U-MIC

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University of Michigan
IRB Collaborative

The University of Michigan's IRBs are committed to providing educational materials online, as well as in the classroom. U-MIC presentations are short videos and voiceover slide shows that address topics relating both to ethics in human subjects research and to IRB procedures.

A

Anonymous, Coded, and De-identified Data in Human Subjects Research

This voiceover slideshow defines anonymous, coded, and de-identified data, clarifying how the three concepts differ.

Assent Requirements and Considerations (Part One: Children)

Federal regulations outline requirements for obtaining the assent of human subjects under 18, as well as cases in which IRBs may waive those requirements. This short presentation offers an overview.

Association for the Accreditation of Human Research Protection Programs (AAHRPP)

AAHRPP is an international, independent, nonprofit organization that reviews and accredits human research protections programs. Since 2008, the University of Michigan has been an AAHRPP-accredited institution and is currently in the process of seeking reaccreditation. This short presentation summarizes the accreditation process.

B

Belmont Report (Part One: Basic Ethical Principles)

The Belmont Report (1979) is a cornerstone document in human subjects research ethics. This first of two video introductions presents the three basic ethical principles put forward in the report.                                                                                                                        

Belmont Report (Part Two: Applying the Principles)

The Belmont Report (1979) is a cornerstone document in human subjects research ethics. This second of two video introductions examines ways in which researchers should apply the basic ethical principles.                                                                                                                                

C

Central Institutional Review Boards

A central IRB is a single institutional review board that provides regulatory and ethical review services for multiple sites participating in a research project.

Certificates of Confidentiality

This presentation provides an overview of Certificates of Confidentiality, which the National Institutes of Health (NIH) issue to protect subjects' sensitive and identifiable information against forced disclosure.

ClinicalTrials.gov: Requirements for Registration and Informed Consent

Guest presenter Diane Lehman Wilson, from the Office of Regulatory Affairs, provides an overview of the ClinicalTrials.gov registry.

Cognitively Impaired Subjects and Legally Authorized Representatives

Consent capacity is the ability to understand information relevant to an informed, voluntary decision to participate in research. Cognitive impairment refers to situations in which a person’s ability to provide valid initial and ongoing consent is limited or absent due to an impairment of memory, understanding, or reasoning. 

Collaborator Agreements: IAAs, IIAs, and CIAs

All institutions engaged in human subjects research that is not exempt from the regulations, and that is conducted or supported by any Department of Health and Human Services agency, must be covered by an Office for Human Research Protections (OHRP) approved assurance of compliance called a federalwide assurance or FWA. An institution may extend its FWA to cover a collaborating individual investigator or other institution. This slide show presentation outlines three different collaborator agreements.

Community-Based Participatory Research (CBPR)

Community-based participatory research involves the collaboration of academic researchers and members of the general community. This short presentation provides an overview.

Comparative Effectiveness Research

Because adequate knowledge about the effectiveness and risks of standards of care is sometimes lacking, studies designed to evaluate two or more standards of care have become common. Such studies are often referred to as “comparative effectiveness research.”

Conflicts of Interest in Human Subjects Research

Occasionally, researchers have financial interests that create the potential for bias. This is referred to as a conflict of interest. This short presentation summarizes considerations for IRB reviewers when study team members have conflicts of interest.

Continuing Review Changes Under the Revised Common Rule (2018)

Under the revised Common Rule, which is scheduled to become effective on January 19, 2018, continuing review is no longer required for some studies. This presentation provides a summary.

Continuing Review Requirements

The new Common Rule permits elimination of continuing review in certain circumstances. This short presentation provides a summary.

D

Data and/or Biospecimen Repositories: IRB Oversight

A research data or tissue bank, or research repository, stores, maintains, and distributes data and/or biospecimens to enable future research. Making data and biospecimens available in repositories, to maximize their utility to the overall research community, is increasingly a priority at both national and institutional levels. This short presentation provides a summary.

Data Management & Security

This presentation offers recommendations for securing electronic research data.

Deception & Concealment in Human Subjects Research

This presentation looks at the ethical use of deception and concealment in research involving human subjects.

Department of Defense Research (Part One)

The Department of Defense has its own regulations governing research involving any DoD component. This presentation provides an overview of these regulations.

