IRB Regulation Adjustments as a Result of COVID-19
Due to the evolving situation with COVID-19 infections, the recent national restrictions placed on face-to-face meetings, and the Institutional Review Boards' role in human subject protection, NMU’s IRB has revised procedures for human-to-human data collection methods in previously approved protocols and new research studies. This includes, but is not limited to, in-person surveys, interviews, and group discussions. Protocols must include signed Research Participant Agreement and Release forms, as well as signed Student Researcher Agreement and Release forms. Inform consent forms must include the following language (lifted from the form for subjects).
No new projects listing face-to-face interactions submitted to the IRB will be approved unless they include the two documents referenced above; projects should utilize alternative methods for data collection via distance technologies (phone, video, internet-based surveys, etc.) when possible.
PIs currently engaged in human-to-human research with previous IRB approval must make modifications to replace human-to-human data collection with distance technologies when possible. Depending on the specific requirements of the project, the NMU IRB can approve administratively, via expedited review, or a convened meeting will be held via Zoom. To expedite requests, faculty PIs should review student protocols and determine the modifications necessary for those students who need them. Faculty must then consult with Dr. Derek Anderson, IRB Chair, (DEREANDE@nmu.edu) to confirm the level of review any such modifications may require.
You can visit the Office for Human Research Protections page to review the current federal guidance.
While private and federal funding sources for research have produced an increase of beneficial knowledge through research, they have also impacted guidelines for human subjects in research. Although most researchers seek to observe ethical research practices, history is replete with examples of researchers mistreating and abusing human subjects. Populations subject to misconduct have included, but are not limited to students, prisoners, disenfranchised and disadvantaged members of society, institutionalized patient populations, laboratory assistants and others. Ethical violations in research have led to national and international efforts to develop ethical principles and codes to protect the welfare and rights of human research subjects.
The links are provided to ensure that all NMU faculty, staff and students involved in using human subjects in their research do so in a way that meets the university’s high academic and ethical standards.
Does your research require IRB review?
According to the Department of Health and Human Services Code of Federal Regulations, to require IRB review, projects must fall under the definition of research, and involve human subjects.
Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge [45 CFR 46.102(l)].
Human subject means a living individual about whom an investigator (whether professional or student) conducts research and (i) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens. [45 CFR 46.102(e)(1)].
If you are unsure whether your work requires review, email IRB Chair, Derek Anderson at firstname.lastname@example.org with a short summary of your project.
Application and Forms
- Human Subjects Research Application
- Human Subjects Project Renewal Form
- Human Subjects Project Modification Form
- Human Subjects Project Completion
- Human Subjects Adverse Event Form
*NOTE: CITI Human Subjects modules expire after four years.
Consent Form Templates and Examples
- Adult Consent Form
- Phone Interview Consent Form
- Informed Consent Form with Recording Example
- Anonymous Consent Form
- Child Assent Form (Age 7+)
- Child Assent Form (Age 7 and under)
- Parent-Guardian Consent Form
- Consent Form for Adults Unable to Provide Legal Consent
- Broad Consent Form
- COVID-19 Research Participant Agreement and Release
- COVID-19 Student Researcher Agreement and Release
Research Compliance & Ethics Updates and Trainings
Northern Michigan University subscribes to the CITI Program for research compliance training. This training is available free of cost for all NMU faculty, staff, and student researchers.
NIH has recently opened additional FREE training options for clinical researchers. This is not a replacement for CITI training, but an in depth class in clinical research. Check it out!
The Graduate Education and Research Office and Grants and Contracts Office presents Workshops for Students, a series of workshops to help you achieve success in your research.
For further information contact the Graduate Education and Research Office at email@example.com.
Use of Deception with Human Research Subjects
The American Psychological Association (APA) acknowledges that there are some studies that cannot be conducted without the use of deception (see APA Code of Ethics). The following guidelines are provided by the APA:
8.07 Deception in Research
(a) Psychologists do not conduct a study involving deception unless they have determined that the use of deceptive techniques is justified by the study's significant prospective scientific, educational, or applied value and that effective nondeceptive alternative procedures are not feasible.
(b) Psychologists do not deceive prospective participants about research that is reasonably expected to cause physical pain or severe emotional distress.
(c) Psychologists explain any deception that is an integral feature of the design and conduct of an experiment to participants as early as is feasible, preferably at the conclusion of their participation, but no later than at the conclusion of the data collection, and permit participants to withdraw their data.
(a) Psychologists provide a prompt opportunity for participants to obtain appropriate information about the nature, results, and conclusions of the research, and they take reasonable steps to correct any misconceptions that participants may have of which the psychologists are aware.
(b) If scientific or humane values justify delaying or withholding this information, psychologists take reasonable measures to reduce the risk of harm.
(c) When psychologists become aware that research procedures have harmed a participant, they take reasonable steps to minimize the harm.
Given these guidelines, all studies involving deception will receive a full review by the NMU HSRRC. Research applicants can expect to respond to the following questions:
- What does the deception entail?
- Why is deception necessary for this study? That is, describe the importance of this research that justifies the use of deception. Describe why using a non-deceptive research methodology is not possible.
- Provide a script that will be used in the debriefing session. Explain how and what subjects will be told during the debriefing.
- Include in the debriefing script that subjects will be told that they have the option of withdrawing from the study, and that upon request, their data will not be used in the study.