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GW-SMC Governance and Procedures Manual

GULF WAR

SERUM MANAGEMENT COMMITTEE

GOVERNANCE AND PROCEDURES MANUAL

Document Owner: GWSMC Secretariat, Research Section, Department of Veterans’ Affairs

TRIM Record: 16326583E

Version: 1.0

Last Updated: June 2016


Revisions and Amendments

VERSION DESCRIPTION

1.0 Terms of Reference, Glossary, all Standard Operating Procedures and Appendices consolidated into a single document for GW-SMC consideration at meeting on 20 July 2016.


TABLE OF CONTENTS

Glossary of Terms 4

Key Stakeholder Organisations 4

Terms of Reference and Governance Rules 5

Requesting Access to Study Data and Serum Samples for Future Research 7

Accessing Blood Serum Samples 11

“Lost to Contact” and “Non-Responders” 13

Destruction of Serum Samples 14

Appendix 1: Summary of Data Serum/Access Protocols 16

Appendix 2: Confidentiality Deed 21

Appendix 3: Certificate of Destruction 25

Appendix 4: Letter of Notification of Sample Destruction 26


GLOSSARY OF TERMS

Term DefinitionGW-SMC Gulf War Serum Management CommitteeCommissions Repatriation Commission and Military Rehabilitation and Compensation

CommissionStudy Data Health data collected for the Gulf War Veterans’ Health Study.Unidentified data Data stored without names or identifying information and without any

information to allow identification.Re-identifiable data Data stored without names or identifying information but with a Study

ID number that allows re-identification in approved circumstances.Data Linkage Key List of study participants and corresponding Study ID numbers, to

facilitate re-identification of study data or blood serum samples.Donors Gulf War Health Study participants who donated blood for long-term

serum storage.Non-responder Participant whose contact details are believed to be up to date, but no

response has been received to recent contact requests.Lost to Contact All possible avenues of regaining contact have been exhausted.Serum Storage Provider Contracted provider of storage for the blood serum samples.Study Data Custodian Organisation responsible for storage and safe-keeping of the Study Data

including responding to approved requests for data access.Data Key Custodian Organisation responsible for storage and safe-keeping of the Data Linkage

Key including checking/validating and responding to requests for access to the Data Linkage Key.

KEY STAKEHOLDER ORGANISATIONS

Organisation RoleDepartment of Veterans’ Affairs Gulf War Study funder, Study Data owner, GW-SMC secretariatMonash University

custodGulf War Health Study research organisation, Study Data Naval Association of Australia Veteran/Study participants representative

Gulf War Veterans’ Association Veteran/Study participants represe

ntativeDepartment of Defence Study participants representativeSA Pathology Serum storage contractorDepartments of Defence and Veterans’ Affairs Human Research Ethics Committee (DDVA HREC)

Approval required for research involving ADF members, and/or ex-serving members

Donors Owners of donated blood serum samples


TERMS OF REFERENCE AND GOVERNANCE RULES

BACKGROUND

Blood serum samples were collected for long-term storage from consenting participants in the Gulf War Health Study (published 2003).

At the time of the most recent audit (2013) there were 2,590 samples remaining in storage where the donor has consented to the long term storage of the sample.

PURPOSE OF THE GULF WAR SERUM MANAGEMENT COMMITTEE

The Gulf War Serum Management Committee (GW-SMC) is responsible to the Repatriation Commission and the Military Rehabilitation and Compensation Commission (the Commissions) for providing annual reporting on operational activities around the continued management and storage of the serum samples and any research proposals that seek access to serum samples or study data.

MEMBERSHIP AND APPOINTMENT

GW-SMC Membership shall be reviewed by the Commissions every three years. Membership may be varied at the discretion of the Commissions.

The GW-SMC will consist of:

o Chairperson - Repatriation Commissioner;o Senior Medical Adviser - Department of Defence;o Senior Medical Adviser - Department of Veterans’ Affairs;o A representative of the Gulf War Veterans Association;o A representative of The Naval Association of Australia;o Assistant Secretary responsible for Research, Department of Veterans’ Affairs.o A representative of the Monash Centre for Occupational & Environmental Health; ando A representative of SA Pathology (trading as IMVS).

A quorum exists if at least a majority of members of the GW-SMC are present at the meeting.

