Human Subjects Research
The information on this page is 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 university, federal, state and other organizations' high academic and ethical standards.
**Sending a campus-wide mass email? Make sure to first complete the MASS EMAIL REQUEST**
- SUBMITTING IRB PROTOCOL
Cayuse (coming soon)
Contact the IRB
IRB committee members
**NOTICE REGARDING MASS CAMPUS EMAILS**
Mass email requests that are not related to research go through the Dean of Students Office. Mass emails related to research must be part of an approved IRB protocol and follow the process below:
1- Contact the IRB chair at email@example.com
2- Submit the Mass Email Application to firstname.lastname@example.org
3- Once approved, review the Mass Email rules and process and follow the ePostal distribution instructions.
- 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
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.
- Register/Log in to CITI Training
- Help navigating Human Subjects CITI Training
- How to add or delete a course
- Workshops for students
Additional training resource: Free NIH clinical research training (not a replacement for CITI training)
Does My 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)].
Class Projects: Faculty who have IRB submission included as part of class coursework must meet with an IRB representative before submitting class projects to the IRB.
If you are unsure whether your work requires review, email IRB Chair, Derek Anderson at email@example.com with a short summary of your project.
Mass Email Request
All emails sent to groups of people on campus must go through a review and approval process.
Mass email requests that are not related to research go through the Dean of Students Office. Mass emails related to research must go through the process below:
1- Contact the IRB chair at firstname.lastname@example.org to determine if IRB review is necessary.
2- Submit the Mass Email Application to email@example.com (please review the Mass Email notes and requirements listed at the top of the application page).
3- Once you have received approval for your mass email request, review the Mass Email rules and process, then follow the ePostal instructions to submit the email for distribution.
IMPORTANT: A faculty member must be the Principal Investigator (PI) for the project; students may not conduct any research project or seek mass email approval without a faculty mentor as PI (see IRB Policy Manual).
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.
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.
Daniel Arnold, MD
Hon. Cheryl Hill
Assistant Director of Graduate Student Affairs and IRB Institutional Coordinatorjantaylo@nmu.edu