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 respect for persons, beneficence, and justice may also serve as a guide to researchers in formulating their protocols and research procedures. Briefly stated:

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 of Decision

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

(a) 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;
(b) Selection of subjects is equitable;
(c) Informed consent will be sought from each prospective subject or legally authorized representative and will be appropriately documented;
(d) Consent procedures are non-coercive (e.g., as from subtle fear of reprisal or undue financial enticement);
(e) When appropriate, the research plan provides for monitoring the data collected to insure the safety of subjects;
(f) When appropriate, there are adequate provisions to protect the privacy of subjects and the confidentiality of data;
(g) When the subjects are likely to be vulnerable to coercion or undue influence, there are appropriate additional safeguards to protect their rights and welfare;
(h) When research procedures involve more than minimal risk, there is adequate consideration time between initial consent request and onset of research procedures;

When the situation warrants, the IRB may determine that certain projects require review more often than annually and that certain projects need verification from sources other than the investigator that no material changes have occurred since the previous IRB/IEC review.

UCSC IRB Reporting Requirements

The UCSC IRB has the duty to report promptly to appropriate officials of the University of California and, through these officials, to the financial sponsors of research, on a variety of matters. These include:

a. any serious or continuing noncompliance by researchers with the requirements and determinations of the UCSC IRB,
b. serious unanticipated injuries or other serious problems involving risks to subjects or others, and
c. suspension or termination of approval of research protocols by the UCSC IRB.

The UCSC IRB also reports directly to the Federal Office for Protection from Research Risks on these matters to the extent that Federal law or policy requires but not otherwise.

Researchers who are applying for a Federal grant are reminded that the Federal granting agency may require the UCSC IRB to certify its approval of the research application for the grant. To assure that the UCSC IRB can do this, researchers should submit their research for human subjects review at the same time that they apply for the grant.