Policies and Procedures for Type 2 Projects

Beyond-the-college no-risk inquiries

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 2” projects, where there are no risks for project participants, but there are features of the project that engage people who are not St. Olaf faculty, staff, or current students.  These requirements are designed to ensure that Type 2 inquiries maintain beneficence, respect, and justice for project participants.

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 2 project.

Characteristics of Type 2 projects

Beyond-the-college no-risk projects have all of the following characteristics:

• The procedures involved in the inquiry do not pose risks to the participants.  An inquiry poses minimal or no risk when the project procedures would not cause participants to experience psychological, social, legal, or physical harm or discomfort beyond what they would be likely to experience in normal daily activities; see the St. Olaf Ethics Plan form for a detailed list of procedures that may pose risks to participants.

• The inquiry is not focused on 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
  • 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 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.

• The people being studied include non-St. Olaf individuals (people who are not current St. Olaf students or employees)  – OR –  findings from the inquiry may be disseminated to audiences beyond the college through publicly-accessible website postings, conference or community presentations, publications, or other means.  (In some cases an investigator may not know whether findings will be externally disseminated; external dissemination may depend on the nature of the findings, acceptance for publication, or other unknowns.  These projects should be treated as Type 2 projects to preserve the option of future dissemination.)

Examples of beyond-the-college no-risk projects are:

1. An academic civic engagement course assignment that includes no-risk interviews with members of a community organization that serves a broad cross-section of Northfield residents

2. A department assessment project where findings may be presented at an academic conference.

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 pose risk or that focus on a “vulnerable population” are Type 3 projects and are also subject to different requirements.

Education requirements for Type 2 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:
  • General Social and Behavioral Investigations
  • Records-Based and Internet Investigations
  • Investigations Conducted Abroad

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.

The General Social and Behavioral Investigations course addresses the ethical concerns that are most likely to arise in almost any type of inquiry involving people.  Most “trainees” can complete the General course in less than two hours.  The other two courses include all the modules in the General course but also include additional modules for projects that involve the analysis of existing and/or internet-based data, or that study people residing outside the US.  If a project supervisor will be overseeing more than one of these types of projects, the supervisor should complete all the corresponding courses.  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.  The St. Olaf IRB Administrator can access CITI records to verify course completions by St. Olaf students and employees.

For student, faculty, and staff investigators:

• Required:  Inquiries Involving People: Ethical Principles, Practical Applications, and Investigator Obligations.  See above for a description of this statement of principles.

• Required: One of the following CITI online mini-courses in research ethics, as appropriate to the project:
  • General Social and Behavioral Investigations course OR
  • Records-Based and Internet Investigations course OR
  • Investigations Conducted Abroad

See above for information concerning the Collaborative Institutional Training Initiative (CITI) research ethics training program.  The General Social and Behavioral Investigations course addresses the ethical concerns that are most likely to arise in almost any type of inquiry involving people.  The other two courses include all the modules in the General course but also include additional modules for projects that involve the analysis of existing and/or internet-based data, or that study people residing outside the US.  If an investigator has already completed a CITI course but needs to complete a different course to accommodate a new project, 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.  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).

Ethics planning forms and review requirements for Type 2 projects

For student projects:

• Required:  Submission of Ethics Plan, along with related forms as appropriate, to the faculty/staff supervisor.  The Ethics Plan and other Research Ethics forms are designed to help investigators know what steps to take in order to design and carry out an ethical inquiry.  The supplementary forms needed depend on the features of the project.  The Ethics Plan form provides guidance concerning appropriate attachments.

• Required:  Ethics Plan 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. Students should not begin contacting prospective participants or otherwise gathering data until their plans have been approved by their faculty/staff supervisor.  Project supervisors are welcome to contact any member of the St. Olaf IRB at any time for advice on a student project plan.

• Required at least once every three years and available any time upon request:  IRB advisory review of Ethics Plan and related forms.  Projects that involve non-St. Olaf participants or dissemination beyond St. Olaf can pose ethical issues that are not raised by within-the-college projects.  When a faculty or staff member is supervising a beyond-the-college no-risk project for the first time, he or she must request an advisory review of the project after he or she has completed his or her own review and has concluded that the project is “approvable.”  The supervisor should submit the student’s Ethics Plan and all attachments to the St. Olaf IRB Administrator.   A member of the IRB will review the documents and provide feedback to the supervisor with any recommendations for additional changes to project plans before the data collection begins.  The supervisor is responsible for overseeing the final design and implementation of the project.  The advisory review process should be repeated every three years, which will enable the faculty/staff member to remain current with any changes in federal guidance or college policy.  This includes renewal of CITI training, which is also required every three years. IRB advisory review is also available for any other project at the request of a faculty/staff supervisor.

• Available upon request: Certification of IRB Advisory Review.  A statement of certification may be desirable if the student investigator hopes to disseminate findings at a research conference or in a publication.  Project supervisors may request certification on the Ethics Plan form.

For faculty and staff projects:

• Recommended:  Completion of Ethics Plan, along with related forms as appropriate.  The inclusion of non-St. Olaf individuals as project participants, or the sharing of project findings with audiences outside St. Olaf, increases the obligation of the college to ensure that participants and their information are appropriately protected.  The completion of a written ethics plan and accompanying documents will help the college meet this obligation.  It will also assist investigators in case their plans change and they decide to share project findings with audiences outside St. Olaf.  In most cases, IRB review of Ethics Plans for Type 2 projects will not be required (see below); instead, the completed ethics plan alone will serve as sufficient documentation, since it is keyed to the ethical principles that the college has committed to uphold.

• Required at least once every three years and available any time upon request:  IRB advisory review of Ethics Plan and related forms.  Projects that involve non-St. Olaf participants or dissemination beyond St. Olaf can pose ethical issues that are not raised by within-the-college projects.  When a faculty or staff member is conducting a beyond-the-college no-risk project for the first time, he or she will receive an advisory review of the project by a member of the IRB. The investigator should submit the completed Ethics Plan and all attachments to the IRB Administrator.   A member of the IRB will review the documents and provide any recommendations for additional changes to project plans before the data collection begins.  The investigator is responsible for considering the IRB’s feedback in the final design and implementation of the project.  Three years after the initial advisory review, the faculty/staff investigator should request another advisory review, which will enable the faculty/staff member to remain current with any changes in federal guidance or college policy. This includes renewal of CITI training, which is also required every three years. IRB advisory review is also available for any other project at the request of an investigator.

• Available upon request:  Certification of IRB Advisory Review.  A statement of certification may be useful if an investigator is seeking grant support, aspires to broader dissemination of the project, or is part of an inter-institutional team where IRB review and approval is required by one or more of the other participating institutions.  Investigators may select this option on the Ethics Plan form.

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.