Human Research Policies, Guidance, & Oversight

Research Ethics

Information about the ethical codes that serve as the foundation for the conduct of research with human participants may be found here: The Belmont Report, Declaration of Helsinki, The Nuremburg Code

Human Research Protection Program Compliance

The University's policy on Human Research Protection Program Compliance (HRP-1001) sets forth Northwestern's commitment to protecting the rights and welfare of human research participants and establishes the framework for the University's Human Research Protection Program (HRPP).

Human Research Protection Program Plan

The Human Research Protection Program Plan (HRP-101) describes how the University complies with the ethical and legal requirements in the conduct of research with human participants.

Investigator Manual

The Investigator Manual (HRP-103) is designed to guide investigators through the policies and procedures relating to research with human participants.

HIPAA Guidance

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

Post-approval Monitoring and For-Cause Audits

Post-approval monitoring and/or for-cause audits provide internal oversight on compliance issues relating to the conduct of human subject research on behalf of the Northwestern University Institutional Review Board (IRB). All active human subject research studies under the purview of the Northwestern University IRB can be chosen for review. Information about the IRB Office’s Post-Approval Monitoring and For-Cause Auditing program.

Regulatory Agencies

Many federal agencies have specific regulations or requirements with regard to research with human participants. Additional information may be found here: Regulatory Agencies

FERPA & Student Health Records

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. Guidance for General Data Protection Regulations (GDPR) compliance in the conduct of human research.

Deception and Incomplete Disclosure

IRB Office Guidelines for Research Involving Deception and Incomplete Disclosure

Mobile Apps and Mobile Medical Apps

 Guidance for Research Involving Mobile Apps or Mobile Medical Apps

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

Public Use Data

Guidance on the Use of Public Use Data Sets

Study Closure

Guidance on Study Closure

Research Participant Payments

Guidance on Research Participant Payments

Research with children

Guidance on Children as Research Participants, Parental Permission, and Child Assent

Registries, Student Subject Pools, and repositories

Guidance on Registries, Student Subject Pools, and Specimen Repositories