Committee members may nominate a proxy by notice to the Secretariat if unable to attend a meeting.

Appointment to the GW-SMC will be by the Secretary, Department of Veterans’ Affairs (DVA) and the Commissions.

The frequency of meetings will be annual, but a meeting may be deferred if no items of business require attention.

Meetings may be conducted in person or via telephone/video conferencing at the Chair’s discretion.

ROLES AND RESPONSIBILITIES


The GW-SMC will manage the long-term storage of the serum samples to ensure that the serum storage provider meets its contractual obligations.

The GWSMC will consult with the Departments of Defence and Veterans’ Affairs Human Research Ethics Committee (DDVA HREC) prior to the destruction of any serum samples.

The GWSMC will advise and make recommendations to the Commissions on the merit of research applications seeking access to serum samples or study data.

All research proposals for access to the serum samples also need approval from the DDVA HREC and any other relevant Ethics Committees.

In performing its duties, the Committee will:

Evaluate the merits of continued retention of the serum samples. Advise and make recommendations to the Commissions if, in the opinion of the GW-SMC, the continued storage is unlikely to lead to scientific advances due to ageing of the samples;

Provide annual reporting to the Commissions and veteran community on the long-term storage and research proposals seeking access to the serum samples; and

Maintain detailed records pertaining to the request for use of the samples.

The Secretariat will report annually via e-mail to Committee members on all issues relating to the business of the Committee.

ROLE OF OBSERVERSObservers will participate in all Committee meetings to provide their knowledge and expertise but do not have voting rights.

COMMUNICATION

The GW-SMC through the Secretariat, is responsible for contacting any applicants of research proposals after the Commissions have made a decision.

All media contact regarding the GW-SMC should be referred to DVA’s Public Affairs team (02 6289 6203 or [email protected]).


REQUESTING ACCESS TO STUDY DATA AND SERUM SAMPLES FOR FUTURE RESEARCH

BACKGROUND

1. Gulf War Veterans’ Health Study participants entrusted the researchers with sensitive information that needs to be carefully managed, in particular:

health and related information – referred to in this document as Study Data;

blood serum samples; and

personal identifying information (name, contact details etc)

GULF WAR STUDY COMMITMENTS TO PARTICIPANTS

2. Any applications to use the study data or serum samples needs to comply with the commitments made to the original participants, as described in the Gulf War Health Study Explanatory Statement and Consent Form. The key commitments were:

The study’s purpose was “to determine whether Defence Force activities at that time [during the Gulf War], may have resulted in any adverse health effect on Australian Defence Force personnel.”

“The Department of Veterans’ Affairs will store a set of this de-identified data indefinitely and the code will be kept [separately]1.”

“DVA can only access the information for the purpose of medical research and only with approval of an overseeing committee which includes representatives from Veterans groups.” [That is, the Gulf War Serum Management Committee.]

“The information I provide and results of my assessments will be kept confidential and only used for this project.”

“Any published reports of this study will preserve my anonymity.”

“I agree that a sample of my blood serum may be stored indefinitely for potential and further medical research. This serum cannot be used for any such purpose without my further specific written consent.”

3. In keeping with these commitments, protocols for accessing the study data and/or serum are outlined below and summarised in the table at Appendix 1 of this Manual.

4. In addition, any data or personal information accessed for any new or ongoing research, must be stored and managed in accordance with the Privacy Act 1988, the current National Health and Medical Research Council (NHMRC) National Statement on Ethical Conduct in Human Research (see http://www.nhmrc.gov.au/guidelines/publications/e72), the Australian Code for the Responsible Conduct of Research, and the custodian institution’s IT/data security policies.

1 Original consent form said the key would be held by the Secretary of the DVA Ethics Committee. This was later agreed by the GW-SMC to be Monash until the data is no longer being used, then the Naval Association.


BLOOD SERUM SAMPLES5. Serum samples from the Gulf War Study are currently being stored for potential use in

future research. Members of the Gulf War Serum Management Committee (GW-SMC) undertake regular inspections of the samples to ensure the samples are stored and maintained appropriately. Inspections will be conducted at an interval determined by the Committee (eg annually).

6. The Gulf War study donors/participants gave consent for their serum sample to be stored indefinitely for potential future medical research. However, the original consent form stated that the serum sample cannot be used for any such purpose without further written consent from the study participants.

