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Review Human Subjects Policy

Guidelines for the HSRRC Process

The Â鶹ÊÓƵ 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. Â鶹ÊÓƵ 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). Â鶹ÊÓƵ’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 from whom a researcher conducting research obtains data through (1) intervention or interaction with the individual, or (2) identifiable private information (CFR 46.102(f)).

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

Interaction includes contact between the investigator and the human subject.

Private Information includes data that has 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.

However, some projects are limited to the gathering of facts by interviewing content experts or consultants.  If no personal information is obtained from the interviewees they do not meet the federal regulation definition of human subjects and therefore the project is not subject to IRB review. Here is an example. Let’s say that you are working on a study project to determine how the Los Angeles Opera determined what its schedule would be for next season, and you were especially interested in how its budget affects that schedule.  You decide to interview Placido Domingo, the artistic director, and James Conlon, the resident conductor, for insight, and you get lots of interesting material. Even though you’re interviewing a human being, you don’t have a human subject because you are simply gathering information about this topic, rather than asking questions about themselves.  Even though you might publish your study, you don’t have a human subject, so you don’t have to go through the IRB process. 

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

Research is defined by the federal regulations if the investigation is systematic and is undertaken to develop generalizable knowledge (45 cfr 46.102(d)).

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

The concept of generalizable knowledge is harder to define, but typically, a project is generalizable if it aims to draw conclusions about people or practices beyond a specific individual, internal program, cohort or population. If you intend to present publically or publish the results of your work, it is probably research, but not always-- public presentation or publication is not a sine qua non of research.  Research is defined by whether or not generalizable knowledge is the result of the project. 

Most activities considered journalism (e.g., investigations and interviews that focus on specific events, views, etc., and that lead to newspaper/news publication, documentary production, or are part of training that is explicitly linked to journalism) do not constitute research, primarily because they are not intended to produce generalizable knowledge and do not require IRB review.  However, journalists sometimes conduct activities that do meet the federal regulations definition of research and are intended to produce generalizable knowledge (e.g., systematic research, surveys, and/or interviews that are intended to test hypotheses), and some of these activities may be subject to IRB review. In such cases investigators should consult with 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, that intend to test economic, or sociological theories or models) do require IRB review.  Columbia University (Institutional Review Board Policy) gives this example of the difference.  A study of the long term social impact of the Vietnam War on American culture that includes oral history interviews with veterans (not generalizable knowledge) does not need IRB review.  Oral histories that are taken to gain an understanding of the impact of PTSD on Vietnam veterans as part of a project to allow the researcher to predict what kinds of exposure in war situations lead to the development of PTSD (generalizable knowledge), does. Please also see the American Anthropological Association’s statement on ethnography, available . Of course, any oral history that has the potential to put any interviewee at any risk requires IRB review. 

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 regulations 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 to teach research methodologies, and are not research.  Any course papers, reports, or comprehensive projects that will not be published in any form and if ALL of the following categories 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 Â鶹ÊÓƵ student or employee is receiving financial compensation for collecting, organizing, analyzing, or reporting the data.

If one or more of these categories 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 that 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 in question number three. 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. EXEMPT refers to research with human subjects where the risk is so low risk that regulators exclude it from more rigorous IRB oversight. The word EXEMPT 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 word EXEMPT in the framework of the federal regulations. If, for example,  an instructor has an academic interest in pedagogy, and they are using their classroom partly as a “laboratory" to test innovations with the goal of contributing to generalizable knowledge (publish or the possibility of publishing) about pedagogy, IRB submission would likely be required, but this research would most likely be EXEMPT from further review.  Of course, any research that puts the subject at any risk must go through the IRB process.

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 where identification of the subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be reasonably stigmatizing or damaging to the subjects' financial standing, employability, insurability, 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 which does not fall into either the exempt or expedited review categories must be submitted for full committee review. The Â鶹ÊÓƵ IRB for governing human subject research meets once a month during the Fall and Spring semesters. It does not meet during the winter or summer breaks. 

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. Confidential data are recorded so that the information is not immediately identified with the subject who supplied it, but such a link is possible. Confidential data are usually coded–that is, the subject is assigned a unique identifier that will be used to identify the data. The code identifies the data and the subject's identity is kept separate from the code and data. Coded data are not anonymous.

6.  What about Internal Data Collection?

There are two different categories related to projects that are internal to Â鶹ÊÓƵ.

One is data collection for internal administrative study only (for example, course evaluations, departmental and program evaluations, other institutional surveys) that will not be distributed outside of Â鶹ÊÓƵ  and are designed for the purpose of improving services and are therefore are not generalizable outside 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.

7.  Do Pilot Projects Require IRB Review?

Pilot projects 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.

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 data bases, and government data bases that are restricted in their use).

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

If the data collected from the Internet or from other on-line digital sources involves human subjects and is intended for eventual publication, then this research requires 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 confidentiality of the participants, and address carefully the potential risks to the human subjects.

E-survey instruments like Qualtrics are not internet data sources.  Â鶹ÊÓƵ has a license to use the Qualtrics survey tool.  Information about use of Qualtrics can be found on the web page of the Center for Digital Liberal Arts (CDLA).  The CDLA also offers instruction in the use of Qualtrics.  

10. Final Considerations: All Projects Must Follow Ethical Standards 

Even when a project is not subject to IRB review, the instructor/faculty member/student is responsible for upholding all applicable ethical standards and guidelines in course related research, pilot projects, and institutional research.

As such, Occidental requires all principal investigators (faculty members, students, administrators & 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 (e.g., grants) to always check the awarding agency’s training requirements.  CITI training in human subject research is required as of August 1, 2018 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 Â鶹ÊÓƵ 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 (your proposal request - see the text link below) and submit it along with any other supporting information, e.g., 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 of June, July and August; therefore, researchers should make appropriate plans.  Customarily, the first committee meeting of the academic year is in early September and the last meeting of the year is in early May.  

CITI training in human subject research is required starting August 1, 2018 as part of the HSRRC-IRB review process, and before approval of a research project.  Principal Investigators including student and faculty reseachers, as well as faculty mentors/supervisors, should plan to complete the training well in advance of submitting a request for human subject research to Occidental's HSRRC-IRB.  Documentation of training should be submitted as a PDF file when you submit a request to conduct research with human subjects 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 viewed and printed:

Approval Requests
Consent Forms

Researchers External to Â鶹ÊÓƵ Wishing to Conduct Research on Â鶹ÊÓƵ Faculty, Staff, or Students

Rationale - Researchers external to Â鶹ÊÓƵ wishing to conduct research on Occidental faculty, staff, and/or students must secure permission prior to initiating any research 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 Occidental Human Subjects Research Review Institutional Review Board.  Permission requests can be made by attaching the following documentation in an email to the Â鶹ÊÓƵ IRB at hsrrc@oxy.edu.  Such requests must include:

• The researcher’s contact information, including email and mailing address.
• The anticipated start/ end dates 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 for the Principal Investigator (e.g., through the Collaborative Institutional Training Initiative [CITI] program), and
• A copy of the IRB approval letter.

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