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.
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.
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.
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.
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.
Research Participant Payments
This guidance describes the types of payments made to research participants and acceptable payment practices.
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.
Registries, Student Subject Pools, and Repositories
These guidelines apply to proposals to store data and/or specimens for future research use.
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.
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.
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.
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.