7. To use the serum samples in any research an applicant needs approval from:

the Repatriation Commission and Military Rehabilitation and Compensation Commission, on advice from the GW-SMC;

DDVA Human Research Ethics Committee; and

any other relevant ethics committees (eg researcher’s home institution).

8. The finite nature of the serum samples is a consideration for the GW-SMC when considering any application for their use.

STUDY DATA9. Most potential future use of Gulf War Study information for further research is likely to

be the Study Data (health information).

10. The baseline Study Data, unlike the serum samples, is not a finite resource and can be used and re-used many times. Therefore, the main factors when considering an application to use the Study Data will include the quality of the research proposal, its purpose, funding source, potential outcomes and likely benefits (or not) for the Gulf War veteran population, their families and/or the general community.

PRIVACY AND DATA ACCESS/LINKAGE11. The protocols outlined in this document aim to respect the trust and sensitivity of

the data by observing the following:

Personal Information (name, contact details, date of birth, next of kin) will be stored separately from the Study Data (health information etc.)

Study data and serum will be stored in unidentified or re-identifiable format only.

Personal Information can be used to contact participants for ongoing study/data management or to recruit for a new study that has been approved.

Study Data can be used, unidentified, for research in keeping with the original study purpose without further individual consent, in accordance with the approvals and protocols for access described in this Manual.

Study Data and/or Blood Serum

Personal Information (name, contact details)

Participants contacted to recruit for new study

Study using identified blood serum/data, only for

consenting participants

Study using de-identified datafor all participants

Materialfrom original

GW Study

Data Linkage Key

NewResearch


Study Data or Serum can be linked with personal information only for approved purposes and only for donors/participants who have specifically consented to linkage for that purpose/study, either in the original study consent form or a subsequent consent form. (See Figure 1.)

Personal Information can be linked with Study Data using the “Data Linkage Key”.

The Data Linkage Key will be stored separately and only accessed for those donors/participants who have specifically consented to linkage for that purpose/study, either in the original study consent form or a subsequent consent form.

The Study Data is owned by DVA (a Commonwealth agency) and therefore linking it to any other datasets will be subject to Commonwealth data linkage policies. See: www.nss.gov.au/nss/home.NSF/pages/Data+Integration+Landing%20Page?OpenDocument

Figure 1: Using Study Data and/or Personal Information


APPROVAL PROCESS

12. A researcher must obtain approval for their proposed research from the following, as relevant:

DVA – Commissions on advice from the GW-SMC (serum or re-identifiable data) or the Assistant Secretary responsible for Research in consultation with the SMC Chair (unidentified data).

All ethics Committees that approved the original study (DDVA, and Monash, plus AIHW for certain data).

New researcher’s institutional Ethics Committee, if applicable.

Any other relevant ethics committee(s).

13. An approval request to DVA should be submitted through the GW-SMC secretariat for processing and include:

Purpose of the proposed research.

Planned conduct and methodology.

Data management, storage and security strategy to retain data confidentiality and integrity.

Funding source and anticipated intellectual property conditions.

Details of the data (fields, range, etc) and/or serum requested.

All necessary Ethics approvals. This may be done later depending on time sequence.

14. The GW-SMC Secretariat will notify the applicant of the result of their request and, if it was approved, ask them to sign a Confidentiality Deed (Appendix 2).

15. If the research is funded by DVA the conditions of a Services Agreement or equivalent may also apply.

16. The GW-SMC Secretariat will send a copy of the notification letter and supporting documents (signed confidentiality deed and ethics approvals) to the Study Data custodian, the Data Linkage Key custodian and (if relevant) the Serum Storage Provider.

INDIVIDUAL ACCESS FOR NON-RESEARCH PURPOSES

17. Individual participants can currently request their own study data from the original (Monash) research team. If the data custodian arrangements change in future, the question of individual access will need to be re-visited.

18. There is no participant access to individual serum samples for testing.

REPORTING

19. The GW-SMC Secretariat, Study Data custodian, Data Linkage Key custodian and Serum Storage Provider will each report to the GW-SMC any request(s) for access to data or serum samples they have received.


