LOW/NEGLIGIBLE RISK HUMAN RESEARCH ETHICS APPLICATION
Human Research Ethics Committee
Please submit in hard copy a signed original: Research Office, Room 128, Faculty Science & Engineering Building (DB17) , James Cook University, Townsville, Qld, 4811. Please also email a pdf of this application (application form and all attachments in one pdf document) to .
HUMAN ETHICS NUMBER(Office Use ONLY) / H
Before starting your application, please read the National Health and Medical Research Council, National Statement on Ethical Conduct in Human Research, 2007
Please answer each question of the checklist to determine the “risk” to participants in your research project. Your answers to the questions listed will determine whether your application can be reviewed as a low/negligible risk application.
If you answer “YES” to any of the questions, it may indicate that your research is not low/negligible risk.
A “YES” answer does not immediately exclude your application from review. Any “YES” answers will be considered by the Executive Review Committee and you will be advised if your application has been accepted as a low/negligible risk application or if it has been determined that it must be referred to the next meeting of the HREC for a full review.
Low risk research is defined as research in which the only foreseeable risk is one of discomfort. Discomforts include, for example, minor side-effects of medication, the discomfort of measuring blood pressure or the anxiety induced by an interview.
Negligible risk research is defined as research in which there is no foreseeable risk of harm or discomfort; and any foreseeable risk is no more than inconvenience. Examples of inconvenience may include filling in a form, participating in a street survey, or giving up time to participate in research.
Are any of the following topics covered in part or in whole in your project?Research about parenting issues / YES / NO
Research investigating sensitive personal issues / YES / NO
Research investigating sensitive cultural issues / YES / NO
Explorations of grief, death or serious/traumatic loss / YES / NO
Depression, mood states, anxiety / YES / NO
Gambling / YES / NO
Eating disorders / YES / NO
Illicit drug use / YES / NO
Substance abuse / YES / NO
Self report of criminal behaviour / YES / NO
Any psychological disorder / YES / NO
Suicide / YES / NO
Gender identity / YES / NO
Sexuality / YES / NO
Race or ethnic identity / YES / NO
Any disease or health problem / YES / NO
Fertility / YES / NO
Termination of pregnancy / YES / NO
Are any of the following procedures to be used in your project?
Use of personal data obtained from Commonwealth or State Government Department/Agency / YES / NO
Use of personal data obtained from State Government Department/Agency / YES / NO
Use of personal information from a non-government organisation / YES / NO
Deception of participants / YES / NO
Concealing the purposes of the research / YES / NO
Covert observation / YES / NO
Audio or visual recording without consent / YES / NO
Recruitment of a third party or agency / YES / NO
Withholding from one group specific treatments or methods of learning, from which they may “benefit” (e.g. in medicine or teaching) / YES / NO
Psychological interventions or treatments / YES / NO
Administration of physical stimulation / YES / NO
Invasive physical procedures / YES / NO
Invasive physical procedures / YES / NO
Infliction of pain / YES / NO
Administration of drugs / YES / NO
Administration of other substances / YES / NO
Exposure to ionising radiation / YES / NO
Tissue sampling or blood taking / YES / NO
Collecting body fluid / YES / NO
Use of medical records where participants can be identified or linked / YES / NO
Genetic testing/DNA Extraction / YES / NO
Drug trials or other clinical trials / YES / NO
Other Risks?
Are there any potential risks to the researcher? (e.g. research conducted in unsafe environments or trouble spots)? / YES / NO
Are there any potential risks to non participants in the research, such as, participant’s family members and social community? e.g. effects of biography on family and friends or infectious disease risk to the community) / YES / NO
Does your project specifically target participants from any of the following groups?
Suffers from a psychological disorder / YES / NO
Suffering a physical vulnerability / YES / NO
People highly dependent on medical care / YES / NO
Children and/or young people without parental or guardian consent / YES / NO
People whose ability to give consent is impaired / YES / NO
Resident of a custodial institution / YES / NO
People unable to give free informed consent because of difficulties in understanding information provided eg. Language difficulties / YES / NO
Members of a socially and/or culturally identifiable group with special social/cultural/ethnic or religious beliefs or political vulnerabilities / YES / NO
Aboriginal and Torres Strait Islander Peoples / YES / NO
Those in a dependent relationship with the researchers eg. Lecturer/student, doctor/patient, teacher/pupil & professional/client / YES / NO
Participants are identifiable in the final report when specific consent for release has not been given / YES / NO
Does your project involve researching in an overseas country?
