Application for ethical approval of a research project involving humans

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

4.    PRIVACY AND CONFIDENTIALITY

4.1       Accessing personal information without consent: Identify if there is a requirement for the researchers to obtain personal information (either identifiable or potentially identifiable) about individuals without their consent and justify why consent will not be obtained. (Note: Personal information includes names, addresses, or information/opinion about an individual whose identity is apparent, or can be reasonably ascertained, from the information/opinion. It also includes health information, eg. health opinions, organ donation or genetic information, and sensitive information, eg. political views, sexual preferences, criminal records.) [No more than 100 words]

4.2       Reporting project outcomes: Describe how the project outcomes will be made public at the end of the project, both to the scientific community (eg in journal articles, conference submissions, the media, results presentations) and to participants (eg. production of a report), or justify why not. [No more than 100 words]

4.3       Level of participant confidentiality: Specify the method of protecting the privacy of participants which will be used, such as one of those listed below. (Note: Where the sample size is very small, it may be impossible to guarantee anonymity/confidentiality of participant identity and therefore participants involved in such projects must be clearly advised of this limitation in the information letter.)

(i)     Complete anonymity of participants (ie. researchers will not know the identity of participants as participants are part of a random sample and are required to return responses with no form of personal identification)

(ii)    De-identified samples or data (ie. an irreversible process whereby identifiers are removed from data and replaced by a code, with no record retained of how the code relates to the identifiers, where it is then impossible to identify the individual to whom the sample of information relates)

(iii)   Potentially identifiable samples or data (ie. a reversible process in which the identifiers are removed and replaced by a code, and those handling the data subsequently do so using the code, where it is possible to link the code to the original identifiers and identify the individual to whom the sample or information relates)

(iv)   Participants being referred to by pseudonym in any publication arising from the research

(v)    Participants having the option of being identified in any publication arising from the research

5.    DATA STORAGE, SECURITY AND DISPOSAL

5.1       Data storage: Describe how and where data will be held (eg. in locked facilities in the department through which the project is being conducted), including any arrangements for data storage during fieldwork. [No more than 100 words]

5.2       Data security: Confirm that the principal researcher OR responsible supervisor will be responsible for security of data collected, or justify otherwise, describe the methods which will be used to ensure confidentiality of data (eg. data and codes securely stored separately to identifying information, password protected computer files, access by named researchers only) and explain if and why individuals other than the named researchers will have access to the raw data. [No more than 100 words]

5.3       Data retention and disposal: Specify how long materials (eg. files, audiotapes, questionnaires, videotapes, photographs) collected during the study will be retained after the study, and how they ultimately will be disposed of in a secure manner. (Note: Research data and records should be maintained as long as they are of continuing value to the researcher and as long as recordkeeping requirements, such as patent requirements, legislative and other regulatory requirements, exist.) [No more than 100 words]

6.    POTENTIAL CONFLICT OF INTEREST

6.1       Potential conflict of interest: Give details of any affiliation or financial interest for researchers in this research or its outcomes or any circumstances which might represent a perceived, potential or actual conflict of interest. [No more than 100 words]

7.    SUBMISSION CHECKLIST

Please confirm all supporting documents are attached (electronic copies preferred):

• Curriculum vitae of principal researcher OR responsible supervisor, with photo
• Curriculum vitae of student researcher, with photo (if applicable)
• Questionnaire and/or interview (where relevant)
• Funding documentation (where relevant)
• Letter of approval and/or NOC from all involved departments
• Participant recruitment documents, eg. mailout, email, advertisement, approval from a third party involved in recruitment, approval from a private source providing contact details (where relevant)
• Documentation of participant requirement, eg. medication schedules, therapy descriptions, intervention methodologies, instructions, tasks, tests, questionnaires or interview guides to be used and a flow chart if this will clarify the procedures (where relevant)
• Participant information letter in simple language (where relevant)
• Consent form (where relevant)

Note: Submission is required both electronically (as a single Microsoft Word document) to irc@phectnepal.org AND as one printed copy with all necessary attachments and signatures (see declaration below) delivered to the phect-NEPAL administration office at Kathmandu Model Hospital (Pradarshani Marg) or mailed to Public Health Concern Trust (phect-NEPAL), GPO Box: 6064, Pradarshani Marg, Kathmandu, Nepal.

8.    DECLARATION BY THE RESEARCHERS

The information contained herein is, to the best of my/our knowledge and belief, accurate and complete.

I/we accept responsibility for the conduct of the procedures set out in the attached application. I/we have attempted to identify all risks related to the research that may arise in conducting this research and acknowledge our obligations and the rights of the participants. I/we have the appropriate qualifications, experience and facilities to conduct the research set out in the attached application and to deal with any emergencies and contingencies related to the research that may arise.

If approval is granted, the project will be undertaken in strict accordance with the approved protocol and relevant laws, regulations and guidelines.

I/we, the researcher(s) agree:

·      To only begin participant recruitment and/or data collection for this research project after obtaining final written ethical approval from the IRC

·      To only carry out this research project where adequate funding is available to enable the project to be carried out according to good research practice and in an ethical manner

·      To provide additional information to the IRC as requested

·      To provide progress reports to the IRC as requested and a final report at the conclusion of the study

·      To maintain the confidentiality of all data collected from or about project participants, and maintain security procedures for the protection of privacy

·      To notify the IRC in writing immediately if any change to the research project is proposed and to await approval before proceeding with the proposed change

·      To notify the IRC in writing immediately if any adverse event occurs after approval has been obtained

·      To agree to an audit if requested by the IRC

·      To only use data and any tissue samples collected for the study for which approval has been given

·      To submit the required processing fee to the IRC (where applicable)

All researchers and/or supervisors associated with this project must sign:

Name (please print)	Signature	Date

9.    DECLARATION BY THE IRC [for office use only]

Date application received:

The IRC has reviewed this project and considers the methodological/technical and ethical aspects of the proposal to be appropriate to the tasks proposed and recommends approval of the project. The IRC considers that the researcher(s) has/have the necessary qualifications, experience and facilities to conduct the research set out in the attached application, and to deal with any emergencies and contingencies that may arise. The researcher(s) will be notified in writing of this approval.

(Note: If the IRC Chair is also involved in this project in any way, the declaration should be signed by another authorised member of the IRC.)

Comments/Provisos:

Name of IRC Chair (please print)
Signature
Date

Reference:
Phect Nepal
Institutional Review Committee
icr@phectnepal.org