MaGiCAD Research
Constitution
The MaGiCAD constitution is a document that aims to set out the principles, and much of the detail, in the way that the MaGiCAD study will be run.
The MaGiCAD Constitution was ratified at the meeting of 25 April, 2003.
A downloadable version of the MaGiCAD constitution is available here. Please note that despite my very best efforts to keep this page and the PDF version of the MaGiCAD constitution up to date, there may be occasions when the constitution itself has been updated prior to this page being updated. In those cases, the original Word copy will be taken to be the most up to date and valid version. Hopefully the PDF version on this page will be generated immediately following any update, but the html version below could be a little behind the other two versions.
3. POLICY ON THE CORE MAGICAD STUDY
3.1 Responsibilities of persons involved
3.1.1 Commercial Sponsor.
3.1.2. Management Committee.
3.1.3. Medical panel
3.1.4. Clinical research associates (CRAs)
3.1.5. Papworth Hospital Research and Development Department
3.1.6. Public Advisory Panel3.2 Composition of the Management Committee
3.3 Alterations to the MaGiCAD Constitution
3.4 Use of MaGiCAD Samples and Data
3.4.1. As part of the Core Study.
3.4.2. As part of a Peripheral Study
3.4.3 As part of an Auxiliary Study3.5.1 Authorship of manuscripts for peer review
3.5.2 Other oral and written presentations
4. PROCEDURE FOR INITIATING AUXILIARY STUDIES
4.2 Applications for use of MaGiCAD Data and/or Samples
4.2.1 Factors to be considered prior to application
4.2.2 The application process
4.2.3 Evaluation of Auxiliary Study proposals4.3 The Data and Materials Distribution Agreement
4.4 Running of the Auxiliary Study
4.4.1 Policy on publications
4.4.2 Collation of data into the MaGiCAD database
APPENDIX 1. PERIPHERAL STUDIES
APPENDIX 4. THE DATA AND MATERIALS DISTRIBUTION AGREEMENT
1. Overview
This document is intended to be a framework policy document for the running of the core MaGiCAD study. It is based on the policy document used by the Framingham study.
The MaGiCAD study consists of a Core Study, as described in MaGiCAD Core Study Management Protocol, as well as Peripheral Studies and Auxiliary Studies.
Peripheral Studies are run alongside the core MaGiCAD study and often require the collection of additional patients, data or samples over and above the Core Study. Peripheral Studies will have a member of the MaGiCAD Management Committee as the Principal Investigator, and each has its own policy document. The Peripheral Studies are listed in Appendix 1.
Auxiliary Studies differ from Peripheral Studies in that the Principal Investigator of the Auxiliary Study is not a member of the Management Committee. In addition, Auxiliary Studies will not require the collection additional samples or data by the MaGiCAD team. We welcome applications to run Auxiliary Studies under the MaGiCAD umbrella. Auxiliary Studies are listed in Appendix 2.
The MaGiCAD study aims to recruit subjects from a range of secondary and tertiary referral centres around the United Kingdom. The study is managed from Papworth Hospital, which is also the central collection hub for the study. The aims of the MaGiCAD study are:
1. to examine further the potential use of metabonomics and genomics as alternative diagnostics for coronary atherosclerosis to the angiogram; and
2. to provide a large, well-characterised, bank of samples that can be used for basic science investigations into atherosclerosis.
A brief overview of the structure of MaGiCAD is shown in the Figure 1.
Figure 1
3. Policy on the Core MaGiCAD
Study
3.1 Responsibilities of persons involved
Each of the groups in the organisation chart above have certain responsibilities with respect to the MaGiCAD study. These are outlined below. The current and past members of each of the groups are given in Appendix 3.
All current and past members of the MaGiCAD team are responsible for
ensuring that their valid contact details are lodged with the MaGiCAD
Study Co-ordinator. Failure to do so, may lead to loss of rights under section
3.5.
The commercial sponsor owns all of the intellectual property generated using the MaGiCAD samples or data, and has full responsibility for all non-academic use of the MaGiCAD samples and data. However, academic rights to the use of the MaGiCAD samples and data have been deferred to the MaGiCAD Management Committee.