ACCESSING BLOOD SERUM SAMPLES

20. Once a request to use the serum samples for research has been approved, the Serum Storage Provider will:

a) Receive a copy of the research approval letter, ethics approvals and signed confidentiality deed from the GW-SMC Secretariat.

b) Receive a spreadsheet of Study ID numbers and Lab Reference numbers for participants in the new study, from the Data Linkage Key Custodian.

c) Identify the location of each participant’s sample according to the Study IDs and Lab Reference numbers.

d) Enter the freezer position number(s) for each participant’s sample into the spreadsheet against the correct Study ID number. Check by a second employee of the accuracy of the entry against the Serum Storage Provider’s database.

e) Notify the Study Data custodian and new researcher in writing of any mismatches and work with them to resolve the mismatch(es), with reference to the original study data/documentation if required, before further action is taken.

f) Match the Study ID and Lab Reference number on each sample’s barcode against the Study ID and Lab Reference number on the spreadsheet. If correct, remove samples from storage. If incorrect, verify and if necessary repeat step 5. Check by a second employee that for each sample the Study ID and Lab Reference number on the spreadsheet and the sample barcode match.

g) Confirm the proposed transport method and storage facilities arranged by the new researcher will maintain the samples at an appropriate temperature. This includes maintaining a temperature equivalent of the storage temperature during transportation to maintain the integrity and stability of the samples.

h) Pack the removed samples for transportation and dispatch, ensuring all aspects of transport and storage comply with relevant provisions from the serum storage contract, including complying with applicable industry standards and section 3.4 of the National Health and Medical Research Council (NHMRC) National Statement on Ethical Conduct in Human Research.

21. The researcher, in accordance with their approved research application and Confidentiality Deed or any other relevant agreement(s), will:

a) Notify the serum storage provider when the samples are received.

b) Store the samples immediately in a secure facility (may be a collaborator or subcontractor) in accordance with industry standards for storage of serum samples and NHMRC best practice guidelines for human tissue samples and human genetic research.

c) Return to the serum storage provider any unused samples suitable for re-use, appropriately marked to record the transportation and return.

d) Destroy any remaining serum not suitable for re-use, once the relevant testing is complete, and inform DVA that this has been done.


On completion of work

22. The Serum Storage Provider, once all work is finished, will:

a) Ensure any remaining samples are returned to the storage facility.

b) Ensure that samples are labelled to reflect where they had been transported and/or partially used as this will lead to degradation.

c) Update records to reflect that the samples have been removed, transported, received and if applicable returned.


“LOST TO CONTACT” AND “NON-RESPONDERS”

DEFINITIONS

23. A participant is classified as ‘“Lost to Contact”’ if all possible avenues of regaining contact have been exhausted without success.

24. A participant is classified as a “non-responder if it is believed contact details are up to date, but no written response has been received.

SERUM SAMPLES OF “LOST TO CONTACT” AND “NON-RESPONDER” DONORS

25. Serum Samples of “Lost to Contact” participants and “Non-responders” cannot be used as the donor of these blood serum samples cannot be identified and therefore cannot be contacted to obtain consent to use their blood serum sample for research.

26. As at February 2010, 4% of the total eligible Gulf War participant population had been classified as ““Lost to Contact”” and 22% had been classified as ““Non-responders””.

27. All effort must be made to contact “Lost to Contact” participants and “Non-responders”. Study participants will be contacted every time an approved researcher requests access to blood serum samples for new research.

28. If follow-up attempts to contact the participants fail, the samples of “Lost to Contact” participants and “Non-responders” will continue to be stored, but will not be used for new research.

APPLICATION TO STUDY DATA

29. De-identified data from “Lost to Contact” and “Non-responder” participants can be used in approved research.

30. Data linkage or other uses requiring further consent from participants will involve trying to contact all participants through available channels, but data from those who are concluded to be still “Lost to Contact” or a “Non-responder” will not be able to be used.


DESTRUCTION OF SERUM SAMPLES

31. Destruction of serum samples will, where possible, be done at the time of the annual serum inspection with two Gulf War Serum Management Committee members present to witness the destruction

32. Urgent requests for destruction of blood serum samples will be considered on a case-by- case basis by the Chair of the GW-SMC, who may authorise travel to the storage facility for at least one member of the Gulf War Serum Management Committee to witness the destruction of the sample(s).

