Social and behavioral science (SBS) projects go to the social and behavioral sciences office and are reviewed by members of Panel E. Panel E reviewers have the appropriate expertise to review social behavioral studies that also include medical procedures but not FDA-regulated research, which must be reviewed by a biomedical panel at NU.
Before you begin your application for IRB review, please review the “New Study” section which will walk you through the IRB review process.
General Time Frames For Review Of Projects By The SBS IRB:
All submissions are reviewed in the order received. As such, turnaround times vary based on volume. IRB Analysts work diligently to provide efficient, thorough and timely review of research to advance the mission of the Northwestern Office for Research and to ensure the rights and welfare of participants are protected. One of the most significant ways to reduce the amount of time for review is to limit change requests as well as status requests. The back and forth requires considerable time, and adds to overall review volume. The following are some tips for submitting a complete and compliant study for review:
- Review the Submission Information section of the IRB website for specific requirements associated with new study requirements, as well as guidance for modifications, continuing reviews, closures, and RNI’s;
- Ensure that current templates are used when preparing study documents;
- Complete the protocol and consent documents with comprehensive and detailed information;
- Verify that information in the protocol is consistent with consent and other study documents;
- Recruitment material should contain all of the required elements listed on the recruitment page on the IRB website;
- Upload all supporting documents, which may include, questionnaires, surveys, approvals/authorizations, study related images/visuals, etc.
Submitting complete, detailed and compliant IRB applications are the best way to reduce turnaround time.
Research conducted by Northwestern University investigators in foreign countries remains under University purview and guidelines. While we do not impose our standards for written documentation on other cultures, we do not relax our standards for ethical conduct of research or for a meaningful consent and/or assent process.
Special attention should be given to local customs and to local cultural and religious norms in developing research, drafting recruitment material as well as written consent documents and data collection instruments. When it is appropriate the IRB will consider alternative consent formats if culturally appropriate. In some instances, it may be appropriate for the IRB to waive some or all requirements for written consent in favor of a verbal consent for cultural, religious or literacy reasons. Research proposals for which this may be reasonable should include explanations of cultural norms or conditions requiring such as waiver. (E.g. societies where no written language is used, or societies where signatures represent the surrender of spirit or soul to the researcher)
Where appropriate, research projects must have been approved by the local equivalent of an IRB before they are presented to the University IRB. Where there is no equivalent board or group, investigators are expected to consult with local experts or community leaders about the project and to secure their support for the conduct of the research. The IRB does require that there be good faith effort applied to secure local cooperation for the research and to document those efforts as part of the application.
In addition, the OHRP International Program works to ensure that human subjects outside of the United States who participate in research projects conducted or funded by HHS receive an equal level of protection as research participants inside the United States. To that end, the Institution’s human research activities, regardless of whether the research is subject to the U.S. Federal Policy for the Protection of Human Subjects (also known as the Common Rule), will be guided by an assurance of specific principles governing the institution in carrying out its responsibilities for protecting the rights and welfare of humans in research conducted at or sponsored by the institution. This requirement of an assurance applies to non-U.S. Institutions such that whenever non-U.S. institutions are engaged in non-exempt HHS-supported or -conducted human research, the HHS human subject protection regulations, 45 CFR part 46, apply.
This means that when appropriate the non-U.S. institution must obtain an FWA which is the only type of assurance of compliance accepted and approved by OHRP. There is a single version of the FWA and the Terms of Assurance for U.S. and non-U.S. institutions. For additional information see: (http://www.hhs.gov/ohrp/register-irbs-and-obtain-fwas/fwas/fwa-protection-of-human-subjecct/index.html)
It should be noted that there when considering local cultural norms, equivalent protections are required (see OHRP guidance for equivalent protections: http://www.hhs.gov/ohrp/international/equivalent-protections/index.html). For example, with all due respect and sensitivity for local customs, minors who are treated as adults in their own country will be treated a minors for the purpose of protection in research. However, the definition of who may provide ‘parental permission’ to participate may appropriately be adjusted based on cultural norms. It is possible, that grandparents or even tribal leaders may be the cultural head of household and may ethically serve as the designated guardian for a minor participating in research. That said, the cultural norms in question must be identified in the research protocol and the exception to policy anticipated.
OHRP also publishes The International Compilation of Human Research Standards, a listing of over 1,000 laws, regulations, and guidelines on human subject protections in over 100 countries and from several international organizations. This document should be consulted to determine country level guidelines on human subject research. Many of the listings embed hyperlinks to the source document.