The management committee will decide on all academic uses of the MaGiCAD samples and data. They are responsible for the scientific conduct of the study and for ensuring that MaGiCAD is run in accordance with the ethical guidelines.
The Lead Clinician will always be a member of the management committee. He or she will have overall responsibility for the clinical conduct of the study.
The Medical Panel is responsible for generating the independent angiogram
reads, and for all other medical issues related to MaGiCAD.
3.1.4. Clinical research associates (CRAs)
The CRAs are responsible for the day-to-day running of MaGiCAD. One
CRA will be designated the Study Co-ordinator and is the designated contact
point for the MaGiCAD Study.
3.1.5. Papworth Hospital Research and Development Department
Papworth Hospital R & D department is responsible for facilitating
the running of MaGiCAD at Papworth Hospital, and ensuring that MaGiCAD
is run within the current Governance framework. In addition, the R & D
Department will be responsible for the authorising of Auxiliary studies
following Management Committee approval.
In accordance with national guidelines on clinical research, all large
clinical studies should have an advisory body consisting of members of
the general public to advise on questions that such studies might address.
The Public Advisory Panel for MaGiCAD will be responsible for providing
advice and feedback on the public view of the study.
3.2 Composition of the Management Committee
The Management Committee shall be composed of between three and six individuals, one of whom shall always be the Lead Clinician. A member of the Papworth Hospital NHS Trust R & D Department shall be on the Management Committee whenever possible.
Current members of the Management Committee may resign, giving a minimum of three months notice in writing, whereupon they will lose their rights as member of the management committee except under section 3.5 which remain in perpetuity unless explicitly forfeited. Resigning members of the Management Committee need not be replaced unless the size of the Committee would fall below three members.
At any time, an individual may be co-opted onto the Management Committee by unanimous agreement of the current Management Committee.
3.3 Alterations to the MaGiCAD Constitution
Alterations to the MaGiCAD constitution may be made by unanimous decision
of the MaGiCAD Management Committee. The Management Committee will endeavour
to ensure that any changes that are made are not effective retrospectively,
except where required by law. Changes will then be circulated to all
involved.
3.4 Use of MaGiCAD samples and data
Prior to any use of any sample from the MaGiCAD study (including serum, plasma, urine or DNA) approval must be sought. For commercial studies, permission must be sought from the Commercial Sponsor. For non-commercial and academic studies permission must be sought from the MaGiCAD Management Committee.
For non-commercial and academic studies, there are three ways in which samples may be used: (A) as part of the Core Study; (B) as part of a Peripheral Study or (C) as part of an Auxiliary Study. All requests for samples from current members of the Management Committee shall be considered as part of the Core Study. All applications for samples from scientists outside the MaGiCAD team shall be considered as Auxiliary Studies. Requests for samples from members of the MaGiCAD team other than members of the Management Committee shall be considered as either part of the Core Study or as Auxiliary Studies at the discretion of the Management Committee.
3.4.1. As part of the Core Study.
Such requests should generally be approved. Only when a substantial quantity of sample is to be used or when the use of sample requires the thawing of the final previously unthawed sample should the request be considered by the Management Committee in the same way as applications under section 3.4.3.
Data collected as part of the MaGiCAD study may be used freely by all members of the MaGiCAD management committee, subject only to the conditions in sections 3.4.2 and 4.4.2.
3.4.2. As part of a Peripheral Study
The Principal Investigator of a Peripheral Study shall have full access to all of the additional data and samples. Access to the additional data and samples by any other scientists, including current members of the Management Committee will be at the discretion of the Principal Investigator.
Any use of the core MaGiCAD data and samples as part of a Peripheral Study is governed as if it were part of the Core Study, in accordance with section 3.4.1 above.
3.4.3 As part of an Auxiliary Study
Applications for use of the MaGiCAD samples or data in an Auxiliary Study must be made in accordance with the conditions set down in Section 5.
Briefly, following a successful application by a principal investigator
the required amount of sample will be provided to the principal investigator.