33. When the Data Key Custodian receives a request for the destruction of a blood serum sample, they will:

verify the identity of the donor(s); verify that the donor(s) has provided appropriate consent for the destruction(s); notify the donor in writing that their sample will be separated from the broader

collection and held for destruction until the next scheduled routine inspection by members of the Gulf War Serum Management Committee;

use the data key to identify the donor’s Study ID and Lab Reference Number(s); and

complete Step 1 and Step 2 of a ‘Certificate of Destruction’ Form (Appendix 3).

34. The Data Key Custodian will notify the Serum Storage Provider that a request for destruction has been received and provide the Certificate of Destruction.

35. If there are any errors on the Certificate of Destruction, the Serum Storage Provider will notify the Data Key Custodian and take no further action until the form is amended.

36. An employee of the Serum Storage Provider will record the location of sample(s) by matching the Study ID and Lab Reference Number(s) on the Certificate of Destruction with the Serum Storage Provider’s database.

37. A second employee will check the accuracy of the entry against the Serum Storage Provider’s database.

38. If there is any discrepancy between the information on the Certificate of Destruction and the information on the database, the Serum Storage Provider will notify the Data Key Custodian in writing and take no further action until the matter is resolved.

39. Two employees of the Serum Storage Provider will travel to the storage facility with theCertificate of Destruction.

40. An employee will locate the sample(s) within the storage facility using the location information on the Certificate of Destruction and match the Study ID and Lab Reference number(s) on the sample barcode(s) against the Certificate of Destruction.

41. A second employee will verify a match between the Study ID and Lab Reference number(s) located on the serum sample barcode(s) and those on the Certificate of Destruction. If correct, the sample(s) will be removed from the storage facility.

42. This process will be repeated for each sample on the Certificate of Destruction form(s).


43. An employee of the Serum Storage Provider will destroy the sample(s) according to procedures for destruction of biohazards in line with South Australia’s Environment Protection Act 1993 and the Environment Protection (Waste Management) Policy 1994.

44. The destruction will be witnessed by a second employee and up to two members of the Gulf War Serum Management Committee.

45. Both employees will sign the Certificate of Destruction.

On completion of work

46. The Serum Storage Provider will keep a copy of the signed Certificate of Destruction and send the original to the data key custodian via registered mail.

47. The Data Key Custodian will provide the donor with a letter notifying that their sample(s) have been destroyed (Appendix 4).

48. The Serum Storage Provider will update their records to reflect that the sample(s) have been removed and destroyed.


SUMMARY OF DATA/SERUM ACCESS PROTOCOLSAPPENDIX 1

Using unidentified existing study data for new analysis

Linking study data and personal informationto recruit participants or link with another data source

Nature of Data sought Unidentified study data, for all Gulf War Health Study participants

Personal Information (contact details) for all Gulf War Health Study participants.

Data Linkage Key. Identified study data/serum, for only those who consent

to the new study.

Approvals required Gulf War Serum Management Committee

Repatriation Commission

All original study Ethics Committees:2

Departments of Defence and Veterans’ Affairs

Monash University

AIHW (if applicable depending on data)

Gulf War Serum Management Committee


All original study Ethics Committees:

Departments of Defence and Veterans’ Affairs

Monash University

AIHW (if applicable depending on data)

New research institution’s Ethics Committee Any other relevant Ethics Committee(s)

Original participants’ consent required?

No. Original study consent sufficient. Yes. Study Data/Serum only available for participants who consent to the new study.

Contract/deed requirements

Deed between the new researcher and DVA, specifying conditions of use.

Deed between the new researcher and DVA, specifying conditions of use.

2 Where the new research will be conducted by a member of the original research team while still employed by Monash University, and the Gulf War Serum Management Committee considers the original Ethics Committee approval(s) cover the proposed new research purpose, no additional Ethics application(s) are required.




Confidentiality Deed Required. If funded by DVA (eg Applied Research Program) the relevant services agreement may be used to cover this requirement.

Confidentiality Deed Required.

Approvals notification Copy of project approval letter and signed Deed/Services Agreement sent to:

Study Data Custodian Data Linkage Key Custodian Serum Storage Provider (if applicable)

Copy of project approval letter and signed Deed/Services Agreement to:

Study Data Custodian Data Linkage Key Custodian Serum Storage Provider (if applicable)

Obtaining consent Not applicable. Data Linkage Key custodian (currently Monash) provides the key to the new researcher, after confirming it complies with the GW-SMC approval letter.

