Application for Technical and Pre-ethical approval

This form should be completed and submitted ELECTRONICALLY. It contains clickable buttons that will direct you through the process according to the responses you make to the initial screening checklist. Please make sure you respond to ALL the required questions.

As you complete the form you will be prompted to save the document for yourself, and when completed to send a copy to the Chair of the Institutional Research Review Board (IRRB) supporting the relevant cognate area.

When this project is authorised your code will be in this box:

Title of research:
Researcher:	Surname First name
Student / staff ID of the Researcher
Status
(Main Supervisor for PGR students)
Email address:
Telephone number:
Department

NIA/	Dated:

The requisite registration fees INR 1000 INR 10000 is paid vide receipt no.

Please complete all the boxes before continuing to the next page

Office Use Only:

What needs approval?

Please indicate which route you wish your application to follow: Route 1 Ethical approval is not required

Route 2 Approval by expedited review

Route 3 Approval without full ethical review

Route 4 or 5 Full ethical review required

STEP ONE: Provide an outline of the project

Everyone must complete this brief outline that shows the Institutional Research Review Board what the project entails.

Where will you get your research material?

Documents:

Unpublished:	Published:	Existing databases:

Other (specify):

Online or social media:

Blogs:	Chat rooms:	Webpages:

Other (specify):

From people by:

Interviews:	Focus groups:	Questionnaires:

Other (specify):

Biological, medical or social data from:

Animals:	Members of the public:

Medical patients:	Social care clients:

Other research material:

Specify:

If human participants are involved are they:

Under 16:	Adults able to give consent: Adults unable to give consent :

Briefly describe your project

Outline:

Aims:

Methods:

STEP TWO: Initial Screening Checklist

Please complete the initial screening checklist by clicking either 'Yes' or 'No' in EACH row:

Subject area If the research involves matters of social, political or personal sensitivity you need to be aware of the boundary between legitimate academic enquiry and unnecessarily offensive or illegal behaviour.
Will the research require the collection of primary source material that might possibly be seen as offensive or considered illegal to access or hold on a computer? Examples might be studies related to state security, pornography, abuse or terrorism.
Will the study involve discussion or disclosure of information about sensitive topics? This may involve legal issues that are nonetheless sensitive (e.g. sexual orientation, or states of health), or topics where illegal behaviour could be revealed (e.g. abuse, criminal activity, under-age drinking or sexual activity).
Participants: recruiting and consent If the research involves collecting data from people you need to be aware of issues related to ensuring that they are able to give informed consent to participate where appropriate. This means being aware of how people are recruited, and whether they understand what information is being collected and why. In some cases data collection has to be covert, or informed consent is not possible from the participants themselves. These require particular attention.
Will the study require the co-operation of a gatekeeper to give access to, or to help recruit, participants? Examples include head teachers giving access to schools, Jailors giving access to prison inmates.
Will it be necessary for participants to take part in the study without their knowledge or consent at the time? Examples might be studies of group behaviour or the use of data that was not intentionally collected for research.
Will the study involve recruitment of patients through Government Schemes such as Janani Suraksha, Bhamashah Yojana? There are particular issues and procedures required if the research will involve Govt. Schemes.
Will inducements be offered to participants? This could include direct payments, the offer of being entered in a prize draw, or, for students, the offer of course credit for participation. It does not include the payment of legitimate expenses.
Does the study involve participants who are particularly vulnerable or unable to give informed consent? You must answer 'yes' if any participants are under 18. Adults with learning disabilities, the frail elderly, or anyone who may be easily coerced due to lack of capacity is considered vulnerable. If you teach and you wish to research your own students, they should be classed as potentially vulnerable.
Data collection Where the collection of data involves more than trivial risk to participants researchers must weigh carefully the necessity of the procedure, the level of possible harm, and the benefits of the research.
Will the study require participants to commit extensive time to the study? Single-session interviews or completing questionnaires once or twice would not be considered excessive, but long-term studies with multiple sampling, intensive data gathering over a day or more, or long interviews and questionnaires that take some hours to complete might fall into this category.
Are drugs, placebos or any other substances to be administered to participants, or will the study involve invasive, intrusive or potentially harmful procedures of any kind? Even simple procedures such as tasting sessions might be dangerous if participants have allergies, so tick yes if the research involves any substance trials.
If there are experimental and control groups, will being in one group disadvantage participants? Examples might be testing new teaching methods where pupils without the trial procedure may be disadvantaged, or trying a new procedure where the outcomes are uncertain.
Is an extensive degree of exercise or physical exertion involved? If participants are unused to such exercise it could put them at risk, so it is important for researchers to be aware of this and communicate it to volunteers.
Will blood or tissue samples be obtained from participants? These procedures require specialist training and are covered by particular ethical codes.
Is pain or more than mild physical discomfort likely to result from the study?
Could the study induce psychological stress or anxiety or cause harm or negative consequences beyond the risks encountered in normal life? This might be because the subject area is sensitive, the nature of task (e.g. decision-making under pressure),or the participants are particularly vulnerable to stress or anxiety (e.g. those with a history of poor mental health).

