Ethics Approval Form - School of Psychology

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19 Feb 2016
UNSW Human Research Ethics Advisory Panel C: Psychology
Application Form – 2016
HREAP File No:
Sona No:
HREC No:
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
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For a NEW project, submit one (1) signed copy of pp.1-7 plus attachments to the General Office.
You may advertise your study and recruit participants only when you have received an email from the Deputy ViceChancellor (Research) approving your project.
Additional forms can be downloaded from: http://www.psy.unsw.edu.au/research/research-resources
Project Title:
Click here to enter text.
Location of Study [e.g., Building and room number]: Click here to enter text.
Declaration of Investigators:
I/we apply for approval to conduct the research. If approval is granted, it will be undertaken in accordance with the protocol described
in this application and other relevant guidelines, regulations and laws.
I/we have read and understood the UNSW and School’s Workplace Health and Safety policies and procedures that apply to this
project, and undertake all appropriate training in Workplace Health and Safety as dictated by UNSW and School policy.
Students see: http://www.psy.unsw.edu.au/current-students/health-safety-students
Staff and others see: http://www.ohs.unsw.edu.au/ohs_training/index.html
Chief Investigator/Supervisor: [Must have academic appointment. cross out inapplicable]: Click here to
enter text.
Title/Position: _______________________________________
Email Contact: [UNSW address required] Click here to enter text.
_______________________________
Date: ______________
Investigators (including students)
Name
UNSW email address
Signature
____________________________
_____________________
_______________________
____________________________
_____________________
_______________________
____________________________
_____________________
_______________________
____________________________
_____________________
_______________________
HREAP Use Only: Stipulations and Amendments
Click here to enter text.
ETHICS APPROVAL: As of_____________, the Human Research Ethics Advisory Panel C (Behavioral)
has recommended to the DVC (Research) that this project, being of minimal ethical impact, should
proceed. When granted, this is valid for five years from this date.
______________________________________ Co-Convenors, HREA Panel C, E J Kehoe/K Martire
______________________________________ Reviewing Member Panel C, ____________________
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______________________________________ Head of School, Simon Killcross
SONA Registration and Request for Allocation of Psychology 1 Participants
[1: If you have NEVER PREVIOUSLY RECRUITED PARTICIPANTS FROM PSYCHOLOGY 1, you must first register
for the SONA sign-up system by sending your name and student/staff identification number to either Linda
Camilleri: [email protected] or Dr. Lisa Williams: [email protected]
You must receive an acknowledgement of this registration before submitting an application for both an
allocation of Psychology 1 students and ethics clearance. Your application may be delayed if you fail to
register for SONA before submitting the application.
This registration need only occur once during your entire time in the School of Psychology – it is not
required for every project]
Tick this box to indicate that you ARE REGISTERED on the SONA system
[2: For PREVIOUSLY APPROVED PROJECTS (i.e., you have an HREAP-C File Number), you may request
additional Psychology 1 participants by completing the “Additional Participants Form” available at
http://www.psy.unsw.edu.au/research/research-resources]
The privilege of using Psychology 1 students carries with it the following responsibilities:
1. You must promptly allocate credits to participants on SONA within 5 working days of a session, and
no later than the Monday following Week 13.
2. You must debrief participants with additional pedagogical information regarding your study in the
following manner:
a. See Item 6d in the following application for details regarding the required content of the
debriefing.
b. For face-to-face studies you must prepare answers to items listed under Item 6d and found
on p.13 of this form. When conducting face-to-face debriefings, provide a printed handout
to each participant, ask for questions, and then ask the participant to sign a debriefing log
indicating that they received a satisfactory debriefing (see p.14 for a template register).
c. For online studies you must prepare answers to items listed under Item 6d and found on
p.13 of this form. When conducting online debriefings, provide an electronic version of the
answers to the questions, provide a point of contact for any questions, and ask participants
to tick a box indicating that they have received the debriefing content.
d. Debriefing registers/responses should be retained by the researcher or academic supervisor,
along with the signed consent forms.
