Low and Negligible Risk Research Sitespecific Assessment

Low and Negligible Risk Research SiteSpecific Assessment

SSA is a component of research governance.It involves assessing the suitability of a site at which the research is being conducted and identifying whether the ‘actual’ and or ‘in kind’ resources required for the conduct and completion of the project can be met by the organisation.

1Project Details

1.1 Project Full Title

1.2 Project Short Title

1.3 HREC Application Reference No.

1.4Local Reference No.

1.5Site Name for this SSA Application

1.6 Type of Research

Please select 1 or more

Multi-site research Clinical trialrelated

Single-site research Not clinical trialrelated

2 Description of Project

Please give a concise and simple description (not more then 400 words), in plain language, of the aims of this project, the proposal research design and the methods to be used achieve those aims).

3 Study Type, NHMRC Discipline

Please list an NHMRC Discipline for the application(For the full list of NHMRC disciplines, please refer to under the heading ‘How to make an HREC application’)

4 Investigators

Please provide a list of the Investigators’ names at this site and attach a curriculum vitae for each Investigator.

4.1Principal Investigator for this site

Title
Surname
First Name
Mailing Address
Suburb /City
Postcode
Country
Organisation
Department
Email
Phone (BH)
Mobile
Qualifications

4.2Associate Investigator(s) for this site

Title
Surname
First Name
Mailing Address
Suburb /City
Postcode
Country
Organisation
Department
Email
Phone (BH)
Mobile
Qualifications

4.3Contact person for this site for this research project*

Title
Surname
First Name
Mailing Address
Suburb /City
Postcode
Country
Organisation
Department
Email
Phone (BH)
Mobile
Qualifications

* The PI will be responsible for ensuring there is a Contact Person at the site who will liaise with the low risk review personnel.

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Low and Negligible Risk Site Specific Application - Victoria

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5 Dates

Please provide the anticipated start and finish dates for the research project at this site

5.1 Start date / * /
5.2 Finish date / # /

* Start date refers to the first point of recruitment i.e. the date when the advertising or screening for participants begins.

# Finish date refers to when no further contact with participants/data source is foreseen including the data analysis and reporting period.

6Participants

6.1What is the proposed number of participants to be recruited at this site?

7Study Agreement

Please refer to the Australian Code for the Responsible Conduct of Research and VMIA Standard Research Agreements.

7.1Is a written research agreement, signed by all relevant parties,attached?

Yes No

Collaborative research involving two or more institutions/parties requires a written agreement to be in place before the research commences.

If No, please give an explanation

If Yes,name the organisation entering into this agreement with your organisation (Health Service, University, Collaborative group etc.)

7.2Has the research agreement been reviewed and approved by an approved legal delegate/team?
Yes No

If No, the agreement mayrequire legal review.Contact your research governance office for advice.

NOTE: For Victoria – the delegated authority to sign ALLagreements is the responsibility of your organisation’s CEO or delegate.

8Intellectual Property Considerations

8.1 Is there a possibility of new Intellectual Property being developed from this project?
Yes No
8.2Does the research agreement state arrangements for the use of existing intellectual property and the parties’ rights in relation to ownership?
Yes No N/A
8.3 Does the research agreement describe arrangements for the use of all new intellectual property developed through the research project?
Yes No N/A
If the answer is Yes to 8.1 and No to8.2 and/or8.3 then you should:
Discuss the issue of incorporating Intellectual Property terms into the agreement with your associates and any legal or business manager assisting with development of the agreement. Please refer to your organisation’s Intellectual Property Policy.

9Resource and Budget Information

Instructions for researchers: Organisations may incur costs in providing support for your research over and above those costs associated with standard care. Any costs over and above routine care which are to be met by the organisation are to be clearly identified and detailed. This includes both the ‘Actual’ costs and ‘In kind’ support. Confirmation of cost estimates, and agreement as to a funding source, is to be provided by the Director of Finance (or equivalent) in the first instance before final authorisation by the organisation’s CEO or delegate.

9.1Has this protocol received research funding (including the researcher receiving any remuneration and/or in kind funding to perform this research) or is this submission being made as part of an application for research funding?

Yes No

If Yes, please complete the budget details below as applicable for this site.

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Low and Negligible Risk Site Specific Application - Victoria

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9.2Study Budget

Include relevant salaries and other costs and attach a copy of the budget to this application.

An explanation of how the research project will be funded at the site must be provided to ensure adequate financial arrangements are planned. Details of the impact of the research and any costs that may be incurred by the organisation should be provided.

Please select the way the amount of funding will be expressed in the table below:

Amount per year

Amount per participant

Both as Amount/year and Amount/participant

Type of funding / Source of funding / Amount ($)
Commercially sponsored
Sponsored, other
(e.g. collaborative groups)
External funding
(e.g.NHMRC, Foundations, etc)
Internal/Departmental funding
Other (specify)
TOTAL FUNDING
for the study

Give details of the type and name of the funding organisation. Use ‘other’ if not specified above.

