Get the free Modification/Amendment/Continuation to Approved Research Activities Involving Human ...

This document is used for requesting modifications, amendments, or continuations to previously approved research activities involving human subjects.

How to fill out modificationamendmentcontinuation to approved research

How to fill out Modification/Amendment/Continuation to Approved Research Activities Involving Human Subjects

1. Review the original approved research protocol and identify the changes that need to be made.
2. Fill out the Modification/Amendment form, ensuring to clearly outline each modification.
3. Provide a justification for each change, explaining why it is necessary for the study.
4. Include any new information that affects the risk to participants or the study's scope.
5. Attach any supporting documents, such as updated consent forms or questionnaires.
6. Submit the completed form and documents to the Institutional Review Board (IRB) or ethics committee for review.

Who needs Modification/Amendment/Continuation to Approved Research Activities Involving Human Subjects?

1. Research investigators who wish to change elements of their approved research protocol.
2. Researchers adding new study sites or changing study staff.
3. Investigators who need to modify the consent process or update participant information.
4. Anyone involved in research where significant adjustments affect the study's ethical considerations or participant safety.

People Also Ask about

What should you do if you deviate from the IRB approved protocol?

For non-exempt research, investigators must report protocol deviations to the IRB by completing and electronically submitting the appropriate Reportable Event Form available in IRBNet. The information in the report should allow the IRB to evaluate the nature and potential consequences of the deviation.

How is research involving human subjects regulated today?

Such research is strictly regulated, with laws at the federal, state, and local levels. Further, professional societies have developed discipline-specific standards, policies, and guidelines for ensuring that the rights and welfare of research participants is protected.

Is the investigator's responsibility to obtain IRB approval of any protocol changes?

This includes amendments involving changes to institutional review board (IRB)-approved protocols. The investigator is responsible for ensuring changes receive IRB review prior to implementation; the IRB is responsible for reviewing the changes to ensure everything continually approves the regulatory criteria.

What happens if you break the IRB rules?

The IRB has the authority to suspend or terminate approval of research not being conducted in ance with the IRB's requirements or that has been associated with unexpected serious harm to subjects.

Is a change in the protocol that does not have prior approval of the IRB is considered to be a protocol?

Implementing changes without prior IRB approval is considered a protocol violation and subject to a noncompliance review. Pre-approval may not be required if the change is made in order to eliminate an immediate hazards to participants.

What is an example of an IRB amendment?

For example, a request to change a survey project's protocol from the collection of anonymous data (which qualifies for an exempt #2 determination) to the collection of sensitive data linked to personal identifiers would require the submission of an amendment for IRB review.

Can an IRB approved protocol be changed CPP?

Amend (modification): After IRB approval, when the PI(s) would like to change things to the approved protocol, they must submit an Amendment Submission. Renew: When the protocol is close to the expiration date, the PIs will receive notifications.

Can an IRB approved protocol be changed?

An amendment to an existing approved Institutional Review Board (IRB) protocol is viewed as any change to what was previously approved during the period for which approval was given. Amendments are categorized as either major or minor and are distinguished based on the type of changes proposed.

For pdfFiller’s FAQs

What is Modification/Amendment/Continuation to Approved Research Activities Involving Human Subjects?

Modification/Amendment/Continuation refers to the processes by which researchers request changes to their already approved research protocols involving human subjects. This can include adjustments to study design, procedures, or participant information.

Who is required to file Modification/Amendment/Continuation to Approved Research Activities Involving Human Subjects?

Researchers or sponsors of studies involving human subjects who wish to make changes to their approved protocols must file a Modification/Amendment/Continuation.

How to fill out Modification/Amendment/Continuation to Approved Research Activities Involving Human Subjects?

To fill out the Modification/Amendment/Continuation form, researchers should provide detailed information about the proposed changes, including the rationale for changes, updated study materials, and any potential impacts on participants.

What is the purpose of Modification/Amendment/Continuation to Approved Research Activities Involving Human Subjects?

The purpose is to ensure that the changes made to a research study are ethically and scientifically sound, do not jeopardize the safety and rights of participants, and continue to comply with regulatory requirements.

What information must be reported on Modification/Amendment/Continuation to Approved Research Activities Involving Human Subjects?

Information to be reported includes a description of the changes, justification for the changes, any new procedures or risks involved, and a revised protocol or consent form if necessary.