Classroom Based Research Projects
All activities meeting any one of the definitions of human subjects research and carried out at Northwestern University (NU) or under its auspices must be reviewed and approved by an NU IRB prior to the start of the activity. That said, the University also recognizes that some student projects conducted to fulfill course requirements involve activities that, in a different context, might meet the definition of human subjects research. It is the policy of the University to not require IRB review of classroom research projects, that are designed to teach students research methods except for the following: Doctoral dissertations; funded research; research conducted through collaborations external to NU, Master‘s theses, and honors theses. All of these must be reviewed and approved by the IRB before students may begin their research.
In the circumstance of a classroom assignment that would otherwise constitute human subjects research but which does not require IRB review because it is a classroom assignment, the individual faculty members and departments are responsible for overseeing the activities as defined below under faculty responsibilities. This means faculty and departments are responsible for ensuring that the students are adequately trained and that their planned research activities are designed with appropriate and adequate safeguards in place in order to ensure that the activities are within the scope of ethical conduct.
Guidelines For A Classroom-Based Research Project
In order to determine if classroom assignment based research does not require IRB approval the following conditions must be met:
- The risk level of the project is minimal (no more than would be encountered in routine daily activities).
- Unless a student is qualified to do so, there may be no studies that involve interaction with vulnerable subjects (e.g., pregnant women, children, prisoners, or cognitively impaired persons). Observational study of protected vulnerable populations can be done with the appropriate protections in place.
- No identifiers are collected.
- The project is limited to surveys/questionnaires/interview procedures, observation of public behavior, or standard educational exercises directly related to the topic(s) being studied.
- Surveys/questionnaires/interviews, if used, may contain sensitive personal questions (e.g., questions about alcohol/drug use, sexual behavior/attitudes, criminal activity, medical history, grades/test scores) or other personal information only if surveys are completely anonymous.
- No Northwestern University faculty, staff or student is receiving monetary compensation or any type of support from an external company/organization/agency for collecting, analyzing or reporting the results of this project.
- The project is not conducted on VA premises and does not use VA resources, and is not otherwise subject to oversight by a federal regulatory body.
- Subjects are recruited in a voluntary manner.
- The data are not archived or saved in any way to be used in the future.
It is also understood that the end result of the research may be presented in the classroom to peers but may not be used for any publication or public presentation outside of the immediate classroom.
Faculty who require students to do classroom based research projects assume responsibility for the conduct of those projects and assure that the guidelines outlined here are met and that research that falls outside of these criteria is submitted to the IRB for a regular review.
It is the responsibility of faculty to determine whether an assigned project involving humans can be classified as a course-related student project under the criteria above. Faculty should contact the IRB office for assistance if needed in making this determination. It is the responsibility of the NU faculty to discuss general principles of ethical conduct in research with the students prior to the initiation of the project. In addition, the faculty member must ensure that all surveys/questionnaires/interviews are preceded by a disclosure of the following points to the respondent. If an information sheet or any recruitment materials are used, these points must be in that document:
- The student identifies him/herself as an NU student who is performing the activity to fulfill a course requirement, and the course is specifically identified.
- The name of the supervising faculty member to contact for questions is provided.
- The persons who have access to the individual data and/or summarized results are specified (e.g., instructor only, company/organization/agency).
- Respondents are informed that their participation is completely voluntary and confidential.
Care should be taken to protect the rights and welfare of the individuals who act as participants. Standard research practices such as obtaining consent, ensuring confidentiality, responsible fieldwork, and giving participants a contact name should be employed.
Due to the COVID-19 pandemic, all In-person meetings are cancelled and moved to a remote format until further notice. Please email the Social Behavioral IRB Office with questions and/or to register for an appointment during the weekly drop-in hours on zoom. In order to ensure privacy of attendees during these meetings, those who express interest will receive a confirmation email that includes the anticipated time for consultation and zoom link. Attendees will be navigated to a waiting-room in zoom when first joining the meeting.
Drop-In hours are currently being hosted on Wednesdays from 2:30-3:30 pm year-round.
To get on the schedule for drop-in hours for the upcoming week, please email firstname.lastname@example.org. Provide your name and specific question/inquiry that you have, and use your Northwestern email account when making the schedule request.
Note that any consultation provided is only advisory in nature and does not take place of formal IRB review.
Other information that may be helpful to review prior to consultation can be found on the IRB website, including Submission Information, Templates & Forms needed to submit for IRB review, eIRB+ electronic submission information, and Training and Education information (including details about CITI courses).
If you have any questions, please contact the office staff.
Braden Van Buskirk, MSW, CIP
Social and Behavioral IRB Manager
Rae Mwangi, MPH, CIP
IRB Analyst Lead
Beth Irwin, MA
IRB Senior Analyst
Rachel Reynolds, MPH