On completion of the Auxiliary Study, any unused sample will be returned
to the MaGiCAD team. Provision of the MaGiCAD samples or data to Principal
Investigators is on the explicit understanding that it will be used solely
for the purpose outlined in their application, and that the proposed
Auxiliary Study will be completed in a timeframe approved by the Management
Committee. Any proposed use of MaGiCAD samples or data outside or beyond
that previously approved for the Auxiliary Study must be the subject
of a further application to the Management Committee.
The Management Committee strongly supports the publication of results from the MaGiCAD study in the peer-reviewed literature. However, there may be occasions when material contained in a proposed manuscript may be of commercial value. Therefore, prior to submission for publication, any manuscript describing MaGiCAD samples or data must be submitted to both the Management Committee and the Commercial Sponsor for approval. The Commercial Sponsor may delay submission of the manuscript for a maximum of three months from the date of receipt only in the case where the manuscripts contains data over which the Commercial Sponsor intends to seek patent protection. The Management Committee may delay or prevent submission of any manuscript deemed to misrepresent any aspect of the MaGiCAD study, or which is deemed to be scientifically invalid, misleading or fraudulent indefinitely, until such concerns have been addressed. In all other cases, both the Commercial Sponsor and the management committee will endeavour to authorise submission of the manuscript within four weeks, and usually considerably earlier.
3.5.1 Authorship of manuscript for peer review
For every publication describing the use of MaGiCAD samples or data the current and all past members of the Management Committee may elect to be authors.
Current members of the Medical Panel may elect to be authors on all publications describing the use of MaGiCAD samples or data, together with past members of the Medical Panel who provided independent readings of at least 50 angiograms (listed in Appendix 3). Past members of the Medical Panel who provided independent readings of less than 50 angiograms may elect to be acknowledged on all manuscripts.
The current Commercial Sponsor and any past Commercial Sponsor(s) that contributed to the funding of MaGiCAD may elect to be acknowledged on all publications.
Current CRAs, as well as all past CRAs that were involved in the recruitment and/or preparation of blood samples of at least 50 patients, may elect to be acknowledged on all publications describing the use of MaGiCAD samples or data. In addition, for the first publication(s) describing the characteristics of the MaGiCAD Core Study these individuals may elect to be authors on the manuscript. On this initial manuscript(s) the appropriate members of the R & D Department at Papworth Hospital may elect to be acknowledged.
The Management Committee stresses that the above is a minimum requirement for acknowledging the input of the various groups to the MaGiCAD study. It may be that for some publications certain members of staff will have invested considerably more time into the work described than would be credited by the above policies. In these cases, further recognition may be necessary and is encouraged.
It is the responsibility of the corresponding author to ensure that all appropriate parties have been contacted and given the option to exercise their right to accreditation in accordance with these conditions. If no valid contact details for an individual are lodged with the Study Co-ordinator, this responsibility of the corresponding author is waived with respect of that individual.
3.5.2 Other oral and written presentations
The Management Committee also encourages oral presentation of data
from the MaGiCAD study. Members of the MaGiCAD team and collaborating
scientists are requested to inform the MaGiCAD Study Co-ordinator when
such a presentation is to be made. Data from the MaGiCAD Core Study,
or analysis of such data, may not be presented in any format whatsoever
without the written permission of the Management Committee. In all presentations,
appropriate acknowledgement must be given to the MaGiCAD team, including
a full list of all team members as listed in Appendix 3.
In making any presentation, other than submission of a manuscript for
peer review under the terms of section 3.5.1, the
presenter must not claim, infer, or imply endorsement of the work presented
by the MaGiCAD team, the Commercial Sponsor or Papworth Hospital NHS
Trust.
4. Procedure for Initiating Auxiliary Studies
The significant amount of time and money invested in collection of the background data and samples of the MaGiCAD cohort should be used in as many ways as possible to further scientific progress. Therefore, we welcome all applications for use of the data and samples by members of the wider scientific community. However, as samples are limited, there will be a review process before any Auxiliary Study is begun.
Although collaboration with one of the scientists involved in the MaGiCAD study is not a condition of receiving either data or samples, we anticipate that the majority of Auxiliary Studies will be done on a collaborative basis with one or more members of the MaGiCAD team.
