What other approvals are required before initiating Human Research?
In addition to securing IRB approval for Human Research (or IRB Office approval for exempt Human Research), you may need to secure other approvals or notifications before initiating your research. Below are examples where other approvals or notifications are relevant. However, this list is not all-inclusive. The IRB Office may ask you to obtain other approvals not listed below on a case-by-case basis depending on the particulars of your research:
- Clinical Affiliates. If you are conducting research at one of the institution’s clinical affiliates, additional approvals or notification may be required. Please find details on securing approval or notification from Clinical Affiliates at https://irb.northwestern.edu/submitting-to-the-irb/types-of-reviews/additional-reviews.html.
These include but are not limited to:
- Radiation Safety
- NMH Clinical Specimens Release Committee (CSRC)
- NMH Nursing Committee
- NMH Office for Research
- NMH Quality Management Committee
- NU Clinical Research Unit (CRU)
- NU Institutional Biosafety Committee (IBC)
- NU RHLCCC Scientific Review Committee (SRC))
- NU Student Surveys Planning Group (SSPG)
- NM Investigational Drug Service (IDS) Pharmacy
- Other Laws and Regulations:
- Childhood Educational Settings. Some school districts have their own IRB or Research Review Board process. You are required to follow the policies and procedures of those bodies. In addition, if you are conducting research within childhood educational settings, e.g., pre-school, primary school, or secondary school, you are required to obtain permission from an educational official, such as the Principal and the teacher(s) at your research site before initiating research. See Additional Requirements for Department of Education (USED) Research (Appendix A-7) for more information about research using educational records (see also WORKSHEET: FERPA Compliance (HRP-331)).
- International Research. If you are conducting research outside of the United States, you are required to follow local regulations governing Human Research for the host country in addition to the requirements described in this document. The IRB Office may request evidence of local Human Research review by an official review body. For additional guidance, please consult the US Department of Health and Human Services’ International Compilation of Human Research Standards and the IRB Office’s Review of International Research Page.
- For researchers planning to conduct international research, please review the Export Controls & International Compliance (ECIC) website for information on high-risk countries, including those subject to Office of Foreign Assets Control (OFAC) sanctions, Military End Use (MEU) restrictions, and other export control limitations.
- Research conducted in countries that are comprehensively OFAC-sanctioned requires a federal license. ECIC can assist with the license application process; however, investigators should be aware that obtaining approval may take several months. Please refer to the ECIC website for the current list of comprehensively sanctioned countries.
- For research conducted in lower-risk countries (i.e., countries not subject to OFAC comprehensive sanctions or MEU restrictions), ECIC review and approval is not required before study initiation. However, researchers are strongly encouraged to review the Export Controls Travel packing list, travel with a clean laptop (ideally a loaner device), and consult ECIC if they plan to export or travel with any equipment other than a standard laptop or if they have questions about international travel or export requirements.
- The IRB Office will also notify the ECIC team when potential concerns are identified in proposed international research, including issues related to export control regulations.
- Nursing Home Research in the State of Illinois. Research in nursing homes in the State of Illinois requires additional state approvals. Please note that if you are conducting nursing home research outside the State of Illinois, you may need additional approvals. Please contact the IRB Office for assistance.
- Medical Students and Postdoctoral Trainees as Research Participants: If you plan to enroll the group mentioned above as research participants, you must obtain additional approval from the Feinberg School of Medicine (FSM) Vice Dean for Education. The Enrollment of Students and Trainees in Research Studies Administrative Policy includes additional guidance and can be found here: https://www.feinberg.northwestern.edu/policies/index.html.
- Biosafety: https://researchsafety.northwestern.edu/biological/institutional-biosafety-committee/
- See the “When am I required to obtain HIPAA Authorization?” section below for more information about research using Protected Health Information.