9.3Will participants receive any reimbursement for expenses or inconvenience incurred during participation in the research?

Yes No

If Yes, please give details

9.4Departments and services involved in research*

* Note: A signed Declaration from the Head of Department must be attached with a completed SSA before Authorisation (see Declarations).

Please list the departments/locations involved in the research at this site

Department/location
(e.g. Pathology, Allied Health) / Name of responsible person

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Low and Negligible Risk Site Specific Application - Victoria

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10Funds Management Details

10.1Which organisation will receive and manage this funding and/or will be the Administering Organisation?

Please provide details regarding invoicingfor costs associated with research conducted at your facility.

Organisation
Details of Contact Person
Title
First Name
Surname
Position
Department
Mailing Address
Suburb /City
State
Postcode
Country
ABN
Business Phone
Mobile Number
Email
Fax
External Administering Organisation Account Details

10.2If your organisation is the administering organisation provide details about the account number(s)/cost centre details into which funds are to be deposited.

Insert theaccount number(s)/cost centre details into which funds are to be deposited:

11Declarations

Declaration by the Principal Investigator(s)/Coordinating Principal Investigatorand Associate Investigator(s) at this site

Project Title (in full):
HREC Reference Number:
Principal Investigator:
Associate investigator(s):

I/we certify that:

• All information is correct and complete as possible;
• I/we have had access to and read the NHMRC “National Statement on Ethical Conduct in Human Research” (2007)
• The research will be conducted in accordance with the National Statement;
• I/we have consulted any relevant legislation and regulations, and the research will be conducted in accordance with these;
• I/we will immediately report to the HREC/Non-HREC review body anything which might warrant review of the research, including:
• Serious or unexpected adverse effects on participants;
• Complaints;
• Proposed changes in the protocol; and
• Unforseen events that might affect continued ethical acceptability of the project;
• I/we have attempted to identify all the risks related to the research that may arise in conducting this research and acknowledge my obligations and the rights of participants;
• I/we will not continue the research if ethical approval or site authorisation is withdrawn and will comply with any special conditions required by the HREC/Non-HREC review body, including;
• Conditions of approval stipulated by the HREC/Non-HREC review body;
• Cooperate with monitoring requirements. At a minimum annual progress reports and a final report will be provided to the HREC/Non-HREC review body.
• I/we have the appropriate qualifications, training, experience and facilities to conduct the research set out in the attached application and to deal with any emergencies and contingencies related to the research that may arise;
• This project complies with the Victorian guidelines for submission for Low Risk Research review.

Investigatorname / Designation / Signature / Date

Designation means designated title related to the project e.g. coordinating principal investigator, principal investigator, co investigator, student, study coordinator or other.

Declaration by delegated Department Head/s at the site where the Principal Investigator/Coordinating Principal Investigatorwill conduct the research for the purpose of resourcing the research project.

Project Title (in full):
HREC Reference Number:
Principal Investigator:
Associate Investigator(s):

I certify that I have read the project details in this SSA for the research project application named above.

I certify that I have discussed this research project and the resource implications for this Department, with the Principal Investigator/Site Coordinator.

I certify that there are suitable and adequate facilities and resources for the research project to be conducted at this site. This is for ‘Actual costs’ and ‘In kind’ contribution.

My signature indicates that I support this research project being carried out using such resources.

Department…………………..……………………………………………………………………………..

Name of Head of Department ……………………………………………………………………………..…….

Signature …………………………………………………………………………Date……………………………

*Where an investigator is also Head of Department, certification must be sought from the person to whom the Head of Department is responsible. Investigators must not approve their own research on behalf of their Department.

Declaration by Head of Supporting Department at this site

This form is to be completed by the Head of any Department that is providing support or services to the research project, but which does not have any member(s) on the research team.

Project Title (in full):
HREC Reference Number:
Principal Investigator:
Associate Investigator(s):

I have discussed this project with the Principal Investigator and have read the research project. I am: (tick whichever applies)

Able to perform the investigations/services indicated, within the present resources of the Department;

Able to perform the investigations/services indicatedif the following financial assistance is provided

Unable to undertake the investigations/services indicated, on the following grounds:

Name………………………………………………………………………………………………….……………..

Department………………………………………………Position……………………………………………….

Signature…………………………………………………Date…………………………..

12Checklist

Please complete the checklist with Yes: No: NA (Not Applicable). Include this checklist with your SSA Form.