Where research is being undertaken in a politically unstable area / YES / NO
Where research involves sensitive cultural/social/political/ethnic/economic or religious issues / YES / NO
Where criticism of the government and institutions may be a risk to participants and/or researchers / YES / NO
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LOW/NEGLIGIBLE RISK HUMAN RESEARCH ETHICS APPLICATION
Human Research Ethics Committee
1 / TITLE OF PROJECT2 / CATEGORY OF RESEARCH / You MUST evaluate the potential discomfort or inconvenience to the participants of your project from the examples below.
Please indicate (X) the risk category
1 / Negligible risk: Research in which there is no foreseeable risk of harm or discomfort and any foreseeable risk is no more than inconvenience, e.g. completing surveys, questionnaires.
2 / Low risk: Research in which the only foreseeable risk is one of discomfort, e.g. insignificant psychological distress or physical discomfort, no deception, standard psychological testing.
3 / Research with the potential to cause mild psychological distress or physical stress. Minor deviation from frank disclosure of the true nature of the research may be involved.
4 / Research with the potential to cause genuine but not severe psychological distress or physical pain with no long term effects. Deception may be involved regarding the true nature of the research.
5 / Research with the potential to cause psychological distress or physical pain. Substantial deception may be involved.
6 / Research involving vulnerable participants; at risk populations; or research that may pose serious ethical considerations.
3 / PERIOD DURING WHICH ACTIVITIES REQUIRING ETHICS APPROVAL WILL OCCUR
COMMENCEMENT DATE / FINISH DATE
4 / PRINCIPAL INVESTIGATOR’S DETAILS
Last Name / ESN[1] / Orgu / Discipline/School or Institution (Country)
First Name and Title
Email / Phone / Fax
REASON FOR RESEARCH / No / Yes / If Yes, which degree (i.e. PhD, MSc)
Does this research contribute towards a formal qualification?
Qualifications
4a / DETAILS of CO-INVESTIGATOR 1 (if applicable)
Last Name, First name and Title / ESN 1 / Orgu / Discipline/School or Institution (Country)
Email / Phone / Fax
REASON FOR RESEARCH / No / Yes / If Yes, which degree (i.e. PhD, MSc)
Does this research contribute towards a formal qualification?
Qualifications
4b / DETAILS of CO-INVESTIGATOR 2 (if applicable)
Last Name, First name and Title / ESN 1 / Orgu / Discipline/School or Institution (Country)
Email / Phone / Fax
REASON FOR RESEARCH / No / Yes / If Yes, which degree (i.e. PhD, MSc)
Does this research contribute towards a formal qualification?
Qualifications
If there are more than two co-investigators involved in this PROJECT, please copy the previous page and attach the details of these co-investigators at the end of this application (Part 1).
5 / SUPERVISOR DETAILS (if applicable)Last Name, First name and Title / ESN 1 / Orgu / Discipline/School or Institution (Country)
Email / Phone / Fax
Qualifications
5a / DETAILS of SUPERVISOR 2 (if applicable)
Last Name, First name and Title / ESN 1 / Orgu / Discipline/School or Institution (Country)
Email / Phone / Fax
Qualifications
If there are more than two supervisors involved in this PROJECT, please copy this page and attach the details of these supervisors at the end of this application (Part 1).
6 / FUNDING SOURCE (MUST be completed) Please explain the source of funding for your project. This includes internal/School sources and any student support funding.Project Title
Funding Body
Fund Scheme / Value / $
7 / Has this project been submitted to any other ethics committee? If YES, please attach a copy of the approval notice. / No / Yes / If Yes, which Ethics Committee?
8 / Is this project a clinical trial? / No / Yes / If YES – Do NOT proceed with this form – please contact the Human Ethics & Grants Administrator for advice.
