The Institutional Review Board (IRB) reviews research studies to protect the rights of participants.
The Northland College IRB requires that all investigators conducting research with human participants complete training with the National Institute of Health. If you have questions, please email the IRB.
All research with human participants performed by faculty, students, and staff must receive formal approval in advance of the research activities by the Institutional Review Board.
- First, determine whether an application is required
- If an application is necessary, complete an application form. A complete application will include all of the following materials:
- Application form
- Research instruments (e.g., surveys, interview guides, focus group guides)
- Consent forms (use and adapt this template)
- Recruitment materials
- Other institutions’ IRB approvals (applicable only for studies taking place in another institution or country)
- NIH training certificates (or equivalent human subjects protection training)
- Research Conflict of Interest Disclosure forms
- Student research applications will be reviewed by the faculty sponsor using a Class Research Project Evaluation Form. The instructor will then forward all application materials and completed form to the IRB. The IRB will review the forms and confirm the instructor’s determination within one week.
- Wait for an IRB determination. Expedited reviews are completed within two weeks of submission, and full board reviews are completed with one month of submission. If an application is incomplete or if the reviewer needs additional information, the review may take longer.
Approvals are granted for one year. After one year, researchers should apply for a renewal using an Annual Review Form.
If you would like to make changes to an approved study, please complete a Modification Form.
Please review the IRB policies and procedures prior to submitting your application.
Q: Do I need to apply for IRB approval?
A: To determine this, answer the following questions:
- Is my project considered research?
If you answers YES to any of the questions a-c below, your study is considered research. Move on to question 2. If you answered NO to all three questions, the IRB application is waived and you are free to begin your study.
- Do you plan to publish the results of your study?
- Do you plan to present the results of your study in a public setting, such as a conference, or poster session?
- Are you completing this project as part your capstone or other degree requirement?
- Is my study considered research on human subjects?
If you answered YES to (a) below and to one or more of questions (b-e) below, you need to apply for IRB approval of your research. If you answered NO to all five questions, you do not need to apply for IRB approval of your research.
- Are people the subjects of study? (If you interview geoscientists to learn about stream hydrology, they are not human subjects, but if you interview them about their experiences as geoscientists, they are human subjects.)
- Does the study involves interacting with living people?
- Is the information individually identifiable (i.e. the identity of the subject may readily be ascertained by the investigator or associated with the information collected?)
- Will you collect information that would ordinarily be private?
- Will you observe behavior where the subjects would reasonably expect privacy?
Q: What do I need to include in my application?
A: In addition to the application form, you should submit your consent form or script you’ll use to secure oral consent. You must also include training certificates and conflict of interest forms. If applicable, you will need to include recruitment notices or email invitations, instruments and guides, and other IRB approvals.
The Northland College IRB requires all investigators conducting research with human participants to complete training with the National Institute of Health.
Q: How long before I get my approval?
A: Applications under expedited review will be reviewed within two weeks of receipt. If the application is incomplete or if the reviewer has questions, review may take longer.
Applications under full-board review will be reviewed within one month of receipt. If the application is incomplete or if the reviewer has questions, review may take longer.
Student applications and faculty evaluation forms are reviewed within one week of receipt. If the application is incomplete or if the reviewer has questions, review may take longer.
Q: Can I start collecting data before my application is approved?
A: No, you may not collect data until your application is approved.
Q: What kinds of projects will not receive approval?
A: Projects that pose a high risk of harm to participants will go to full-board review. Risks might include the risk of emotional trauma, liability, loss of status, job loss, and other social and economic risks. A high risk project may be approved if investigators take steps to minimize risks, and if the study will make a significant contribution to the academic field.
Q: I have IRB approval for my project, but I want to make changes to my study. Do I need to reapply?
A: If your approval is still valid (i.e. it has been less than one year since you received approval) you can apply for a modification. If the changes are minor, they will receive expedited review. Major changes may require full board review. Major changes include a change in the population being studied, research questions, and level of risk.
Q: How long is my approval good for?
A: IRB approval is granted for one year. Researchers should apply for a renewal each year.
Q: I am no longer collecting data but my approval will expire soon. Do I need to apply for renewal?
A: Yes. If you are still working with your data and the data set contains individual identifiers you should apply for renewal, even if you have completed data collection.
Q: Do I need to close my study?
A: Investigators should apply for study closure after the study is concluded. A study may be closed when a) all interventions or interactions with participants are concluded, and no further data will be obtained, and b) Analysis of identifiable private information is concluded (investigators are only conducting analysis of aggregate data sets without individual identifiers or identifiable private information). Exempt studies do not require closure.
Please note, if a study approval expires after the one-year approval period, the IRB will automatically assign a closed status to the study.
Q: How long do I need to keep my data for after I complete my study?
A: All data must be kept for three years after study closure, adhering to the standards of confidentiality outlined in your approved IRB application.
After three years, data should be deleted in consultation with the Northland College I.T. department, if necessary, to ensure all electronic records are deleted. All hard copies of data files should be shredded. Graduating students should work closely with their faculty sponsor to follow these guidelines.
Q: Do I need to use a consent form to document consent?
A: Research projects require informed consent, but if using a consent form is impracticable or places participants at risk, you can apply to modify consent in the appropriate section of your application.
Q: Can I deceive participants or withhold information about my study?
A: You may be able to withhold information or deceive participants about some aspects of your study. In these types of studies, participants are unable to provide fully informed consent.
- IRBs will first decide whether the information to be withheld could influence the decision of prospective participants about participating in the research. Research will not be permitted if the subjects are not being informed of aspects they would consider material to a decision to participate.