New researcher3 writes to GWS participants with information about the new study and requests consent. Those who agree send the new study consent form to the new researcher.

New researcher conducts follow-up mail-outs, tracks Return To Senders etc. and at conclusion of recruitment provides updated contact information back to Data Linkage Key custodian.

3 The “new researcher” in this context includes where a member of the original research team is conducting a new or follow-up study.




Matching consenting participants to GWS study data

Not applicable New researcher matches names of consenting participants with names in the Data Linkage Key, creates a list of Study IDs (and date of birth for cross-checking) of consenting participants.

Obtaining GWHS study data

Study Data custodian checks data request against the GWSMC approval letter and extracts approved data.

Study Data custodian provides data in an appropriate, secure format within a reasonable timeframe.

New researcher sends consent forms and list of consenting ID Numbers (with dates of birth) to Study Data custodian and/or Serum storage provider.

Data/Serum custodian confirms compliance with approval letter, discusses exact requirements (variables etc) with the researcher and extracts the data/serum for consenting participants. A second employee checks the data and it’s sent to the researcher in an appropriate, secure format.

Storage of data during study period

Acknowledge receipt of data, store it securely protected from damage or loss, and accessed only by persons who have signed the confidentiality Deed.

Data must be acknowledged on receipt and stored securely, protected from damage or loss and accessed only by persons who have signed the confidentiality Deed.

End of Project data management (not applicable for serum samples)

New researcher keeps the data for time required to finish and publish approved analysis. Any analysis not in the approved proposal requires a further, separate application.

Once complete, the data is returned to the Study Data custodian. The timeframe for return will be specified in the confidentiality Deed.

New researcher keeps the data collected in their own study, combined with Study Data, ensuring all contact details are updated and health data is kept separate from identifying information. The Study Data cannot be used for any other purpose without repeating the approvals process above.

New data collected is provided to the Study Data custodian at the conclusion of the new study, including all documentation/data dictionary, and becomes part of the GWS data collection.




Data ownership GWS Study Data ownership remains with DVA

GWS Study Data ownership remains with DVA New study data ownership to be specified in Deed

or Services Agreement

Consent forms storage Not applicable After conclusion of the new study, consent forms are held for permanent storage in the original study participants’ files.

Resources Study Data custodian is responsible for identifying and extracting study data in accordance with approved research protocol. Reasonable cost recovery charges can be applied to the new researcher.

Delivery timeframe may vary (eg 2 weeks to 3 months) according to whether charges apply.

New researcher is responsible for all other work, at their expense.

Data Linkage Key custodian is responsible for releasing and transferring the Key to the new researcher, and re-integrating updated contact information. Reasonable cost recovery charges can be applied to the new researcher.

Study Data custodian is responsible for:

extracting study data for consenting participants only (using Study ID numbers provided by new researcher), reasonable cost recovery charges can be applied and timeframe set accordingly; and

integrating/storing new data as part of the GWS Study Data collection.

New researcher is responsible for all other work, at their expense.

Analysis and Publication

Results to be published only in aggregate form, no individual’s results to be identifiable.

Results to be published only in aggregate form, no individual’s results to be identifiable.




Acknowledgements Original GWS participants, original researchers, data owner/s (DVA – and AIHW if applicable)

Original GWS participants, original researchers, data owner/s (DVA – and AIHW if applicable)

Dissemination A copy of any report, findings, presentations and publications to be provided to DVA

Participants to be informed of all new research and findings, usually by notification/publication or link on the DVA website

Other conditions, such as DVA review/approval of proposed publications and media releases, may apply according to the Deed or Services Agreement

A copy of any report, findings, presentations and publications to be provided to DVA

Participants to be informed of all new research and findings, usually by notification/publication or link on the DVA website

Other conditions, such as DVA review/approval of proposed publications and media releases, may apply according to the Deed or Services Agreement

Documentation The Study Data custodian will keep a of log all access to the data, including:

Purpose of the research; Copy of approval letter and Deed; Contact details for principal

researcher; Date data sent to researcher; and Date data returned.

The Study Data custodian will keep a log of all access to the data, including:

Purpose of research; Copy of approval letter and Deed; Contact details for principal researcher; Record of what data is provided to the new researcher; Date data sent to the researcher; and Date data returned for re-integration.


