The following are the steps for submitting amendment request for ethical approval of research involving human subjects:
Researchers are required to apply for amendment request first before carrying out changes in the research study. Implementing changes in the research without obtaining prior amendment request approval from KEP is an ethical violation and may result in termination of KEP’s ethical approval of the research protocol.
I. Summary of Amendment Procedure
In short, the procedure for submitting and reviewing an amendment is the same as the procedure for submitting and reviewing a new protocol. Minor amendments will get an expedited review and major amendments will get a full board review. Researchers are still required to submit an application before the deadline for submitting a cycle. Amendment applications that are submitted after the deadline will be processed in the next cycle.
KEP may grant exceptions to the cycle rule for administrative amendment. This type of amendment can be reviewed and approved outside of the regular monthly KEP cycle.
Researchers wishing to apply for amendment request will need to submit the following documents:
Send the documents to KEP’s e-mail address email@example.com with the subject: Request for Amendment to Research Protocol – (Registration Number)
II. Types of Amendment
Very minor changes that do not increase risk and affect the subjects and study design of the study in any way. The following are the categories of amendments that may be subject to administrative review:
i. Editorial changes that do not alter the meaning of a sentence/paragraph such as correcting spelling, typography, translation, grammar, and adding a few sentences with the intention of clarifying, on instruments, consent forms, recruitment materials, or other documents that are directly related to the research subjects. Examples:
ii. Changes in procedures, whether in experiments, recruitment, data collection, or other processes throughout the course of the study, which in no way increase the risk of research subjects or change the research design significantly. Examples:
iii. Addition or change the research team members outside of the Principal Researcher and Associate Researcher. Example:
iv. Changes in compensation for research subjects that are not significant enough to create coercion and/or undue influence on the subjects. Examples:
v. Additions and/or changes to the research team members as long as they do not have a negative effect on the competence and credentials of the research team. Examples:
vi. One small change from one of the categories of Minor Amendment.
vii. Minor changes from any of the categories may be subject to administrative review if the study protocol was initially approved through the exempt review procedure.
B. Minor Amendment
The type of amendment that does not significantly affect the assessment of the risks and benefits of the study and does not substantially change the purpose or design of the study. Here are the categories of minor amendments:
i. Minor changes in consent form. Example:
ii. Minor changes to recruitment procedures, recruitment materials or submission of new recruitment materials to be used according to the pre-approved recruitment methods. Examples:
iii. Minor changes to the research instrument. Example:
iv. Increasing the number of samples as long as it does not negatively change the risk/benefit ratio of the study. Examples:
v. Minor changes to the study design. Examples:
Note: If the amendment request falls into this category, the research is not entitled to administrative review category No. VI even though these changes are the only changes in the protocol.
C. Major Amendment
The type of change that significantly affects the assessment of the risks and benefits of the study or substantially changes the purpose or design of the study. Here are the categories of major amendment:
i. Changes that significantly alter the risk/benefit ratio of the study or specifically increase the subject’s risks. Examples:
ii. Changes to the inclusion and exclusion criteria that impact the risk/benefit ratio of the study
iii. Significant changes in the study design. Examples:
iv. Significant changes to the consent form or other related documents that are directly related to the research subjects. Examples:
v. New or revised financial conflict of interest. Example: