Standard Operating Procedures

The above “Standard Operating Procedures” document represents the main corpus of UC policies and procedures for the UC IRB. If you have a specific issue you’d like to research on IRB policies and procedures, we advise you to take a look at the SOP document.

The College is required to annually assure the federal government that such safeguards are being provided and enforced. These safeguards derive from the following ethical principles, which were first articulated in the Belmont Report issued by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in 1979:

Respect for persons:

Recognition of the personal dignity and autonomy of individuals and special protection of those persons with diminished autonomy or particular vulnerabilities, including prisoners, children, those who are mentally or cognitively disabled, pregnant women, or economically or educationally disadvantaged persons. Human subjects should enter into research voluntarily and with adequate information.

Beneficence:

The obligation to protect persons from harm by maximizing anticipated benefits and minimizing possible risks. Possible risks to human subjects should be weighed against possible benefits to the subjects, and the possible advancement of knowledge. 

Justice:

Fairness in the distribution of research benefits and burdens. In selecting human subjects for research, investigators should ensure that no group of participants is either consistently selected to participate in research, or consistently deprived of the opportunity to do so.

Comment on this Policy

The goal of this policy is to allow for the conduct of responsible research involving human subjects, and to protect the health and welfare of those individuals who are subject to such research. 

While this Policy covers all research on human subjects and intends to safeguard those subjects’ rights, researchers themselves also bear responsibility for safeguarding those rights. Thus, they should adhere to the following Statement of Principles and Ethics. 

STATEMENT OF PRINCIPLES & ETHICS

Compliance with Law, Standards, and College Policy:

Researchers plan and conduct research with human participants in a manner consistent with federal and state law and regulations, as well as professional disciplinary standards governing the conduct of research. As required by this Policy, researchers obtain institutional approval prior to conducting research.

Informed Consent to Participate:

Prior to conducting research (except research involving only anonymous surveys, naturalistic observations, or similar research), researchers enter into an agreement with participants that clarifies the nature of the research. Researchers inform participants of all features of the research that might influence their willingness to participate. Further, researchers respect each participant’s freedom to decline to participate in research or discontinue participation at any time for any reason and without penalty.

Minimization of Invasiveness and Harm:

Researchers protect participants from physical and mental discomfort, harm, and danger. Risks to participants are minimized and explained to the participant before she or he agrees to participate. If the research procedure has undesirable effects on participants, the researcher should remedy these effects.

Deception in Research:

 Researchers do not conduct an investigation involving deception unless they have determined that the use of deceptive techniques is justified by the prospective scientific or educational value and that equally effective alternative procedures that do not use deception are not feasible.

Confidentiality and Privacy:

 All personally identifiable information obtained from participants is confidential. When the possibility exists that others may obtain this information, researchers inform participants of this before they consent to participate. All information and data are handled, stored, and discarded in a manner that insures the confidentiality of each participant.

OTHER DEFINITIONS

Vulnerable Populations - sick persons, pregnant women, fetuses, prisoners, children, elderly persons, mentally disabled persons, and persons who are educationally or economically disadvantaged.

Research Practicum - is a course of study that involves the supervised practical application of previously studied theories of research method. A number of departments offer courses that require students to interview or observe other people. The purpose of these courses is to train students and give them an opportunity to practice various research methods. Such projects do not require review by the Board.

Research Project - is any student-initiated and/or student-conducted research that does not fall under the definition of a research practicum, which uses human subjects, and intends to contribute to generalizable knowledge. Thus, it requires review and approval by the Institutional Review Board. Honors projects that involve the use of human subjects fall within this category.

Research- a systematic investigation designed to develop or contribute to generalizable knowledge.

Generalizable Knowledge - intent it to share with scientific community, information is intended to be used outside the institution.

Human Subject - a living individual about whom an investigator conducting research: (1) obtains identifiable information through intervention or interaction with the individual intervention, and uses, studies, or analyzes the information, or (2) obtains, uses, studies, analyzes, or generates identifiable information.

Identifiable Private Information - private information for which the identity of the subject is or may readily be ascertained by the investigator or associated with the information. Possible information could include: name, social security number, medical record number, specimen number, etc.

Respect for Persons - recognition of the personal dignity and autonomy of individuals and special protection of those persons with diminished autonomy or particular vulnerabilities, including prisoners, children, those who are mentally or cognitively disabled, pregnant women, or economically or educationally disadvantaged persons. Human subjects should enter into research voluntarily and with adequate information.

Beneficence - the obligation to protect persons from harm by maximizing anticipated benefits and minimizing possible risks. Possible risks to human subjects should be weighed against possible benefits to the subjects, as well as against the possible improvement of knowledge.

Justice - fairness in the distribution of research benefits and burdens. In selecting human subjects for research, investigators should ensure that no group of participants is either consistently selected to participate in research, or consistently deprived of the opportunity to do so.

Minor Change - changes that have no impact on risk level, selection of subjects, informed consent, data monitoring, privacy and confidentiality. Examples include: new student investigators, deleting questions from surveys, procedures that pose minimal risks of harm.

Quorum- the minimum number of members required to make the vote official.