Policies and Procedures for Type 3 Projects

Inquiries involving risk or focused on the study of a vulnerable population

St. Olaf College maintains a written assurance to the federal government that all of its inquiries involving people will be guided by the three ethical principles of beneficence, respect, and justice.  This web page describes the ethics requirements for “Type 3” projects, where project procedures may pose some kind of risk for participants, or the project is focused on the study of federally-defined “vulnerable populations.”  These requirements are designed to ensure that Type 3 inquiries maintain beneficence, respect, and justice for project participants.

Comprehensive information about policies for all project types is provided in Research Ethics for Inquiries Involving People: Education, Ethics Planning, and Review Policies.  Projects that are supported by federal funding may be subject to additional requirements for education, ethics planning, and review; please confer with the St. Olaf Institutional Review Board chair to determine the appropriate procedures for a federally-funded Type 3 project.

Characteristics of Type 3 projects

Type 3 inquiry projects have either or both of the following characteristics:

  • Project procedures pose some kind of risk for the people being studied.  This includes projects that may cause the people being studied to incur psychological, social, legal, or physical harm or discomfort that exceed what they would encounter in normal daily activities.  See the St. Olaf Ethics Plan form for a detailed list of procedures that may pose risks to participants.
  • The project is focused on the study of a “vulnerable population.  Persons who are members of “vulnerable populations” (a term that is used in federal policies for the protection of research participants) may be susceptible to undue influence or coercion, or may experience greater risk as a result of project participation, and therefore require special protections.  Examples of “vulnerable populations” include:
    • Minors (children and adolescents under the age of 18)
    • Individuals who may be educationally or economically disadvantaged (e.g., recent immigrants, low-income persons, persons of color)
    • Adults (age 18 or older) whose decision-making may be compromised for reasons of mental illness, developmental disability, age-related dementia, or other condition
    • Individuals in correctional institutions, health care facilities, or long-term care facilities
    • Individuals with physical conditions that may make some types of procedures riskier for them (e.g., pregnant women, persons with food allergies)

A project is considered to be “focused” on the study of a vulnerable population when most or all of the participants are members of one or more of these groups and when the principal purpose of the project is to draw conclusions about that category of persons.  If a project includes some “vulnerable” persons simply because they happen to be part of the larger group being studied, but the project is not principally about those persons (e.g., a study about college student behaviors in which some of the sampled students are low-income), then the project is not considered to be focused on a vulnerable population.

Projects that involve risk and/or the study of a vulnerable population may or may not involve non-St. Olaf participants, and may or may not include dissemination beyond the college.  The education, planning, and review procedures for these projects are determined by the fact that they involve risk or study vulnerable subjects, not by whether the participants or the dissemination are internal or external.

Examples of projects involving risk or the study of vulnerable subjects are:

  1. Interviews with people that include questions about upsetting experiences or illegal activities;
  1. A survey of high school students.

Projects that do not pose risks, are not focused on a vulnerable population, do not include participants who are not current St. Olaf students or employees, and do not involve sharing of results outside St. Olaf, are Type 1 projects and are subject to different requirements.  Projects that do not pose risks and are not focused on a vulnerable population, but that include participants who are not current St. Olaf students or employees, or that may involve sharing of results outside St. Olaf, are Type 2 projects and are also subject to different requirements.

Education requirements for Type 3 projects

For supervisors of student projects:    

  • Required:  Inquiries Involving People: Ethical Principles, Practical Applications, and Investigator Obligations.   This is a statement of principles prepared by the St. Olaf IRB that summarizes the basics of research ethics in inquiries involving people.  It is organized around the principles of beneficence, respect, and justice, and explains the specific features that investigators usually need to build into their project design to ensure that those principles are honored.
  • Required: One of the following CITI online mini-courses in research ethics, as appropriate to the project:
    • Investigations with Greater than Minimal Risk
    • Investigations of Vulnerable Populations
    • Investigations Conducted Abroad
    • Records-Based and Internet Investigations

St. Olaf subscribes to the University of Miami’s Collaborative Institutional Training Initiative (CITI) program, which provides on-line mini-courses in research ethics to investigators in thousands of academic institutions, government agencies, and commercial organizations within and beyond the US.  Each course consists of a series of topical modules, accompanied by a short quiz at the end of each module.  A minimum score of 80% for the course as a whole (not necessarily each individual module) is required for successful course completion. To assist new CITI trainees in navigating the CITI site and selecting the appropriate course(s), the St. Olaf IRB has prepared a detailed guide on How to Access and Complete Appropriate Training on the CITI Website. In order to remain current with any changes in federal guidance, renewal of training is required every three years.

All of the course options listed above include a common set of core modules and additional modules specific to the type of project being undertaken.  If a project supervisor will be overseeing more than one of these types of projects, the supervisor should complete all the corresponding courses.  So, for example, a project that involves interviews with low-income clients of a social service agency in India would require completion of both the Investigations of Vulnerable Populations course and the Investigations Conducted Abroad course.  The CITI system is set up to recognize modules that have already been completed, so completing an additional course will require completing only the modules that were not included in prior courses.  Most “trainees” can complete a CITI course in less than two hours.

