Human Subjects in Research

DNAIRB 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.

Institutional Review Board (IRB)

 

Guidelines and Policy


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 dereande@nmu.edu with a short summary of your project. 


      Application and Forms

      Consent Form Templates and Examples

      Training 

      *NOTE: CITI Human Subjects modules expire after four years. 

      Qualtrics

       

      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 graduate@nmu.edu.

      research_and_compliance