9 / PRIVACY INFORMATION
Does this project involve gaining access to medical information from a COMMONWEALTH AGENCY? / No / Yes / If YES, which Commonwealth Agency?
If YES, does the project require the disclosure of personal information from the Commonwealth Agency, i.e. identifiable information? / No / Yes / If NO, what type of information will you be accessing?
If you answered YES to either question above - Will you obtain informed consent from the individuals to whom the information is related? / No / Yes / If NO, please explain why not?
Does this project involve the collection, use or disclosure of health information from a PRIVATE SECTOR organisation? / No / Yes / If YES, which Private Sector Organisation?
Is the data from the private sector organisation going to be used for research which is related to: / No / Yes
· research relevant to public health or safety
· the compilation or analysis of statistics relevant to public health or safety
· management, funding or monitoring of a health service
Will you obtain informed consent from the individuals to whom the health information is related?
If, NO, please explain why not? Impracticable? De-identified data?
10 / BACKGROUND AND SIGNIFICANCE OF THE PROJECT
Please supply below a brief description of your project in LAY language. Please explain the purpose of the project and the broad context of the project, i.e. Why should this project be done? Why is it needed? Please explain the potential benefits to the participants and to the general community. (You must provide references for your project outline.)
NO MORE THAN HALF A PAGE IN LENGTH
11 / AIMS OF THE PROJECT: Please clearly state the aims of this project and the expected research outcomes? NO MORE THAN HALF A PAGE
12 / ROLE AND EXPERTISE OF INVESTIGATORS IN THIS PROJECT (All sections MUST be completed for each investigator and supervisor on the project.)
1) Please include details of the role of the Principal Investigator, Co-Investigators, Supervisors, students and other collaborators involved in the project. Please also explain the involvement of any reference or community groups in the project.
2) Please provide details of the expertise of the Principal Investigator, Co-Investigators, Supervisors, students and other collaborators in the research methods proposed in this project.
13 / PARTICIPANT DETAILS
13.1 / How many participants are expected to be involved in the project? / M / # / F / # / Total / # / Under 18 Years / #
Of these participants are any students of JCU? / M / # / F / # / Total / # / Under 18 Years / #
13.2 / Are any of the participants involved in the project expected to be members of an Aboriginal & Torres Strait Islander community? / M / # / F / # / Total / # / Under 18 Years / #
If YES, to Q.13.2 – IF YES, PLEASE SEEK ADVICE . Projects targeting Aboriginal and Torres Strait Islander Peoples cannot be reviewed as a Low/Negligible Risk Application. Please also see Aboriginal and Torres Strait Islander Ethics Application for further information.
13.3 / Does this project involve patients (whether in hospital or in the community) of a health service district? IF YES you may need to follow the External HREC Approval procedures. See link above for further information. / No / Yes / If YES, please provide details of the health service district ethics committee that granted the ethics approval
13.4 / Does this project involve children? / No / Yes / Have you obtained a “suitability card” from the Qld Commission for Children & Young People? What is its number and expiry date? Attach a copy.
14 / PLEASE DESCRIBE THE TARGET GROUPS INVOLVED IN YOUR PROJECT e.g. farmers in a particular region, Grade 12 female music students, JCU first year students in a certain subject, etc. PLEASE ALSO DETAIL ANY EXCLUSION CRITERIA FOR PARTICIPANTS
(If more than 3 groups, please insert another row.)
Groups:
1
2
3
PLEASE LIST THE SITES WHERE THE PROJECT WILL BE CONDUCTED OR SITES WHERE PARTICIPANTS WILL BE RECRUITED
If your project involves any organisations, please list the names of the organisations below:
Name of Organisation / Letter Approval/Support
ATTACHED / No / Yes
If letters of support are still to be obtained, please confirm below:
I confirm that when I receive letters of support for my project these will be immediately forwarded to the Research Office. / No / Yes
15 / Please provide a DETAILED METHODOLOGY for the project: Please explain clearly and concisely how the project will be carried out, including: justification of specific methods used, completion time of each protocol, e.g. expected duration of interview, completion time of a questionnaire, etc; how the data will be analysed; role of each investigator and timeline if applicable. NO MORE THAN 1 PAGE
Please indicate the data collection techniques to be used in the project: