Application for
ethical approval
of a research project involving humans |
APPLICANT INSTRUCTIONS
·
This form must be
submitted to the IRC if you wish to undertake research activities involving
human participants for which participant recruitment and/or data collection is
to be conducted within any section of phect-NEPAL.
·
Please use the
information provided in italics throughout this document as instructions of how
to complete the relevant section, and delete these instructions before
submitting the document (retain the bold subheadings). Follow the instructions
carefully to ensure you include all necessary information as incomplete
forms will not be accepted.
·
See section 7 for
submission requirements and attach all relevant documents.
PRIVACY INFORMATION:
The information you provide on this form is collected for the primary purpose
of assessing your application. This information may also be entered on to a
database to assist with administration, correspondence and statistical
analyses. These records are only accessed by members of the IRC and affiliated
staff at phect-NEPAL and are kept in a manner to ensure confidentiality. Although
this information is not usually disclosed to other individuals, there may be
some circumstances which require the information to be disclosed. If you choose
not to complete all questions on this form it may not be possible for the IRC
to assess your application. For privacy related concerns please contact the IRC;
email: irc@phectnepal.org , ph: +977-1-422-2364.
PROJECT TITLE
Principal researcher OR responsible supervisor: (one individual only)
Note: This individual is responsible for effective oversight of the
project in order to maintain proper ethical conduct and therefore must be
appropriately qualified and experienced in carrying out the research process
(ie. in the case of a student project, the research supervisor or guide should
be listed here and details of the student undertaking the research should be
listed in the section below).
·
Contact details: (including both phone and email)
·
Experience and qualifications relevant to the project: (attach curriculum
vitae of maximum two pages, including passport-size photo)
Student researcher: (if applicable)
·
Contact details: (including both phone and email)
·
Experience and qualifications relevant to the project: (attach curriculum
vitae of maximum two pages, including passport-size photo)
Other researcher(s) and/or supervisor(s): (if applicable)
·
Experience and qualifications relevant to the project: (please list here)
1. PROJECT DETAILS
1.1
Summary in simple language: Provide a brief summary of the project
outlining the broad aims, general background, research question(s), research
design, research participants and what they will be asked to do and the
importance of the research. This description MUST be in everyday language
and free from any jargon, technical terms or discipline-specific phrases so
that it may be understood by an individual without specialist training in the
area of research. [No more than 300 words]
1.2
Background, literature review and justification: Provide a brief background
of the study, literature review, including references, with justification as to
why this research should proceed and an explanation of any expected benefits to
the community. [No more than 500 words]
1.3
Aim(s) and objective(s): State the project aim(s) and objective(s) and,
where relevant, the specific hypothesis/hypotheses to be tested. [No more
than 100 words]
1.4
Method(s):
a)
Data collection method: Describe any data collection techniques which will be used. (If using a questionnaire
or interview, attach copies.) [No more than
100 words]
b)
Participant tasks: Outline all tasks to be completed by participants, and the estimated
time commitment involved. [No more than 100
words]
c)
Data collection period: State the proposed start and completion dates for data collection.
(Note: The IRC will advise if the submission of progress report(s) will be
required during this time period.) [No more than 50 words]
d)
Data collection personnel: List who will collect the data. (Note: If parts of the
project will be carried out by independent contractors, the responsibility for
effective oversight and proper ethical conduct of the project remains with the
principal researcher OR responsible supervisor.) [No more than 100 words]
e)
Data analysis method: Describe how data will be analysed. [No more than 100 words]
1.5
Researchers involved: Specify which of the individuals listed on page 1 will actually carry
out the research, and with which component of the methods they will be
involved. Include whether they are; phect-NEPAL staff, student(s) (provide
title of degree), personnel in conjunction with other centres (provide details
of relevant ethics committees), or other external personnel. [No more than 50 words]
1.6
Monitoring: Outline how the conduct of this project will be monitored to ensure it
complies with the protocols set out in this application, such as via regular
meetings between all involved researchers/supervisors. (Note: This is
especially relevant in cases of student research projects, or where several
people are involved in recruiting, interviewing or administering procedures, or
when research is carried out at some distance from the principal researcher OR
responsible supervisor such as in rural areas.) [No more than 200 words]
1.7
Funding: If funding will be sought, provide details of any already granted and/or
advise the IRC of the details as soon as any funding is granted. In the case of
research projects independent from phect-NEPAL, please acknowledge that all
necessary funds required for the research project to be carried out must be
provided by the researcher. [No more than 50
words]
1.8
Risks to researchers: Outline any potential risks to the researchers and the strategies which
will be in place to reduce these risks. [No more than 100 words]
2. PARTICIPANT
DETAILS
In the case of
retrospective studies, the ‘participants’ are the data sets which will be
collected.
