Assistance to Principal Investigators

Research Ethics Readiness Support

Current Challenges in Research Ethics Application

Lack of clarity

When is an Institutional Review Board (IRB) review and approval needed?

Lack of understanding of ethics application

Unfamiliarity with IRB requirements or application process
Unfamiliarity with ethics principles and research regulations that may apply

Resource constraints

Time constraint - Lack of understanding prolongs IRB approval timeline
Personnel constraints – Effort needed to understand to follow-up with IRB queries successfully
Funding constraints – Time and Personnel constraints impact grant approvals

We provide expertise and resource relief to Principal Investigators and Research Organisations by supporting the drafting and follow up of Institutional Review Board (IRB) applications until approval, therefore saving the PIs’ valuable time and enabling innovations to be deployed for clinical studies more efficiently.

This range of services is currently only available in Singapore. Every country has a different procedure for IRB applications.

Pre-Application Guidance and Support

The first step we support Principal Investigators is to gather pertinent information Needed for an Institutional Review Board (IRB) Application on behalf of the PIs

Background information on proposed project

Study objectives(s)/ research question(s), current gaps/ limitations (related to the current standard of care)

Proposed clinical outcome measures/ endpoints

Details of the intervention/ proposed solution

Product brochure, instructions for use/ approved indication(s), how the solution will be used in the upcoming study, etc

Detailed study procedures

Experimental procedures, standard of care procedures, potential risks

Proposed study design

Type of study (pilot/ feasibility study/ randomized control trial/ pragmatic trial, etc)

Study population type and sample size required to test the solution

Inclusion and exclusion criteria, sample size calculation/ justification

Statistical analysis plan for collated study data

Study conduct operational details

Informed consent process, data collection and storage process, etc

Unsure if the study design meets requirements? Or unable to provide study design?

Access-2-Healthcare have in-house clinical specialists that can provide study design drafting if the endpoints and procedures are provided

Support in New Clinical Research Applications

We are supporting the PIs every step of the way

PRE-CONSULTATION

Understanding enterprise needs
Evaluation of certification necessities
Point of contact (POC) between Principal Investigator (PI) and Institutional Review Board (IRB)

IRB APPLICATION

Pre-Filling of form with Principal Investigator (PI)

INFORMED CONSENT FORM

Co-Drafting of Informed Consent Form (ICF) with Principal Investigator (PI)

STUDY PROTOCOL

Cross-check protocol and application submission
IE: Institutional Review Board (IRB) application form, Informed Consent Form (ICF) , data collection form