NHSBT ODT Research Approval Application Form

APPLICATION FORM REQUIRED FOR STUDY CATEGORIES 4-7. PLEASE SEE PAGE 3 FOR FURTHER DETAILS.

TITLE OF STUDY[1]
CONTACT DETAILS
Date / NHSBT Study Ref:
Sponsor
Includingtelephone number and
Email address / Organisation:
Contact details:
Chief Investigator / Title and Name:
Email address:
Research Unit(s) / Name:
Address:
Lead research contact person[2] / Title and Name:
Telephone number:
Email address:
Proposed Study Start date
Estimated Study End Date
STUDY ABSTRACT
Introduction
Including study population
Aims
Method
Including intervention/ control[3]
Outcomes
LAY SUMMARY[4]
Non-scientific study description
ORGAN/ TISSUE DETAILS
Organ/ tissue type
Total number of organs/ tissues required
Ischemic time restrictions
Does your study allow for organs/ tissues to be recycled[5] / Yes
No
If yes, please specify:
  • Estimated time of completion: ______
  • Estimated condition[6]: ______
______
STUDY CATEGORISATION
Please tick the box in the right hand column applicable to your study
1. Data study. Studies with a pure statistical focus, not requiring access to “relevant material” e.g. undertaking analysis of existing data on transplantation.RINATG application form not required.
2. Qualitative study. Studies with a descriptive or behavioural focus, not requiring access to “relevant material” e.g. examining attitudes toward organ donation.RINTAG application form not required.
3. Biological sample study. Studies looking to access blood, urine and tissue samples from deceased organ donors. Facilitated via the national biobank resource Quality in Organ Donation (QUOD). Samples are collected at four different time points covering the donor management period, all the way through to the point of organ retrieval.RINTAG application form not required[7].
4. Study on organs deemed untransplantable following removal from the donor. Studies requesting access to solid organs by generic research consent/ authorisation i.e. organs that are removed from the donor for the purpose of transplantation but are subsequently deemed unsuitable for transplantation. Organs are offered via the NHSBT Duty Office to approved studies. RINTAG prioritises and ranks approved research studies.
5. Study on organs removed specifically for research[8]. Studies proposing to retrieverelevant materialfrom donors, purely for research purposes and as such will require specific consent/ authorisation from donor families, in addition to normal consent/ authorisation to remove other organs for transplantation. Studies in England, Wales and NI require HTA licensing considerations, according to the Human Tissue Act 2004. Licenses are not required in Scotland.
6. Donor intervention study. Studies looking to undertake interventions in DCD donors prior to death, and/ or interventions to DBD donors e.g. drug administration to facilitate organ preservation.
7. Other studies. Studies which may require access to relevant material and/ or donors and is expected to have an impact on the donation, retrieval, and/ or transplantation processes.
N/A / If applicable, please specify: ______
BANDING CLASSIFICATION
Please tick the box in the right hand columnapplicable to your study
If successful will the research organ be transplanted? / Yes
No
BINARY CATEGORIES
Please tick the box in the right hand column applicable to your study
Does the study involve multiple research groups working together? / Yes
No
If yes, please specify: ______
Is the study aligned to Taking Transplantation to 2020? / Yes
No
If yes, please specify how:
  1. Increasing the number of potential donors
  2. Improving donor conversion rates
  3. Making the most of donor organs
  4. Increasing retrieval and transplantation of organs
  5. Resuscitation of retrieved organs
  6. Improving survival of transplant patients
  7. Systems to support organ donation and transplantation.