3. All research participation, including all parts of multipart studies and debriefings, with students from
PSYC1001, PSYC1011, GENS9001, and GENS9002 must be completed by 12 midnight on the Friday
of Week 13.
4. For every 10 sessions posted to SONA, 1 session must be offered after 5pm.
[Continue to NEXT PAGE for requesting and allocating Psychology 1 student participants]
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Request for allocation of Psychology 1 Participants (cont.)
Tick this box if either/both Part 1 or Part 2 of your study will be run online ☐
Duration [in 15 min increments – minimum of 30 minutes; If
MORE than 1 hour provide your justification in the box below]
PART 1
PART 2
Duration here
Duration here
PART 1
PART 2
Credit here
Credit here
Click here to enter text.
Requested Credit Per Participant [in 0.25 increments –
minimum: 0.5 point; For multipart studies provide total credit
across all parts]
Requested Number of Participants [In total]: Click here to enter text.
Total Requested Hours [= Credit Per Participant X Number of Participants]: Click here to enter text.
If Total Requested Hours is MORE than 100 HOURS provide justification below
Click here to enter text.
Preparation Instructions [Describe below; Optional; Indicate tasks participants will need to do or not do
prior to arriving at the study]:
Click here to enter text.
Eligibility Criteria [Describe below; Optional; Note this is NOT based on pre-screening]
Click here to enter text.
Tick this box if your study has Pre-Screening Criteria.
Brief Description of Study [Describe below; Required; Indicating the overall purposes and what the
participants will be asked to do; STRICTLY no more than 245 characters (including spaces and
punctuation) If your study is a two- part study you must include this fact in the 245 characters. Student
participants will view this information before signing up for the study. Your application will be returned
to you and may encounter a two-week delay if your description exceeds the 245-character limit]
Click here to enter text. 245 Character MAXIMUM
Character Count [including spaces and punctuation]: Click here to enter text.
☐Tick this box to DECLARE that your description contains 245 CHARACTERS or fewer.
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THE UNIVERSITY OF NEW SOUTH WALES
Human Research Ethics Advisory Panel (HREAP) C – APPLICATION FORM
IMPORTANT: please follow [instructions], answer ALL questions, and
attach documentation where required
1. Investigator’s School/Unit/Centre: Click here to enter text.
Investigators
Chief
Investigator/
Supervisor
Investigator
Title
Family Name
First Name
Phone/Mobile
Status *
Investigator
Investigator
Investigator
*Status = Academic Staff, Post-doc, PhD student, MPsych student, Honours student, Research Assistant
2. Project Title:
Click here to enter text.
[In answering the following questions, please be guided by both the instructions accompanying each
question and the 2007 National Statement on Ethical Conduct in Human Research: html version; pdf
version]
3.
Project Description: [Please provide a description of the project (300 word max) in the text box
below. This description should briefly summarise the aims and general hypotheses. However, for reaching
a judgment about the ethics of the project, this description should focus on what will happen to the
participants (i.e., a summary of the procedure). Think about what the participant will be exposed to. Please
attach a copy of questionnaires and/or example of other stimulus materials, where feasible].
Click here to enter text. 300 word MAXIMUM
4.
Potential for Harm to Participants and/or Investigators
a. Is there a plausible risk of harm, either physical, psychological, social,
cultural or financial? [See National Statement: 1 Principles; Describe
any plausible risk(s) of harm and your precaution. Risks regarding
DECEPTION should be addressed under Item 9]
b. Are there plausible risks of harm to researchers?
c. Have you read the guidelines for managing distressed participants?
4a. ☐YES
☐NO
4b. ☐YES
☐NO
4c. ☐YES
☐NO
[See p.10 of this form; Each year, there are a tiny number of participants who become distressed. It can
occur for reasons unrelated to the study. For example there has been a participant who fainted, possible
due to overheating. The guidelines should be used with discretion and within the researchers’
competence. If additional assistance is needed, it should be sought promptly. Students should definitely
contact their supervisor]
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5.
Recruitment of Participants: [See National Statement: Sections 4, 5, 6, 7, 8 and 9.
a. Is there any possibility of coercion of participants to enroll in the
5a. ☐YES ☐NO
study?
b. Are participants in a dependent relationship with the Investigator
(e.g., teacher-student)?