- If non-deceptive alternatives are available the research study will not be permitted.
- IRB will also consider whether all of these criteria are met:
- The research involves no more than minimal risk to the subjects and
- The waiver or alteration will not adversely affect the rights and welfare of the subjects and
- The research could not practicably be carried out without the waiver or alteration.
If deception is approved, you may be asked to debrief participants after participation. Debriefing will be required if it contributes to the subject’s welfare (e.g., corrects painful or stressful misperceptions, reduces pain, stress, or anxiety related to participation). Debriefing may not be allowed if it may harm participants in some way (e.g., participants’ self-esteem, anxiety, guilt, hurt, etc.).
Q: Can I conduct research with tribal communities?
A: Work with tribal communities must be authorized by tribal leaders, or supported by a tribal organization. Studies may be subject to review by the Indian Health Service National Institutional Review Boards and Independent Tribal IRBs if applicable.
Q: How do I keep my data confidential?
A: Participant’s privacy can be protected by using identification numbers or pseudonyms instead of names or other identifying information. All data should be secured, for example in a locked file cabinet or secured electronic file.
In some cases your study may involve revealing participants’ identities. If this is part of your research plan, it needs to be clearly explained in your application and adequately justified. You should include it in the consent process so that participants understand what is being made public and expressly consent to having their information made public. Benefits must outweigh risks.
Researchers should take careful precautions to safeguard participant data. For example, collect only the data necessary to answer the research questions, remove all identifiable information from your files, do not collect social security numbers, student IDs or Driver’s License numbers, set secure firewalls for your electronic files, password protect computers, and use locked file cabinets to store data files.
All research files should be kept for three years after study closure adhering to confidentiality standards outlined in the approved IRB application.
Q: Do I need IRB approval if I’m analyzing data already collected by someone else?
A: The use of secondary data without any identifying information and made publicly available does not constitute research with human subjects and does not require IRB review. Investigators should verify if their public-use data sources include a confidentiality agreement or IRB review statement. If you have questions, contact the IRB. Please note, IRB review and approval is needed if identifying information is included in the dataset.
Q: I want my students to do a research project as a class assignment. Do I need IRB approval?
A: Instructors should decide whether planned activities constitute research. For example, an assignment to conduct a survey to better understand survey methodology may not be considered research. The instructor should consider whether the project fits the definitions of research with human participants.
All student led research must have a supervising faculty member. All students and faculty sponsors must have training in the protection of human subjects.
For projects that employ only one procedure, only one IRB application and Class Research Project Evaluation Form is needed. Faculty members may apply for approval prior to the start of the semester if the study procedures have been pre-established.
For individual or group investigations, students should complete an application and submit it to their instructor. The instructor will evaluate the application using a Class Research Project Evaluation Form and indicate whether it is approved or not. The form and all application materials should be submitted to the IRB. The IRB will review the forms and confirm the instructor’s determination within one week.
Q: Can I invite my students to participate as research subjects?
A: If you are inviting students to participate, you should include precautions to avoid coercion and address the power differential. For example, if you are offering extra class credit, you must also include other options for students to obtain extra credit that involve alternatives to participation with comparable procedures and time investments. Recruitment must be done in such a way that students may decline participation without consequence to their class standing.
Q: If my project was approved by an IRB at another institution, do I still need to get approval?
A: For research studies initiated at another institution, the researcher must submit to the IRB chair the protocol and approval notice granted by the other institution. The IRB will determine if the project was reviewed by a qualified IRB at another institution that complies with federal policies to safeguard the rights and welfare of human participants.
If the project has not been reviewed elsewhere, then the Northland College IRB will conduct its own review.
All research with human participants conducted under the auspices of the Northland College IRB will be guided by the three ethical principles set forth in the Report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (the Belmont Report): respect for persons, beneficence and justice.
All persons involved in conducting and reviewing research with human subjects, regardless of whether or how the project is funded, have an obligation to apply the principles set forth in the Belmont Report:
- Respect for persons: Individuals should be treated as autonomous agents and persons with diminished autonomy are entitled to extra protections. In application, researchers must ensure that participants are informed about the research procedures and enter the research voluntarily.
- Beneficence: Individuals should be protected from harm, and the benefits of participation will be maximized while any potential harm will be minimized. In application, researchers must take steps to minimize risk, ensure that risks are reasonable in relation to benefits, and maintain confidentiality.
- Justice: This principle requires an equitable distribution of benefits and burden. In application, researchers must ensure participants are selected equitably, and that vulnerable populations are not exploited.
Research is defined as “the systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge” [CFR title 45 part 46.102(d)].
Human Subject is defined as “a living individual about whom an investigator (whether professional or student) conducting research obtains (1) Data through intervention or interaction with an individual, or (2) Identifiable private information” [CFR title 45 part 46.102(f)].
The Northland College IRB includes staff and faculty members, and one community member who is not otherwise affiliated with Northland College. Members are scientists and non-scientists, appointed or voted in, and serve three-year staggered and renewable terms. The Chairperson is elected by members of the Board and serves a two-year term. To the extent possible, Northland College promotes membership diversity with respect to race, gender, and cultural backgrounds.
Northland College IRB Membership
- Rutherford Goldstein, Assistant Professor of Psychology, IRB Chair
- Travis Proctor, Assistant Professor of Religious Studies
- Angela Stroud, Assistant Professor of Sociology and Social Justice
- Questions can be emailed to email@example.com, or you may call 715-682-1536, or reach us by mail 1411 Ellis Avenue, Ashland, WI 54806-3999.