Due to the potentially wid-ranging nature of auxiliary studies, it
is possible that many auxiliary studies would not fall under the original
MaGiCAD ethical approval. Following a successful application to the MaGiCAD
Management Committee, the application will be examined by the Papworth
Hospital NHS Trust R & D Department to confirm whether a further
application to the local ethical committee is required. See Section
4.2.3 below.
There is a considerable amount of background information available on each of the MaGiCAD patients. For full information on the questionnaire that has been administered to the patients and the information taken from the medical notes please see our web-site at http://www.magicad.org.uk/.
For measurement of coronary artery disease status, we have the details of the angiogram read by the patient’s own clinician during their treatment. In addition, each patient’s angiogram has been re-read by one or more senior cardiologists.
For each patient arterial blood was taken, and both serum and platelet-poor
plasma prepared. A single spot urine sample was also aliquoted and frozen.
DNA will also be prepared from the majority of the MaGiCAD patients.
Each of these samples are precious, and supplies are very limited. Therefore,
samples will not necessarily be available for each proposed Auxiliary
Study.
4.2 Applications for use of MaGiCAD data and/or samples
4.2.1 Factors to be considered prior to application
The Principal Investigator of a proposed Auxiliary Study will be responsible for all additional costs that are incurred by the MaGiCAD team in complying with their request. This includes both the obvious and the hidden costs, such as:
a) any administration expenses involved, including removal of identifying data so that patients’ confidentiality will be protected
b) any costs for notification of alert values.
c) any costs for coordinating the provision of data and/or samples
It is also imperative that confidentiality of the patients is maintained. The recipient of data agrees not to use any of the data or samples in any effort whatsoever to establish the individual identities of the MaGiCAD patients. Partly to protect the confidentiality of the patients, investigators granted access to data must adhere to the Data and Materials Distribution Agreement (DMDA) outlined below (Appendix 4).
Note that any application from a for-profit entity, or from any individual using funds that derive from a for-profit entity, requires the approval of the Commercial Sponsor.
In order to gain access either to the MaGiCAD database or to samples collected within MaGiCAD (serum, platelet-poor plasma, spot urine or DNA) the application form provided on the web-site (http://www.magicad.org.uk) must be completed and submitted to the Study Co-ordinator. This form consists of various background information, including:
a) A description of the samples and/or data requested.
b) Whether collaboration with members of the MaGiCAD study is planned, and to what extent the MaGiCAD team members will be involved in the Auxiliary Study.
c) A description of any additional work that would have to be undertaken by members of the MaGiCAD team (other than collation of the standard dataset and postage etc.).
d) A summary of how the study will be funded.
This electronic form must be accompanied by a Research Proposal. The Research Proposal should contain the following information:
a) A description of the aims and methods of the study
b) Proposed study design, including power calculations to justify sample size
b) Proposed timetable of the study, including proposed date of return of data to MaGiCAD
d) Experience of the laboratory in performing the appropriate assays.
A brief curriculum vitae of the Principal Investigator must also be supplied, including a list of recent publications. Further supporting documentation may also be provided if absolutely necessary, although we would strongly prefer that this be kept to a minimum.
Applications will be evaluated by the MaGiCAD Management Committee using the criteria given below (Section 4.2.3). In addition, since Auxiliary Studies may not fall under the existing ethical approval for the core MaGiCAD Study, the application for an Auxiliary Study will be evaluated by the Papworth Hospital NHS Trust R & D Department, in part for investigation into possible conflict with the MaGiCAD ethical approval. The result of the evaluations will be passed on to the applicant as soon as possible.
4.2.3 Evaluation of Auxiliary Study proposals
The MaGiCAD Management Committee will review the proposals as rapidly as possible following submission. This review process should usually take no more than 8 weeks. The following criteria will be used to evaluate the proposal:
a) Scientific merit. This includes justification of the rationale for doing the study, study design, power and preliminary data
b) Amount of samples requested. Requests for larger quantities of sample are less likely to be approved
c) Resources. The Auxiliary Study must have the resources, including funds and staff, to complete the project.
Furthermore, it is a prerequisite that proposed Auxiliary Studies do not interfere with, nor significantly overlap with, the MaGiCAD Core Study or currently approved Peripheral or Auxiliary Studies.
