Human Research Policies & Guidance
Please reference the Northwestern University IRB policies and guidance below, as well as our webpages on various guidance topics.
PoliciesPolicies page includes information on human research policies, guidance, and oversight. Specifically, you can read more about human research protection program compliance (HRPP), the human research protection program plan, the investigator manual, HIPAA guidance, and post-approval monitoring and for-cause audits.
eIRB+ and IRB Electronic Signature Policy
The Health Insurance Portability and Accountability Act (HIPAA) addresses the role of the University and the University’s IRB with respect to HIPAA obligations.
Human Research Protection Program Compliance
Human Research Protection Program Plan
Minors Acting as Research Study Team Members
The Minors Acting as Research Study Team Members Policy addresses minors, i.e., persons who are under age 18, acting as research interns or volunteers for human participant research studies at Northwestern University. This policy is not intended to limit or prohibit minors as human research participants.
For IRB Office guidance on studies involving minors as research participants, please see our Guidance on Children as Research Participants, Parental Permission, and Child Assent (further down this webpage).
Post-Approval Monitoring and For-Cause Audits
Release of Regulatory Inspection Documents
Use of Northwestern University IRB Services
Guidance documents offer the research community guidelines over more specific study instances. For example, if you are proposing to store data and specimens for future use, re-consenting participants, using mobile apps or mobile medical devices, or if you want to know more about participant payments, study closure, or public use data. There are many documents available to guide you and your research needs.
Deception and Incomplete Disclosure
Deception and incomplete disclosure are valuable research methodologies that come with its own set of challenges to ensure research is conducted ethically. The document contains guidelines and points to consider when conducting research utilizing deceptive or incomplete disclosures.
IRB Office Guidelines for Research Involving Deception and Incomplete Disclosure
Determining Engagement in Human Research at Northwestern University and Affiliated Institutions
This guidance should be used to determine whether an activity constitutes Human Research and whether Northwestern University or its Affiliated Institutions are engaged in that activity.
Guidance on Determining Engagement in Human Research at Northwestern University and Affiliated Institutions
Evaluating Reports of Data Incidents
This guidance can be used to distinguish between the different types of data, the difference between privacy and confidentiality, and provide guidance on preparing Reportable New Information (RNI) submissions involving data.
FERPA & Student Health Records
The purpose of this guidance is to explain the relationship between the Family Educational Rights and Privacy Act (FERPA) and the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule, and how these two laws apply to records maintained on students.
Joint Guidance on the Application of FERPA and HIPAA To Student Health Records
General Data Protection regulations (GDPR)
GDPR, or Regulation (EU) 2016/6793 of the European Parliament and of the Council, is an EU legislation that protects natural persons with regard to the processing of personal data and on the free movement of such data. See our GDPR consent template here.
Guidance for General Data Protection Regulations (GDPR) compliance in the conduct of human research.
Investigational Medical Devices
This document offers investigators guidance on the use of investigational medical devices in human subjects research. The guidance defines investigational medical devices, provides insight to the regulatory requirements and offers points to consider when seeking approval.
Guidance on Use of Investigational Medical Devices in Human Subjects Research
Mobile Apps and Mobile Medical Apps
This document offers investigators guidance on the use of mobile apps or mobile medical devices. The guidance defines mobile apps and mobile medical apps, provides insight to the regulatory requirements and offers points to consider when seeking approval.
Guidance for Research Involving Mobile Apps or Mobile Medical Apps
Personal Information Protection Law of the People’s Republic of China (PIPL)
Public Use Data
Public use data are files prepared by investigator or data supplies with the intent of making them available for public use. The data available to the public are not individually identified or maintained in a readily identifiable form. This document provides investigator guidance on Northwestern University’s practice regarding the use of specified “public use” data sets.
Quality Improvement and Program Evaluation Projects
This guidance provides assistance in determining which projects are solely QI/PE, which are human subjects research, and which are both QI/PE and research.
Guidance on Quality Improvement and Program Evaluation Projects
Re-Consent/Notification of Study Participants
This guidance provides assistance in determining when study participants need to be informed of new information and/or re-consented.
Registries, Student Subject Pools, and Repositories
These guidelines apply to proposals to store data and/or specimens for future research use.
Guidance on Registries, Student Subject Pools, and Specimen Repositories
Remote Post-Approval Monitoring and Directed (For Cause) Audits
The Remote Post-Approval Monitoring and Directed (for cause) Audit Guide exists to assist Investigators in preparing for a remote IRB review of their research records.
Guidance on Remote Post-Approval Monitoring and Directed (For Cause) Audits
Research Document Retention Requirements for Principal Investigators
This guidance contains Principal Investigator responsibilities and requirements for research document retention including research records/study files, research data/source documentation, consent forms, HIPAA authorizations, and more.
Research Document Retention Requirements for Principal Investigators
Research Participant Payments
This guidance describes the types of payments made to research participants and acceptable payment practices.
Research that Involves Use of Protected Mental Health and/or Developmental Disabilities Information
This guidance highlights considerations for use of protected health information, covered by the Illinois Mental Health & Developmental Disabilities Confidentiality Act (MHDDCA), for research-related purposes.
Guidance on Research that Involves Use of Protected Mental Health and/or Developmental Disabilities Information
Research Using Amazon Mechanical Turk (MTurk)
MTurk “workers” (participants) created the following guidance for researchers to consider before using the site.
Guidelines for Principal Investigators Using Amazon Mechanical Turk
Research with Children as Research Participants
This guidance discusses who is considered a child for research purposes, and provisions for obtaining assent from children and permission from the parent(s) or guardian.
Guidance on Children as Research Participants, Parental Permission, and Child Assent
This guidance explains the circumstances in which a study may be closed from IRB oversight, as well as ongoing researcher responsibilities that apply to closed studies.
Suicidality in Human Research Protocols
Research studies that include assessments of suicidality require additional monitoring of participants’ responses. This guidance details what researcher responsibilities are when suicidal ideation/behaviors are identified and under what study settings, what information needs to be included in the protocol, and what consent language is required.