IRB Review and Approval Process

The IRB Review Process

At the time an application for review of proposed human subjects research is submitted in Cayuse Human Ethics, all documents will be examined for compliance with submission requirements. The Office of Research Compliance Administration staff will perform a preliminary review of the study and may send a request for clarification/revision/additional documentation  to the Principal Investigator (PI) or Student Co-PI. Incomplete submissions will not be reviewed until the PI has provided all necessary materials as determined by ORCA staff.

Ethical Principles

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

1. Respect for Persons means that investigators 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.

Regulatory Criteria for IRB Approval

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

1. Risks to subjects are minimized:

   1. By using procedures that are consistent with sound research design and that do not unnecessarily expose subjects to risk, and

   2. Whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.

2. Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research). The IRB should not consider possible long-range effects of applying knowledge gained in the research (e.g., the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility.

3. Selection of subjects is equitable. In making this assessment the IRB should take into account the purposes of the research and the setting in which the research will be conducted. The IRB should be particularly cognizant of the special problems of research that involves a category of subjects who are vulnerable to coercion or undue influence, such as children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons.

4. Informed consent will be sought from each prospective subject or the subject's legally authorized representative, in accordance with, and to the extent required by, §46.116.

5. Informed consent will be appropriately documented or appropriately waived in accordance with §46.117.

6. When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.

7. When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.

   1. The Secretary of HHS will, after consultation with the Office of Management and Budget's privacy office and other Federal departments and agencies that have adopted this policy, issue guidance to assist IRBs in assessing what provisions are adequate to protect the privacy of subjects and to maintain the confidentiality of data.

When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these subjects.

Once approval is received research may begin as written. If changes are needed, they first must be submitted via a Modification Submission in Cayuse Human Ethics and approved before enacting them unless to prevent immediate hazard to subjects.

Review Process FAQ