HBR Case Study Circulars

The NHG Health RI shares good practices and negative examples using short case studies on a regular basis to help researchers understand the what-to’s and how-to’s of HBRA.

NOTE

These Circulars are access-restricted to NHG Health Staff only.
NHG Health-Intranet access is required before they can be downloaded.

Case Studies 2025

HBR Case Study 66 - Patient Identifiers Collected Without IRB Review

HBR Case Study 65 - Inadequate Screening Process Leading to Inappropriate Enrollment

HBR Case Study 64 - Failure to Provide Required Discharge Medication

HBR Case Study 63 - Blood Sample Mix-up Leading to Repeat Invasive Procedure

Case Studies 2024

HBR Case Study 62 - Is IRB Approval Required for Recruitment Outside of Approved Protocol

H BR Case Study 61 - Inappropriate Patient Identifier Collection and Subject Recruitment

H BR Case Study 60 - Common ICF Mistakes

HBR Case Study 57 - 59 - ICF and Data Handling

CS56 Blood from Subject Collected Despite Saying “NO”

CS55 Subject Required to Pay for Research Procedure as a Result of Study Team’s Oversight

CS54 No Written Consent Obtained from Subject

Case Studies 2023

CS53 No Prescribed Witness During Consent Process

CS52 Recruited Subjects Who Did Not Meet the Inclusion Criteria

CS51 Conflict in Payment Information Given to Subjects

CS50 Biospecimen Collected Without Informed Consent Documentation

Case Studies 2022

Table

CS48 Investigator Also Signed Off as Witness in ICF

CS47 No Witness During Informed Consent Process

CS46 Recruited Subjects Did Not Fulfill Inclusion Criteria

CS45 Missing Informed Consent Forms

CS44 Recruitment of Subject Below the Approved Age

CS43 Subject Underwent Study Procedure Twice Due To Error in Visiting Schedule

CS42 Subjects Recruited Twice

CS41 Missing Witness Signature on the Informed Consent Form

CS40 Informed Consent Obtained Without Presence of HBRA Witness

CS39 Study Team Did Not Check for Exclusion Criteria and Recruited Ineligible Patient for the Study

Case Studies 2021

Table

CS37 and 38 Incorrect Version of Consent Form Used and Incomplete Signatory of Informed Consent Form

CS36 Over-Recruitment

CS35 Additional Samples Collected From Subject

CS33 and 34 Non-Eligible Subjects Recruited for Research

CS32 Recruitment of a Subject who is Above the Approved Upper Age Limit

CS31 Use of ICF missing 12(1)(l) element

CS30 Research Activities Conducted During Study’s IRB Approval Lapse Period

CS29 Double Recruitment of the Same Participant

CS28 Wrongful Recruitment of Subjects Who Did Not Meet Inclusion Criteria

CS27 Recruitment of Subject Below Eligible Age

CS26 Recruited Subjects Who Did Not Meet Study’s Inclusion Criteria

CS25 Minors Recruited Without Documented Informed Consent From The Parents Legal Guardian

Case Studies 2020

Table

CS24 Lost Informed Consent Forms

CS23 Research Procedure Performed Twice as Participant Was Enrolled Twice

CS22 Wrong Version of Informed Consent Form Used

CS21 Sample Collection Not in Accordance to Research Protocol

CS20 Recruitment of Subject Below Eligible Age

CS19 Ineligible Participant Recruited

CS18 Two Participants Recruited Despite Not Meeting Eligibility Criteria

CS17 Poorly Fitted Head Device Poses Risk to Subject

CS16 Witness Absent When Taking Informed Consent For Interventional Study

CS15 Recruiting With Consent Form That Did Not Contain All Elements Of HBRA Section 12(1)

CS14 Recruitment Of Individual Who Did Not Meet Inclusion Criteria

CS13 Appropriate Consent Not Obtained From Minors

CS12 Witness Was Present During The Consent Taking Process But It Was Not Documented

CS11 Principal Investigator Missed Out HBRA Witness During Consent Taking

CS10 Recruitment Of Subjects Without Informing About Potential Incidental Findings

CS09 Recruitment Of Individual Who Did Not Meet Inclusion Criteria

CS08 Recruitment Of The Same Individual Twice

CS07 Collection Of Data Without Written Consent

CS06 20 Year-Old Recruited Into Research Study Without Parental Consent

CS05 Missing Signed Informed Consent Forms

CS04 Subjects Recruited Into Study Involving Blood-Taking Using Consent Form That Did Not Contain All Elements Of HBRA 12(1)

CS03 No Witness Was Present When Taking Consent From Subject For Study Involving Blood-Taking

CS02 Urine Collected From Dementia Subject After Son Gave Verbal Agreement

CS01 Blood Was Drawn From A Research Subject Without Appropriate Consent

NOTE

These Circulars are access-restricted to NHG Health Staff only.
NHG Health-Intranet access is required before they can be downloaded.