Human Subjects Review (HSR)

Activities that often Do Not Require Human Subjects Review

Not every academic project or activity involving human participants requires human subjects review. This page provides examples of some types of projects that do not typically require human subjects review and approval. If you have questions about whether a project might require review, consult Who Must Apply for Human Subjects Review? or contact Evergreen's IRB administrator.

Students frequently engage in academic activities that involve human participants. For further information about how to proceed with classroom or independent learning contract activities, whether or not the project requires IRB review and approval, please refer to Guidelines for Student Work with Human Subjects.

Projects that do not require IRB review and oversight may still present risks to human participants and thus call for the exercise of ethical principles and practices. Researchers and faculty advisers have primary responsibility for ensuring that any activities involving human participants are handled ethically. The principles articulated in the Belmont Report should guide any investigation relying on human participants, whether or not it requires human subject oversight: first, minimize the risk to participants (beneficence); second, ensure all participants consent and are fully informed about the research and any risks (autonomy); third, promote equity in research (justice). Many professions also have their own guides for the ethical conduct of research.

Examples of projects that do not require human subjects review

The following categories of activities frequently are not human subjects research and do not require a human subjects review application. Please read each entry carefully, however, as there may be circumstances in which some activities cross the threshold and require review.  If you have questions, ask John McLain, Academic Grants Manger, ext. 6045.

Class projects that involve human participants and systematic research methods, but present no more than minimal risk and do not result in generalizable research

Frequently, faculty develop course-related activities or students propose independent research projects that are designed to provide opportunities to practice research methods (e.g., interview, observation and survey techniques; data analysis; research design). If such projects are limited in scope, present no more than minimal risk to participants, and do not lead to generalizable results, they do not require human subjects review. Students working on such projects should nevertheless ensure full disclosure about the purpose of their project and obtain participant consent.

Information gathered informally for class discussion or to provide ideas for creative work

Course-related activities or independent student projects that gather information from people outside of a class purely for the purposes of providing material for class discussion, reflection, demonstration, or illustration, or as background information for creative writing, theater, or other projects, are not research and do not require IRB review, even if the activity gathers information from people under 18 years of age (or other protected category), so long as the work meets the federal definition of minimal risk. Sometimes this work is documented in a personal journal, notes, or written reflections. This type of activity (e.g., informal questioning of students, parents, asking other faculty for views, etc.) is not research so long as it does not systematically gather information that is intended to contribute to generalizable knowledge.

Class demonstrations and laboratory exercises using students enrolled in an academic program

In-class demonstrations, lab exercises, or other non-invasive (i.e., not involving collection of physiological samples beyond pin-prick methods) collection of information from students who are enrolled in an Evergreen academic program for which the activity is a part, pose only minimal risk as defined by the federal guidelines, and are conducted for demonstration purposes, rather than for the purpose of developing or contributing to a knowledge base, are exempt from IRB review. That is, an activity is exempt if it simply demonstrates a phenomenon or helps students gain skills in particular experimental methodologies, and is not a systematic investigation intended or designed to contribute to generalizable knowledge.

Class demonstrations using participants not enrolled in the course

Educational activities that gather information from participants who are not students in the class, even from children below 18 years of age (or other protected groups) for demonstration purposes and/or educational training of teachers are exempt from IRB review if they involve only standard educational/developmental demonstrations or assessments (e.g., Piagetian stages, infant behavior, etc.) that do not provide information that might be used to categorize and/or diagnose children or other participants in a way that might adversely impact them (e.g., IQ tests, measures of behavior problems, measures of social functioning). An example of such an activity might be having a toddler visit class to demonstrate an aspect of child development, or having an adult attend a class session to be asked questions by students, or otherwise provide information. These kinds of class activities are not research that requires IRB review unless they are designed or intended to gather information that contributes to generalizable knowledge.

Student teaching and educational internships

Information gathered during the normal course of student teaching do not require human subjects oversight.  These activities include supervised teaching experiences, supervised volunteer teaching work, observations of classroom activities, case studies shared only with supervisors or faculty and fellow student teachers, and other activities where the primary purpose is to help students develop more effective teaching practices. Student teachers and interns should adhere to all applicable federal, state and local laws and policies governing the protection of student information. The Family Educational Rights and Privacy Act (FERPA) establishes federal requirements for maintaining confidentiality of student records.  (Note: Projects that evaluate educational practices in typical educational settings are, by law, often exempt from IRB oversight, but still require an application to determine the exemption status.)

Clinical internships and practice

Activities that gather information from human beings during the normal course of supervised clinical practice or training are exempt, even when the work involves protected categories of participants, if the activity is part of a standard, recognized therapeutic program.  Standards of confidentiality for health care records are well established and should be followed by student interns at all times. The federal Standards for Privacy of Individually Identifiable Health Information (part of the Health Insurance Portability and Accountability Act—HIPAA) are a good place to start, but each clinical setting will have its own practices in place. If the clinical work experience involves experimental procedures, or is part of an ongoing research program, then such activity requires human subjects review, either from Evergreen or the sponsoring organization/institution.

Informational interviews and surveys that are not about individual human beings

Projects where the investigator is not collecting data or private information about individual, living human beings are not human subjects research. Examples of these types of projects might include:

  • Surveys or interviews of natural resource managers about policies and practices governing the protection of endangered species.
  • Interviews of clinical practitioners about the types of therapies available to treat certain conditions.
  • Requests for aggregated, non-identifiable demographic data about specific populations (such as those receiving services at a clinic or enrolled in a school).
  • Interviews about the structure, purpose, strategies, or environmental challenges of organizations.

Oral histories and biographies

Oral histories and biographies that describe or document particular lives, phenomena, or historical events are exempt from IRB review. Oral histories and similar investigations that are intended to produce generalizable conclusions (e.g., that serve as data collection intended to test economic, sociological, or anthropological models/theories) do require IRB review. The Oral History Association has published Principles and Best Practices for Oral History.

Journalism and documentary production

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) are not research, and do not require IRB review.  When journalists conduct activities normally considered scientific research intended to produce generalizable knowledge (e.g., systematic research, surveys, and/or interviews that are intended to test theories or develop models), some of these activities may be subject to IRB review. In such cases investigators should consult with the IRB. The Society of Professional Journalists has established a Code of Ethics governing journalistic activities. The study, Honest Truths, by the Center for Social Media at the American University School of Communication, may be helpful for documentary media producers.

Institutional assessment, quality assessment, quality improvement

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) does not generally require IRB review or approval, because such activities usually serve to assess and document matters specific to the college, rather than contribute to generalizable knowledge.  The privacy of participants in these projects should be protected and participation must be voluntary.  The treatment of private student information of the type frequently used in assessment is protected by the provisions of the Family Educational Rights and Privacy Act (FERPA). In some instances, assessments of this kind can have a broader applicability (such as through presentations to outside entitities, or participation in multi-institutional studies that compare and contrast student characteristics) and should undergo review.

Case studies

Case studies—explorations of particular individuals or small groups in very specific contexts--generally do not involve systematic investigation or lead to generalizable results and, therefore, do not meet the definition of research involving human subjects and do not require prior IRB review and approval. However, a report of a series of cases may qualify as human subjects research and should be submitted for review and approval.