| Who must apply to the IRC for ethics approval? |
| Any individual, group or institution seeking 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. |
|
|
| |
| Why does my research need ethics approval? |
The process of ethical approval seeks to ensure that all research involving or impacting on humans has the highest standards of academic integrity and ethical practice in order to safeguard the dignity, rights, safety and wellbeing of the research participants (see Ethics in human research). Therefore no research involving humans should take place without ethical approval from a properly constituted ethics committee, and it is unlikely research without such approval
could achieve publication in a peer-reviewed journal. |
|
| |
| Can I start participant recruitment and/or data collection before receiving an IRC approval letter? |
| No participant recruitment and/or data collection may take place until final written ethical approval has been obtained from the IRC. |
|
| |
| How do I submit my application for review? |
| The provided IRC application form (see Downloads) must be completed in full and submitted both electronically and as a printed copy (see Contact details). Incomplete applications will not be accepted. |
|
| |
| Why do I need to submit my application electronically and as a printed copy? |
| The electronic copy is used to determine date of submission, and will be forwarded to the members of the IRC for review. Where possible, all attachments should be included in the electronic submission. The printed copy will be retained for the IRC records and must be signed by all named researchers and include copies of all relevant attachments. |
|
| |
| Can I meet with the IRC to explain my research project and/or make a presentation? |
| No, researchers may not have any direct contact with members of the IRC in regards to their application. All necessary information regarding the research project should be provided with the written application and all communication shall be via email (see Contact details). |
|
|
| |
|
| Why do I need to provide copies of the researchers' curriculum vitae? |
| It is essential that research involving humans is supervised and/or carried out by individuals who have appropriate qualifications and experience with the research process, to ensure proper ethical conduct will be maintained at all times. The IRC will use the curriculum vitae to determine if the researchers are appropriately qualified and experienced. |
|
|
| |
|
| Who must apply to the IRC for ethics approval? |
| Any individual, group or institution seeking 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. |
| |
| Why do I need to provide the researchers' photo? |
| Due to the need to correctly identify researchers, and the possibility that individuals of the same
name may seek to carry out research projects, a photo of the principal researcher and/or student researcher are required. |
|
| |
| When can I submit my application? |
| Applications may be submitted at any time, however please plan ahead to allow the necessary processing time. |
|
| |
| Are there any costs involved in processing my application? |
| There is a processing fee for the review of all research proposals submitted by researchers not affiliated with phect-NEPAL. The fees are as follows: external research without funding – Rs. 2000; external research with funding – Rs. 5,000; external research with international funding
Rs. 10,000. |
|
| |
| How long does application processing take? |
| Applications will be reviewed within one month of electronic submission, however if any changes and/or further information is requested by the IRC the application may require further review at following meeting(s) and may take additional time for processing. |
|
| |
| When does the IRC meet? |
| Meetings are held once monthly, in the last week of the month. Special meetings may be called in the interim, at the discretion of the IRC Chairperson. |
|
| |
| My application was rejected, suspended or terminated; can I appeal? |
| Yes, one appeal is allowed per proposal per rejection, suspension or termination notification. The appeal form must be completed (see Downloads) and submitted electronically to the IRC. The
matter will be discussed at the next IRC meeting with specific review of the reasons for which the research was rejected, suspended or terminated. The following decision of the IRC will be final. |
|
| |
| The IRC reviewed my application and requested more information; how do I provide it? |
| Edit the appropriate sections of your application, by including additional information and/or making changes where necessary, and re-submit electronically to the IRC with an additional document briefly outlining where any changes were made. |
|
| |
| The IRC asked me to make changes to my application; do I have to? |
| In order to re-submit your application for review you must either make the changes suggested by the IRC or provide justification for your initial choices. The IRC will then re-review your application, however there is no guarantee that your research project will be approved. |
|
| |
| My research was approved, what now? |
If you have received a letter of ethics approval, signed by the Chairperson of the IRC, then you are free to undertake participant recruitment and/or data collection during the time period specified in the letter. You must submit any progress and/or completion reports to the IRC in a timely manner, as specified in the letter. |
|
| |
| What reports do I need to submit to the IRC during my research? |
| You are responsible for submitting timely progress reports to the IRC, as specified in the relevant ethics approval letter. This usually consists of a progress report at the conclusion of data collection and a final report upon completion of the study (see Downloads). You may also be requested to submit annual reports if your study is of duration greater than one year and/ or more regular progress reports if your study is determined to be high risk. Special reports are required in the case of any adverse events occurring during the study (see details below) and if any ethical issues are encountered. |
|
|
|
| |
|
| How can I apply for more time to finish data collection? |
| If you wish to make any changes to the research protocol approved by the IRC, including an extension of data collection time, an amendment request (see Downloads) must be completed and submitted to the IRC for review. Data collection may not be carried out beyond the originally approved time period until approval of the amendment(s) is received from the IRC in writing. |
|
|
| |
|
| I want to modify my research protocol; do I need to notify the IRC? |
| If you wish to make any changes to the research protocol approved by the IRC, an amendment request (see Downloads) must be completed and submitted to the IRC for review. No changes may be made until approval of the amendment(s) is received from the IRC in writing. |
|
|
| |
|
| An unexpected or adverse event occurred during my research; do I need to notify the IRC? |
| Yes, a report must be promptly submitted to the IRC if any unexpected or adverse events occur during the research, using the template provided (see downloads). This report will be reviewed by the IRC and any recommendations provided in writing. |
|
|
