Low-Risk-Application-Form-RetrospecticAnalysisofPatientData

Important Information and Instructions for ApplicantsThis application form is to be used by researchers seeking a Low Risk review for a research project which involves analysing data col

Important Information and Instructions for Applicants

This application form is to be used by researchers seeking a Low Risk review for a research project which involves analysing data collected from patient records, where data is de-identified

• To find out if your research project is eligible for a Low Risk Review, you should complete a Low Risk Review Checklist and refer to Section 2 of the National Statement regarding risk and benefit

• Read the UNDA human research policy and procedures found at Human Research Ethics - Policies and Procedures All UNDA researchers are expected to read and adhere to these documents

• Familiarise yourself with the National Statement on Ethical Conduct in Human Research (2007, updated

May 2015 ) (NS) This document provides the primary guidelines for this application and for ethics review Hyperlinks to relevant chapters are included throughout this application

• Download a new form from ethics application forms to ensure that you are using the most current version

of this form

• Handwritten applications will not be accepted

• Type an X in checkboxes that apply

• Provide descriptive responses to questions beginning with How, Describe, Outline, Explain, Why and Provide details

• Keep in mind that most HREC members are not researchers and will not be familiar with your research,

so please use plain language and ensure that all technical terms, jargon and acronyms are clearly defined

• Provide all necessary attachments where indicated

• Your completed application must be submitted to your School Research Committee (SRC) for review The SRC Chair will then forward your application to the Research Office for HREC sub-committee review Applications without SRC approval will not be considered

• Data collection must not commence until written approval has been provided by the HREC sub-committee

• Please note: The HREC sub-committee may decide the application does not qualify for as “Low Risk” and will therefore require a Full Review application or may find the study requires substantial changes prior to the commencement of the study

• The HREC will not grant retrospective ethics approval i.e data collection has commenced

Application for Low Risk Ethical Review of a Research Project involving a Retrospective Analysis of Patient Data.

HREC Reference Number (Research Office use only)

1.1 Project Title:

1.2 Project Type: (Type ‘X’ to options that apply)

  Other      

1.3 Expected commencement date:      

Estimated project completion date:      

1.4 School / Institute:      

1.5 Research Team Details

a) Chief Investigator / Supervisor: (must be UNDA staff member with responsibility for the UNDA arm of the project)

Mailing Address      

Indicate what this

researcher will do in

the context of this

project.

Supervise data collection Collect the data Other (outline below)

Describe the

relevant experience

this researcher has

specific to this

project

b) Co-Investigator / Student:

Mailing Address      

Indicate what this

researcher will do in

the context of this

project.

Supervise data collection Collect the data Other

Describe the

relevant experience

this researcher has

specific to this

project

c) Co-Investigator / Student:

Mailing Address      

Indicate what this

researcher will do in

the context of this

project.

Supervise data collection Collect the data Other

Describe the

relevant experience

this researcher has

specific to this

project

d) Co-Investigator / Student:

Mailing Address      

Indicate what this

researcher will do in

the context of this

project.

Supervise data collection Collect the data Other

Describe the

relevant experience

this researcher has

specific to this

project

(Copy and paste boxes for additional researchers)

1.7 Research Project Location

a) Where is the location of the data that researchers are seeking to collect?

b) Is permission required to gain access to the data?

  YES   NO If YES, specify from whom and attach a copy of the approval letter.

c) Describe how the data will be collected.

1.8 Other HREC Approvals

[Refer to NS 5.2.8]

a) Does this project have approval by another HREC/s? Does this project have approval by another HREC/s and/or will this project be submitted to another HREC/s for review?

  YES   NO If YES, provide the name of the HREC/s, and indicate the status of the application ateach (i.e submitted, approved, deferred or not approved) Indicate which committee you

consider to be the primary HREC for this project and why.

Attach copies of approval letters and any relevant correspondence.

1.9 Monitoring of Research Conduct

[Refer to NS Chapter 5.5 regarding researchers’ responsibilities for monitoring of research projects.]