2.1
Sample participant group: Describe the inclusion criteria which define
the sample participant group (eg. age, gender, background, profession,
location). If relevant, also describe the target group to which the results may
be applied. [No more than 50 words]
2.2
Number and source of participants: Provide the proposed number and source of
participants. Attach a signed letter of approval or no objection certificate
(NOC) from all departments where participant recruitment and/or data collection
will take place (electronic copies are preferred). [No more than 50 words]
2.3
Justification of participant numbers: Where applicable, provide a justification of sample
size (including details of statistical power of the sample, where appropriate),
explaining how this sample size will allow the aims of the study to be
achieved. [No more than 50 words]
2.4
Exclusion criteria: Describe any exclusion criteria which will be applied to the
participant group and justify why this criteria has been selected. (Note: These
are the criteria which the researcher selects and not those factors which are out
of their control, such as individuals declining to participate or failing to
attend follow up sessions.) [No more than 50
words]
2.5
Potentially vulnerable participants: Identify if any potentially vulnerable participants
are to be included in the study (eg. children, pregnant women, human foetuses,
persons with intellectual disabilities, minorities, persons highly dependent on
medical care, military personnel and inmates). Provide justification as to why
the research must include these participants and cannot be performed
with equivalent less vulnerable participants. [No more than 50 words]
2.6
Dependent relationships: Identify any participants in dependent or unequal relationships with
any of the researchers (eg. doctor/patient, teacher/student, counsellor/client,
warden/prisoner and employer/employee), particularly those individuals involved
in recruiting for or conducting the project. Such a relationship may compromise
a participant’s ability to give consent which is free from any form of
pressure. Therefore if such relationships exist, explain both the relationship
and the steps to be taken by the researchers to ensure that participation is
purely voluntary and not influenced by the relationship in any way. Explain the
special precautions which will preserve the rights of such people to decline to
participate or to withdraw from participation once the research has begun. [No more than 200 words]
2.7
Participant recruitment:
a) Method: Indicate all
method(s) of recruitment:
(i)
Mail out (Describe who will be distributing it and attach a copy)
(ii)
Email (Describe who will be distributing it and attach a copy)
(iii) Telephone
(iv) Advertisement
(Describe where it will be placed, eg. waiting room wall, newspaper,
newsletter, and attach a copy)
(v) Recruitment carried
out by the researcher(s)
(vi) Recruitment carried
out by a third party, eg. employer, teacher, doctor (Attach an approval letter
confirming the willingness of the third party to provide to potential
participants)
(vii) Contact details
obtained from public documents, eg. phone book
(viii) Contact details
obtained from private sources, eg. employee list, membership database (Attach
an approval letter confirming the willingness of the proposed source to provide
to potential participants)
(ix) Personal contacts
(x) Participants from a
previous study (Provide details)
(xi) Snowball, ie
participants suggest other potential participants
(xii) Other (Please
explain) [No more than 50 words]
b)
Participant identification: Describe how, by whom and where potential participants
are to be identified or selected for this research. [No more than 100 words]
c)
Participant invitation: Describe how, by whom and where potential participants are to be approached
or invited to take part in this research. [No more than 100 words]
2.8
Requirement from participants: Provide details about
what you will ask participants to do, or what is to be done to them, and the
time commitment that will be required from them. Include a clear step-by-step
description of what participants will experience if they choose to take part in
your project, including medications, interventions, therapies, tasks,
interviews etc. (Attach copies of any medication schedules, therapy
descriptions, intervention methodologies, instructions, tasks, tests,
questionnaires or interview guides to be used and also a flow chart if this
will clarify the procedures.)
2.9
Potential risks to participants: Define the risk of physical and/or psychological
stress, inconvenience or discomfort beyond the normal experience of everyday
life, in either the short or long term, from participation in this project.
Confirm that these risks are all outlined on the information letter in simple
language and, where relevant, on the consent form, or justify their omission.