APPENDIX 2

Use of Gulf War Serum / Data

CONFIDENTIALITY DEEDThe person described on the Signature Section (the signatory) makes this Confidentiality Deed.

This Confidentiality Deed relates to the following Gulf War Health Study serum samples and/or study data:[describe data/serum provided, eg which fields and whether all participants or a sub-group]

The specified serum samples and/or study data are provided for use in research that has been approved by the Gulf War Serum Management Committee for the purpose of:[describe the approved research, including expected completion/publication timeframe]

The signatory must provide DVA with a copy of any published report, findings or presentations arising from use of the confidential information. These may be disseminated to Gulf War Health Study participants, or more broadly, at DVA’s discretion.

1. Obligations1.1 [Maintain confidentiality]The signatory agrees:

(a) to keep the confidential information, specifically serum samples and/or study data, confidential;

(b) to use the confidential information, specifically serum samples and/or study data only for the purpose for which it was made available and only disclose that information on the same terms as in this Deed to any officer, employee, agent or subcontractor who needs to know the information in connection with that purpose;

(c) apart from disclosure under paragraph (b), not to disclose to any person or to copy, use, develop or exploit the confidential information, and not to transmit it by any means, unless DVA has expressly consented in writing to such an activity;

(d) to ensure that no publication based on the confidential information would identify or be able to identify any individual study participant;

(e) to suitably encrypt or protect the storage of the confidential information;(f) to comply with any procedures or directions given by DVA for the management,

storage and protection of the confidential information.

1.2 [Need to Notify] The signatory agrees to immediately notify the Data Linkage Key Custodian, the Study Data Custodian and DVA if any of the confidential information has been used, copied, exploited or disclosed without authority.

1.3 [Indemnity] The signatory indemnifies DVA for any loss resulting from a breach of this Deed by the signatory, its officers, employees, agents and subcontractors.

2. Return of confidential information2.1 [No longer need to know] The signatory agrees to immediately return to the [Data Key

Custodian / Study Data Custodian – delete as applicable], or completely remove from any electronic devices in its custody or control, all copies of the confidential information (including any stored in electronic form on any device, eg, CD or DVD) that is in its custody or control, when:(a) the confidential information is no longer needed for undertaking the purpose for

which it was made available;(b) DVA directs, at any time, the return of the confidential information;(c) the signatory ceases to undertake the approved research; or(d) the signatory, its officers, employees, agents or subcontractors breach any provision

of this Deed; and


(e) where not otherwise already returned, [XXX eg 3 months or as preferred] after completion of the purpose for which it was made available.

2.2 The signatory agrees to certify in writing to the Data Key Custodian, that confidential information has been completely removed from electronic devices.

2.3 [Other copies] If required to return the confidential information under clause 2.1 and any is beyond the signatory’s custody or control, the signatory will provide full details of the custodian and whereabouts of that information.

3. General3.1 The signatory acknowledges that:

(a) rights and remedies under this Deed are cumulative unless they, specifically, have been exercised or waived;

(b) this Deed is not intended to exclude the operation of any principle or remedy of law intended to protect the confidentiality of the confidential information (including injunction to restrain breach of confidence or fiduciary duties); and

(c) this Deed can only be varied with the express written consent of DVA.

3.2 This Deed:(a) does not transfer any interest in any intellectual property rights; and(b) is governed by the laws of the Australian Capital Territory.

4. Interpretation4.1 In this Deed, unless the contrary intention appears:

(a) citations of statutes are to statutes of the Commonwealth of Australia;(b) a reference to a law or publication includes a reference to that law or publication

as amended or replaced;(c) words and phrases are to be interpreted by reference to clause 5;(d) where a word or phrase is given a defined meaning (appearing in bold in defined terms

and when otherwise first occurring in the document), any other part of speech or other grammatical form in respect to the defined term or phrase has a corresponding meaning;

(e) words in the singular include the plural and vice versa;(f) a reference to a gender denotes any other genders; and(g) a reference to the word ‘include’ or ‘including’ is to be construed without limitation.