5b. ☐YES
☐NO
c. Will participants be offered an inducement to encourage their
5c. ☐YES ☐NO
involvement?
[If you answered YES to any of these questions (5a-c) please describe fully how participants are to be
recruited and how other issues are to be resolved below. Please attach any recruitment advertisements
and posters. The credit offered to Psychology 1 students is considered an inducement.]
Click to answer here if YES to 5a, b or c
d. Will you be using Psychology 1 participants?
5d. ☐YES
☐NO
[If you answered YES provide responses to the debriefing questions listed below in the text box. You should
provide participants with a debriefing handout based on the Template on p.13 of this form. This handout
should be discussed with participants during a 5-10 minute mandatory debriefing at the end of each
session.
(1)
(2)
(3)
(4)
(5)
(6)
What kind of study is it, e.g., descriptive, correlational?
What are the independent variables? How are you operationalizing them?
What are the dependent variables that were measured? How are you operationalizing them?
What is one potential confounding variable and how have you attempted to control for it?
What is one potential ethical issue, and how has the experimenter attempted to resolve it?
How did the experimenter get from first year psychology to conducting this research? e.g., include a few ‘high
points’ to give the student some idea of the career path to research].
Click to answer debriefing questions here
e. Will you be using participants who are NOT Psychology 1 students?
5d. ☐YES
☐NO
[If you answered YES provide a description of how those participants will be recruited for your project.
Among other things, please indicate the places where you will recruit, rate of any reimbursement, your
recruiting advertisements, any personal approaches, and special characteristics of the target population.
Recruiting advertisements should be attached]
Click to answer here if YES to 5e
6.
Informed Consent and Debriefing: [See National Statement: Sections 1, 6, 14, 15 and 16]
a. Will you seek written informed consent from participants?
6a. ☐YES ☐NO
[If you answered NO, please justify why not. If you answered YES attach Participant Information Sheet(s)
and Consent Form(s) prepared in close accordance with the HREC proforma.]
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Click to answer here if NO for 6a
b. Will you be providing a debriefing?
6b. ☐YES
☐NO
[If you answered NO, please justify why not below. If you answered YES please describe the debriefing
below. Note: Debriefing is MANDATORY whenever Psychology 1 students (see Item 6d) and/or deception
(see Item 10) are used.]
Click to answer here for 6b
7.
Privacy, Confidentiality, Anonymity: [See National Statement: Section 17]
a. Is there a requirement for the researchers to identify, collect, use, or 7a. ☐YES
disclose information of a personal nature (either identifiable or
potentially identifiable) about individuals without their consent?
☐NO
[This question primarily concerns situations covered by the Privacy Act, in which you are collecting
information from databases kept by third parties such as government departments or human resource
departments in a business. If you do wish to obtain data about identifiable individuals from such data bases,
please complete the HREA Panel Privacy Form.]
b.
Is there a possibility of participants being inappropriately identified 7b. ☐YES
or confidential data being divulged during or after the research has
taken place?
☐NO
[If you answered YES please describe the measures you will take below to ensure privacy, confidentiality and
anonymity are preserved. One favoured measure is to irretrievably strip the names and other identifying
information from the data records.]
Click to answer here if YES for 7b
c.
Please confirm that data will be stored for a minimum of 7 years in a 7c. ☐YES
secure location.
☐NO
8. Observation and Records:
a. Is it necessary in your research to make recorded observations of 8a. ☐YES ☐NO
participants? [e.g., audiotapes, videotapes]
b. Is it necessary to use records or database information?
8b. ☐YES ☐NO
[If you answered YES to either question, please explain below why and how this will be done].
Click to answer here if YES for 8a or b
9. Deception/Debriefing:
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a.
Is it necessary in your research to deceive participants?
9a. ☐YES
☐NO
[See National Statement: Section 17. If you answered YES, please explain why and how this will be done.
“Deception” refers to misleading the participants about what will be happening to them by commission or
omission. However, “deception” does NOT include instances in which you do not tell the participants your
hypotheses to avoid demand characteristics].