HREC Reference Number:
Project title (in full):
Principal Investigator:
Coordinating Principal Investigator:
Person completing the form / Office use only
Has a cover letter, with brief description of the project listing enclosed documents and application signed by local Principal Investigator been attached? / Yes / No / NA / Yes / No / NA
Has a CV for each researcher been attached? / Yes / No / NA / Yes / No / NA
Has a site contact person for this project been nominated? / Yes / No / NA / Yes / No / NA
Has a copy of the HREC approval letter been attached? / Yes / No / NA / Yes / No / NA
Has a copy of the final LNR Application Form been attached? / Yes / No / NA / Yes / No / NA
Has a copy of the protocol been attached? / Yes / No / NA / Yes / No / NA
Are all Participant Information, Consent and Revocation Forms attached showing the name of the Institution as the letterhead, and contact details of the Principal Investigator? The version number and date, assigned HREC numbers and page numbers e.g. Page 1 of 10 should be in the footer? / Yes / No / NA / Yes / No / NA
Have the local site Participant Information and Consent Form(s) been attached? / Yes / No / NA / Yes / No / NA
Has a copy of the site specific advertisement been attached? / Yes / No / NA / Yes / No / NA
Has a copy of any other document, which will be given to research participants been attached? E.g. identification card, patient diary etc. / Yes / No / NA / Yes / No / NA
Is a research study agreement, which has been reviewed and approved been attached? / Yes / No / NA / Yes / No / NA
Have you completed all the financial details? / Yes / No / NA / Yes / No / NA
Has the Resource and Budget Information section, including relevant signatures, been completed? / Yes / No / NA / Yes / No / NA
Is the “Declaration by Coordinating Investigator” signed? / Yes / No / NA / Yes / No / NA
Is the “Database of Research Activity” section(if applicable) completed? / Yes / No / NA / Yes / No / NA
Is the “Declaration by Principal Investigator and Associate Investigator/s” section completed? / Yes / No / NA / Yes / No / NA
Is the “Declaration by Head/s of Department” section completed? / Yes / No / NA / Yes / No / NA
Is the “Declaration by Head/s of Supporting Department” section signed for each supporting department (if applicable)? / Yes / No / NA / Yes / No / NA
Are all pages (including attachments) numbered and dated in the footer? / Yes / No / NA / Yes / No / NA

Forward the completed SSA and all relevant supporting documentation to the site Research Governance Office/r

13Recommendations

Project Title (in full):
HREC Reference Number:
Principal Investigator:
Associate Investigator(s):

13.1Research Governance Officer

The Site Specific Assessment (SSA) form for the above research project has been completed (with all attachments).

SSA Authorisation is: / ๐
๐
๐ / Recommended
Not recommended
Requires Chief Executive / delegate consideration

If not recommended or requires Chief Executive/delegate consideration, give reasons:

Delegated Research Governance Officer:

Signature: / Date: / //

13.2Authorisation by CEO or delegate

Project Title (in full):
HREC Reference Number:
Principal Investigator:
Associate Investigator(s):
This research is: / ๐
๐ / Authorised
Not authorised

Specify conditions applying to authorisation (if any) or reasons for not authorising:

My signature indicates that I authorise/do not authorise this research project to commence at this site on the condition that all the scientific and ethical aspects of the Human Research Ethics Committee approved protocol are met.

Name of CEO or delegate:
Signature: / Date: / //
Name of the site for the research to be conducted:

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Low and Negligible Risk Site Specific Application - Victoria

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14Attachments

Core attachments
Recruitment/invitation / Yes No N/A
Protocol / Yes No N/A
Participant Information / Yes No N/A
Consent Form / Yes No N/A
Peer review / Yes No N/A
PHA / Yes No N/A
Letters of support / Yes No N/A
Study materials / Yes No N/A
HREC approvals / Yes No N/A
Indemnity form / Yes No N/A
Insurance form / Yes No N/A
Research contract / Yes No N/A
Curriculum Vitae of the investigators / Yes No
Attachments that may be required / appropriate
Personalised to the site:

• Copies of advertisement, letter of invitation etc.

/ Yes No N/A
Copy of the study protocol / Yes No N/A
Personalised to the site:

• Copy or script for participant information re consent
  
• Copy or script for parent, legal guardian or person responsible information re consent

/ Yes No N/A
Copy of peer review report or grant submission outcome / Yes No N/A
Copies of letters from relevant persons in support of the research application. / Yes No N/A
Copies of questionnaires, data collection tools, patient cards, case report forms etc. / Yes No N/A
Copy of the review of an HREC or Low & Negligible Risk review body / Yes No N/A
Indemnity for the HREC and institution where the research is being conducted (if applicable) / Yes No N/A
Legal document outlining who is responsible for aspects of the research protocol / Yes No N/A
Evidence of qualifications of the investigators/study team / Yes No N/A

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Low and Negligible Risk Site Specific Application - Victoria

Version Date: December 2010