Department of Defense Research (Part Two)

This slide show represents the second of two tips summarizing Department of Defense regulations for human subjects research.

Diversity and Inclusiveness in Human Subjects Research

When incorporating race and ethnicity factors and data in research, FDA recommends use of the categories standardized in 1997 by the federal government’s Office of Management and Budget. This short presentation outlines these categories and other recommendations for achieving diverse and inclusive research populations and outcomes.

Play presentation -- Time: 4:20
Voiceover script (PDF)

Document Version Comparison in eResearch

A Compare feature has been built into eResearch Regulatory Management, which enables users to compare two versions of the same document by displaying change tracking. This short presentation provides a summary.

Play presentation -- Time: 4:18
Voiceover script (PDF)

E

Electronic Data Security

The Office of Human Research Compliance Review and the Information Technology Services department offer suggestions for securing study data stored electronically. This presentation offers a summary of their recommendations.

Electronic Informed Consent Using SignNow (Part One: Overview)

Electronic informed consent, or eIC, is the use of electronic processes and systems to convey study information to potential subjects or legally authorized representatives and to obtain and document their informed consent. SignNow is electronic signature software available for use by UM personnel and students from all University of Michigan campuses, including Michigan Medicine. This presentation provides an overview of SignNow functionality.

Electronic Informed Consent Using SignNow (Part Two: Managing Templates with Variable Signers)

SignNow templates allow users to prepare documents in advance so that they are immediately ready for use each time a potential subject is identified. However, different circumstances may call for various combinations of document signers. Managing SignNow templates to accommodate multiple variable combinations of signers can be achieved by different methods. This presentation summarizes two approaches.

Enrollment of Human Subjects

IRBs and other research administration committees at U-M are adopting a single standard definition of enrolled. Guest presenter Lark Speyer summarizes enrollment reporting in eResearch.

eResearch Regulatory Management Upgrade (April 2017)

The eResearch Regulatory Management system underwent a software upgrade on April 30, 2017. This upgrade brought about cosmetic and layout changes, as well as some minor changes in the software’s functionality. This short presentation provides a summary of the changes.

eResearch Regulatory Management: Posted Correspondence

eResearch Regulatory Management enables some study team members, IRB members and staff, and the staff of other committees involved in the review and approval process to communicate within the Regulatory Management system. This functionality is called posted correspondence. This short presentation provides an overview.

eResearch: Using Notes as Place Markers

This slide presentation explores using eResearch notes as reminders to complete all sections of your application before submitting it to IRBMED.

eResearch: Viewing Submission Summaries

This presentation shows you how eResearch's submission summary pages can help you prepare for your IRBMED meeting.

Exception from Informed Consent Requirements for Emergency Research (EFIC)

The Food and Drug Administration’s regulation at 21 CFR 50.24 allows a narrow exception to the requirement to prospectively obtain and document informed consent from research subjects. According to the regulation, IRBs may approve certain emergency research protocols in which subjects are unable, due to their medical condition, to give informed consent at the time of enrollment. This short presentation provides a summary.

Exemption 7 and Two-Year Approval - ARCHIVED

These flexibility initiatives were active 2015 - June 10, 2018. The presentation is obsolete as of June 11, 2018.

2015: To utilize federal regulations’ existing flexibility regarding non-federally-funded, non-FDA regulated research, IRBMED has launched two new initiatives: Exemption 7 and two-year approval periods. This short presentation summarizes these two initiatives.

Exemption Changes Under the Revised Common Rule (2018)

Revisions to the Common Rule, which are scheduled to become effective in January 2018, include changes to existing exemption categories, as well as the addition of some new categories. This short slide show offers an overview of these changes.

Exemptions 1 and 2 in Human Subjects Research (and 2A)

A few specific sub-categories of human subjects research are defined as “Exempt” from the federal regulations governing IRB operations. This short presentation offers a summary of Exemptions 1 and 2.

The "Exemption 2A" flexibility initiatives was active May 1, 2015 - June 10, 2018. It is obsolete as of June 11, 2018. Exemption 3 under the Revised Common Rule in some ways resembles the old Exemption 2A: see also the U-MIC "Exemption Changes Under the Revised Common Rule (2018)."

Expedited Review: Category 5

For minimal-risk research that falls under one of nine categories, federal regulations allow review by an IRB Chair or designee, with no vote by the full IRB. This short presentation outlines category 5: research involving materials collected for non-research purposes.

F

Family Educational Rights and Privacy Act (FERPA)

The Family Educational Rights and Privacy Act (or FERPA) is a federal law that protects the confidentiality of personally identifiable information contained in a student’s educational record.

FDA Guidance on the Impact of the COVID-19 Pandemic on the Conduct of Clinical Trials (March 2020)

In March 2020, the Food and Drug Administration (FDA) issued guidance to assist sponsors and researchers in ensuring the safety of study subjects, maintaining good clinical practice, and minimizing risks to research integrity during the coronavirus disease 2019 (or COVID-19) pandemic. This short presentation offers a summary of the guidance.

FDA Inspections of Institutional Review Boards

FDA conducts periodic, scheduled inspections of IRBs, to determine whether they are complying with FDA regulations and laws and following their own written procedures. This short presentation gives an overview.

G

Genetic Information Nondiscrimination Act (GINA)

This slide show provides an overview of GINA, a federal law that prohibits health insurance companies and employers from discriminating based on genetic information.

H

HIPAA Privacy Rule: Requirements and Waivers

The HIPAA Privacy Rule guards patients' protected health information (PHI) and governs how researchers may access, use, and disclose PHI in research. This slide show provides a summary.

Human Research Protection Programs (HRPP)

The HRPP has become an essential component of ensuring human subjects protections. This slideshow summarizes the concept in general and outlines the University of Michigan's HRPP.

Humanitarian Use Devices (HUDs)

Humanitarian Use Devices (HUDs) are used to treat conditions that affect fewer than 4,000 Americans per year. This short slide show outlines the requirements for HUD use and research.

I - K

Impact of the COVID-19 Pandemic on the Conduct of Clinical Trials (FDA Guidance: March 2020)

In March 2020, the Food and Drug Administration (FDA) issued guidance to assist sponsors and researchers in ensuring the safety of study subjects, maintaining good clinical practice, and minimizing risks to research integrity during the coronavirus disease 2019 (or COVID-19) pandemic. This short presentation offers a summary of the guidance.

Informed Consent Changes Under the Revised Common Rule (2018)

The Final Common Rule, revised in 2017 and scheduled to become effective on January 19, 2018, includes a number of changes pertaining to informed consent. This short presentation provides an overview.

Informed Consent Documentation

This short presentation outlines federal requirements for documenting subjects' consent to take part in research, as well as circumstances under which IRBs may waive the documentation requirement.

Informed Consent for Genetic Sub-Studies

This presentation outlines options for obtaining subjects' consent to take part in genetic sub-studies.

Informed Consent in an Emergency Care Setting

In certain cases, it is possible to obtain legally effective informed consent in an urgent or emergency care setting. This presentation examines the variables that IRBs and researchers must consider when determining whether consenting emergency care patients for research is appropriate.

International Council on Harmonisation: Good Clinical Practice (ICH-GCP)

The International Council on Harmonisation (ICH) brings together the drug regulatory authorities and the pharmaceutical industry of Europe, Japan, and the United States. ICH offers many benefits to regulatory authorities and the pharmaceutical industry, and ultimately promotes the protection of public health. This short presentation summarizes ICH-GCP requirements.

Investigator Responsibilities per the HRPP Operations Manual & the Common Rule

The University of Michigan Human Research Protection Program’s Operations Manual addresses the roles and responsibilities of researchers, including principal investigators, or PIs. This slideshow outlines these responsibilities.

Investigator Responsibilities: Protecting the Rights Safety & Welfare of Study Subjects (FDA Guidance)

In 2009, the Food and Drug Administration published guidance on the responsibilities of investigators conducting drug, biologic, and device trials. This short presentation provides an overview.

In Vitro Diagnostic Products (IVDs)

In vitro diagnostic (IVD) products are defined in FDA regulations at 21 CFR 809.3(a) as those reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. This presentation summarizes IVDs.

IRB Membership Requirements & Quorum

Federal regulations and the University of Michigan Human Research Protection Program's Operations Manual address requirements for IRB membership and approval of proposed research at convened IRB meetings. This short slide show offers a summary.

IRB Regulatory Determinations

For each application it reviews—whether during a convened Board meeting or by expedited review—the IRB must make certain regulatory determinations. This slide show offers a summary.

Key Information in Informed Consent Documents

The revised Common Rule, which became effective January 21, 2019, includes a new requirement that informed consent documents begin with a summary of key information most likely to aid potential subjects' decision whether to take part in research. This short presentation provides an overview.

L

Lotteries as Incentives in Human Subjects Research

This short slide show explores lotteries as incentives for research participation, including a summary of Michigan's legal requirements.

M

Meeting Minutes from IRB Board Meetings

IRBs maintain meeting minutes to document key elements of convened board meetings. This short presentation summarizes the requirements.

Michigan Genomics Initiative (MGI): Uses of Resources

As part of the U-M Precision Health Initiative, increased integration is becoming possible across several large-scale institutional research resources, including the Michigan Genomics Initiative (MGI), the Central Biorepository, and DataDirect. This short presentation provides an overview.

Mobile Medical Apps (FDA Guidance)

In February 2015, the Food and Drug Administration issued guidance pertaining to mobile medical applications. More recently, UM has added mobile medical app–related sections to the eResearch application system. This short slide show provides an overview of regulatory considerations regarding mobile medical apps.

N

O

P

Parental Permission in Research Involving Minors

In most instances, federal regulations require that researchers also obtain the permission of each minor subject’s parents or legal guardian. This short slide show summarizes federal and institutional requirements and expectations.

Post-Approval Study Monitoring: Understanding the Investigator's Role (Part One)

Principal Investigators have ongoing responsibilities after IRB approval of their study to ensure compliance with human subjects protections standards. Generally, these tasks can be performed by the investigator him or herself or delegated to qualified individuals. One of these primary responsibilities is monitoring the conduct and progress of the research study. This two-part presentation—developed in collaboration of the Office of Regulatory Compliance Review (ORCR)—provides an overview.

Post-Approval Study Monitoring: Understanding the Investigator's Role (Part Two)

Principal Investigators have ongoing responsibilities after IRB approval of their study to ensure compliance with human subjects protections standards. Generally, these tasks can be performed by the investigator him or herself or delegated to qualified individuals. One of these primary responsibilities is monitoring the conduct and progress of the research study. This two-part presentation—developed in collaboration of the Office of Regulatory Compliance Review (ORCR)—provides an overview.

Prisoners as Research Subjects (Part One: Federal Requirements)

This first of two companion presentations defines key terms and outlines the federal regulations governing enrollment of prisoners as subjects in research.

Prisoners as Research Subjects (Part Two: Certification and IRB Review)

This presentation--the second of two tips on prisoners in research--summarizes the certifications one must obtain before enrolling prisoners as study subjects, as well as the role of the IRB.

Prisoners in Epidemiological Research

This tip revisits the subject of prisoners in research, summarizing the Department of Health and Human Services' 2003 waiver permitting prisoner participation in epidemiological studies.

Privacy & Confidentiality in Human Subjects Research

This short video addresses human subjects' rights to privacy and confidentiality.

Protected Health Information (PHI)

HIPAA's Privacy Rule regulates how researchers use and disclose PHI. This short slide show outlines PHI requirements for researchers.

Q

R

The Revised Common Rule

On January 21, 2019, revisions to HHS regulations at 45 CFR 46 subpart A, known as the Common Rule, became effective. This presentation summarizes the changes in the revised Common Rule.

S

Scheduled Continuing Review: Document Review & Finalization

As part of their review of renewal applications, IRBs must review and approve supporting documents as long as they are in use. This presentation provides a summary.

Screening and Recruitment

Study recruitment and subject screening are related, but distinct, activities. Recruitment involves information and activities designed to provide information to potential subjects. Screening involves the collection of information from or about potential subjects to determine whether they are eligible to participate in the research. This short presentation summarizes screening and recruitment in human subjects research.

Secondary Use Applications - ARCHIVED

eResearch "intake" of secondary use applications changed significantly as of June 11, 2018 Release 4.3. The basic principle remains that a secondary use project may be "non-exempt (comprehensively regulated)," "exempt human subjects research," or "activities not regulated as human subjects research," depending mostly on the identifiability of the data accessed by the researchers. However, many of the specific eResearch suggestions in this presentation are obsolete.

2014: The purpose of this presentation is to examine what secondary use is as it relates to human subjects research and when the secondary use application type in eResearch is applicable.

