How the IRB Makes Decisions

The Review Process

At the time protocol materials are received, all documents will be examined for compliance with submission requirements. The IRB Administration staff perform a preliminary review of the protocol and may question the Principal Investigator (PI) directly on any concern before the actual IRB review. The PI must respond to the comments before the protocol is distributed and reviewed by the IRB. Incomplete submissions will not be accepted for review until the PI has provided all necessary materials as determined by the IRB staff. The IRB staff will notify the submitting Investigator to obtain any outstanding documentation or additional information before the application is forwarded for IRB review.

Ethical Principles

In reviewing research involving human subjects, the UCSC IRB is guided by three ethical principles propounded in the Belmont Report of the National Commission for the Protection of Human Subjects. These principles of may also serve as a guide to researchers in formulating their protocols and research procedures. Briefly stated, they are the following:

  1. Respect for persons means that researchers should obtain the informed consent of all human subjects invited to participate in research. In order to respect subject autonomy, the consent process should include giving subjects full and comprehensible information about the research and provide clear assurances of the subjects' voluntary participation.
  2. Beneficence , or concern for the wellbeing of subjects, means that the risk of harm to subjects should be the least possible, and that the sum of benefits to the subjects and the importance of the knowledge to be gained should so outweigh the remaining risk of harm to the subject as to warrant a decision to allow this risk.
  3. Justice means that the selection of human subjects should be fair and equitable and that the risks and benefits of research should be distributed among subjects in a fair and equitable manner, with particular concern for subjects whose personal status or condition as children, prisoners, patients, impoverished persons places them in a vulnerable or dependent status.

Criteria for IRB Approval

Before approving a project, the UCSC IRB will determine that all of the following requirements are satisfied:

  1. Risks to subjects are minimized and are reasonable in relation to anticipated benefits , if any, to subjects and the importance of the knowledge that may reasonably be expected to result;
  2. Selection of subjects is equitable;
  3. Informed consent will be sought from each prospective subject or legally authorized representative and will be appropriately documented;
  4. Consent procedures are non-coercive (e.g., as from subtle fear of reprisal or undue financial enticement);
  5. When appropriate, the research plan provides for monitoring the data collected to insure the safety of subjects;
  6. When appropriate, there are adequate provisions to protect the privacy of subjects and the confidentiality of data;
  7. When the subjects are likely to be vulnerable to coercion or undue influence, there are appropriate additional safeguards to protect their rights and welfare;
  8. When research procedures involve more than minimal risk, there is adequate consideration time between initial consent request and onset of research procedures;

Once approval is received research may begin as written. If changes are needed, they first must be submitted and approved before enacting them unless to prevent immediate hazard to subjects.