The APIN IRB may suspend a protocol, for example, in instances where the outcome is obvious, already known or when there is a violation of protocol/ non-adherence to approved protocol.
Failure to submit progress reports may serve as sufficient grounds to suspend a research protocol. Other grounds for the suspension of a research protocol include instances where the researcher has failed to renew or apply for an extension within four to six months to the expiration of the approved protocol. The APIN IRB may disapprove or suspend an approved protocol, based on a consideration of all or any of the following reasons:
- - Protection of human subjects of research
- - Unanticipated risks to research subjects
- - Poor scientific base of research
- - Poor data management in the course of research
- - Researchers unqualified to conduct a proposed study
- - Absence of informed consent
- - Non-adherence to Nigerian or international laws
- - Insensitivity to local customs
- - Laws, traditions and any other factor that may not be in line with ethical conduct of research.
If a decision is made to suspend a protocol, the researcher will usually be notified by e-mail, within two weeks, the notification letter containing detailed information on the decision of the IRB
Other parties that will be notified include the APIN Management, Protocol sponsors, and regulatory authorities. The researcher may not conduct any further activity associated with the protocol until the suspension is lifted. If the APIN IRB places restrictions on some components of a protocol, the researcher may not progress further with those components. Appropriate communications will be made accordingly.