5. Definitions5.1 In this Deed, unless the contrary intention appears:

Confidential information

Means information (including any disclosed or created orally by any person) that is personal information or by its nature confidential, is designated confidential by DVA or that I know (or ought know) is confidential, including hard copy documents such as consent forms which have identifying information, system passwords or access identification and actual or potential commercial transactions, but does not include information that:(a) is, or becomes, public knowledge (other than contrary to law);

(b) the signatory possessed, without restriction against disclosure, before receiving equivalent information from the data key custodian or study data custodian;

(c) the signatory developed independently, or acquired from a person who had developed it independently or lawfully acquired it with no obligation restricting its disclosure; or

(d) a law compels disclosure but only to the extent of the information requested under that law.

Data Linkage Key List of study participants and corresponding Study ID numbers, to facilitate re- identification of study data or blood serum samples.

Data Key Custodian Organisation responsible for storage and safe-keeping of the Data Linkage Key including checking/validating and responding to requests for access to the Data Linkage Key.

DVA Means the Commonwealth of Australia, as represented by and acting through the Department of Veterans’ Affairs (DVA), and, where relevant, the Repatriation Commission and the Military Rehabilitation and Compensation Commission.

Intellectual property rights

Includes, regarding in any country in the world and including the ability to register these rights (where applicable), any intellectual property rights recognised at law and international law.

Law Includes any relevant:(a) legislation, whether primary, delegated or subordinate, of the

Commonwealth of Australia or of a state, territory or local government; and(b) judicial law (including the common law and the rules of equity).

Loss Includes any damage, liability, loss, injury or death, including economic loss and legal costs or expenses arising on a solicitor/own client basis.

Military Rehabilitation and Compensation Commission

Means a Commonwealth body corporate established under the Military Rehabilitation Compensation Act 2004 or any other government agency that carries out functions equivalent to the Military Rehabilitation and Compensation Commission.

Person Includes an individual, a body corporate (eg, an incorporated association, a statutory authority or a company, including a financial or trading corporation), a body politic (eg, a government), an office, commission, authority, committee, tribunal, board, institute, trust, partnership or any other organisation or unincorporated association.

Personal information Means information or an opinion (including information or an opinion forming part of a database), whether true or not, and whether recorded in a material form or not, about a natural person whose identity is apparent, or can be reasonably ascertained, from the information or opinion.

Purpose Nature and scope of the work for which the serum and/or study data is provided, as described at the beginning of this Deed. Must be in accordance with written approval from the Gulf War Serum Management Committee.


Means the body corporate continued in existence under the Veterans’ Entitlements Act 1986 or any other government agency that carries out functions equivalent to the Repatriation Commission.

Study Data Custodian

Organisation responsible for storage and safe-keeping of the Study Data including responding to approved requests for data access.


SIGNATURE SECTIONExecuted by the signatory as a Deed -

Signed sealed and delivered by:

Name and, if relevant, position, of signatory [name][position]

Address of signatory [address]

Signature of signatory and date / /

In the presence of:

Name of the witness [name]

Signature and date

/ /


APPENDIX 3

CERTIFICATE OF DESTRUCTION

1.

Identification of Study ID (SOP Step 1)

Study ID Date

Action Officer Signature

Witness Signature

2. Identification of QML Barcode ID(s) (SOP Step 1)

Sample 1 QML Barcode ID: Date


Witness Signature

Sample 2 QML Barcode ID: Date


Witness Signature

3.

Identification of Sample Position(s) (SOP 2)

Sample 1 Box No: Position No:

Action Officer Signature Date

Witness Signature Date

Sample 2 Box No: Position No:

Action Officer Signature Date

Witness Signature Date

4.

Removal of Sample(s) (SOP Step 4)

Sample 1 Removed Date


Witness Signature

Sample 2 Removed Date


Witness Signature

5.

Destruction of Sample(s) (SOP Step 5)

Sample 1 Destroyed Date


Witness Signature

Sample 2 Destroyed Date


Witness Signature


APPENDIX 4

Letter: Notification of Sample Destruction to Donor

[Name] [Address]

Dear [Donor]

I wish to inform you that your blood sample taken as part of the Gulf War Veterans Health Study has been removed from storage and destroyed as per the Request for Destruction Form you completed. Please note that no other sample from this study collected from you remains in storage.

If you have any queries about the destruction of your sample, you can contact [Monash University] by telephone on ……. , or by email at ……..

If you have general queries about your blood sample, including the study, please contact the Department of Veterans’ Affairs at [email protected].

Yours sincerely

[Representative of Data Linkage Key Custodian]

Date

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