Click to answer here if YES for 9a
10.
Funding and Conflicts of Interest:
a.
b.
Is the research being funded by an agency outside the University of 10a. ☐YES ☐NO
New South Wales?
Is there any conflict of interest (including financial gain) likely to 10b. ☐YES ☐NO
result from this project?
[If you answered YES to either of these questions, please provide details below and attach documentation.
Note: Externally-funded projects that are of minimal ethical impact can be approved by the HREAP].
Click to answer here if YES for 10a or 10b
11.
Organisations other than the University of New South Wales:
a. Are there organisations other than UNSW or another collaborating 11a. ☐YES
university involved in this research?
☐NO
[If you answered YES, please provide details below. Please attach a letter of support for the research from
the organization. Provisional approval can be given pending receipt of a letter of support.]
Click to answer here if YES for 11a
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[Important: Use letterhead paper for page 1]
Approval No (when available)
THE UNIVERSITY OF NEW SOUTH WALES (AND OTHER PARTICIPATING ORGANISATION[S] )
PARTICIPANT INFORMATION STATEMENT
(Title of project)
Participant Selection and Purpose of Study
You are invited to participate in a study of (state what is being studied). We hope to learn (state what the study is designed to
discover or establish). You were selected as a possible participant in this study because (state why the participant was selected).
Description of Study and Risks
If you decide to participate, we (or other designated research person[s]) will (describe in simple language the procedures to be
followed, including the use of placebos, their purpose(s), how long the procedures will take, and their frequency).
(Describe the discomforts and inconveniences reasonably to be expected.
included.)
An estimate of the total time required should be
(Describe the possible risks reasonably to be expected; if none are expected state:) No risks are reasonably expected as a result of
your participation in this study
We cannot and do not guarantee or promise that you will receive any benefits from this study. (if there are reasonable benefits to
be expected by the participant add:) However (then describe any benefits reasonably to be expected).
(Describe appropriate alternative procedures that might be advantageous to the participant, if any. Any standard treatment that
is being withheld must be disclosed.)
Confidentiality and Disclosure of Information
Any information that is obtained in connection with this study and that can be identified with you will remain confidential and will
be disclosed only with your permission or except as required by law. If you give us your permission by signing this document,
we plan to discuss/publish the results (state the persons or agencies to whom the information will be furnished, the nature of the
information to be furnished, and the purpose of the disclosure). In any publication, information will be provided in such a way
that you cannot be identified.
Recompense to participants
(If the participant will receive remuneration, describe the amount or nature. If there is a possibility of additional costs to the
participant because of participation, describe it.)
Your consent
Your decision whether or not to participate will not prejudice your future relations with The University of New South Wales (and
the participating organisation[s]). If you decide to participate, you are free to withdraw your consent and to discontinue
participation at any time without prejudice.
Inquiries
If you have any questions or concerns following your participation, (Title, name phone number) will be happy to address them.
(Student investigators, in addition to your name and phone number, please include the name and phone number of your
supervisor). Complaints may be directed to UNSW’s Research Ethics & Compliance Support, phone 9385-4235/ 9385-4958,
email. [email protected]
Please keep this information sheet and one copy of the Participant Consent Form. The investigator will keep the other signed
copy. Both copies should be signed by you and the investigator.
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THE UNIVERSITY OF NEW SOUTH WALES (AND THE OTHER PARTICIPATING ORGANISATION[S] )
Approval No (when available)
PARTICIPANT CONSENT FORM
(Title of project)
You are making a decision whether or not to participate. Your signature indicates that, having read the information
provided on the participant information sheet, you have decided to participate.
……………………………………………………
Signature of Research Participant
.…………………………………………………….
Signature of Parent or Guardian (when relevant)
……………………………………………………
(Please PRINT name)
.…………………………………………………….
(Please PRINT name)
……………………………………………………
Date
……………………………………………………
Signature(s) of Investigator(s)
.…………………………………………………….
Please PRINT Name
REVOCATION OF CONSENT
(Title of project)
I hereby WITHDRAW my consent to participate in the research proposal described above and direct that any data collected from
me be destroyed.
