Procedure for IBC Protocol Registration and Review

a) All proposals approved by SSC, ACUC and or/ ERC the PI must submit his/her protocol to the HSE Office for IBC approval. In the case of non-funded research, the HSE Office should be informed prior to study initiation.

b) KEMRI Biosafety policy requires that Principal Investigators should undergo Supervisors Training and should acquire approval for the infectious material in use for his/her experiments.

c) Individuals planning to obtain materials which may pose biological hazards for which biosafety level 2 or greater practices, techniques, equipment, or facilities are required must contact the HSE Office prior to receipt of such materials. If applicable the appropriate shipping or Material registration forms (See the KEMRI Biosafety manual) must be completed and submitted with the Application Form for IBC approval.

d) A copy of the proposal and an application for IBC approval should be submitted to the HSE Office. The Biosafety Officer or designee will present the request to the Chair IBC.

e) The KEMRI-IBC will review the submission and grant permission if the application fulfills applicable requirements stipulated in the KEMRI Biosafety manual. A Project Approval Certificate will be issued to signify approval.

f) The permit holder will be required to notify the IBC in case of any Amendments or transfer of the signing authority.

a) Principal Investigators must submit a rDNA registration form for all protocols involving experiments involving rDNA to the HSE Office at least two weeks prior to the IBC meeting.

b) Upon receipt of an appropriately completed protocol the HSE Office assigns an IBC number to the protocol.

c) HSE Office staff assigns the detailed protocol to the IBC primary reviewer, who has received training on Biosafety, and schedules the protocol for review at next IBC meeting.

d) The HSE Office staff is responsible for providing the Biosafety Officer or designee the IBC€™s primary reviewer, and the IBC members with agenda notices and protocol review packets, following standard operating procedures for disseminating information prior to the IBC meeting.

e) The Biosafety Officer or his/her designee provides the IBC with data safety expertise, especially with respect to risk assessment. The Biosafety Officer may attend the convened IBC meeting or send comments in writing. The designated primary reviewer, who has biosafety expertise, is responsible for conducting primary review.

f) A KEMRI €“IBC Approval form has been developed to assist PIs in determination of other forms or requirements for IBC approval. Other requirements for protocol submission are as follows:

Experiments involving deliberate transfer of rDNA into human subjects must also be reviewed by the NBC/NCST and/or by the funding agency.

PIs using viral vectors in research must submit a Viral Vector Registration Form (Appendix 2) to the HSE Office for IBC approval. In addition, if animals are to be used in the research, a "Standard Operating Procedure" for handling these animals must be submitted to the HSE Office and approved.

Experiments involving any animal work must also be approved by the ACUC .

Experiments using any Select Agents as defined by the KEMRI Biosafety manual must be submitted to the HSE Office for registration and have approval from the IBC.

Complaints and Alleged Noncompliance

a) If the IBC receives a complaint from a subject, subject family member, staff, or researcher concerning alleged noncompliance or subject rights and welfare, the Biosafety Officer or designee immediately (i.e., within 2 days) notifies the Chair IBC.

b) The Biosafety Officer initiates an inquiry following standard IBC operating procedures. After the IBC has completed its review of the complaint/alleged noncompliance, the Biosafety Officer is responsible for providing the Chair IBC, NBC/NCST and /or applicable funding agency.

Quality Assurance/Improvement Findings

1. If the protocol or donor agency funding the project conducts a directed or routine Quality Improvement Review (QIR) of an IBC protocol, the PI or Quality Assurance Unit (QAU), Study monitor is responsible for providing the Biosafety Officer with a copy of the findings of the directed or routine QIR.
2. If the Biosafety Officer or designee or any IBC personnel audits or inspects an IBC protocol, the Biosafety Officer or designee is responsible for providing the Study monitor and/ or applicable stakeholders with a copy of the report.