If the application is approved by the MaGiCAD Management Committee, the proposal will be forwarded to the Papworth Hospital NHS Trust R & D Department for their approval. Following the review process, the applicant will be notified of the result of the application. If the application is approved, the applicant must then complete and return the DMDA prior to postage of the samples and data to the applicant (see Section 4.3 and Appendix 4 below). If the Management Committee or the Papworth Hospital NHS Trust R & D Department reject the application, the reasons for a negative outcome will usually be passed on to the applicant. If these issues can be suitably addressed by the applicant the application may be re-submitted, at the discretion of Management Committee.
4.3 The Data and Materials Distribution Agreement
(DMDA)
Prior to distribution of any data or samples, the Principal Investigator must sign a DMDA governing the use of the data and samples (see Appendix 4). A summary of the DMDA is given below.
The researcher(s) participating the Auxiliary Study agree:
1. to be bound by the provisions of this constitution;
2. to use MaGiCAD data or samples for the sole purpose of the described research project;
3. that the DMDA (together with the data and samples) is non-transferable;
4. to retain control over all data and samples and to return unused samples;
5. to acknowledge the Commercial Sponsor’s custodianship of all MaGiCAD samples and ownership of the MaGiCAD data, including any intellectual property developed using the MaGiCAD data or samples during the performance of the Auxiliary Study;
6. not to attempt to identify or contact study participants;
7. to comply with subjects’ informed consent;
8. not to use biological materials in human experimentation;
9. to complete the Auxiliary Study within the timeframe agreed with the Management Committee;
10. to comply with the requirements of section 3.5 with regard to submission of manuscripts for publication;
11. to provide a copy of all data generated in the Auxiliary Study to the MaGiCAD Study Co-ordinator, subject to the provisions of section 4.4.2; and
12. to meet all costs, included those associated with the collation and distribution of the data and samples, incurred in the performance of the Auxiliary study.
A hard copy of the completed and signed DMDA must be received before any data or samples will be released. On receipt of the signed DMDA, samples and/or a CD-ROM with the appropriate data will be mailed to the Principal Investigator, typically within four weeks.
4.4 Running of the Auxiliary Study
After approval of an Auxiliary Study, adherence to the Research Protocol as submitted in the application is imperative. If changes in the structure or concept of the Auxiliary Study, or extensions to the Study, are proposed or unavoidable, the MaGiCAD Study Co-ordinator must be contacted. Depending on circumstances, a further application to the Management Committee may have to be made.
All publications, presentations and abstracts arising from use of MaGiCAD data and/or samples must be reviewed and approved by the MaGiCAD management committee prior to submission or presentation in accordance with Section 3.5.
4.4.2 Collation of data into the MaGiCAD database
Copies of all data collected during the Auxiliary Study must be provided to the MaGiCAD Study Co-ordinator. This data should be supplied in both a raw (completely unmodified in any way) format as well as in the format(s) used for any analyses. Both electronic and hard copies must be provided, within the timeframe agreed with the Management Committee.
The Principal Investigator of the Auxiliary Study shall have the first
and exclusive opportunity to analyse, present and publish all aspects
of the data collected from within the Auxiliary Study. The data shall
not be made available to other researchers (including members of the
MaGiCAD team) for analysis until a period of 12 months after receipt
of the data by the Study Co-ordinator. From this time onwards, all data
from the Auxiliary Study will be incorporated into the MaGiCAD database
and may be distributed to the Principal Investigators of future approved
Auxiliary Studies.
Where any of the provisions of this constitution are in conflict with
the provisions of earlier legal agreements, the provisions of the earlier
agreement shall be deemed to have priority.
All formal contacts between parties required by this constitution may be made by electronic mail (provided that an acknowledgement from the other party is received) or in writing.
The Principal Investigator of each Auxiliary Study shall be considered the sole point of contact with the MaGiCAD team. Communication with this individual shall be deemed to discharge all responsibilities of the MaGiCAD team required by this constitution.
The current MaGiCAD Study Co-ordinator (whose up-to-date contact details
are available on the website at http://www.magicad.org.uk )
shall be deemed the sole point of contact with the MaGiCAD team. Communication
with this individual shall be deemed to discharge all responsibilities
of the external researchers for contacting the MaGiCAD team (including
the Management Committee) that are required by this constitution.
