Minimal Risk Review Form

advertisement
FORM 2
HUMAN RESEARCH ETHICS COMMITTEE
Minimal Risk Review Checklist
Please complete the checklist below to ascertain whether your research project would be eligible to be
submitted to your School’s Ethics in Human Research Committee (SEHRC) for ethical review as a minimal
risk research. Student researchers must review the completed checklist with their supervisors. If you
answer “YES” to any items in the checklist your project would normally not be eligible for submission to
the appropriate School Ethics Committee for review (unless you can make a special case – refer section 6)
and you should complete an ethics application form NEAF and email it to ethics@csu.edu.au for review by
the Human Research Ethics Committee.
Please note MINIMAL RISK research can be defined as where the foreseeable risk to participants is
no more than one of discomfort. For example:
 questionnaires and/or surveys, anonymous or otherwise, online etc. involving non-sensitive
topics
 observations, with or without consent
For more information, refer to the National Statement on ethical conduct in human research 2007
Chapter 2.1: Risk and Benefit.
Timing constraints are not an acceptable reason for seeking expedited review through this process where projects are of
more than everyday risk.
PROJECT TITLE
CHIEF INVESTIGATOR
Name (Title/ given
name / family name)
Qualifications
Student No(if
applicable)
SUPERVISOR
Name (Title/given name
/ family name)
Qualifications
School/Research Centre/
External Organisation (of
Chief Investigator or
supervisor)
Level of Study
(eg Undergraduate
practicum/clinical research project,
Honours research project,
postgraduate Masters or PhD)
Course
Subject Title and Code
Brief outline of the project (2 lines)
MRRC Version 6
1
Last updated -November 2012
Next review November 2013
FORM 2
1.
EXTERNAL REQUIREMENTS
Is the research being funded by an agency outside the University, which requires
Human Research Ethics Committee approval involving community
representation? [If you have answered “YES” to this question you must forward the
CSU ethics application form to the Human Research Ethics Committee]
Is the project hosted/auspiced by an organisation other than CSU If you have
answered “No” proceed to point 2. Risk Assessment
Is the project seen as being ‘owned’ primarily by the Organisation or CSU If the
organisation provide
Name of host organisation
YES
NO
YES
NO
research involving children and young people
YES
NO
research about parenting
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 taking
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
anger management
YES
NO
impulse control
YES
NO
self esteem
YES
NO
Brief outline of the project (2 lines)
Approval process followed including committees/position of person(s) approving the proposal
Agreement about Intellectual Property of researcher and organisation
2.
RISK ASSESSMENT
A. Are any of the following topics to be covered in part or in whole?
MRRC Version 6
2
Last updated -November 2012
Next review November 2013
FORM 2
domestic violence
YES
NO
elderly neglect
YES
NO
divorce
YES
NO
adults abused as children
YES
NO
participant(s) being asked to provide information on another person
YES
NO
any similar topic of possible concern
YES
NO
use of researcher devised questionnaire researching a sensitive topic (eg.. depression)
YES
NO
use of personal data obtained from organisations (including Commonwealth or State
Government Department/Agency)
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 via 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
any psychological interventions or treatments
YES
NO
administration of physical stimulation
YES
NO
invasive physical procedures
YES
NO
infliction of pain
YES
NO
administration of drugs
YES
NO
administration of other substances
YES
NO
administration of ionising radiation
YES
NO
tissue sampling or blood taking
YES
NO
collecting body fluid
YES
NO
genetic testing/DNA extraction
YES
NO
use of medical records where participants can be identified or linked
YES
NO
drug trials and other clinical trials
YES
NO
administration of drugs or placebos
YES
NO
potentially humiliating tasks
YES
NO
any other similar procedures
YES
NO
B. Are any of the following procedures to be employed?
MRRC Version 6
3
Last updated -November 2012
Next review November 2013
FORM 2
C. Other Risks
Are there any risks to the researcher, (e.g. research undertaken in unsafe, isolated
environments or trouble spots)?
YES
NO
suffering a psychological disorder
YES
NO
suffering a physical vulnerability
YES
NO
people highly dependent on medical care
YES
NO
minors without parental or guardian consent
YES
NO
people whose ability to give consent is impaired
YES
NO
residents of a custodial institution
YES
NO
unable to give free informed consent because of difficulties in understanding information
statement (eg language difficulties)
YES
NO
members of a socially identifiable group with special cultural or religious needs or
political vulnerabilities
YES
NO
those in dependent relationship with the researchers (eg lecturer/student,
doctor/patient, teacher/pupil, professional/client)
YES
NO
those in a social/personal relationship (eg friendship) with the researcher/s
participants able to be identified in any final report when specific consent for this has not
been given
YES
YES
NO
NO
Indigenous Australians
YES
NO
small sample size which may lead to participant identification in final report
YES
NO
any similar vulnerability concerns
YES
NO
interviews being conducted in participant’s home
YES
NO
interviews being conducted in an isolated area
YES
NO
any other similar concerns
YES
NO
research being undertaken in a politically unstable area
YES
NO
research involving sensitive cultural issues
YES
NO
research in countries where criticism of government and institutions might put
participants and/or researchers at risk
YES
NO
3.
PARTICIPANT VULNERABILITY ASSESSMENT
Does the research specifically target participants from any of the following groups?
4.
RESEARCH LOCATION ASSESSMENT
Location of interviews:
5.
RESEARCH IN OVERSEAS SETTINGS ASSESSMENT
Does the research involve any of the following:
MRRC Version 6
4
Last updated -November 2012
Next review November 2013
FORM 2
6.
SPECIAL CASE ASSESSMENT
If you have answered “YES” to an item in the checklist but you still believe that because of the particular
nature of the project and the participants your project may still be eligible for expedited review. Please
provide details below, or attach an additional sheet. You must then submit these reasons with the checklist
to the Chair of your School’s Ethics in Human Research Committee (SEHRC) for consideration and
approval of your special case.
SPECIAL CASE DETAILS:
RESEARCHER SIGNATURE:
……………………………………………………………………………………………………
SUPERVISOR’S SIGNATURE (if applicable)
APPROVAL BY SEHRC OF SPECIAL CASE
The SEHRC has met and considered the special case details associated with this project and agree / do
not agree that the project can be submitted to the School Ethics in Human Research Committee for review.
Other comments:
SEHRC CHAIR SIGNATURE:
……………………………………………………………………………………………………
If you have answered “NO” to all items, attach this checklist to your completed NEAF and submit to your
School’s Ethics in Human Research Committee (SEHRC). Please note the SEHRC may forward your
application onto the HREC for review if they deem your research not to be minimal risk.
If you have answered “YES” to one item or more and are NOT requesting a special case email your
completed NEAF to ethics@csu.edu for review by the full Human Research Ethics Committee.
MRRC Version 6
5
Last updated -November 2012
Next review November 2013
Download