GRIFFITH UNIVERSITY
COURSE PROTOCOL
STUDENT PROJECT TO BE COVERED A HUMAN RESEARCH COURSE PROTOCOL

Course Title

		

		
		
School & Faculty

		

Course Convenor

Title

		
		
Family Name		

		
Given Names		

		
Qualifications		

		
		
Address for correspondence, contact details during business hours and email address		

		

Student Investigator/s (please list all members of the research team)

Title

		
		
Family Name		

		
Given Names		

		
Qualifications		

		
		
Address for correspondence, contact details during business hours and email address		

		

All members of the team to be covered by the Griffith University Human Research Protocol should be listed
Please copy and repeat the above as needed

	
Proposed Commencement and completion dates for the course proposal 
(Format DD  MMM  YYYY)		From:		To:		

	

	
Office Use Only
COURSE CONVENOR DETERMINATION

University Ethics Database Protocol Number

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Duration of Ethical Clearance

The proposal is approved through to the following date:

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Authorisation

Course Convenor:

Signature:	

	

	

1	Additional approval requirements

	1a	Has this proposal been reviewed by any other Human Research Ethics Committee?			Y / N		

		
	If you have answered YES, please include a copy of the approval from that committee.	

	1b	Does this project involve work within the scope of the Gene Technology Regulation Act?			Y / N		

		
	If you have answered YES, has FINAL approval been given by the University's Institutional Biosafety Committee?  Please attach notification of the approval from that committee.	

	1c	Does this project involve work with any of the infective micro-organisms listed in the Australian / New Zealand Standard 2243.3:1995.  Safety in Laboratories – Microbiology Section 4 Degree of Hazard from Micro-organisms?			Y / N		

		
	If you have answered YES, please attach notification of approval from the University's Institutional Biosafety Committee.	

	1d	Does this project involve work with any human pathogen; human blood, body fluids or tissues,	etc?			Y / N		

		
	If you answered YES, please provide details of the materials and/or procedures, which require approval and attach University Risk Assessment documentation (http://www.gu.edu.au/ua/hrm/health/frameset1sub9.html) where appropriate.	

2	Research categories:

	Please tick the research categories relevant to the student projects to be covered by this course proposal or set the shading for the relevant block at 25%.  At least one category should be marked for each grouping.  For "Other", please specify.	
		
	A. Participants	
		
		Healthy members of the community			Clinical clients (e.g., patients)	
		
		University students			Aboriginal or Torres Strait Islander people	
		
		Employees or officers of a specific company or organisation			Member of a socially disadvantaged group	
		
		Members of a specific community group, club or association			Person in a dependent or unequal relationship (e.g., student/supervisor or doctor/patient relationships, incarcerated persons)	
		
		Clients of a service provider			Person with an intellectual or mental impairment	
		
		Health Service clients (e.g., users or clients of a health service)			Person dependent on medical care	
		
		School children			Cadavers or cadaveric organs, human tissue or samples	
		
		Hospital in-patients			
Other:	
		
	B. Participant Age Range	
		
		Children (under 14)			Young People (aged 14 – 17)	
		
		Adults (aged 18 or over)			University students (aged 17)	
		
	C. Research procedures 	
		
		Anonymous questionnaires or surveys			Collection of body tissues or fluid samples	
		
		Coded (potentially identifiable) questionnaires or surveys			Procedures involving physical experiments (e.g., exercise, reaction to computer images)	
		
		Identifiable questionnaires or surveys			Procedures involving administration of substances (e.g., drugs, alcohol, food)	
		
		Examination of normal educational practice or education instructional strategies, instructional techniques, curricula, or classroom management methods, journal, existing	 data, documents  etc			Physical examination of participants (including e.g., blood pressure and heart and temperature monitoring)	
		
		Examination of medical, educational, personnel or other confidential records			Surgical procedures	
		
		Observation (overt)			Aggregated quantitative analysis	
		
		Observation (covert)			Aggregated qualitative analysis	
		
		Interviews (structured or unstructured)			Individual/case qualitative analysis 	
		
		Telephone interviews			
Other:	

	D. Research areas		E. Ethically sensitive designs	
		Social Science research			Comparison or evaluation of clinical procedures	
		
		Humanities research			Comparison or evaluation of counselling or training methods	
		
		Educational research			Clinical trial (CTN / CTX)	
		
		Psychological research			Comparison of evaluation of drugs or surgical or other therapeutic devices	
		
		Health research			Investigation of effects of an agent (drug or other substance)	
		
		Biomedical research			Investigation of bio-mechanical processes	
		
		Epidemiology			None in Section E	

Other:			
Other:	

		
3	Description of Project: Please describe the objectives of the individual student project in terms easily understood by the lay reader, using simple and non-technical language. (Please do not exceed 100-150 words)	

		

		
4	Aims of the project: List the aims and potential significance of the problems to be addressed by the individual student research project. (Please do not exceed 100-150 words)	

		

		
5	Describe the potential participants of the study: Please provide details of the participants of the study, including – from what target group(s) will they be drawn, how many participants will be involved, their age range, and whether they share any common characteristics, for eg: intensive care unit nurses, health volunteers, university students).	

		
		
	5a	Rationale for the selection of this participant pool: Referring to the categories of participants to be involved in this research project identified in Q2A and Q2B above, why have participants from this/these group(s) been chosen?	

		
		
	5b	Identification, first contact and recruitment of the participant pool: How will participants be recruited?  Please state how persons will be identified as potential participants; how they will be approached initially; how they will be informed about the research project; and the means by which they will be screened.  If some form of advertisement or flyer is to be used, please attach the wording.	

		
		
	MINORS	
		
	5c	If the participant pool will include persons aged under 18, please indicate the ages and/or age range of participants.	

		
		
	5d	If the participant pool will include persons aged under 18, please indicate how students will seek the informed consent of the parent / guardian of the minors.	

		
		
	5e	If the participant pool will include persons aged under 18, please indicate how students will seek the assent / consent of the minors.	

		
		
	MENTALLY / INTELLECTUALLY IMPAIRED	
		
	5f	Will the participant pool include persons who have impaired capacity?  If yes, please indicate the nature of the impairment (eg age, brain injury, unconsciousness, mental illness, intellectual disability) and whether this is likely to be intermittent or enduring, and how recruitment will be conducted.	

		
		
	LANGUAGE ISSUES	
		
	5g	Will the research be conducted in a language other than one that is likely to be familiar to the potential participants, and / or is the literacy level of the potential participant pool likely to be an issue?  If yes, how will these issues be addressed?	

		
		
	DEPENDENT RELATIONSHIP	
		
	5h	Are the potential participants in a dependent relationship that is likely to impact upon the voluntary nature of their participation and / or raise additional ethical issues?  If yes, how will this be addressed?	

		
		
	INCENTIVES	
		
	5g	Will any reimbursement or inducement be offered to participants?  If so, please provide details.	

		
		
	EXISTING RELATIONSHIP	
		
	5h	Are the researcher(s) likely to have any existing relationship with the potential participants?  If so, please provide details.	

		

		
6	Location at which the project is to be conducted: Please state the location at which the study involving human participants will be conducted (eg: Griffith University Psychology Clinic, Royal Brisbane Hospital).	

		

7	Benefits / risks

	7a	What are the anticipated benefits of the research, both in terms of the contribution to your learning and research development and the other potential benefits?	

		
		
	7b	To whom will the benefits flow?	

		
		
	7c	Potential Risks.  Please indicate if you consider there are any potential risks associated with the proposed procedures, whether to participants or to researchers.  Please tick the appropriate risk categories or set the shading for the relevant block at 25%, and elaborate in 7d.	
		
		Physical risks			Psychological risks	
		
		Social risks			Any other risks	
		
		Legal risks			There are no risks	
		
	7d	What are the risks associated with the research?	

		
		
	7e	To whom do the risks apply?	

		
		
	7f	What, if any, strategies will be used to negate these risks?	

		
		
	7g	What, if any, strategies will be used to minimise these risks?	

		
		
	7h	What, if any, strategies will be used to manage these risks if they occur?	

		
		
	7i	Why do the benefits of the research outweigh the risks?	

		

8	Informed consent

	8a	How will informed consent (or, where appropriate, assent) be obtained from participants? (tick, then briefly describe)	
		
	Standard procedure:		Non-standard procedures:	
		
		Active (opt in), in writing			Active (opt in), verbally	
		Active (opt in), return of questionnaire			Passive (opt out), in writing	

		
	8b	Will additional consent also be obtained from other parties?  If so describe why this is to be done and outline the process to obtain this consent.	

		
		
	8c	Will substituted consent be obtained on behalf of a participant with impaired capacity?  If so, please note, national guidelines require that consent is obtained from the participant’s guardian, attorney (under an enduring power of attorney for personal matters) or statutory health attorney (spouse, carer, relation or close friend aged over 18 years).	

		
		
	8d	If appropriate, what strategies will be used to scaffold and / or confirm this consent? (Note: scaffold means additional strategies to assist participants to understand what will happen; confirm means to check that consent has been truly and accurately informed)	

		

9	Privacy

	9a	Will the research involve access to identified personal information (eg contact lists) held by another agency / body subject to the Commonwealth Privacy Act 1988 or Queensland Information Standard 42?			Y / N		

		
	If you have answered YES, please outline the measures to obtain prior consent from the identified individuals, or the procedures to address the regulatory privacy considerations.  If an exemption under s95 / s95A of the Privacy Act is to be sought please contact the Secretary of the HREC for details of the information that must be provided with your application.	

		

10	Confidentiality

	10a	Collection of information: Please indicate in what form personal information will be collected.  Please tick the appropriate categories or set the shading for the relevant block at 25%.	
		
		Identified information			Re-identifiable / coded information	
		
		De-identified information			No personal information will be collected	
		
	10b	Storage of information: Please indicate in what form personal information will be stored.  Please tick the appropriate categories.	
		
