Within-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 1” projects, where both the project participants and the dissemination of findings are internal to the college and there are no risks for project participants. These requirements are designed to ensure that Type 1 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 1 project.
Characteristics of Type 1 projects
Within-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 are limited to current St. Olaf students or employees. An inquiry may be a Type 1 inquiry if the ONLY participants are currently-enrolled St. Olaf students or currently-employed faculty or staff.
- The results of the inquiry are not shared outside the college. This means that findings are not posted on the college website, distributed to external organizations, presented at conferences, published, or otherwise shared with audiences or individuals external to St. Olaf. Findings that are shared in campus poster sessions or oral presentations with a limited number of non-St. Olaf guests in attendance are still considered “internal,” since the primary audience for these presentations consists almost exclusively of St. Olaf students and employees.
Examples of within-the-college no-risk projects are:
- Student interviews with other St. Olaf students for a class project involving questions posing no more than minimal risk, with results to be shared only with the instructor and other students in the class;
- A no-risk survey of St. Olaf staff by a St. Olaf office for internal use.
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 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 1 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.
- Recommended: One of the following CITI online mini-course in research ethics:
- General Social and Behavioral Investigations
- Records-Based and Internet Investigations
St. Olaf subscribes to the University of Miami’s Collaborative Institutional Training Initiative (CITI), 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.
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, and this is the appropriate course for most supervisors. Most “trainees” can complete the General course in less than two hours. However, if students are likely to conduct projects involving the analysis of pre-existing data and/or data available on the internet, it is recommended that the supervisor complete the Records-Based and Internet Investigations course, which includes all the modules in the General course but also includes additional modules for projects that involve the use of existing and/or internet-based data. (If a supervisor has already completed the General course but later needs to complete the Records-Based and Internet course, the system will show most of the modules as already passed; only the new modules will need to be completed.) 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).
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.
- Optional: One of the following CITI online mini-courses in research ethics:
- General Social and Behavioral Investigations
- Records-Based and Internet Investigations
See above for a description of the content of these courses. CITI training is particularly recommended for investigators whose inquiry involving people is part of a larger learning experience in social research, or who are likely to undertake future inquiries involving people. 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 1 projects
For student projects:
- Recommended: Completion of Ethics Plan and related forms as appropriate. The Ethics Plan, the Project Information for Participants worksheet, and other forms are designed to help investigators know what steps to take in order to design and carry out an ethical inquiry. While college policy does not require the completion of an Ethics Plan for Type 1 projects, a project supervisor may elect to require the use of this form because of its educational value as well as its benefits for the ethical design of the project.
- Required: Review and approval of project ethics by faculty/staff supervisor. Whatever the supervisor’s requirements for planning and documentation may be, the supervisor should ensure that the ethics provisions of the project (whether recorded on the Ethics Plan form or in some other way) uphold the principles of beneficence, respect, and justice as described in Inquiries Involving People: Ethical Principles, Practical Applications, and Investigator Obligations. Supervisors who require students to complete the St. Olaf Ethics Plan 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. In either case, student investigators should not begin their data-collection (including recruitment of prospective participants) until after the faculty/staff project supervisor has determined that the investigator has met all education and planning requirements established by the supervisor, including the satisfactory completion of any St. Olaf forms.
- Recommended: Advisory IRB review of Ethics Plan for new project supervisors; no IRB approval required. Although formal review of ethics plans for within-the-college no-risk projects is not required, first-time supervisors of a student inquiry involving people may find it helpful to require the student to complete a written Ethics Plan, use the St. Olaf Ethics Plan Review form to prepare feedback for the student, and then seek an advisory review by an IRB member before final project approval. The completed Ethics Plan can be submitted to the IRB Administrator with a request for a review. Faculty and staff supervisors are welcome to contact any member of the St. Olaf IRB at any time for advice on a student project plan.
For faculty and staff projects:
- Recommended: Completion of Ethics Plan and related forms as appropriate. The use of the Ethics Plan form is particularly encouraged for investigators who are new to inquiries involving people.
- Recommended: Advisory IRB review of Ethics Plan for new project investigators; no IRB approval required. Although formal review of ethics plans for within-the-college no-risk projects is not required, first-time faculty and staff investigators may find it helpful to prepare a written Ethics Plan and seek an advisory review by an IRB member. The completed plan can be submitted to the IRB Administrator with a request for a review. Any investigator conducting a Type 1 project is welcome to consult at any time with any member of the St. Olaf IRB for advice on project design.