Human Research Policies & Guidance

The Health Insurance Portability and Accountability Act (HIPAA) addresses the role of the University and the University’s IRB with respect to HIPAA obligations.

• Research Privacy and Confidentiality Policy
• Research Recruitment Guidance – FAQs

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).

The Use of Northwestern University IRB Services Policy exists to assist Human Research Investigators and their study teams in determining whether they may use Northwestern University’s Institutional Review Board (IRB) services.

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

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

The Emergency Disaster Flowchart provides Investigators and Research Teams with a resource for determining the appropriate considerations when an Emergency Disaster occurs.

Decision-Guide: Study-Specific Emergency-Disaster Risk Mitigation Planning

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.

Guidance on Evaluating Reports of Data Incidents

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

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.

 

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 

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

The Personal Information Protection Law of the People’s Republic of China (PIPL) addresses the activities of handling the personal information of natural persons within the borders of the People’s Republic of China. Please find associated guidance documents below.  Reference this page for a translation of the full policy.   See the Consent Templates page for the PIPL Compliant Consent (HRP-591). Please also see the guidance provided by Office of Research here.

• PIPL Guidance For Human Research HRP-1916 
• PIPL Human Research Flow Chart HRP-1112

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.

Guidance on the Use of Public Use Data Sets

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

This guidance provides assistance in determining when study participants need to be informed of new information and/or re-consented.

Guidance on Re-Consent / Notification of Study Participants

These guidelines apply to proposals to store data and/or specimens for future research use.

Guidance on Registries, Student Subject Pools, and Specimen Repositories

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

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

This guidance describes the types of payments made to research participants and acceptable payment practices.

Guidance on Research Participant Payments

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

MTurk “workers” (participants) created the following guidance for researchers to consider before using the site.

Guidelines for Principal Investigators Using Amazon Mechanical Turk

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.

Guidance on Study Closure

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.

Guidance on Suicidality in Human Research Protocols