The Management Committee reserves the right, by unanimous decision,
to undertake additional agreements related to MaGiCAD, provided only
that they are not in conflict with the provisions of this constitution.
For example, the Management Committee may agree to distribute data from
the MaGiCAD database through a mechanism other than an Auxiliary Study.
Violation of any one of the provisions of this constitution does not
invalidate the requirements of any other provision. Any such violation
should be reported as soon as possible to the Management Committee, who
reserve the right to seek any appropriate remedy.
In the event of disagreement over the interpretation of any part of this constitution, or over any issue not covered by the provisions of this constitution, the general principle set out herein shall form the basis for resolution. Where agreement cannot be reached, a final decision, binding on all parties, shall be sought from an Arbitration Panel consisting of three senior academics from Cambridge University independent of MaGiCAD and selected by the R&D Planning Group at Papworth Hospital in consultation with the Management Committee.
Appendix 1. Peripheral Studies
Principal Investigator: Dr David Grainger
The aims of this study are:
- To collect a samples of arterial and venous blood from a group of patients
- To investigate the effect of administering heparin to patients on the levels of circulating chemokine concentrations.
Patients were recruited between: April and July 2002 (17 patients in total)
Principal Investigator: Dr David Grainger
The aims of this study are:
- To collect information about patients arriving at Out-patients Clinics at secondary referal centres throughout East Anglia
- To determine the best strategy for introducing a metabonomics-based test for coronary artery disease into the existing clinical management paradigm
Patients were recruited between: Not yet begun
Last updated: 25 April 2003
Appendix 2. Auxiliary Studies
None
Last updated: 25 April 2003
Appendix 3. The MaGiCAD Team
TCP Innovations Ltd
UK registered company 4333576 (England & Wales)
9 St. John’s Street, Duxford, Cambridge, CB2 4RA, UK.
Current Members:
Dr. Peter Schofield (Lead Clinician)
Dr. David Grainger
Dr. David Mosedale
Dr. Sarah Clarke
Dr. Hester Goddard
Past members:
Prof. Jim Metcalfe
Current members:
Dr. Peter Schofield
Dr. Sarah Clarke
Dr. Sadia Khan
Past members:
Dr. Duncan McNab
A3.4 Clinical Research Associates
Current members
Ms. Annik Panicker (Study Co-ordinator)
Translational Research Unit, Papworth Hospital NHS Trust, Papworth Everard, Cambridge CB3 8RE
Dr. Claire Nugent
Mrs. Caryl Barnard
Past members
Mrs. Sarah Hayns
Rebecca Schofield (less than 50 patients)
Current members
None
Last updated: 17 December 2004
Appendix 4. The Data and Materials Distribution Agreement
The undersigned parties hereby enter into this Distribution Agreement as of the date specified on the final page hereof.
Definitions
For purposes of this agreement,
“Clinical Data” refers to all data, and associated records, collected and recorded for the MaGiCAD study;
“Biological Material” refers to blood samples and products thereof including cell pellets and extracted DNA collected and prepared for the MaGiCAD study;
“Commercial Sponsor” refers to the organisation in section A3.1 of the MaGiCAD Constitution.
“Management Committee” refers to those current members of
the MaGiCAD management committee as described in Appendix
3 of the MaGiCAD Constitution.
Recipient
___________________________________________, a [non-profit] OR [for-profit] Corporation with a principal address at ____________________________________ (“Recipient”) requests access to MaGiCAD Clinical Data, and/or Biological Material at its sole risk and at no expense to the MaGiCAD team.
Agreed Terms And Conditions
It is mutually agreed as follows:
1. Biological Material. The Management Committee and the Commercial Sponsor agree to transfer to the Recipient such Biological Material described in Schedule 1 for use by the Recipient's Principal Investigator named below ("Principal Investigator") to conduct the research described in Schedule 3.
2. Clinical Data. The Management Committee and the Commercial
Sponsor agree to provide the Recipient with such Clinical Data described
in Schedule 2 for use by the Recipient's Principal Investigator to conduct
the research described in Schedule 3.
