AUSTIN HEALTH DATABASE ACCESS FORM

This form is to be used when a project requires access to:

* Clinical data from a REGISTERED Austin Health clinical database. If the database has not yet been registered you may not use this form. Contact the Office for Research with questions

* Research data from an approved research database

This form is not to be used if:

* The research project involves procedures other than simply accessing an Austin Health clinical database for clinical evaluation or quality assurance work

* Patients need to be contacted for further information

* Data from other organisations will also be used as part of this project

* Identifiable data will be accessed by staff who do not have rightful access and consent was not obtained to use this data for research; or

* There is a reasonable expectation that the research findings arising from the project may have an impact on the clinical care of patients

NOTE: In each of the above cases a New Application for research ethics approval is required.

PLEASE NOTE:

1. Please complete either this Data Access Form OR a New Application, not both

2. Databases must be registered with the Office for Research before approval is granted to access them for research purposes using this form.

3. Data Custodians are required to approve access (signature on last page).

Please fill this form in electronically and submit to the Office for Research.

(Note: if digitalsignatures are not used, then a hard copy is required alongside the electronic submission)

Section 1: Application & Applicant Details
1.1Project Title /
1.2Approval Period Required
(up to 5 years) /
1.3Principal Investigator (PI)
(must be an Austin Health employee) /
1.4 PI email address /
1.5 PI phone number /
1.6 Austin Health Department /
Section 2: Database Details
2.1 From which clinical database (or research project) will data be used?
i.e. database/project name or Medical Records /
2.2 Database (of HREC) Registration Number /
2.3a Do you have rightful access to the data?
i.e. part of the treating team or department (for clinical data), or part of the investigative team (for research data) /
2.3b Are you using de-identified data?
NB: If identifying information will be removed prior to use, then choose ‘yes’ / Choose an item. /
2.3c Have patients provided consent for their data to be used in this manner (i.e. for this research project)?
If yes, please attach an example copy / Choose an item. /
Comment (if required): /
If no to ALL of 2.3a-c above, you are required to complete an ethics application.
2.4a Is data being provided to an institute external to Austin Health? / Choose an item. /
2.4b If yes, have you attached the:
1) Institutional HREC approval (from the external institute); and
2) Material Transfer Agreement / Choose an item. /
Section 3: Participant Details
3.1 What patient population is to be studied? / Choose an item. /
3.2 Approximately how many patient medical records or datasets will be used? /
Section 4: Project Protocol
4.1 Provide a background for the project including rationale and aims (1 page)
4.2 Describe any foreseeable ethical issues and how they will be addressed including risk to patient privacy and relevance to clinical care.

Agreement & Signatures
NOTE: A signatures ribbon will appear at the top of the screen. To add digitalsignatures please click ‘view signatures’ and choose ‘sign’ on the appropriate signatory from the list (i.e. PI or database custodian). Then follow the prompts to insert a digital signature.
Principal Investigator (PI): I agree to access and use data exclusively for the purpose described above, and will not pass the data on to a third party.
Name: /
Signature: / X______
Principal Investigator
Database Custodian (for clinical databases) or Principal Investigator (for research databases)
I am satisfied with the proposed use of the data and will allow the Principal Investigator access to re-identifiable or non-identifiable data when approval for the research is granted by the Office for Research.
Note:
  1. Please contact the Office for Research if the Database Custodian name is unknown.
  2. Please print this page multiple times when multiple databases are to be accessed and thus multiple data custodian sign-offs are required.

Name:
Signature / X______
Database Custodian
Research Ethics & Governance (Office Use Only)
Comments:

Database Access Form V1.020161108 1