I understand that such withdrawal WILL NOT jeopardise any treatment or my relationship with The University of New South
Wales, (other participating organisation[s] or other professional[s]).
……………………………………………………
Signature
.…………………………………………………….
Date
……………………………………………………
Please PRINT Name
The section for Revocation of Consent should be forwarded to (INSERT name and address of Chief Investigator).
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Managing Distressed Participants
In the event that any participant becomes distressed during or following an experimental session, the
following steps should be considered and taken as appropriate:
-
The experiment should be terminated immediately. The experimenter should discuss the
participant’s reactions with them, normalize their distress, and debrief them about the experiment,
as appropriate. The experimenter should assess the participant’s state and ensure that they have
settled before they leave the session. As an additional measure of caution, the supervisor must be
notified at this point, first, by voice communication, and, failing that, by a text-based
communication. It may be appropriate for the supervisor to speak with the participant before they
leave the testing session.
-
Both the experimenter and the supervisor should obtain the participant’s contact details, so that the
participant can be contacted the following day (or a few days later, as appropriate – and as agreed
with the participant). The supervisor should also arrange a time with the participant to meet with
them over the course of the following week in order to conduct a follow-up. The participant should
also be provided with the contact details of both the experimenter and the supervisor, and
encouraged to contact them in the event that they have any ongoing difficulties or are still
experiencing distress prior to the arranged follow-up session.
-
At the follow-up session, the supervisor should review the participant’s mood and assess any
ongoing reactions following the experiment (e.g., intrusive images of a distressing film-clip). As
appropriate, the supervisor should make every effort to normalize these reactions, but should also
thoroughly assess their severity. The appropriate course of action will depend on the participant’s
presentation, whether they are still experiencing any difficulties, and their level of distress. Options
that could be considered vary from no further contact, additional follow-up by phone, an additional
meeting/s in person, through to the supervisor making a referral to a relevant clinical service. If no
further contact with the participant is considered necessary, the supervisor should ensure that the
participant has their contact details, and be reminded that they can contact them in the future in the
event of any ongoing or later difficulties.
-
Finally, both the researcher and supervisor should notify the ethics committee that approved the
application in a timely manner and provide a detailed account of the incident, along with the course
of action that has been taken to provide follow-up of the participant. Both the supervisor and
researcher should take detailed notes about the event, and should provide this to the ethics
committee.
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Procedure for Application - Do Not Include These Pages With Your Application
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
(1)
Ethics clearance is required for all studies and teaching exercises in which human
participants are recruited from any source, including family and friends.
Ethics clearance can be obtained at either a university level or school level as follows:
University Level: Applying for university-level approval from the University’s Human
Research Ethics Committee (HREC). This level of approval is required if any of the
following are involved.
 Penetration of the participants’ skin or body orifices by any substance or device
 Exposure to painful or intense levels of auditory, visual, or other stimuli
 Long periods of any form of stress, including work, sleep deprivation, confinement, or
sensory deprivation
 Any risk of physical or mental harm.
 Significant deception
(Externally-funded projects that are minimal ethical impact can be approved by the
HREAP, subject to ratification by the HREC)
If you need HREC approval, go to the Research Office web site:
http://www.ro.unsw.edu.au/ethics/human/
and proceed with their application process. If in doubt, talk to the Conveners of the School’s
ethics panel (Jessica Grisham, Jim Kehoe).
When you have obtained HREC approval, submit the School Research Registration form
(page 1) and attach a copy of your HREC approval letter.
(2)
School Level: If you do NOT need university-level approval, then apply for School-level
approval by filling in the attached application form and consent letter, which together are
shown on pp. 1-9 of this document.
On the basis of previous experience in the School, here are some hopefully helpful hints
regarding key questions on the application form.
Q3. Description of Project (300 words absolute maximum).
The process of ethical approval requires a light assessment of the scientific merit of the
study. However, the justification of the scientific merit does not need to be as detailed as
the justification used for granting bodies or journal reviewers. Hence, please confine this
section to no more than a single page that describes the main aims and methods to be used
in your study. If you can cite peer-reviewed precedents, they serve as ready indicators of
your project’s scientific merit. Please keep to the word limits.