Date (dd/mm/yy):

Researcher: Enter your name here to confirm you have answered all the questions on the checklist:

STEP THREE: If you answered “yes” to any of the questions on the initial screening checklist (and these responses were all coloured blue), you must complete the Decision Tree

When you click the button below, the only rows that will show are those where you clicked a blue 'YES' in the initial checklist. You then need to decide if a full ethics proposal might still be required by looking at the criteria and clicking the Yes or No response in the remaining rows as appropriate.

If you answered YES response to this Question:	A Full Ethics Proposal is required if:	Full Ethics proposal required?
1	Will the research require the collection of primary source material that might possibly be seen as offensive or considered illegal to access or hold on a computer?	Required under all circumstances
2	Will the study involve discussion of, or the potential disclosure of, information about sensitive topics?	Participants include children. Subject matter relates to illegal activities.
3	Will the study require the co-operation of a gatekeeper to give access to, or to help recruit, participants?	Gatekeepers are overseas.
4	Will it be necessary for participants to take part in the study without their knowledge or consent at the time?	Required under all circumstances
5	Will the study involve recruitment of patients through the Goverment Schemes?	Required under all circumstances
6	Will inducements be offered to participants?	Payments per person or prizes. Any reward related to students gaining credit or marks for participation.
7	Does the study involve participants who are particularly vulnerable or unable to give informed consent?	Any adults are unable to give their own consent.
8	Will the study require participants to commit extensive time to the study?	Participants will be under observation for more than 8 hours in any session or required to give over 24 hours in total.
9	Are drugs, placebos or any other substances to be administered to participants, or will the study involve invasive, intrusive or potentially harmful procedures of any kind?	Any drug or invasive procedure such as injection.
10	If there are experimental and control groups, will being in one group disadvantage participants?	There is no evidence to show how experimental group will fare, or there any evidence that they may be disadvantaged. Any procedure where untreated group would remain at risk of significant harm or disadvantage compared with experimental group.
11	Is an extensive degree of exercise or physical exertion involved?	Participants include likely vulnerable groups (e.g. those with history of heart problems, strokes, obesity etc.)
12	Will blood or tissue samples be obtained from participants?	Required under all circumstances
13	Is pain or more than mild physical discomfort likely to result from the study?	Required under all circumstances
14	Could the study induce psychological stress or anxiety or cause harm or negative consequences beyond the risks encountered in normal life?	Required under all circumstances

If you have answered NO to all the questions, a full ethics proposal is NOT required. However, you must complete the Research Ethics Mitigation Form and submit this with your application for Pre-ethical approval to the relevant IRRB in order to show how you will mitigate the ethical issues identified in the checklist.

If you answered “YES” to any questions in the decision tree, your research must undergo a full ethical review, so go straight to STEP FOUR

Research Ethical Considerations Mitigation Form

You need to complete this if you answered “YES” to any question in the initial screening checklist (coloured blue), but your research does not require a full ethical review.