Does the study evaluatenovel technology/ies in organ transplantation? / Yes
No
SCORING CRITERIA[9]
Please tick the box in the right hand column applicable to your study, to the best of your knowledge
Time-scale from start of study to increase number of organs available for transplantation? /
  • Within 18 months
  • 19 - 36 months
  • > 37 month
  • Not applicable

GOVERNANCE STATUS
Please tick the box in the right hand column applicable to your study
Protocol /
  • Provided[10]
  • In development
  • Outstanding

Funding /
  • Funding gained
  • Sought
  • Outstanding
  • Externally peer-reviewed
  • Institutional peer-reviewed
  • Not peer reviewed
If relevant, please specify
a) Funding period: ______
b) Awarding body: ______
REC /
  • Provided[11]
  • Sought
  • In development
  • Outstanding
  • Not required
If relevant, please specify
a) The REC reference no:______
b) The REC approval date: ______
c) REC valid until: ______
d) Reason for exemption:
______
HRA /
  • Provided[12]
  • Sought
  • In development
  • Outstanding
  • Not required
If relevant, please specify
IRAS number: ______
MHRA[13] /
  • Provided
  • Sought
  • In development
  • Outstanding
  • Not required

NHSBT OPERATIONAL SUPPORT / Please tick the below box if your study will require written NHSBT operational support [14]
HTAREQUIREMENTS /
  • Provided
  • Sought
  • In development
  • Outstanding
  • Not required
If required, please specify
a) Have you obtained and provided NHSBT ODT with a support letter from the DI
b) The licence no. under which relevant material will be removed: ______
c) Under whichtype of HTA licence:
______
d) Which areas are covered by the HTA licence,
for your study: ______
HTA Code of Practice
The new HTA Code of Practice on Research recommends that if studies are known or likely to involve the commercial sector, genetic testing, use of animal studies or cost recovery (tissue banks) then a reference to this should be provided in information used to support the consent process[15].
Please indicate in the boxes below if your research involves any of the following 3 categories?Please do not leave this section blank.
Commercial sector/ Tissue banks (fees for cost recovery) / Yes
No
If yes, please specify: ______
Genetic testing/ DNA analysis / Yes
No
Use of human tissue in animals / Yes
No
OTHER
Have you engaged with the press about the present proposal[16]? / Yes
No
If yes, please specify: ______
Have you arranged transportation?[17] / Yes
No
N/A
If yes, please specify: ______
Geographical restrictions
where applicable:______
Do you have access to NHSBT’s Electronic Offering System (EOS)? / Yes
No
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[1] For guidance on the application process, please see the Research Handbook, here, and contact the Research Project Manager.

[2]If different from above

[3] Including retrieval method; consent process; NHSBT resources required (i.e will the study require additional consent to be obtained by SNOD and/ or additional intervention by NORS team/s?)

[4] Pending RINTAG approval, the lay summary will be made publically available on the ODT Clinical site, here, when the project is activated.

[5] For use in another study following your completion. Facilitated via the Duty Office.

[6] Include relevant details such as; remaining tissue (part or whole organ), available post perfusion etc

[7] Researchers are encouraged to seek approval via The Quality in Organ Donation (QUOD) initiative directly, here.

[8]Studies which require specific research consent and HTA licence requirements (HTA 2006 applicable in England, Wales and Northern Ireland) will not be subject to the allocation of organs via the Duty Office. These organs/ tissues will be sourced at the local (HTA approved) site.

[9] The scoring criteria is only applicable for study categories 4 and 7

[10] Please submit the study protocol to NHSBT ODT along with this application form

[11] Please forward the REC favourable opinion letter onto the NHSBT ODT, once obtained

[12]Documents submitted to the HRA will need to be forwarded onto the NHSBT ODTin all cases, along with the HRA Initial Assessment Letter or HRA Approval letter

[13] Please find more details of MHRA requirements, here.

[14] Applicable to study categories 4, 5 (and 6 where relevant)

[15] NHSBT is collecting information for reasons of oversight and compliance

[16] Researchers are required to agree a strategic comms. plan with NHSBT prior to any engagement with the media. This is of particular relevance for study categories 5-7.

[17] It is the researcher’s responsibility to arrange and assume the costs for transportation of research organs. This will need to be confirmed prior to going live. This primarily applies to study category 4.