3. Submission to the Terms of the MaGiCAD Constitution. The Recipient agrees
to be bound by the entire provisions of the MaGiCAD Constitution, the provisions
of which are incorporated by reference herein.
4. Research Project. The Recipient agrees that the Clinical Data and Biological Material, its progeny, and unmodified and modified derivatives thereof provided to the Recipient will be used by Recipient solely in connection with the research project described in Schedule 3 (“Research Project”). The Clinical Data and Biological Material will not be used in any experiments or procedures that are not disclosed and approved as part of the Research Project.
5. Non-transferability. This Agreement is not transferable. The Recipient agrees that any changes made to the Schedules, and/or appointment by the Recipient of another Principal Investigator to complete the Research Project, require execution of a new DMDA in which the new Principal Investigator and/or new Schedules are designated.
6. No Distribution, Avoidance of Waste, Return of Material. The Recipient agrees to retain control over the Clinical Data and Biological Material, its progeny, and unmodified or modified derivatives thereof, and further agrees not to transfer Clinical Data or Biological Material, its progeny, and unmodified or modified derivatives thereof, with or without charge, to any other entity or any individual. Recipient agrees, in handling the Biological Material, to make reasonable efforts to avoid contamination or waste of the samples. When the Research Project is completed, or at the expiry of the timeframe for conducting the Research Project agreed between the Recipient and the Management Committee, whichever occurs first, the Biological Material will be either returned to the MaGiCAD Study Co-ordinator, or disposed of as mutually agreed upon by the parties to this Agreement, unless an extension of this Agreement is obtained.
7. Intellectual Property. The Recipient acknowledges that ownership of all Clinical Data and custodianship of all Biological Material is retained by the Commercial Sponsor. Furthermore, ownership of all intellectual property developed using the Clinical Data or Biological Material shall be wholly owned by the Commercial Sponsor. The Recipient agrees to execute all relevant documentation to assign any and all rights in intellectual property developed using the Clinical Data or Biological Material to the Commercial Sponsor, at the Commercial Sponsor’s discretion and at the Commercial Sponsor’s cost.
8. Non-identification. The Recipient agrees that the Clinical Data and/or Biological Material will not be used in any effort whatsoever to attempt to establish the individual identities of any of the subjects from whom Clinical Data and/or Biological Material were obtained.
9. Compliance with Subject’s Informed Consent. Recipient agrees that Biological Material, its progeny, and unmodified or modified derivatives thereof will not be used for any purpose contrary to the subjects’ applicable signed informed consent document(s). It is the responsibility of the Recipient's Principal Investigator to consult with the Management Committee and ascertain, specifically and in detail, the terms and conditions of applicable MaGiCAD informed consent documents.
10. Use in Human Experimentation Prohibited. The Recipient agrees that Biological Material, its progeny, and any unmodified and modified derivatives thereof will not be used in human experimentation of any kind.
11. Timeframe. The Research Project exactly as outlined in Schedule 3 must be wholly completed within the Timeframe agreed by the Recipient and the Management Committee in writing.
12. Acknowledgements. The Recipient agrees to conform with the stipulations set out in the MaGiCAD Constitution concerning oral and written presentations, disclosures, and publications resulting from all analyses of Clinical Data and Biological Material.
13. Return of data. The Recipient agrees to provide a copy of all data generated using the Clinical Data or Biological Material to the MaGiCAD Study Co-ordinator, as detailed in the MaGiCAD Constitution.
14. Costs. All costs related to the performance of the Research Project, as well as contingent costs to the MaGiCAD team associated with collation and distribution of the Biological Material and Clinical Data will be born by the Recipient. Such contingent costs shall not exceed those agreed in writing by the Recipient.
15. No Warranties. No warranties, express or implied, are offered as to the merchantability or fitness for any purpose of the Biological Material and/or Clinical Data provided to the Recipient under this Agreement, or that the Biological Material and/or Clinical Data may be exploited without infringing the intellectual property or proprietary rights of any third parties.
