What Type of Review is Needed?

The level of risk to the human subjects determines the type of review. Anything more than minimal risk requires full-committee review. Anything minimal risk or less may qualify for expedited review or exempt certification. Once the project begins, there will be continuing reviews at least every 12 months.

“Minimal Risk” means that “the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examination or tests.” (45 CFR 46.102)

EXEMPT CERTIFICATION
Projects that do not need HSIRB review, but require the submission and review of a Request for Exemption form to certify the exempt status. Research projects classified as 'exempt' can still involve human subjects. However, it poses little risk to the participants. Therefore, it is exempt from the federal regulations. Federal regulations allow certain lines of research to be exempt from the regulations. Link to a list of exemptions paraphrased from 45 CFR46 (b).

EXPEDITED REVIEW
Federal regulations allow certain types of research to be reviewed under expedited procedures

FULL REVIEW
Projects involving human subjects and do not fall into either the exempt or expedited review categories are given a full review. This level of review is reserved for research projects that present more than minimal risks to subjects.

HOW TO WRITE A HUMAN SUBJECTS RESEARCH PROTOCOL(Guidelines)

Guidelines

Write protocol according to the guidelines above.
Submit 2 copies of protocol to Dr. Tracey L. Poston in the Office of Research (511 Main) at least one week prior to scheduled meeting.

WHAT HAPPENS AFTER A PROTOCOL IS SUBMITTED?
After review, the IRB Administrator will notify the investigator in writing as to the status of the protocol. Any changes recommended by the HSIRB must be incorporated into the protocol and implemented.

Copies of revised documents are forwarded to the Executive Secretary for the protocol file before the research begins.

Amendments to an approved protocol may be submitted in writing to the Executive Secretary. Amendments will be reviewed by the HSIRB chair and Executive Secretary to determine if the amendment represents a significant change from the approved protocol. If deemed significant, a new protocol must be submitted for full HSIRB review.

If project lasts more than 12 months, undergo Continuing Review.

CONTINUING REVIEW
All protocols approved by the HSIRB must undergo continuing review at least every twelve months.

The frequency of review is dictated by the risk to the subjects and is stipulated on the approval form sent to the investigator(s). This continuing review allows for the protocol
to be analyzed in order to determine if the anticipated risks/benefits stated in the protocol actually occurred during the experimental phase. It determines if the safeguards stated in the original protocol are adequate or if they need to be modified.

What You Must Do:
File a Request for Continuation of Previously Approved Protocol form

This form requests the following information regarding the status of the research project:
• Number of subjects enrolled to date,
• Any Adverse Events or Unanticipated Outcomes (see below) involving risks to subjects,
• Any withdrawal of subjects or complaints about the research,
• Any findings relevant to risk/benefits ratio.
• Include two (2) copies of the updated protocol with Consent/Assent, instruments, questionnaires, etc. to the HSIRB.

Conditions of approval and renewal date specified on the review form represent the minimum requirements for the research.

• Responsible investigators must continually review the project as it unfolds to determine if there are any findings that would affect a subjectís willingness to participate in the research.

• There may be need to revise the protocol and/or revise the Consent Document to reflect these findings.

• The HSIRB must be notified immediately and the research halted if there are instances where the health and safety of subjects are compromised.

UNANTICIPATED OUTCOMES
During the course of the experiment, investigators must continuously monitor the results to determine if risks and benefits to the subjects have changed. Additionally, other related studies may provide information that would affect risk/benefit ratio.

The investigator is charged with notifying the HSIRB if the risks to subjects have changed and what steps are being taken to reduce the risks to subjects and to increase the benefits.

A revised protocol and Consent Document needs to be forwarded to the HSIRB. Subjects previously enrolled may also need to be notified of the unanticipated outcomes.

ADVERSE EVENTS
Adverse Events are serious unanticipated developments which affect the health and safety of the research subjects. The researcher must report these events immediately to the HSIRB and suspend the research until the nature, severity and frequency of the events are analyzed. The death of a research subject, whether related to the study or not, must be reported to the HSIRB immediately.