Skip to content
Main Menu

Tag: igs

Research Conducted in Elementary and Secondary Schools

Categories:

Research Conducted in Elementary and Secondary Schools Introduction Guidance Documents and References Points to Consider ⏴back to Guidance Series Research Conducted in Elementary and Secondary Schools Version: September 22, 2020 Introduction This guidance focuses on research conducted in elementary and secondary schools. For more information on research conducted in post-secondary schools, please see the IGS: […]

Read More
September 22, 2020

Research Design

Categories:

Research Design Introduction Guidance Documents and References ⏴back to Guidance Series Research Design Version: September 10, 2020 Introduction “It is not unusual for institutional review board (IRB) members, institutional officials, and researchers to debate the role of the IRB in evaluating study design or other aspects that affect the fundamental quality of the science of […]

Read More
September 10, 2020

Research Conducted in Post-Secondary Schools

Categories:

Research Conducted in Post-Secondary Schools Introduction Guidance Documents and References Points to Consider ⏴back to Guidance Series Research Conducted in Post-Secondary Schools Version: September 10, 2020 Introduction This guidance focuses on research conducted in post-secondary schools with individuals 18 and older. For more information on research conducted in elementary and secondary schools, please see the […]

Read More
September 10, 2020

Advertisements

Categories:

Advertisements Guidance Documents and References Points to Consider ⏴back to Guidance Series Advertisements Version: September 9, 2020 Guidance The IRB reviews recruitment methods, including advertisements, to ensure that they do not interfere with the equitable selection of participants.  The IRB reviews proposed advertisements and solicitations for research participation to ensure that they do not violate […]

Read More
September 9, 2020

Recruitment Methods

Categories:

Recruitment Methods Guidance Documents and References Points to Consider Appendices ⏴back to Guidance Series Recruitment Methods Version: September 4, 2020 Guidance The IRB reviews the process of screening, recruiting, and determining eligibility. The IRB reviews proposed recruitment procedures and advertisements to ensure that they do not violate the regulatory requirements of consent. For more information […]

Read More
September 4, 2020

Placebo Comparators

Categories:

Placebo Comparators Guidance Points to Consider ⏴back to Guidance Series Placebo Comparators Version: September 4, 2020 Guidance A protocol that involves removing participants from the standard medication for their disease or condition, and randomizing them to receive either an investigational agent or a placebo, may raise issues of participant safety.  If some participants will receive […]

Read More
September 4, 2020

Risk Assessment

Categories:

Risk Assessment Guidance Documents and References Points to Consider ⏴back to Guidance Series Risk Assessment Version: August 14, 2020 Guidance The IRB must conduct an assessment of the risks to participants in order to determine whether a study is approvable. In order to approve research, the IRB must find that: Risks to subjects are minimized […]

Read More
August 14, 2020

HIPAA Privacy Rule & Authorization

Categories:

HIPAA Privacy Rule & Authorization Definitions Guidance Documents and References Footnotes ⏴back to Guidance Series HIPAA Privacy Rule & Authorization Version: October 21, 2019 Definitions Breach.  The term ‘breach’ means the unauthorized acquisition, access, use, or disclosure of protected health information which compromises the security or privacy of such information, except where an unauthorized person […]

Read More
October 21, 2019

Gender Inclusive Language in Research

Categories:

Gender Inclusive Language in Research Definitions Guidance Documents and References ⏴back to Guidance Series Gender Inclusive Language in Research Version: August 15, 2019 Definitions Gender or Gender Identity describes the internal/psychological sense of self, regardless of biology. Response options to questions categorizing gender would typically include woman, man, transgender, and non-binary. Sex is the biological […]

Read More
August 15, 2019

Neonates

Categories:

Neonates Definitions Guidance Documents and References Points to Consider ⏴back to Guidance Topics Neonates Version: January 21, 2019 Definitions Subpart B: This term refers to the regulations which apply to research involving neonates as subjects. Subpart B is found in 45 CFR 46 (DHHS). Neonate: Newborns from the time of delivery up until 28 days […]

Read More
January 21, 2019