Q4. “Potential Harm” Risk Assessment
Because studies with a plausible likelihood of appreciable harm to the participants’ physical
and mental wellbeing require application to HREC, this School-level assessment will
ordinarily be brief and deal with issues such as confidentiality, potential embarrassment
arising from certain kinds of questions, potential annoyance arising from mild deception, or
minor, non harmful physical discomfort.
Where there is an unlikely but plausible risk of distress being experienced by a participant
from the type of questions being asked of them, then include in your application the name
and contact number of a clinical psychologist. Make sure the clinician has expressly agreed
to such a referral in advance. DO NOT simply refer the participant to the UNSW Student
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Counseling Service. You must have permission from the clinical psychologist. (See also
the guidelines for managing distressed participants on p. 10 of this form.)
Q6a. Informed Consent
See pp. 8-9 for templates of participant information sheet and consent form: Where the
consent of a parent or guardian is needed, the following website has alternative templates:
http://www.ro.unsw.edu.au/ethics/human/information_consent.shtml. For surveys, answer
“NO” and insert in explanation, e.g., “anonymous survey returned at participant’s
discretion.”
Q. 6b. Debriefing (Point form):
Debriefing is standard in psychological studies. Please indicate how you will debrief the
participants, including how you will tell the participants the aim of your study, tell them
how their data contribute to that aim, and give the participants a genuine opportunity to ask
questions and voice any concerns or difficulties they may have experienced.
For studies that use Psychology 1 students, the debriefing information must also
address the educational value of participating in the study and the six questions (see
Item 5d).
Processing Sequence
1.
Investigator downloads and completes these forms available at web address:
http://www.psy.unsw.edu.au/research/research-resources
2.
Investigator submits one signed copy of the application and attachments to staff at the
General Office.
3.
Forms are put into Ethics Convenors’ pigeonhole in the general office (Kristy Martire, Jim
Kehoe).
4.
Ethics Convenor assigns file numbers and clarifies any information with investigator and/or
supervisor (for undergrads/Hons students, the convenors will usually contact the
supervisor).
5.
Convenor signs off and passes forms and correspondence to another HREAP member for
further consideration. If needed, meeting with applicant/supervisor to resolve any concerns.
6.
Head of School signs off and passes forms to Linda Camilleri
([email protected], Room 1013)
7.
Linda does the following:
a. Linda sends an email recommending approval to the Deputy Vice Chancellor
(Research). The researchers will be cc’d into this email, but it is only a notice of the
recommendation not an approval.
b. The DVC (Research) will reply usually quickly with an approval. With that
message in hand, the researchers may begin to recruit participants.
c. If there is a Psychology 1 allocation, adds the study to the Sona system..
d. Returns one copy of page 1 to supervisor’s pigeon hole.
e. Files original application
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Sona # when received
Additional Study Information
Title:
(a) What kind of study is it, e.g., descriptive, correlational, experimental?
(b) What are the independent variables? How are you operationalising them?
(c) What are the dependent variables that were measured? How are you operationalising them?
(d) What is one potential confounding variable and how have you attempted to control for it?
(e) What is one potential ethical issue, and how has the experimenter attempted to resolve it?
(f) Briefly, how did the experimenter get from first year psychology to conducting this research?
-------------------------------------------------------------------------------------------------------------------------
Sona # when received
Additional Study Information
Title:
(a) What kind of study is it, e.g., descriptive, correlational, experimental?
(b) What are the independent variables? How are you operationalising them?
(c) What are the dependent variables that were measured? How are you operationalising them?
(d) What is one potential confounding variable and how have you attempted to control for it?
(e) What is one potential ethical issue, and how has the experimenter attempted to resolve it?
(f) Briefly, how did the experimenter get from first year psychology to conducting this research?
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SONA STUDY NUMBER ______
By signing, I indicate that I have received a verbal debriefing an information handout regarding this study.
Date
Signature
STUDENT ID
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