Appendix 3: Atlantic PATH Full Data & Biological Sample Access Application Form

Appendix 3: Atlantic PATH Full Data & Biological Sample Access Application Form

Note: Please submit this formelectronically.

This Full Data & Biological Sample Access Applicationform is a mandatorystep for requests for access to the Atlantic Partnership for Tomorrow’s Health Study (Atlantic PATH) Research Platform.

A complete application form may be submitted after a researcher has received Research Ethics Board (REB) or equivalent approval (mandatory) and funding (if required).

The purpose of this form is to:

(a) allow us to finalize the feasibility and availability of the data and/or biological samples required for the project;

(b) enable the researcher to provide detailed information about the project;

(c) allow us to finalize cost recovery estimate and timescales; and

(d) enable the Atlantic PATH Data Access Committee (DAC) to review the request;

Once the Atlantic PATH DAC has approved the access request, we must receive an original signed copybefore theapproved data and/or biological samples are released.

Please refer to Appendix 1 for a visual depiction of the Atlantic PATH Data & Biological Sample Access Process.

Please complete this form electronically and submit by email to:

Contents

1.Document Checklist

2.Project Title

3.Project Team

4.Authorized Institutional Representative

5.Project Information

6.Data Requested

7.Biological Samples Requested

8.Physical Measures Requested

9.Ancillary Studies

10.Conflict of Interest

11.Security

12.Return of Project Data Files

13.Applicant Declaration

1.Document Checklist

Please ensure that all required documents are submitted with the application and the version number and date is summarized in this table.

 / Documents Required / Version
Number / Version Date
(yyyy,mm,dd)
 / Completed Full Data & Biological Sample Access Application Form (signed and dated)
 / Purposes & Objectives (max 0.5 pages)
 / Significance & Benefits (max 0.5 pages)
 / Methodology (max 2 pages)
 / Detailed budget
 / Ancillary Studies:
 Collection forms and/or instruments (if applicable)
 Data
 Biological samples
 Physical Measures
 Project participant Consent process(if applicable)
 Project participant Consent form
 / Research Ethics Application & Supporting Documents
 / Ethics Letter of Approval
 / Ethics Waiver of Consent (if applicable)
 / Funding confirmation
 / Research Plan (e.g. Research Proposal)
 / Principle Investigator’s current CV (if Student, please provide Academic Supervisor’s current CV)
 / Contact details of any team member requiring access to line level coded data and reason for access

2.ProjectTitle

______

3.Project Team

Please list principal investigator(s) (PI) and their affiliation(s). If the PI is a student, please list the Supervisor and their affiliations.

Please attach an abbreviated CV (maximum 2 pages) for the PI or the Thesis Supervisor if the PI is a student.

Is this a student thesis or project? Yes No 

Project Team: Principal Investigator (PI)
Name
Affiliation(s)
Primary role/position
Mailing Address
City / State/Province
Post code / Country
Email Address
Phone number / Fax number
Select one: / Co-Investigator  Thesis Supervisor 
Name
Affiliation(s)
Primary role/position
Email Address / Phone number
Will this person have access to data? / Yes No 
If yes, please give rationale as to why data access is required:
Please attach information about additional Co-Investigators.

4.Authorized Institutional Representative

Please provide a valid institutional e-mail address and a full postal address of the host institution.

Name
Title
Institution
Mailing Address
City / State/Province
Post code / Country
Email Address
Phone number / Fax number

5.Project Information

Please complete the following as fully as possible. Although a copy of the protocol should also be attached, please re-enter the information into the form.

