³Ô¹ÏÌìÌÃ91

Review Human Subjects Policy

Review Non-human Subjects Policy

For approval request forms, consent forms, and other documents, please consult the drop-down menu within the In This Section box on this page.

Guidelines for the HSRRC Process

The ³Ô¹ÏÌìÌÃ91 HSRRC IRB, in accordance with Federal Policy for the Protection of Human Subjects (Title 45 of the Code of Federal Regulations (CFR) Part 46, known as the Common Rule), regulates all research involving human subjects. ³Ô¹ÏÌìÌÃ91 is committed to safeguarding the rights and welfare of individuals participating as subjects in research. These safeguards are based on the ethical principles listed in the Belmont Report: Respect for Persons, Beneficence, and Justice. The College has an agreement with the Office for Human Research Protections (OHRP) in the Department of Health and Human Services (DHHS), known as a Federalwide Assurance (FWA). ³Ô¹ÏÌìÌÃ91’s FWA number is: FWA00005302.

Review the questions below to determine if your project must go through the IRB process for approval before you begin to collect any data.

1. How do I know if I am using human subjects?

Human subjects are defined as living individuals about whom a researcher conducting research obtains data through (1) intervention or interaction with the individual, or (2) identifiable private information (45 CFR 46.102(e)).

Intervention includes physical procedures involving the human subject by which data are collected. These procedures could either be applied directly to the subject or be manipulations of the subject’s environment.

Interaction includes contact between the investigator and the human subject.

Private Information includes data that have been collected about a human subject, which the individual can reasonably expect will not be made public. Private information is identifiable when the identity of the subject is or may be readily ascertained by the investigator or the identity of the subject may be readily associated with the information.

2.  How do I know if I am doing research and therefore need IRB review?

Research is defined by the federal regulations as an investigation that is systematic and that is designed to develop or contribute to generalizable knowledge (45 CFR 46.102(l)).

Systematic investigation is any activity that involves a prospective plan that uses data collection, either quantitative or qualitative, and analyzes these data to answer a question or to address a hypothesis. Examples of systematic investigation that are common at ³Ô¹ÏÌìÌÃ91 are surveys, questionnaires, interviews, and cognitive or perceptual experiments.

The concept of generalizable knowledge is typically understood to be a project that does not aim to draw conclusions about a specific individual, but rather to reveal something about the community or group to which people belong. If you intend to present publicly or publish the results of your work, it is probably research, but not always. Research is defined by whether or not generalizable knowledge is the goal of the project. 

Most activities considered journalism do not constitute research, because their goal is to provide an accurate and evidence-based portrayal of the individuals involved, not to develop generalizable knowledge. These activities do not require IRB review. However, journalists sometimes conduct activities that do meet the federal definition of research, as they are intended to produce generalizable knowledge (e.g., systematic research, surveys, and/or interviews that are intended to test hypotheses about a given population), and some of these activities may be subject to IRB review. In such cases investigators should consult the IRB.

For the category of Oral History, some clarification of IRB oversight is in order. Oral histories and biographies that describe or document particular lives, phenomena, or historical events do not need IRB oversight. However, oral histories and similar investigations that are intended to produce generalizable knowledge (for example, studies intended to test economic or sociological theories or models) do require IRB review. Please also see the American Anthropological Association’s statement on ethnography, available . Of course,the IRB should be consulted for any oral history that has the potential to put any interviewee at any risk. 

Gathering data and information for purposes of institutional assessment, quality assurance, or quality improvement (e.g., surveys about student satisfaction with college services, analyses of the effectiveness of academic programs, market surveys) serve to assess and document matters specific to the College, rather than contribute to generalizable knowledge. This activity, therefore, does not meet the federal definition of research and does not require IRB review.

