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Human Research Policies & Guidance

Please reference the Northwestern University IRB policies and guidance below, as well as our webpages on various guidance topics.

Policies

Policies 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 eIRB+ and Electronic Signature Policy establishes the validity of electronic communications sent through eIRB+ and electronic signatures as equivalent to hand-written signatures for means of obtaining Informed Consent.

HIPAA

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

The University’s policy on Human Research Protection Program Compliance (HRPP)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.

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

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. For more information see our Post-Approval Monitoring and For-Cause Audits & Directed Reviews webpages.

Release of Regulatory Inspection Documents

The Release of Regulatory Inspection Documents Policy exists to assist human research Investigators and their study teams in responding to sponsor requests for documents related to institutional and investigator Regulatory Inspections.

Use of Northwestern University IRB Services

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.

Guidance

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.

Guidance on Evaluating Reports of Data Incidents

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.

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

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.

Guidance on the Use of 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.

Guidance on Re-Consent / Notification of Study Participants

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.

Guidance on Research Participant Payments

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

Study Closure

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