ASM events
This conference is managed by the American Society for Microbiology
Table of contents
No headers

Information taken from The University of Findlay Policies and Procedures Guidelines for Human and Animal Subjects Institutional Review Board, amended August 2010. Available on UF intranet, 7/23/2012.

Introduction

The University of Findlay has established a Research Review Committee to review and approve all research involving human and animal subjects. All human and animal subjects research conducted at the University must be reviewed and approved by an Institutional Review Board (IRB) prior to the start of the research.

The National Research Act Public Law 99-156, the Food and Drug Administration regulations published at 21 CFR 50 and 56, Health and Human Subjects regulations published at 45 CFR 46, The Health Research Extension Act of 1985, and the National Commission for the Protection of Human Subject of Biomedical and Behavioral Research provide guidelines for research with human subjects to ensure their protection in the design and conduct of research.

Based on these federal regulations, it is the responsibility of the investigator to refer his or her project to the IRB for review whenever human and animal subjects are being considered for research, even if the investigator does not consider the subjects to be at risk. The Review Board will have the responsibility for determining what does or does not meet the criteria for exempt, expedited review or full review.

 

B. Basic Principles

The fundamental responsibility of the IRB is to assure that all ethical issues have been fully addressed in the protection of human subjects who volunteer to participate in research studies. The Research Review Board members consider:

1) the risk-benefit relationship to the subjects,

2) the informed consent process and document(s) to be used appropriately, and

3) the importance of the knowledge expected to be gained through the research.

 

In addition, the IRB reviews the information to determine whether subjects are informed about the nature of the study, the details of their participation, and the voluntary nature of their participation, and whether the risks and benefits of the research are evenly distributed among the possible subject populations.

 

The risks imposed upon the subject vary with different types of research. There may be physical, psychological, social or ethical risks. There are two classifications of risk used in determining standards of review. A subject is at minimal risk when the potential for harm is not greater, considering the probability and magnitude, than ordinary encountered in a daily life, or during the performance of routine physical or psychological examinations or tests, as determined by the general population. A subject is at significant risk when the potential for harm is greater, considering the probability and magnitude, than ordinarily encountered in daily life, or during the performance of routine physical or psychological examinations and tests, as determined for the general population. (see IRB Principal Investigator Protocol Brochure)

 

Each research project is approved by the Review Board for a fixed number of subjects and for a set period (one year). The maximum period between reviews is one year. An application form has been developed to facilitate re-approval of research projects while ensuring a complete review of the project.

 

C. Submission Deadlines

If the research is categorized as either exempt or expedited, there is no submission date for these types of research (refer to Section III “Types of Research”). If the research project is neither exempt nor expedited, then the submission deadline for IRB forms is two weeks before the scheduled IRB meeting dates. It the responsibility of the investigator to submit the IRB forms in a timely manner. The IRB chair will conduct an initial screening of all research proposals submitted to ensure that the applications are complete and to determine the category of research.

 

D. Screening Process

All applications are screened by the chair of the IRB for complete documentation before determination if the project is exempt from review, requires expedited review, or a full review by the board members. If the application is incomplete or otherwise not fully prepared for IRB review, it is returned to the investigator for completion or additional information. On occasion, an IRB chair may contact the investigator by phone or letter requesting clarification of protocol issues or revisions in consenting documents. The chair may, at his/her discretion, refer the review of a research project to the another IRB member if he/she determines a) there is a conflict of interest among the investigator(s), or b) more appropriate expertise lies in the other IRB member(s).

 

E. Notification

Investigators will be sent an acknowledgment letter and IRB identification number indicating that their proposal is complete, or that specific modifications or additional materials are required from the IRB. No use of human subjects is permitted before such approval. The IRB will send copies of the approval to the principal investigator who must be a faculty/staff member even if a student project. Following approval, the principal investigator is responsible for carrying out the project precisely as presented to the IRB. Any changes in the protocol, additional elements, or problems that arise in the course of the project, must be reported to and reviewed by the IRB before use of human subjects may continue.

Tag page
You must login to post a comment.