Scientific Abstract: scientific description of the research project and its specific hypotheses
(500 words or less)
Lay Summary of Project: Short description for the general public - Scientific jargon and acronyms should be avoided as much as possible. This description will be made available on the Atlantic PATH researcher website. (250 words or less)
Project Design
Please describe the proposed design, methodology and analysis plan of the proposed project, including:
Project objectives and outcome measures; specific research questions; and the methods that will be used to analyze the project data.
Please append the following:
Purposes & Objectives (maximum 0.5 pages) / Attached 
Significance & Benefits (maximum 0.5 pages) / Attached 
Methodology (maximum 2 pages) / Attached 
What are the proposed public or scientific benefits and potential harms of this research, and how do the benefits outweigh the harms?
What are the foreseeable risks arising from the use of personal information and how will the risks be mitigated?
Is this an ancillary project – i.e. will the project involve contacting Atlantic PATH participants for additional data and/or biological sample collection? Yes  No 
If yes, please provide details in Section 9 of this form.
Proposed Timelines

1. when will the data be needed (if known)?
2. when will biological samples be required (if known)?
3. expected end date of project?

/ Timeline:
a.
b.
c.
Funding
Has the project funding been approved?
Yes No Grant application in process Not Applicable 
If “NO” or “Not Applicable” selected, please explain why funding was denied or is not required:
If “Yes” or “Grant application in process”, please specify Funding Source(s):
______
Please note that access will not be provided until sufficient resources are in place.
Please append the following:
Detail budget for the project / Attached 
Document(s) confirming approved funding/ access to funds / Attached 
Time schedule of funding - Please note specific time constraints, e.g. student project:
From ______To ______
Ethics Approval
Atlantic PATH and the Atlantic PATH Data Access Committee are not responsible for the ethics approval/monitoring of individual research projects and bear no responsibility for the Applicant’s failure to comply with local/national ethical requirements.
Please note that access will not be provided until Ethics approval is in place.
Has this project been approved by a research ethics board (REB) or a comparable decisional committee that has been formally designated to approve and/or monitor research involving humans with the aim of protecting the rights and welfare of the research participants?
Name of REB(s): / Yes* / Decision pending* / Application to be submitted
 /  / 
 /  / 
* Please attach application, supporting documents and communication from the REB if “yes” or “decision pending”
Has the project been or will it be peer reviewed? Yes No 
If yes, by what organization? ______
Additional Approval(s)
Will the data received from Atlantic PATH be linked to data from other sources? Yes  No 
Are any other approvals required e.g. for linkage projects? Yes  No 
List all data linkages required and all organizations that are the custodians of the data:
Please describe the process to obtain access to additional data and describe methodology of any proposed linkages:
Investigations
Has the Principal Investigator or any research team member been the subject of an investigation of professional misconduct in relation to any research endeavours?
Yes  No 
If yes, please provide details ofall past and ongoing investigations including the investigating organization or body and the nature of the investigation. Please provide copies of all comments or decisions rendered in connection to any investigations.
Dissemination
How will the results of the research project be disseminated? Please select as appropriate:
Publication Poster Presentation Oral Presentation 
Please provide additional details:
Proposed Timelines

1. when will the data be needed (if known)?
2. when will biological samples be required (if known)?
3. when will data, biological samples or physical measures collection as part of Ancillary projects be completed?
4. when will data analysis be finished and data returned to Atlantic PATH and copies erased/destroyed?
5. when will biological samples analysis be finished and unused biological samples retuned to Atlantic PATH?
6. expected end date of project?

/ Timeline:
a.
b.
c.
d.
e.
f.

6.Data Requested

Description
Type of data being requested: / Individual level de-identified data
Biological Samples
New data (ancillary project)
New samples (ancillary project)
A copy of the Atlantic PATH data dictionary is available at: atlanticpath.ca
Target date for receipt of data:
Expected time period during which access to the requested data is required:
Please provide the following information for each objective of the research project.
Clearly Identify Objective:
Inclusion criteria:
Exclusion criteria:
Describe Methodology:
Variables: Please review the detailed data dictionary available for download from atlanticpath.ca
Please select Variables needed for this objective:
Variable / Level of Identification / Time Span / Why is this: / Data Source
element required in the analysis? / level of identification required?
e.g. Age / Age of each person >30 / 1999-Present / To calculate age adjusted incidence rates / Categorized age variable cannot be used for calculating age adjusted incidence rates / Atlantic PATH
Clearly Identify Objective:
Inclusion criteria:
Exclusion criteria:
Describe Methodology:
Variables: Please review the detailed data dictionary available for download from atlanticpath.ca
Please select Variables needed for this objective:
Variable / Level of Identification / Time Span / Why is this: / Data Source
element required in the analysis? / level of identification required?
e.g. Age / Age of each person >30 / 1999-Present / To calculate age adjusted incidence rates / Categorized age variable cannot be used for calculating age adjusted incidence rates / Atlantic PATH

Please add additional pages for additional objectives.

