Research Ethics Application for Conducting Research

RESEARCH ETHICS APPLICATION FOR CONDUCTING RESEARCH

FORM 1: 2017

Office use only

PLEASE STUDY THE FOLLOWING BEFORE COMPLETING THE APPLICATION

INFORMATION FOR APPLICANTS

1. This template is the official application form that must be used by applicants to apply for research ethics clearance for research.
2. This application form (FORM 1) provides for the following types of application

(a)Academic Research (Degree purpose only)

(b)Complimentary Medicines Research

(c)Clinical Data Audits and Survey

(d)Genetic Sub-Study

(e)Human genetic research

(f)Medicinal Clinical Trial Application

(g)Medical Device Clinical Trial Application

(h)Post Marketing survey and Research

(i)Non-Interventional Research/ Observational research

(j)Re-Approval of studies (Annually)

(k)Registry

1. The DMTS HREC does not undertake retrospectivereview. If data collection has already started or is in progress, the research ethics review committee (RERC) will not consider the application.
2. Late submissions to the DMTS HREC will stand over to the nextreview meeting.
3. The DMTS HREC will evaluate the ethical soundness of the application.
4. On submission, a research ethics clearance number will be allocated to the research project. This number should be used in all communications of the project with the DMTS HREC (pre- and post approval).
5. Decisions reached by the DMTS HREC could be one of the following:

(a)Approved or approved with provisions

(b)Referred back – requires modification or clarification

(c)Disapproved with reasons.

1. Expedited review is possible for proposals which meet the criteria for negligible or low risk research projects. The chairperson may assist with the expedited review or nominate sub-committee to review the application based on the anticipated risk of the study.
2. Decisions will be communicated within 5 days after the committee meeting.
3. If the application is referred back,theapplicant is required to respond to ethics committee within one week of receipt of formal feedback. All modifications should be clearly highlighted (using track changes) in the revised protocol and supporting documents. If no feedback is received within 3 months, the application will be removed from the DMTS HRECreview process and the applicant will be required to reapply.
4. The DMTS HREC will issue an ethics clearance certificate once all the process of ethical scrutiny is satisfactorily met. The Process flow is accessible on DMTS HREC website on the

TABLE OF CONTENTS

SECTION 1: RESEARCHER DETAILS

SECTION 2: PROPOSAL SUMMARY SHEET

SECTION 3: DETAILS OF PROPOSED RESEARCH

SECTION 4: METHODOLOGY

SECTION 8: DECLARATION

PRIVACY INFORMATION:

The information you provide on this form is collected for the primary purpose of assessing your research ethics application. This information will also be entered onto a database to assist with administration, correspondence, and statistical analyses. These records are accessed by duly authorised staff of DMTS HREC. Records will be made available to authorised third parties should the need arise. All records are kept in a manner that will ensure confidentiality and secured and stored for 15 years after the expiry of the term of approval.

SECTION 1: RESEARCHER DETAILS

1.1Details of main researcher / Principal Investigator

*Attach a copy of CV (in a prescribed format)

1.2Details of main co-investigators / Supervisor (for academic research) (list all)

*Attach a copy of CV (in a prescribed format)

1.3Is this protocol for degree purposes? (tick )

1.4Type of application

(tick )in box [if other, provide details in the space allowed for comments]

SECTION 2: PROPOSAL SUMMARY SHEET

2.1Title of the research project

2.2Research Purpose and Objectives/Anticipated outcomes

2.3Did the proposal undergone the scientific peer review committee? If so, provide evidence (tick )

SECTION 3: DETAILS OF PROPOSED RESEARCH

3.1Does your project involve organisations or institutions that require permission for research activities? (tick )

3.2Is your project funded or sponsored by any organisation?(tick )

3.4If rejected or not accepted, please provide reasons for such

SECTION 4: METHODOLOGY

4.1Research Design/Approach

Describe the research design you intend to use, e.g. descriptive, case study, randomised, etc. If your research will proceed in different phases, describe each phase sequentially.

4.2Details of participants of the proposed research project (*Add additional rows if more than one sampling group is used)

4.2.1Describe the participants (in groups) involved in your research project, including the site population, sampling method and sample size.

4.2.2 Please specify the inclusion and exclusion criteria for participant group.

4.2.3 Describe the proposed duration of the study (start to end date)

4.3 Will the research be conducted in minors, If so please justify

4.4 Will your research involve collection of human tissue samples?(tick )

*Submit related Material Transfer Agreement

SECTION 8: DECLARATION

I, ...... (full name of main researcher), declare that I shall carry out the study in strict accordance with thenational and international best practices in ethical principles. I shall conduct the study in strict accordance to the protocol. I will communicate any protocol deviations or violations accordingly in writing.

I further undertake to inform the research ethics review committee in writing of any adverse events that occur arising from the injury or harm experienced by the participants in the study.

I shall maintain the confidentiality of all data collected from or about the research participants, and impose strict controls in the maintenance of privacy.

I shall record all data captured during interviews in accordance with ethical guidelines outlined in my proposal.

I will not collect any data retrospectively or without the approval of the ethics committee.

As Principal Investigator of this research I am aware of a potential conflict of interest which may affect the ethical conduct and scientific integrity of the study.

......

(Signature of applicant) (Date)

......

(Principal investigator) (Date)

Approved by supervisor (if applicable)

I ...... (name of supervisor) declare that I have checked that this form is complete and I subsequently approve the submission of the proposal for ethical clearance. If applicable, I will ensure that the student reports unanticipated problems or serious adverse events to the HERC.

......

(Supervisor Signature) (Date)

1

DMTS HREC 29 April 2017