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Guidance Documents

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.

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

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

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

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

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

Research Participant Payments

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

Guidance on Research Participant Payments

Research with Children

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

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

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

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

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