16. Recipient's Responsibility for Handling Biological Material. The Recipient acknowledges that Biological Material has the potential for carrying viruses, latent viral genomes, and other infectious agents. The Recipient agrees to treat Biological Material as if it were not free of contamination, and that Biological Material will be handled by trained persons under laboratory conditions that afford adequate biohazard containment. By accepting Biological Material, Recipient assumes full responsibility for its safe and appropriate handling.
17. Non-Endorsement, Indemnification. Recipient agrees not to claim, infer, or imply endorsement of the Research Project, the entity, or personnel conducting the Research Project or any resulting commercial product(s) by any individual or entity involved with the MaGiCAD study including, but not limited to, the Commercial Sponsor, the Management Committee and/or Papworth Hospital NHS Trust. To the extent permitted by law, the Recipient agrees to hold the Commercial Sponsor, the Management Committee, Papworth Hospital NHS Trust and any other individual or entity associated with the MaGiCAD study, and the agents and employees of each of them, as well as their successors in title, harmless and to defend and indemnify all such parties for all liabilities, demands, damages, expenses, and losses arising out of the Recipient's use for any purpose of the Clinical Data and/or the Biological Material, its by-products, or modified or unmodified derivatives.
18. Accuracy of Data. The Recipient agrees that the Commercial Sponsor and Management Committee are not responsible for the accuracy of Clinical Data provided by other Recipients in previous Auxiliary Studies.
19. Recipient's Compliance with IRB Requirements. The Recipient acknowledges that the conditions for use of this Biological Material have been approved by the Recipient's Institutional Review Board (IRB) or equivalent ethical review body. Recipient agrees to comply fully with all such conditions and with the subjects' informed consent documents, and any additional conditions imposed in writing by the Commercial Sponsor or Management Committee. Any changes required by the Recipient’s IRB or equivalent body are still subject to the provisions of Clause 6, even if such changes are required by law.
20. Amendments. Amendments to this Agreement must be made in writing and signed by authorized representatives of all parties.
21. Termination. The Management Committee or the Commercial Sponsor may immediately terminate this Agreement if Recipient is in default of any condition of this Agreement and such default has not been remedied to the satisfaction of the Management Committee and Commercial Sponsor within 30 days after the date of written notice by the Management Committee or Commercial Sponsor of such default. Upon termination of this Agreement, the Recipient agrees to cease work on the Research Project with immediate effect and to return all Clinical Data and unused Biological Material to the MaGiCAD Study Co-ordinator.
22. Enforcement. The Commercial Sponsor and/or the Management Committee shall have the right to take any action or remedy available to it in law against the Recipient for violating or threatening to violate the confidentiality requirements of this agreement, the limitations on the use of the Clinical Data or Biological Material provided, or both. Proceedings may be initiated against the violating party, legal representatives, and assigns, for a restraining injunction, compensatory and punitive damages and/or any other proceeding in law, including obtaining the proceeds from any intellectual property or other rights that are derived in whole or in part from the breach of the confidentiality requirements or use limitations of this Agreement. Furthermore, the Recipient acknowledges and agrees that a breach or threatened breach of the confidentiality requirements or use limitations of this Agreement may additionally subject the Recipient to legal action on the part of MaGiCAD Study subjects, their families, or both.
23. Accurate Representations. The Recipient expressly certifies that the contents of any statements made or reflected in this document are truthful and accurate.
This Distribution Agreement is entered into as of: ________________________________(effective date)
RECIPIENT:
Name of Recipient Entity:
Name and Title of Recipient's Authorized Representative:
Authorized Representative’s Email Address:
Authorized Representative’s Telephone Number:
Signature of Recipient’s Authorized Representative:
Date:
PRINCIPAL INVESTIGATOR:
Principal Investigator's Name and Title:
Principal Investigator's Surface Mail Address:
Principal Investigator's Email Address:
Principal Investigator's Telephone Number:
Signature of Principal Investigator:
Date:
MaGiCAD MANAGEMENT COMMITTEE:
Name and Title of MaGiCAD Management Committee’s Authorized Representative:
Signature of MaGiCAD Management Committee’s Authorized Representative:
Date:
COMMERCIAL SPONSOR:
Name and Title of Commercial Sponsor’s Authorized Representative:
Signature of Commercial Sponsor’s Authorized Representative:
Date: