researcher (if not the researcher or deputy undertaking the
retrieval) an appropriate time and location for the collection of the samples.
 The retrieved material is transferred to the custodianship of the research team.
 Recording the retrieval of organs/tissue for research according to current
legislation and local governance arrangements.
Members of the National Organ Retrieval Service may agree to retrieve organs or
tissues for research purposes but this is not part of the NHSBT commissioned service
and the researcher must engage separately with the retrieval teams and NHSBT will
accept no responsibility for the actions of the Retrieval Team.
5. Confirmation of responsibilities
Prior to commencement of the project, the Principle Investigator will be required to
confirm in writing to NHSBT that they understand their responsibilities and ensure
compliance with all regulations laid out in the Human Tissue Act 2004(England, Wales
and Northern Ireland) .
(Template Version 07/10/08)
Cross-Referenced in Primary Document: MPD1029
Page 3 of 4
FORM FRM4657/1
Effective: 28/03/13
NHS BLOOD AND TRANSPLANT
ORGAN DONATION AND TRANSPLANTATION:
Researcher Responsibilities MOU
Name of Principle Investigator:
Title of Project:
Date:
I confirm that, as Principle Investigator, I will ensure that I will take responsibility for the
good governance of the study.
I understand that retrieval of organs and tissue for research is covered by the Human
Tissue Act 2004 (England, Wales and Northern Ireland) and the Human Tissue
(Scotland) Act 2006 and this requires me to ensure that, amongst other requirements:
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valid consent/authorisation has been given for removal of tissue/organs;
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retrieval of organs and tissues for the purposes of research must take
place in premises licensed by the Human Tissue Authority for that purpose
(not required in Scotland);
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I will accept responsibility for ensuring that the appropriate licence is in
place before removing any tissue/organ for research or asking another to
do so (not required in Scotland);
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I will agree with the local Designated Individual the actions required to
ensure removal of material for research under their removal licence
complies with the local governance arrangements;
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that once I (or a deputy) have accepted an organ or tissue for my study
that I take full responsibility under my REC approval and/or storage
licence for its timely collection and transportation from an agreed location,
storage and disposal as described in the Human Tissue Act 2004.
(England, Wales and Northern Ireland);
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I will provide feedback on the progress of the study to NHSBT and inform
them when I have received the number of samples outlined in my protocol.
Signed: ...............................................................
Date: ....................................................
(Template Version 07/10/08)
Cross-Referenced in Primary Document: MPD1029
Page 4 of 4