7.Biological Samples Requested

Does the proposed project include analysis of biological samples? Yes No 

Please provide the following information for each objective of the research project.
Clearly Identify Objective:
Biological Sample Requirements
Type / Volume / Number of samples

1. EDTA Buffy coat

1. RBC

1. PST Plasma

1. EDTA Plasma

1. Serum

1. Urine

1. Saliva

Justification for volume and number of biological samples requested, including power calculation if applicable.
Inclusion criteria:
Exclusion criteria:
Additional parameters required:
Where will biological samples be stored and analyzed? List all locations.
Target date for receipt of biological samples:
Expected period of time during which access to the biological samples is required:
Describe process for transporting biological samples.
Describe security and process for storing biological samples.
Please describe the stability of the biomarker(s) of interest, given the biological samples collection and pre-processing protocol – please review the biological samples pre-processing protocol that were followed.
Please describe the proposed laboratory assay to complete the analysis and its precision in relation to the research question.
Please describe the ability of the biomarker(s) of interest to reflect long-term blood levels (if applicable).
Please describe the impact of the freeze-thaw cycle on the biomarker(s) of interest if this information is available.
Please give details, including physical location, of the laboratory where the analysis will be carried out, including the accreditations held by this lab.

Please add additional pages for additional objectives.

8.Physical Measures Requested

Does the proposed project include analysis of physical measures? Yes No 

Please provide the following information for each objective of the research project.
Clearly Identify Objective:
Physical measure
Inclusion criteria:
Exclusion criteria:
Type / Number of samples

1. Height

1. Weight

1. Body fat %

1. Blood pressure

1. Bone density

1. Body segmented analysis

Please add additional pages for additional objectives.

9.Ancillary Studies

Does the proposed project involve contacting Atlantic PATH participants for additional data and/or biological sample collection? Yes  No 
Please provide copies of all data collection methods and/or instruments such as questionnaires.
Additional data collection:
No  / Yes If yes, please select method:
Mail out questionnaire:
Online questionnaire:
In-person administration:
Additional biological sample collection:
No  / Yes If yes, please select method:
Self-collected by mail:
In-person collection:
Additional physical measures collection:
No  / Yes If yes, please select method:
Self-report by mail:
In-person collection:
Please provide the following information for each objective of the research project.
Clearly Identify Objective:
Inclusion criteria:
Exclusion criteria:
Please give a brief description of methodology and rationale including number of participants, instruments to be used, biological samples to be taken, consent process.
Project Administration: Please select how you collect additional data &/ biological samples::
Option 1:
Atlantic PATH will:

• Contact Research Participants and collect consent, data and/or biological samples.

• Compile the data and provide the Approved Researcher with de-identified data and biological samples for analysis.

/ Option 2:
Atlantic PATH will:

• Contact Research Participants and provide the Approved Researcher’s contact information.
• Encourage Research Participants to contact the Approved Researcher.

Approved Researcher will:

• Collect consent, data and/or biological samples from Research Participants.

Please attach the following as applicable for the project: / Attached
 Collection forms and/or instruments
 Data
 Biological Samples
 Physical Measures
 Project participant Consent process
 Project participant Consent form / 






10.Conflict of Interest

Will the Applicant’s interest in the disclosure of the personal health information or the conduct of the research potentially result in an actual or perceived conflict of interest on the part of the Applicant? Yes □ No□
If yes, please provide details about the potential conflict and how the Applicant intends to address the potential conflict.