Outline the arrangements planned to minimise the risks involved in these
procedures. [No more than 200 words]
2.10
Payments or incentives offered to participants: Describe and justify any
proposed payments, reimbursements or rewards to be offered to participants in
terms of amount, form and purpose. [No more than
50 words]
3. INFORMED
CONSENT
Before research is undertaken, the informed and
voluntary consent of participants is required. Information needs to be provided
to participants at their level of comprehension regarding the purpose,
methods, demands, risks, inconveniences, discomforts and possible outcomes of
the research. Such information should usually be provided in an information letter written in simple language,
in the appropriate language for that participant or participant group. The
participant must be provided with a copy of the letter which they may keep for
their own records, should they wish to. Each participant’s consent needs to be
clearly established and recorded, on a separate document to the information
letter (eg. by using a signed consent form, returning a completed survey or recording an
agreement for an interview).
3.1 Providing information for participants: Provide details of the method you
will use to explain the research project to participants and invite their
participation (eg. provision of information in a letter written in simple
language). Describe arrangements which will be made to ensure that participants
who have difficulty understanding certain written or spoken languages can
comprehend the information provided about the research project (eg. provision
of the information letter in their local language). [No more than 100 words]
3.2 Information letter in simple language (if applicable): Confirm
that the information letter for participants will meet the following checklist
of criteria (attach copies of the letter in all languages relevant to your
study participants, ie. in English and/or Nepali, and any other relevant
language):
(i)
Is printed on relevant letterhead (where possible) OR
includes the full contact details of the institute with which the researchers
are affiliated OR clearly states that the researcher is working independently
and includes lists relevant qualifications
(ii)
Includes clear identification of all institutes and
department(s) involved, the principal researcher OR responsible supervisor (including
phone and email contact details), all other researchers and lists the study
level if it is a student research project
(iii)
Advises that the project is for research purposes,
states the title of the project and provides details of the purpose of the
research project
(iv)
Provides details of the required participant
involvement (eg. involvement in interviews, completion of questionnaire(s), provision
of bodily fluid and/or tissue samples, audio/video taping of events) and
estimated time commitment
(v)
Provides details of any risks involved and the
procedures in place to minimise these
(vi)
Advises that the project has received ethical
approval from the IRC
(vii) If
the sample size is small, identifies that this may have implications for
protecting the identity of participants and explains the potential for
participants to be (re)identified
(viii) Includes
a clear statement that, if participants are in a dependent relationship with
any of the researchers, their involvement in the project will not affect
ongoing assessment/grades/management or treatment of health (if relevant)
(ix)
States that involvement in the project is voluntary
and that participants are free to withdraw their consent at any time and to
withdraw any unprocessed data previously supplied
(x)
Provides details as to whether or not data is to be
destroyed after a minimum period (if relevant)
(xi)
Provides advice that if participants have any concerns
about the ethical conduct of this research project they can contact the IRC;
email: irc@phectnepal.org, ph: +977-1-422-2364
3.3 Obtaining consent: Explain how participant consent will be
established (eg. by signing a consent form, by returning a completed survey or
via a recorded verbal agreement). In the case of illiterate individuals, a
consent form must be read out by the researcher in the presence of an
independent witness, then the thumb print of the participant be obtained
alongside the name and signature of the witness. In the case of participants who
are unable to give informed consent themselves (eg. minors or intellectually
disabled individuals) explain who will consent on their behalf and how such
consent will be obtained. [No more than 50 words]
3.4 Consent form (if applicable): Confirm that the consent form will meet the following
checklist of criteria (attach copies of the form in all languages relevant to
your study participants, ie. in English and/or Nepali, and any other relevant
language) and will be retained by the researcher once signed:
(i)
Is printed on relevant letterhead (where possible) OR
includes the full contact details of the institute with which the researchers
are affiliated OR clearly states that the researcher is working independently
and lists their relevant qualifications
(ii)
Includes the title of the project and names of all
involved researchers
(iii)
States the project is for research purposes
(iv)
States that involvement in the project is voluntary
and that participants are free to withdraw at any time, and free to withdraw
any unprocessed identifiable data previously supplied
(xii) Outlines
particular requirements of participants (eg. involvement in interviews,
completion of questionnaire(s), provision of bodily fluid and/or tissue
samples, audio/video taping of events) and estimated time commitment
(v)
Includes details of the arrangements to protect the
confidentiality of data
(vi)
Specifies that there are legal limitations to data
confidentiality
(vii) If
the sample size is small, confirms that this may have implications for
protecting the identity of the participants and explains the potential for
participants to be (re)identified
