iium rESEARCH eTHICS cOMMITTEE

A research ethics amendment is a change to a research project’s design or implementation that is made after the project has been approved by an ethics committee. 

When to submit an amendment 

• If there are significant changes to the project’s design or implementation
• If the changes are not expected to increase the project’s risks

What to include in an amendment 

• A request to change the approved protocol
• A statement about how the changes will affect the project

A Serious Adverse Event (SAE) is an unwanted and harmful effect of a research procedure that is unexpected and can be life threatening. In research ethics, SAEs are reported to the sponsor and ethics committee within a specified time frame. 

What is an SAE? 

• An SAE is an adverse event (AE) or adverse drug reaction (ADR) that is life threatening or has serious consequences
• SAEs can include death, hospitalization, disability, or birth defects
• SAEs can also include important medical events that may not be life threatening but require medical intervention

Who is responsible for reporting SAEs? 

• The principal investigator (PI) is responsible for reporting SAEs to the sponsor and ethics committee
• The PI should report SAEs within the specified time frame, which is often 24 hours

Why are SAEs reported? 

• SAEs are reported to ensure the safety of research participants and to ensure that the research is conducted ethically

A “continuing review” is a process where a research ethics committee (REC) periodically re-evaluates an ongoing research study to ensure that the ethical standards set during initial approval are still being upheld, including monitoring participant safety, assessing any new risks, and reviewing progress reports submitted by the researchers, usually done at set intervals throughout the study duration. 

Key points about continuing review:

Purpose: To maintain ethical oversight throughout the research project, ensuring that participants remain protected and the study is conducted according to approved protocols. 

What is reviewed:

• Progress reports detailing study findings and participant recruitment 
• Any significant changes or amendments to the study protocol 
• Reports of adverse events or unexpected issues affecting participants 
• Any protocol deviations or violations 

Frequency: Done on an annual basis, but can be more frequent depending on the study’s risk level and the IREC’s guidelines. 

Submission requirements: Researchers typically need to submit a “continuing review form” to the IREC, which includes details about the study’s progress, any updates, and any issues that need to be addressed. 

Action by the IREC: The IREC will review the information submitted and may decide to:

• Continue approval without changes 
• Request modifications to the study protocol 
• Suspend or terminate the study if serious ethical concerns are identified 

A “research ethics end report” is a document submitted to an ethics review board at the conclusion of a research project, detailing how the study adhered to ethical principles throughout its duration, including any challenges encountered, mitigation strategies employed, and a summary of the data collected while ensuring participant privacy and protection. 

Key elements of a research ethics end report:

• Project overview: A brief recap of the research question, methodology, and study population.
• Ethical considerations addressed: A list of relevant ethical principles (e.g., informed consent, confidentiality, beneficence) and how they were implemented throughout the research process. 
• Informed consent procedures: Explanation of how informed consent was obtained, including the consent form content, process for obtaining consent, and any modifications made during the study. 
• Data collection and storage: Details on data collection methods, data storage protocols, and measures taken to protect participant privacy. 
• Adverse events and mitigation strategies: Reporting of any unexpected negative impacts on participants, how they were addressed, and any adjustments made to the study design as a result. 
• Data analysis and reporting: A description of how data was analyzed, including any ethical considerations regarding data interpretation and reporting. 
• Conflicts of interest: Disclosure of any potential conflicts of interest, including financial or personal, and how they were managed. 
• Dissemination plan: Explanation of how research findings will be communicated, including publication plans and considerations for protecting participant privacy. 

Importance of a research ethics end report:

• Accountability: Demonstrates that researchers have conducted their study with ethical integrity and adhered to relevant guidelines. 
• Transparency: Provides a clear record of the research process, including any challenges or deviations from the original protocol. 
• Continuous improvement: Enables ethics review boards to identify areas for improvement in research practices. 

A protocol deviation is when a study procedure or treatment plan is not followed as outlined in the approved protocol. Protocol deviations can be accidental or unintentional. 

Examples Failing to follow safety monitoring plans, Using unapproved recruitment procedures, Rescheduling a study visit, Failing to collect a questionnaire, and A subject refusing to participate in a study activity. 

Impact:

Protocol deviations can impact the integrity of the study, the rights of participants, and the safety of participants. They can also undermine the scientific validity of the study. 

Reporting:

Protocol deviations should be reported to the Institutional Review Board (IRB) as soon as the deviation is discovered. 

Mitigation:

Depending on the severity of the deviation, the site may need to create a mitigation strategy. This strategy is sometimes called a Corrective and Preventive Actions (CAPA) plan.