11.Security

In order to protect Atlantic PATH participants’ data and biological samples, Atlantic PATH require that authorized users have sufficient security in place to safeguard Atlantic PATH data and biological samples. Atlantic PATH requires specific IT security practices to be followed to avoid any misuse or inadvertent disclosure of information that could indirectly identify research participants or disclose their private data to unauthorized individuals. If you make local copies of Atlantic PATH controlled data, you must effectively minimize the risk that this information might be disclosed to individuals who have not agreed to the Atlantic PATH’s privacy protection conditions.

You are required to observe the following practices:

• Maintain all Atlantic PATH’s controlled data in secure physical computer systems. If data are stored on portable computers (whether laptops or other mobile devices), they must be encrypted to avoid any potential disclosure in the case of loss or theft.
• Implement appropriate access security to ensure that only the authorized individuals mentioned above (Section I) will have access to the controlled data. This requires, for example, that if Atlantic PATH data are stored on a shared computer system or a file server, that it is password and encryption-protected. Moreover, if the computer that holds Atlantic PATH data is backed up, that the backed up media must also be encrypted and stored in a secure location.
• Ensure all individuals who will use Atlantic PATH’s controlled data (Section I above) are trained in the responsible use of participant information and are familiar with the terms and conditions of the Data Access Agreement. They must also be briefed on the security plans described in this section.
• Ensure controls are in place to prevent access by computer hackers, or contamination by viruses and spyware of Atlantic PATH data stored on a network-accessible computer.
• Ensure all local copies of Atlantic PATH data are destroyed upon completion of the data analysis phase of the Research Project. If necessary, copies of Atlantic PATH data may be kept for archival purposes in conformity with national audits or legal requirements.

Security
Does the host institution have a formal IT security policy? Yes □No □
Please attach or provide an Internet-accessible link:
______
Describe the secure location where data will be held:
Describe the safeguards in place, both physical and electronic, to protect the privacy and security of Atlantic PATH data and/or biological samples
Describe how access will be limited to those individuals named in the access request if Atlantic PATH data will be stored on:

• a shared computer system or network accessible computer

• laptops and other portable devices.

Describe your plan to control and monitor which individuals will have access to Atlantic PATH’s controlled data and how you will familiarize them with the restrictions on its use.
Specify procedures that will be followed should unauthorized access or disclosure occur.
Describe all safeguards that will be in place to protect the security and integrity of biological samples that may be released.
Describe the plan to archive or destroy Atlantic PATH’s controlled data after the Data Access Agreement expires and/or the project is completed.

12.Return of Project Data Files and Biological Samples

How will the project file, including any new data or biological samples collected or derived as part of the proposed project, be returned to Atlantic PATH?
When will the file be returned?
What are the archive requirements for audit purposes?
Timeframe?
Format?
How will security be maintained for the project time period?
How will data be destroyed at the end of the project time period?

13.Applicant Declaration

I haveread and agree to comply with the Atlantic PATH Data & Biological Samples Access Policyand the Atlantic PATH Privacy & Confidentiality Policy.

Specifically, I, the Applicant, declare that:

1. This research project complies with the relevant Provincial Privacy Legislation detailed in the Access Policy.
2. I will only use the data and/or biological samples received for the purposes of thisproject as detailed in this Full Application.
3. This research project cannot reasonably be accomplished without the use of personal health information.
4. I will use the personal health information in the most de-identified form possible for the conduct of this research project;
5. I will ensure the security and confidentiality of the personal health information received from Atlantic PATH and its destruction when this research project is finished.
6. My interest in the disclosure of the personal health information or the conduct of this research project will not potentially result in an actual or perceived conflict of interest on my part.
7. I will return a copy of any and alldata derived or collected as part of this research project to Atlantic PATH at the end of the data analysis phase.
8. I will return any and allunused portions of biological samples collected from Atlantic PATH, and/or portions of samples collected as part of this research project to Atlantic PATH at the end of the biological samples analysis phase.
9. I will provide a copy of all published reports and articles related to this research project to Atlantic PATH.

Name of Applicant (please print): ______/ Title: ______
Position: ______
Signature of Applicant: ______/ Date: ______

If student thesis or project: