Guidance Jul 23, 2021 Multi-Site and Performance Site applications: Reporting to IRBMED This document provides the reporting requirements to IRBMED for both Multi-Site HUM application and Performance Site HUM application when U-M is a coordinating center is not the single IRB (sIRB)/IRB of record/reviewing IRB for sites other than U-M... Tags: Study Coordinator CTSO Work Guide
Guidance Jun 4, 2021 Information Blocking in a Blinded Study Single Blind Studies : A research study done in such a way that the participants do not know (are blinded to) what treatment they are receiving to ensure the study results are not biased (the power of suggestion). Blinded studies are sometimes... Tags: MiChart OnCore Support Participant Management
Guidance Mar 19, 2021 Research Involving Children Who Are Wards of State or Any Other Agency, Institution, or Entity
Guidance Mar 18, 2021 Assent of Children in Research The IRBMED has developed an assent template for researchers to use in developing an assent document appropriate for children ages 10 to 14. It is available here . Below are frequently asked questions about assent. Links to additional information are...
Guidance Mar 8, 2021 Children in Research The involvement of children of any age in human subjects research involves additional regulatory and ethical considerations. Resources on the main categories for consideration follow. Children are persons who have not attained the legal age for...
Guidance Mar 8, 2021 Record Keeping Guidelines Research records include, but may not be limited to, consent forms case report forms (CRFs) subject-specific forms for adverse events, notes to file, and protocol deviations Record retention must be consistent with IRB-approved methods for data... Tags: Regulatory Study Coordinator Study Teams
Guidance Feb 26, 2021 Elements and Uses of a Repository A research repository is defined as a collection of data/biospecimens that have been collected and stored with the intention of using the materials for future research , either by the investigator who collected them or by sharing the materials with...
Guidance Feb 22, 2021 International Council for Harmonisation: Good Clinical Practice (ICH-GCP) The following information applies to the conduct of clinical research at the University of Michigan under ICH-GCP E6(R2) Guidelines. International Council for Harmonisation (ICH) Good Clinical Practice ( GCP ) standards (ICH-GCP) standards are fully...
Guidance Nov 2, 2020 FDA guidance - General, Drug and Biologicals, Medical Devices, and FDA operations The term “ test article ” is found in the FDA regulations on Protection of Human Subjects ( 21 CFR 50.3, Definitions (j)). The term includes drugs (including botanicals, biologicals , and gene therapy, and genetically derived products that meet the...
Guidance Oct 21, 2020 Prisoners in Research Convened Board review and approval of research designed to study incarcerated persons, or persons likely to become incarcerated , is a multistep process and must be conducted in accordance with the requirements in 45 CFR 46 Subparts A (Common Rule)...
Guidance Aug 31, 2020 Certification Preparatory to Research Review of data and/or biospecimens preparatory to research are not regulated under the Common Rule if any data obtained is not used for future research. However, if you or any member of the study team will be accessing Protected Health Information (...
Guidance Aug 10, 2020 Decedents Research involving data and/or biospecimens from decedents (deceased i ndividuals) is not regulated under the Common Rule. However, if you or any member of the study team will be accessing Protected Health Information (PHI) of the decedent(s), the...
Guidance Aug 10, 2020 Limited Data Sets Research on coded private information , or on non-identifiable information, is not regulated under the Common Rule . However, HIPAA Privacy Rule protections apply if a coded or non-identifiable data set contains Protected Health Information (PHI) in...
Guidance Jul 29, 2020 Seeking Reconsent from Research Participants Informed consent is an ongoing, interactive process throughout a participant’s study involvement, rather than a one-time information session. In addition to encouraging subjects to ask questions and raise concerns, it may become necessary to seek...
Guidance Jul 22, 2020 Study-Specific Adverse Event (AE) Reporting Plans The IRBMED Standard Adverse Event (AE) Reporting Timetable is designed to accommodate a wide range of study designs and risk levels. These standard guidelines apply only to IRBMED reporting; they do not apply to reporting that may be required by...
Guidance Jun 11, 2018 Adverse Event Reporting Internal adverse events are events that involve subjects or others whom the UM investigator is responsible for and/or events for which a UM IRB has direct oversight. These guidelines apply only to IRBMED reporting. They do not apply to required...
Guidance Jun 11, 2018 Adverse Events (AEs), Other Reportable Information and Occurrences (ORIOs), & Other Required Reporting Investigators and research staff are responsible for reporting information concerning the approved research to the IRB in a timely fashion, understanding and adhering to the reporting guidance provided here and on the detail pages linked below, and...
Guidance May 7, 2018 Deception and Concealment Deception in human subjects research means deliberately misleading subjects about the nature of a study. Concealment means deliberately withholding certain information. Studies involving deception or concealment must meet all criteria for a waiver...
Guidance May 7, 2018 FDA Expanded Access Program at the University of Michigan For assistance in obtaining approval to use an Expanded Access investigational product, contact MICHR IND / IDE Investigator Assistance Program (MIAP) by emailing [email protected] The FDA Expanded Access program allows a...