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Adverse Events/Unanticipated Problems Assessment Flowchart
Last Updated: August 23, 2022
Advertisements
Last Updated: September 9, 2020
Basic Physiological Research
Last Updated: September 19, 2019
Applicable State Laws
Last Updated: February 16, 2024
Certificates of Confidentiality
Last Updated: April 26, 2024
Compensation of Research Subjects
Last Updated: April 13, 2021
Writing a Review Summary
Last Updated: July 15, 2020
Biopsies for Research Purposes
Last Updated: May 26, 2021
Considerations for Pregnancy Testing Prior to Radiation Exposure for Research Purposes
Last Updated: March 4, 2016
Equitable Selection of Participants
Last Updated: August 26, 2019
Ethical Considerations for Surrogate Consent
Last Updated: February 16, 2024
Expedited Category 8(a) Decision Chart
Last Updated: March 21, 2022
Expedited Category 9 Decision Chart
Last Updated: November 20, 2020
IRB Authority: Observation of Consent & Conduct of Research
Last Updated: August 25, 2019
SIRB Site-Control Review Instructions
Last Updated: November 17, 2020
Verification from Other Sources
Last Updated: April 30, 2019
Virtual IRB Meetings
Last Updated: March 16, 2020
Waivers of Consent for Research with Prospective Data Collection
Last Updated: July 18, 2024
Concise Summary
Last Updated: February 3, 2022
Consent During the COVID-19 Public Health Emergency
Last Updated: September 22, 2020
Data & Biospecimens, Future Use
Last Updated: October 22, 2024
Deception and Debriefing
Last Updated: June 25, 2012
Devices Guidance
Last Updated: October 22, 2024
Elements of a Data Monitoring Plan
Last Updated: September 29, 2022
Elements of a Safety Monitoring Plan
Last Updated: September 29, 2022
Exempt Research
Last Updated: March 6, 2024
Expedited Review of Research
Last Updated: February 21, 2023
Exercise Testing in Research
Last Updated: May 26, 2016
Gender Inclusive Language in Research
Last Updated: August 1, 2019
Genetic Research
Last Updated: February 2, 2021
Help Sheet for Exemption Umbrella Protocol Applications
Last Updated: March 21, 2014
HIPAA Privacy Rule and Authorization
Last Updated: October 21, 2019
Human Tissue Transfer
Last Updated: August 9, 2022
Including Spanish-Speaking Individuals in Research
Last Updated: July 22, 2024
IND Exemption Criteria
Last Updated: August 14, 2019
International Research
Last Updated: August 22, 2022
Investigators and Key Study Personnel
Last Updated: July 8, 2022
Investigator Responsibilities for Device Studies
Last Updated: February 22, 2023
Investigator Responsibilities for Drug Studies
Last Updated: February 22, 2023
Mandatory Reporting
Last Updated: January 20, 2021
Multimedia Recordings
Last Updated: October 17, 2019
Parental Permission and Child Assent
Last Updated: February 16, 2024
Payments for Referrals to Research Studies
Last Updated: February 6, 2024
Placebo Comparators
Last Updated: September 4, 2020
Pregnancy During Research Participation
Last Updated: April 28, 2021
Research Involving Pregnant Women and Fetuses
Last Updated: April 26, 2024
Privacy and Confidentiality
Last Updated: April 5, 2016
Recruitment and Enrollment of Employees in Research
Last Updated: August 24, 2022
Recruitment Methods
Last Updated: September 4, 2020
Regulatory References – Consent Language for Future Use of Information or Biospecimens
Last Updated: July 16, 2021
Required Documents and Forms for IRB Applications
Last Updated: July 3, 2023
Research Conducted in Elementary and Secondary Schools
Last Updated: September 22, 2020
Research Conducted in Post-Secondary Schools
Last Updated: September 10, 2020
Research Design
Last Updated: September 10, 2020
Research Involving Children
Last Updated: February 2, 2022
Research Involving Economically or Educationally Disadvantaged Individuals
Last Updated: August 10, 2022
Research Involving Individuals with Decisional Impairment
Last Updated: February 16, 2024
Research Involving Neonates
Last Updated: April 8, 2022
Research Involving Prisoners
Last Updated: August 22, 2022
Research Involving Risk of Suicide
Last Updated: September 14, 2021
Research Involving Wards of State
Last Updated: August 11, 2016
Risk Assessment
Last Updated: August 14, 2020
Secondary Analysis of Public Use Datasets
Last Updated: January 20, 2022
Short Form Consent Process Instructions for Use
Last Updated: December 13, 2022
Surrogate Consent by a Legally Authorized Representative
Last Updated: February 16, 2024
Sponsor-Investigator Guidelines and Responsibilities
Last Updated: August 7, 2019
Summary Guidance: Creating and Managing Tissue Banks for Research
Last Updated: September 15, 2013
The 18 Protected Health Information (PHI) HIPAA Identifiers
Last Updated: March 20, 2013
Transitioning to the Final Rule
Last Updated: April 6, 2022
Transplantation of Fetal Tissue
Last Updated: June 25, 2012
UPDB Consent and Authorization Requirements
Last Updated: October 2, 2019
Waiver or Alteration of Consent
Last Updated: July 18, 2024