The St. Olaf IRB Administrator can access CITI records to verify course completions by St. Olaf students and employees, and successful completion of the appropriate course(s) by the project supervisor is a prerequisite for IRB review, which is required for all Type 3 projects.

For student, faculty, and staff investigators:

  • Required on-line training:  One of the following CITI online mini-courses in research ethics, as appropriate to the project:
    • Investigations with Greater than Minimal Risk
    • Investigations of Vulnerable Populations
    • Investigations Conducted Abroad
    • Records-Based and Internet Investigations

See above for information concerning the Collaborative Institutional Training Initiative (CITI) research ethics training program.  A minimum score of 80% for the course as a whole (not necessarily each individual model) is required for successful course completion. Investigators should consult How to Access and Complete Appropriate Training on the CITI Website for guidance on navigating the CITI training website and selecting the appropriate course(s). In order to remain current with any changes in federal guidance, renewal of training is required every three years.

All of the course options listed above include a common set of core modules and additional modules specific to the type of project being undertaken.  Some projects may require completion of more than one course.  For example, a project that involves interviews with low-income clients of a social service agency in India would require completion of both the Investigations of Vulnerable Populations course and the Investigations Conducted Abroad course.  If a project requires completion of more than one course, the CITI system will recognize modules that have already been completed, so completing an additional course will require completing only the modules that were not included in prior courses.

The St. Olaf IRB Administrator can access CITI records to verify course completions by St. Olaf students and employees, and successful completion of the appropriate course(s) by the investigator is a prerequisite for IRB review, which is required for all Type 3 projects.

Ethics planning forms and review requirements for Type 3 projects

For student projects:

  • Required:  Completion of an Ethics Plan, along with related forms as appropriate.  The supplementary forms needed depend on the features of the project.  The Ethics Plan form provides guidance concerning appropriate attachments.
  • Required:  Completion of an Application for IRB reviewProjects that pose risks to participants or that study vulnerable persons (see below) require the completion of an Application for IRB Review in addition to the Ethics Plan and other supplementary forms.  The application for IRB review solicits information about the project that is not elicited by the Ethics Plan or related forms.  The application is accompanied by the Ethics Plan and all attachments when it is submitted to the IRB for review (see below).
  • Required:  Ethics Plan and IRB Application review and approval by faculty/staff supervisor.  The supervisor reviews the Ethics Plan and accompanying documents in relation to the principles of beneficence, respect, and justice as described in Inquiries Involving People: Ethical Principles, Practical Applications, and Investigator Obligations and as amplified in the CITI course(s) applicable to the project.  The supervisor may wish to use the St. Olaf Ethics Plan Review form to provide feedback and indicate project approval once the investigator has made any needed changes to the plan.  Project supervisors are welcome to contact any member of the St. Olaf IRB at any time for advice on a student project plan.
  • Required:  Ethics Plan and IRB Application review and approval by the St. Olaf IRB.  After the project supervisor has completed his or her own review and has concluded that the project is “approvable,” the supervisor (NOT the student) should submit the student’s Application for IRB review, the Ethics Plan, and all attachments to the St. Olaf IRB Administrator.  One or more members of the IRB will review the documents and communicate the findings to the project supervisor.  Project revision may be required as a condition of IRB approval.  Students should not begin contacting prospective participants or otherwise collecting data until the project supervisor has been notified of IRB approval.  Both the student investigator(s) and the faculty/staff supervisor must have completed the appropriate CITI training in order for the IRB to review the project.

For faculty and staff projects:

  • Required:  Completion of an Ethics Plan, along with related forms as appropriate.  The supplementary forms needed depend on the features of the project.  The Ethics Plan form provides guidance concerning appropriate attachments.
  • Required:  Completion of an Application for IRB reviewProjects that pose risks to participants or that study vulnerable persons (see below) require the completion of an Application for IRB Review in addition to the Ethics Plan and other supplementary forms.  The application for IRB review solicits information about the project that is not elicited by the Ethics Plan or related forms.  The application is accompanied by the Ethics Plan and all attachments when it is submitted to the IRB for review (see below).
  • Required:  Ethics Plan and IRB Application review and approval by the St. Olaf IRB.  The investigator should submit the Application for IRB review, the Ethics Plan, and all attachments to the St. Olaf IRB Administrator.  One or more members of the IRB will review the documents and communicate the findings to the investigator.  Project revision may be required as a condition of IRB approval.  An investigator should not begin contacting prospective participants or otherwise collecting data until the he or she has been notified of IRB approval.  The investigator must have completed the appropriate CITI training in order for the IRB to review the project.

Investigators and project supervisors are welcome to confer with any member of the IRB at any stage of project design, preparation of ethics planning forms, or project review.