1 Guidelines for Applicants v5.0, August 2015.docx

GUIDELINES FOR APPLICANTS (v5.0, August 2015)

1. APPLICATION PROCESS Check sample availability Prior to submitting a biological study application, applicants should check the availability of the type and numbers of samples required for their study, via email (cclgtissuebank@le.ac.uk) or contact the Tissue Bank manager. Application form and supporting documents The Biological Study Application Form can be downloaded from the CCLG website (http://www.cclg.org.uk/tissue-bank/) and completed electronically. Completed application forms must be submitted with the following document(s):

• Curriculum Vitae • Grant Award Letter (confirming funding for the study, if applicable) • Supporting letters from collaborators (if relevant) • Other supporting documentation (i.e. grant-funding application, external peer-review

comments, etc.) [NOTE: It is not acceptable to complete the application form by referring to a pre-existing grant application attached to your application. All boxes on the application form must be completed.] Email the completed application form and supporting documentation to cclgtissuebank@le.ac.uk or post to:

Sue Thornton Children’s Cancer and Leukaemia Group University of Leicester Clinical Sciences Building Leicester Royal Infirmary Leicester LE2 7LX

Upon receipt of an application form, it is initially screened for completeness and relevant supporting documentation. Any obvious problems/ omissions from the application will be notified to the applicant as soon as possible. All applications are reviewed by the CCLG Biological Studies Steering Group (BSSG). The Scientific Review Coordinator co-ordinates the review process, as soon as they are received.

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2. REVIEW PROCESS Internal review All applications will be reviewed by at least 3 members of the BSSG or by independent expert reviewer(s) if the BSSG considers that more expert advice is required (unless the application has already been approved by a recognised funding body/ organisation). Responsibility for final scientific approval of all applications resides with the BSSG.

External review

Funded applications If your study has been approved for funding by a national/ international grant awarding body and has been reviewed by an external panel of experts, your application will not be sent for further external review provided the following conditions are satisfied: i. The grant award letter is submitted with the application; ii. The CCLG biological study application submitted does not differ from the application

reviewed by the funding body, unless the amendments were in response to advice from the external reviewers (amendments should be made clear in the application);

iii. If the funding for the project is part of a programme grant, this will not be considered as having been externally reviewed, unless reviews are submitted which specifically relate to the project in the application.

Applications which are not currently funded or funded by soft monies, or local charitable funds do not require financial support If a study falls into one of these categories and has not been reviewed by an external panel of experts, it will be sent to at least 2 independent experts for review.

3. APPROVAL PROCESS

All applicants will receive a response upon receipt of their application. After completion of the review process, applicants will be notified of the outcome. These are one the following categories:

• Approved • Approved subject to satisfactory responses to comments from BSSG (applicants

must respond to comments within 8 weeks, failure to do so will result in the application being automatically withdrawn.).

• Not Approved If more than one application is approved which competes for the same samples, prioritisation will be guided by the reviewers’ scores.

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4. RESEARCH ETHICS COMMITTEE APPROVAL

All projects approved by the BSSG are automatically granted (generic) ethical approval under the auspices of the NRES approval for the CCLG Tissue Bank protocol. Any project not fulfilling the following criteria will need to obtain separate NRES approval via the IRAS system, in order to access samples from the Bank. These criteria are:

• The research is restricted to the prevention, detection, diagnosis, treatment and patho-physiology of children’s cancers.

• The application has been reviewed and approved by the BSSG. • The research will only use samples for which consent has been obtained from

patients/ parents for storage and use in research/ where samples have been stored for research purposes with the previous agreement of the East Midlands – Derby Research Ethics Committee (REC).

• No patient identifiable information will be released to researchers. • The research does not aim to have direct impact on individual patient healthcare.

No samples or data will be released without confirmation of appropriate REC approval.

5. SAMPLE RELEASE

Process for releasing samples from the Bank is as follows: • Following BSSG approval of the study, the researcher should confirm sample

requirements, review anonymised pathology reports and view the digital imaging hub database to determine suitable samples required.

• A material transfer agreement (MTA) will be issued to the researcher to sign off along with all other parties.

• Upon receipt of a fully signed MTA, the Tissue Bank Manager will issue a request to the Central Bank (Newcastle) and/or to banking centres to release the samples.

• Samples will be despatched by the CCLG Biobank Technician (Alison Page (alison.page@ncl.ac.uk)) and/or by pathology staff in centres, who will contact the researcher to arrange the transport of samples (NOTE: the researcher is responsible for all transport costs.).

• Samples will be despatched within 25 working days of receiving the request. • Where paraffin embedded tissue is requested, some centres may not release the

whole block, in which case unstained sections on slides and/or curls will be requested for release (NOTE: the researcher is responsible for all transport costs.).

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6. REMAINING SAMPLES OR DERIVATIVES AFTER USE IN RESEARCH

At the end of the study any surplus samples or derivatives (extracted DNA/ DNA, etc.) if correctly stored, should be returned to the Central Bank for storage and use in future studies. If sample quality has been compromised they should be disposed of in accordance with the Human Tissue Act 2004. Formalin Fixed Paraffin Embedded tissue blocks should be returned to banking centres or the Central Bank (who will return blocks to the original centres).

7. ANNUAL PROGRESS REPORTS

Annual progress reports for all studies should be completed and provided to the BSSG. Failure to submit annual progress reports will disqualify a researcher from further access to samples from the Bank. An end of study report should be provided upon completion of the study.

8. PUBLICATION POLICY

All publications arising from approved projects must be listed in annual and final study reports. The appropriate acknowledgement of the Bank and samples must be incorporated in published papers, as detailed below. For biological studies which have had active input of clinical correlates and patient follow-up information, the following wording must be placed at the end of the list of authors: "On behalf of the Children’s Cancer and Leukaemia Group (CCLG)." The Tissue Bank funding should be cited in the acknowledgments as follows: "The CCLG Tissue Bank is funded by Cancer Research UK and CCLG, and supported by contributing CCLG Centres, including members of the ECMC Paediatric network." For biological studies where the tissue samples form only part of a greater collection, then the Tissue Bank should be included in the acknowledgements as follows: “We thank the CCLG Tissue Bank for access to samples, and contributing CCLG Centres, including members of the ECMC Paediatric network. The CCLG Tissue Bank is funded by Cancer Research UK and CCLG.”

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PROCEDURE FOR REVIEW OF A CCLG BIOLOGICAL STUDY APPLICATION

Internally reviewed by 3 BSSG members or independent expert reviewers, if required

Outcomes:

• Approved • Approved subject to satisfactory responses to

comments from BSSG (discussed at next BSSG meeting, if required)

• Not Approved (discussed at next BSSG meeting)

Outcomes following discussion at BSSG meeting:

• Approved • Approved subject to minor amendments • Not Approved

Notification of outcome to researcher

Researcher should email cclgtissuebank@le.ac.uk or contact Tissue Bank Manager regarding availability of suitable samples

Researcher submits completed CCLG Biological Study application to Biological Studies Administrator

Application is sent to BSSG Scientific Review Coordinator

Review scores are collated by BSSG Scientific Review Coordinator