How will the Chief Investigator/Supervisor monitor the conduct of the research team to ensure that the research project complies with the protocol set out in this application, the University policy Code

of Conduct for Research and the National Statement?

2 Project Details

2.1 Keywords

Provide a list and definitions for any project specific technical terms and acronyms which may assist the HREC to understand this application.

Term

Lay Explanation

2.2 Target Participant Group

Adults (over the age of 18 years)  

Children and Young people (anyone under the age of 18 years) (NS 4.2)1  

People with a cognitive impairment, an intellectual disability or mental illness (NS 4.5)  

People who may be involved in illegal activities or residents of custodial institutions (NS 4.6)  

Aboriginal and/or Torres Strait Islander people and/or communities (NS 4.7)2  

People identifiable by their membership of a cultural, ethnic or minority group  

2.3 Aims of and Justification for the Research Project

[Refer to NS Section 1 , 5.2.5, 5.2.6 ]

•State clearly the Aims/Research Questions/Hypothesis of the research project.

•Explain clearly the importance/significance of the research project

•Provide a brief description of relevant background, current research/literature review.

2.4 Research Project Design

[Refer to NS Section 3.2 on Ethical considerations specific to databanks.]

a) Clearly specify the information that will be collected about each individual and used for this project.

b) How many individual datasets are anticipated to be collected, and on what basis is this number considered sufficient to address study aims?

Justification of sample size for quantitative studies is usually based on a power calculation (Consult a statistician

if unsure or use an online sample size calculator e.g http://powerandsamplesize.com/ )

c) Outline how the data will be analysed to achieve the aims of the project

3 Waiver of Consent

[Refer to NS Chapter 2.3 on qualifying of waiving conditions of consent.]

3.1 Why do the benefits of the research justify any risks of harm associated with not seeking consent? NS 2.3.10b

3.2 Why is it impractical to obtain consent? NS 2.3.10c

3.3 Is there any reason for thinking that participants would not consent if they were asked? Why

do you believe this is so? NS 2.3.10d

3.4 How will the participant’s privacy be protected? NS 2.3.10e

3.5 Explain how confidentiality of participants and their data will be protected in the dissemination

of research results NS 2.3.10f

3.6 Will the results of the research have significance for the participants’ welfare?

  YES   NO If Yes, how will the information arising from the research be made available to the

participants? NS 2.3.10g

4 Data Management and Dissemination of Research Outcomes

[Refer to Chapter 2 of the Australian Code for the Responsible Conduct of Research and University policy ‘ Code of conduct for research’ ]

4.1 How and where will the data, collected specifically for this research project, be stored during the research project?

4.3 How will the research project outcomes be disseminated at the end of the project?

(E.g thesis, journal article, book, web page, conference paper, the media etc.)

5 Declaration by the Research Team

• The information provided in this application is truthful and to the best of my/our knowledge, accurate

• The research project will be conducted in accordance with this application, National Statement on Ethical Conduct in Human Research, The University of Notre Dame Australia’s policies and the Australian Code for the Responsible Conduct of Research.

Name of Researcher Signature of Researcher Date

Please check that the following documents are attached to your application

Permission letter to access data / Site-Specific approval letter (Section 1.7b)  

7 Declaration by School Research Committee (SRC)

Applications not approved by the SRC will not be considered

The SRC has reviewed this project and considers the methodological/technical and ethical aspects of the proposal to be appropriate to the tasks proposed

 YES   NO

The SRC considers that the researcher has the necessary qualifications, experience and facilities to conduct the research set out in the attached application, and will be able to deal with any emergencies and contingencies that may arise

 YES   NO

SRC Comments/Provisos:

Name of SRC Chair      

Signature      

Note: If the SRC Chair is also a named researcher on this project, the declaration must be signed by another authorised member of the SRC

The SRC must forward the original application, including relevant attachments to the Research Ethics Officer for review by a HREC sub-committee