		Identified information			Re--dentifiable / coded information	
		
		De-identified information			No personal information will be stored	
		
	10c	Publication / reporting of information: Please indicate in what form personal information will be published or reported.  Please tick the appropriate categories.	
		
		Identified information			Re--dentifiable / coded information	
		
		De-identified information			No personal information will be published	
		
	10d	Describe the procedures that will be adopted to ensure confidentiality during the collection of the data, in the storage of the data, and in the publication of results.	

		
		
	10e	If participants are to be identifiable, or potentially identifiable in any publication or report*, outline the procedures for participants to authorise the release of their responses / information and to confirm the accuracy of attributed comments.
(* Note that pseudonyms may not ensure anonymity in case descriptions)	

		
		
	10f	Will a recording (whether audio, audio-visual or other) of participants be made?  If so, for what purpose will this recording be used?	

		
		
	10g	If a recording is to be made, will this be retained and used beyond the initial transcription / analysis or will it be erased following transcription?  If it is to be retained, how will confidentiality be ensured?  How will specific consent for any subsequent use be obtained?	

		
		
	10h	Will the research involve the collection of information about the conduct of an undisclosed crime, or an imminent crime OR information that may expose others to criminal, civil or other proceedings OR information that the researcher(s) may be required to disclosure to third parties?  If so, how will this situation be handled and what information about these possibilities (and cautions) will be provided to potential participants?	

		

11	Debriefing: Will participants be debriefed at the completion of the research?  If so, please outline (also include details of agencies to whom participants may be referred if they have been distressed by the procedures).	

		

		
12	Feedback: In what form will feedback / summary of results be made available to participants?	

		

13	Other Ethical Issues

	13a	Will any treatment known to be beneficial be withheld from one group of participants, that is, will a control or comparison group be used?			Y / N		

		
	If you have answered YES, please justify the use of a control group and explain how that group will be assisted if the intervention proves to be beneficial.	

		

	13b	Does the research require the approval of another agency (e.g., the agreement of the principal of a participating school, or the approval of an organization or government department)?			Y / N		

		
	If you have answered YES, please indicate the status of this approval or an assurance that prior approval will be obtained.	

		

	13c	Does the researcher have a conflict of interest, or perceived conflict of interest (e.g., a commercial body is funding the research and there is a likely gain to that body if certain results are found)?			Y / N		

		
	If you have answered YES, please indicate how this conflict of interest, or perceived conflict of interest will be disclosed to potential participants.	

		

	13d	Does the research involve the intentional recruitment of Indigenous persons, or the likely coincidental recruitment of Indigenous persons as the majority of the participant pool, or issues of significance to the Indigenous community?			Y / N		

		
	If you have answered YES, please indicate how you have appropriately consulted with the relevant Indigenous community, how the results of the research will be made available to that community, and how the research is beneficial to that community (or at least not contrary to the interests of the community).	

		

	13e	Does the research involve the intentional recruitment of members of a collectivity, or the likely coincidental recruitment of members of a collectivity as the majority of the participant pool, or issues of significance to a collectivity?			Y / N		

		
	If you have answered YES, please indicate how you have appropriately consulted with the relevant collectivity, how the results of the research will be made available to that collectivity, and how the research is beneficial to that collectivity (or at least not contrary to the interests of the collectivity).	

		

	13f	Are there any other ethical issues associated with the research that you wish to bring to the attention of the Course Convenor?			Y / N		

		
	Please provide the detail of the additional ethical issues, including matters relating to the ethical principles of respect for persons, beneficence, justice, research merit, and research safety.	

		

17	Applicant declarations

Project Title

		

		

We the undersigned confirm that all members of the research have read the current NHMRC National Statement on the Ethical Conduct of Research Involving Humans and the GU Research Ethics Manual.  We accept responsibility for the ethical and appropriate conduct of the procedures detailed in this Checklist, confirm that we will conduct this project in accordance with the principles contained in the Statement, the GU Research Ethics Manual, and confirm that the research team will comply with any other condition laid down by the Griffith University Human Research Ethics Committee.

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	Signed								

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	Signed								

ADD ADDITIONAL BOXES AS REQUIRED FOR ADDITIONAL MEMBERS OF THE RESEARCH TEAM

Privacy Statement on Office for Research Forms

The Office for Research (Griffith University) will on occasion collect, store and use personal information only for the purposes of conducting the business of those committees administered and supported by the Office of Research, administering grant applications, administering the human research ethics and animal ethics arrangements, and keeping research teams and other interested parties informed. The information collected is confidential and will not be disclosed to third parties without your consent, except to meet government, legal or other regulatory authority requirements, including the requirements of granting bodies you nominate.  This particular form will be stored by your Course Convenor and made available to the Office for Research on request.  For further information consult the University’s Privacy Plan at https://www.griffith.edu.au/about-griffith/corporate-governance/plans-publications/griffith-university-privacy-plan or telephone (07) 3735 4375.