The remaining rows in the following pages should be those where you clicked a 'Yes' answer in the initial checklist. Complete the right hand box to show how you will address the ethical issues that your project raises

Q#	Question:	What you need to show:	Type your response in the box in this column, which will expand if necessary.
1	Will the research require the collection of primary source material that might possibly be seen as offensive or considered illegal to access or hold on a computer?	Show why collection of data is necessary to the research, how material will be handled and stored, and how offense will be mitigated as far as possible in final outcomes.
2	Will the study involve discussion of, or the potential disclosure of, information about sensitive topics?	Show how anonymity and confidentiality will be maintained. Ensure there are clear procedures for the event of disclosure of illegal activity, and these are made clear to participants before consent is given. Show how will data be held and how offense will be mitigated as far as possible in final outcomes
3	Will the study require the co-operation of a gatekeeper to give access to, or to help recruit, participants?	Show how gatekeepers will be instructed and that undue coercion will be avoided. Demonstrate that informed consent and rights to withdraw will be made clear to all participants.
4	Will it be necessary for participants to take part in the study without their knowledge or consent at the time?	If you answered yes a full proposal is required
5	Will the study involve recruitment of patients through the Government Schemes?	If you answered yes a full proposal is required
6	Will inducements be offered to participants?	Show how recruitment will be advertised, and how payment / prize draws will be made and gifts distributed. Show how will anonymity and confidentiality be maintained if participants need to give contact details to receive rewards.
7	Does the study involve participants who are particularly vulnerable or unable to give informed consent?	If children, show how parental consent will be obtained, or why it may not be needed (e.g. for some older teenagers). For other vulnerable adults if they can give consent show how will this be obtained to ensure that it is informed
8	Will the study require participants to commit extensive time to the study?	Justify the required commitment in terms of research outcomes. Show how participants will be fully informed of what will be required to participate.
9	Are drugs, placebos or any other substances to be administered to participants, or will the study involve invasive, intrusive or potentially harmful procedures of any kind?	Show how participants will be warned about allergies or other risks from the treatment. Show procedures in the case of sudden medical problems.
10	If there are experimental and control groups, will being in one group disadvantage participants?	Show that the test is necessary for long term or wider benefits to all potential users. Show that risk to experimental group in minimal.
11	Is an extensive degree of exercise or physical exertion involved?	Show how participants will be screened to reduce likelihood of problems. Show how participants will be warned of risks. Show procedures in the case of sudden medical problems.
12	Will blood or tissue samples be obtained from participants?	If you answered yes a full proposal is required
13	Is pain or more than mild physical discomfort likely to result from the study?	If you answered yes a full proposal is required
14	Could the study induce psychological stress or anxiety or cause harm or negative consequences beyond the risks encountered in normal life?	If you answered yes a full proposal is required

Researcher: Enter your name here to confirm you have answered all the required questions on the mitigation form

STEP FOUR: Research proposal to be considered by means of a full ethical review

You must complete this part of the form if either:

You answered a 'red' YES in the Initial Screening Checklist in Part One of this form. OR

You gave one or more non-red YES answers in the Initial Screening Checklist and the Decision Tree indicated that a full proposal was required.

You have to complete this form because what you propose to do raises substantive ethical issues. This proposal will be considered by the Institutional Research Review Board supporting your cognate area, who will want to know clearly and precisely what you are proposing to do and how you will ensure that you follow best ethical practice. Make sure that you address how you propose to manage all potential ethical issues, specifically those identified in the checklist and/or decision tree.

Title of project
Name of researcher
Status
Supervisor (if student research project)

_______________________________________________

Office Use Only

Date of submission	Action	Outcome

Chair/ Secretary of IRRB should enter their NIA username in the box and then click the green button to authorize this project. If you are logged on the Institute network and are using the macro-enabled form, an authorization code will be generated automatically on page 1 of the form. Otherwise this will need to be inserted by hand.

Insert Appended Material Here

Copy of reference from Classical Texts for the Interventional Drug/s.

* Please Email the Saved Copy to: deanresearchnia@gmail.com

* Please bring a printout of the saved document to IRRB meeting.