3.  Do student course projects need IRB review?

Certain course activities might seem to be research but do not meet the federal government’s definition of research. These are activities that are intended solely to teach research methodologies. Any course papers or reports that will not be made public in any form, if ALL of the following are true, do not need IRB review. 

a. The project is limited to surveys/interviews/observations of public behavior directly related to topics that are being studied in the course.

b. These surveys/interviews/observations contain no personal questions (for example: no questions about sexual behavior or attitudes, drug use, criminal or illegal activity, grades, medical history) or any other information that could stigmatize, hurt, or put at risk, any individual.

c. There is no identifying information that could link an individual with collected data so that the linkage could harm their reputation, employability, financial standing, or place them at risk for criminal or civil action.

d. The participants in the project are not from a vulnerable population or protected category. These subjects include, but are not limited to, pregnant women, minors, prisoners, elderly persons, and the cognitively impaired.

e. The collected data will not leave the classroom setting.

f. No ³Ô¹ÏÌìÌÃ91 student or employee will receive financial compensation for collecting, organizing, analyzing, or reporting the data.

If one or more of these statements are NOT true, your project will need to engage the IRB process.

However, even if all of these categories are true, the instructor may choose to have students engage the IRB process as one of the course outcomes.

Instructors/faculty members who do not require their students to engage the IRB process are required to submit to the HSRRC a verification that the projects being conducted in every course meet the conditions mentioned above. Faculty/Instructors please use the Classroom Activities Faculty Form.

4. What are the Human Subjects IRB Review Categories? 

EXEMPT FROM FURTHER REVIEW  Exempt is a term defined by the federal regulations. The word is often used more broadly by those not familiar with the regulations to describe any project that does not require IRB review. This is an imprecise application of the term in this context. Exempt research is deemed to involve no more than minimal risk and falls under specific categories defined by the federal regulations. Potentially exempt research still requires IRB review and determination for exempt status, but it doesn't require the same level of ongoing oversight as other categories of research.

EXPEDITED REVIEW  This level of review only applies to research involving no more than minimal risk. Minimal risk is defined as a risk level similar to what is encountered in daily life or during performance of routine physical or psychological exams or tests. The expedited review procedure may not be used when identification of the subjects and/or their responses would reasonably place them at risk of criminal or civil liability or lead to stigmatization or damage to the subjects' financial standing, employability, insurability, or reputation, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal. 

FULL COMMITTEE REVIEW  Proposed human subject research that does not fall into either the exempt or expedited review categories must be submitted for full committee review. The Human Subjects Research Review Committee, ³Ô¹ÏÌìÌÃ91’s human subjects IRB, meets once a month during the Fall and Spring semesters. It does not meet during the winter or summer breaks. Please consult the committee’s calendar and submit all materials several weeks in advance to ensure review of your proposal.

5.  What is the difference between confidential and anonymous data?

Anonymous data are recorded so that the information can never be linked to the subject who supplied it, even by the researchers themselves. Confidential data are recorded in such a way that identification of the subjects’ identity is possible, but their identity is kept private by the researcher. Confidential data are usually coded – that is, the subject is assigned a unique identifier that is associated with their data. The code that identifies the subject is stored separately from the data.

6.  What about Internal Data Collection?

There are two different categories related to projects that are internal to ³Ô¹ÏÌìÌÃ91:

One is data collection for internal administrative study only (for example, course evaluations, departmental and program reviews, institutional surveys) that will not be distributed outside of ³Ô¹ÏÌìÌÃ91. They are designed for the purpose of improving services and therefore are not generalizable outside of the College. This activity does not need to engage the IRB process.

A second category of research pertains to classroom activity where instructors/professors study techniques or technologies in order to improve their pedagogy. These can be systematic studies with data analysis from before and after the application of the innovation. No IRB review is required when the intention is solely to improve the teacher’s own teaching methods or curriculum, or even when a whole department implements a new curriculum based on data collected in the classroom. Only when the results are intended to be shared to contribute to generalizable knowledge is IRB review required.

7.  Do Pilot Projects Require IRB Review?

Pilot studies are preliminary investigations to determine if a study is feasible. Their purpose is to refine data collection techniques and research design on a small scale. As these studies are not, in and of themselves, going to contribute to generalizable knowledge, and therefore are not research, they do not need IRB review.

However, certain pilot projects do need IRB review. Those that:

• engage vulnerable populations. (These subjects include, but are not limited to, pregnant women, minors, elderly persons, and the cognitively impaired.)
• involve more than minimum risk.
• use data that is sensitive in nature.
• may be used later for publication purposes (i.e., if pilot data might be included in the final project, IRB approval should be secured before pilot data collection).