Significant & Nonsignficant Risk Devices in Human Subjects Research

Federal regulations guide IRBs in determining whether investigational medical devices present significant or nonsignificant risk to subjects. This short presentation offers an overview.

SignNow in Electronic Informed Consent (Part One: Overview)

Electronic informed consent, or eIC, is the use of electronic processes and systems to convey study information to potential subjects or legally authorized representatives and to obtain and document their informed consent. SignNow is electronic signature software available for use by UM personnel and students from all University of Michigan campuses, including Michigan Medicine. This presentation provides an overview of SignNow functionality.

SignNow in Electronic Informed Consent (Part Two: Managing Templates with Variable Signers)

SignNow templates allow users to prepare documents in advance so that they are immediately ready for use each time a potential subject is identified. However, different circumstances may call for various combinations of document signers. Managing SignNow templates to accommodate multiple variable combinations of signers can be achieved by different methods. This presentation summarizes two approaches.

Single Institutional Review Boards: IRBMED Process

A single IRB (sIRB)—also called a reviewing IRB or IRB of record—assumes IRB responsibilities for one or more other institutions with whom it is engaged in multi-site research. This presentation offers a general overview of IRBMED’s sIRB process. 

Single Institutional Review Boards (sIRB): Overall PI Responsitibilties

A UM principal investigator in multi-site research for which IRBMED serves as single IRB—commonly referred to as the “overall principal investigator”—bears additional responsibilities. This presentation summarizes IRBMED's checklist of additional responsibilities that an overall PI should be prepared to accept.

Single Institutional Review Board for Multisite Research (NIH Policy)

In June 2016, the National Institutes of Health issued a formal policy regarding use of a single institutional review board (or sIRB) for multisite research. This presentation summarizes the policy.

Site-specific Protocol Addenda

In certain circumstances, IRBMED may permit the University of Michigan’s participation in a multi-site study only if U-M–specific protocol modifications are implemented. This presentation outlines procedures.

Speciality Informed Consent Templates: One-Time Blood or Tissue Sample & Eligibility Screening

IRBMED has recently begun to offer specialty informed consent templates, tailored to specific study scenarios. This short presentation introduces two new specialty templates.

T

Third Parties in Human Subjects Research

When research subjects make reference to individuals who are not involved in the study at hand and with whom researchers have no interaction, we call these individuals third parties. This presentation provides a summary.

U

Umbrella Projects

Guest presenter Lark Speyer offers an overview of projects lacking immediate plans for involvement of human subjects—known as umbrella projects.

Unanticipated Problems Involving Risk to Subjects or Others (UPIRSOs or UaPs)

Federal regulations require researchers to report unanticipated problems involving risk to subjects or others. This short presentation provides an overview.

V

Version Control of Informed Consent Documents

To ensure that study teams modifying consent documents utilize the most recent IRB-approved version, IRBMED has standardized practices for version control of informed consent documents.

Vulnerable Subject Populations in Human Subjects Research

Federal regulations and institutional policy identify certain categories of research subjects (known as vulnerable populations) who are likely to be vulnerable to coercion or undue influence. This slideshow summarizes these populations and the special responsibillies associated with research in which they may be enrolled as subjects.

W - Z

Waivers of Informed Consent in FDA-Regulated Research

A December 2016 amendment to the Federal Food, Drug and Cosmetic Act (FD&C Act) provided FDA with authority to permit waivers of consent for minimal-risk clinical investigations when specific criteria are met. This slide show summarizes FDA guidance regarding waivers of informed consent in FDA-regulated research.

Writing Informed Consent Documents (Part One: Fundamentals)

In the first of two presentations on writing informed consent documents, IRBMED's technical writer offers some basic recommendations for crafting documents that are both readable and comprehensible to subjects.

Writing Informed Consent Documents (Part Two: Exhibit)

The previous presentation offered recommendations for creating effective informed consent documents. This instructional presentation applies these principles in the revision of a problematic consent passage.

Questions?

Contact us at irbmed@umich.edu or 734-763-4768 / (Fax 734-763-1234)

2800 Plymouth Road, Building 520, Room 3214, Ann Arbor, MI 48109-2800

A list of IRBMED staff is available in the Personnel Directory, or view the list of Regulatory Teams.

Edited By: larkspur@umich.edu
Last Updated: December 16, 2022