8.  Does Analysis of Existing Data Require IRB Review?

Existing data are also called secondary data. Secondary data analysis involves using existing data from other sources to answer new questions.

IRB review is NOT needed if the source of the data is public (for example, data from public libraries or newspapers) and the analysis of the data will not make the data individually identifiable.

IRB review IS needed if the source of the data is not public (for example, private databases and government databases that are restricted in their use).

9. Do Internet/Online Based Projects Require IRB Review?

All projects including data that are collected from the internet or other online digital sources that involve human subjects and are intended for eventual publication or public presentation require IRB review.

All such studies involving digital technologies must ensure compliance with the principles of voluntary participation and informed consent, provide for the anonymity and/or confidentiality of the participants, and address carefully the potential risks to the human subjects. If data are collected from social media, it is also the responsibility of the researchers, when designing a protocol, to understand and comply with social media’s terms of use, relevant College policies, and applicable laws and to be aware of any research or recruitment-related restrictions on the social media through which they intend to conduct their research activities. This includes advertising, privacy, and prohibited content policies.

10. Final Considerations: All Projects Must Follow Ethical Standards

Even when a project is not subject to IRB review, all faculty, staff, and students are responsible for upholding all applicable ethical standards and guidelines in personal and course-related research, pilot studies, and institutional research.

As such, Occidental requires all researchers (faculty members, students, administrators, and staff) engaged in human subject research to certify to the HSRRC-IRB that they have completed human subjects training before starting a research project. It is also important for investigators who receive external funding to always check the awarding agency’s training requirements. CITI training in human subject research is required as part of the HSRRC-IRB review process and before approval of a research project. 

If there is any question about whether a project should be subject to review, please consult the ³Ô¹ÏÌìÌÃ91 HSRRC IRB.

To Submit a Proposal for Review

If you are a member of the Occidental community planning any sort of research concerning human subjects, please complete the appropriate Approval Request Form and submit it along with any other supporting information, e.g., a consent/assent form, to hsrrc@oxy.edu. The proposal will be reviewed by the IRB Coordinator for completeness. Then, depending on the nature of the research requiring review, it will either be reviewed by the full committee or receive an expedited review. Please note: The committee meets monthly during the regular academic year, and does not generally meet during the summer months Therefore, researchers should make appropriate plans.

CITI training in human subject research is required as part of the HSRRC-IRB review process, and before approval of a research project. All persons engaged in human subjects research, including Principal Investigators, research assistants, and faculty mentors/supervisors, should plan to complete the training well in advance of submitting a request for human subject research review and approval to Occidental's HSRRC-IRB. Documentation of training should be submitted as a PDF file when you submit your proposal and other materials to the HSRRC-IRB Office at hsrrc@oxy.edu.

Research may not begin until you have been formally notified that your proposal has been approved by the HSRRC Chair or designated HSRRC member. 

The Approval Request Form (proposal request) and accompanying forms can be found here:

Approval Requests
Consent Forms

Researchers External to ³Ô¹ÏÌìÌÃ91 Wishing to Conduct Research involving ³Ô¹ÏÌìÌÃ91 Faculty, Staff, or Students

Researchers external to ³Ô¹ÏÌìÌÃ91 wishing to conduct research involving Occidental faculty, staff, and/or students must secure permission prior to initiating any contact with the Occidental community.

External Researchers with Approval from their institution:

External researchers who have secured approval from their institution’s own Institutional Review Board (IRB) who propose to use members of the Occidental community as research participants must request permission from the Chair of the ³Ô¹ÏÌìÌÃ91 HSRRC-IRB. Permission requests can be made by attaching the following documentation in an email to the IRB at hsrrc@oxy.edu. Such requests must include:

• The researcher’s contact information, including email and mailing address
• The anticipated start/end dates that the Occidental community will be engaged
• All materials approved by the researcher’s institution (e.g., application, consent documents, recruitment materials)
• A copy of the Principal Investigator’s experience/expertise related to the research (e.g., resume, CV)
• A copy of research training (e.g., through the Collaborative Institutional Training Initiative [CITI] program)
• A copy of the IRB approval letter

During the review of such a request, the Occidental IRB Chair will consult with other relevant departments and offices to ensure that the research may proceed. After consideration, Occidental’s IRB Chair will respond to the request in a timely fashion.