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"Human Subjects Protections" is a collective term for the federal, state, and university policies, procedures, and ethical considerations that protect the rights and welfare of human beings who participate in research as the subjects of that research. The Human Research Protections Program (HRPP) provides the institutional guidelines for human subjects research at U-M.
- AAHRPP The Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP), helps organizations worldwide strengthen their human research protection programs and provides a list of accredited organizations both nationally and internationally.
- AAHRPP Tip Sheets Use these brief documents from AAHRPP to review the standards and elements that form an accredited human research protection program. U-M IRBs and ORCR are encouraged to review all tip sheets.
- AAHRPP U-MIC Download the University of Michigan IRB Collaborative (U-MIC) presentation (with audio) describing the AAHRPP re-accreditation process (~ 6 minutes). Last Updated: November 2020
- Abuse and Neglect Reporting (PDF) State of Michigan reference document outlining regulatory requirements for reporting abuse and neglect, including contact information.
- Amendment Tip Sheet (PDF) Screenshot with annotated guidelines for amending the Project Summary and Supporting Documentation sections of an IRB application. Provided by IRB-HSBS. Last Updated: 2024
- Authorization Agreement Process
- Basic Elements of Informed Consent PDF. Lists the basic and additional elements required for inclusion or to be included, as appropriate to the research, in the informed consent documentation, along with the citiation number [e.g., _0116(b)(1)] within the revised Common Rule. New elements associated with the 2018 Common Rule are indicated in bold text.
- Certificates of Confidentiality
- CIA World Fact Book Provides information on the history, people, government, economy, geography, communications, transportation, military, and transnational issues for 267 world entities.
- Class Assignments & IRB Approval
- Clinical Trials Participation - FAQ for Parents
- Clinical Trials Registration & Results Reporting
- Collaborative Research: IRB-HSBS sIRB Process
- Communications Handbook for Clinical Trials PDF - Strategies, tips, and tools to manage controversy, convey your message and disseminate results. Designed to serve the needs of anyone who conducts, plans, or implements clinical trials; especially trials that evaluate new drugs or interventions in a global community setting.
- Continuing Review Process
- Coordinated Services & Practices (CSP)
- Creating a Continuing Review eResearch Regulatory Management (eRRM) system instructions to submit a request for a continuing review of an approved study to the IRB for re-approval. Provided by ITS.
- Creating a Termination Report eResearch Regulatory Management (eRRM) system instructions to submit a request to terminate (close) an approved study. Provided by ITS.
- Creating an Adverse Event / ORIO eResearch Regulatory Management (eRRM) system instructions to create and submit an adverse event or other reportable inforamation/occurence report for IRB review. Provided by ITS.
- Data Security Guidelines
- Decision Trees: Exempt Human Subjects Research Decision trees displaying the criteria and potential review paths, including system generated determination, for exempt categories 1 - 4, 7 & 8 under the 2018 Common Rule.
- Electronic Human Research Documentation Certification Guidance (PDF) Outlines the procedure for creating, naming, certifyng and storing electronic copies of human research documentation as required by U-M, FDA, and other reserch sponsor polices, and provides a Certified Copy coversheet template. Last updated: 06/06/2022
- Engagement of Institutions in Human Subjects Research HHS definitions and examples of human subjects research terminology
- eResearch Regulatory Management (eRRM) Training Website listing links to job aids and other reference materials to learn how to use the eRRM system to complete, update, and review an IRB application.
- Ethical and Policy Issues in Int'l Research: Clinical Trials in Developing Countries National Bioethics Advisory Commission report (pdf) - discusses ethical issues that arise when research is sponsored or conducted in developing countries, where systems for protecting human participants equivalent to those of the U.S. have not yet been established.
- Ethical Considerations in Biomedical HIV Prevention Trials Published by United Nations AIDS and the World Health Organization in 2007 (with additional information added in 2012). This is an excellent resource about conducting clinical trials internationally. See the UNAIDS website (www.unaids.org) for available foreign language translations.
- Extension of an FWA to Cover Collaborating Individual Investigators and Introduction of the Individual Investigator Agreement
- FERCAP Forum for Ethical Review Committees in the Asian and Western Pacific Region (FERCAP), aims to improve understanding and implementation of ethical review for behavioral and biomedical researchers in Asia and the Western Pacific region.
- Fogarty International Center Bioethics Information and Resources The National Institutes of Health Fogarty International Center supports and facilitates global health research conducted by U.S. and international investigators, builds partnerships between U.S. health research institutions and those abroad, and aids in training the next generation of scientists to address global health needs. Fogarty also aims to strengthen research bioethics expertise in developing countries by providing resources and information to bioethicists, research ethics committee members, researchers, students, etc.
- How to Register a Clinical Trial
- How to Report Clinical Trial Results
- HRPP Advisory Council
- HRPP Education Resources
- HRPP Guidance: Additional Requirements for Department of Defense (DOD) Sponsored Research Summary of guidelines and requirements to conduct human subjects research sponsored by the U.S. Department of Defense (DOD). Last updated: February 2023
- HRPP Guidance: Additional Requirements for Department of Energy (DOE) SponsoredResearch Summary of guidelines and requirements to conduct human subjects research sponsored by the U.S. Department of Energy (DOE), includes a checklist for reviewing protocols that use personally identifiable information (PII). Last updated: Nov. 2019
- HRPP Guidance: Additional Requirements for Department of Justice (DOJ) Sponsored Research Summary of guidelines and requirements to conduct human subjects research sponsored by the U.S. Department of Justice (DOJ). Last updated: Nov. 2019
- HRPP Guidance: Additional Requirements for Environmental Protection Agency (EPA) Sponsored Research Summary of guidelines and requirements to conduct human subjects reserach sponsored by the U.S. Environmental Protections Agency (EPA). Last Updated: Nov. 2019
- HRPP Guidance: International Conference on Harmonization Good Clinical Practice (ICH-GCP) Outlines the investigators and IRB responsibilities when a human subjects study will be conducted (and reviewed) in compliance with ICH-GCP E6(R2) guidelines. Last updated: 05/12/2020
- HRPP Guidance: Protecting Participant Privacy and Maintaining Confidentiality of Data Outlines the privacy and confidentiality considerations and responsibilities for the investigator conducting research and the IRB in reviewing studies to protect participants of human subjects research, with links to resources. Last updated: 05/12/2020
- HRPP Guidance: Additional Requirements for Department of Education (ED) Sponsored Research Summary of guidelines and requirements to conduct human subjects research funded by the U.S. Department of Education (ED). Last Updated: Nov. 2019
- HRPP Operations Manual Describes the overarching rules governing the University of Michigan's Human Research Protection Program (HRPP) and outlines responsibilities, processes, and guidelines for the U-M investigators, the institutional review boards (IRBs), administrators, and others under the HRPP. [PDF] Last updated: April 2023
- HRPP Organization Chart U-M Human Research Protection Program (HRPP) Organization Chart. Last updated: 02/28/2024
- HRPP Policies
- HRPP U-MIC Download the University of Michigan IRB Collaborative (U-MIC) presentation (with audio) describing U-M's Human Research Protection Program (HRPP) ~ 3 minutes.
- HRPP: Additional Agency Requirements Some federal agencies have additional human subjects protection requirements. AAHRPP site visitors expect you to be familiar with these requirements. As applicable to your research, review the "additional requirements" documents for the DOD, ED, DOE, DOJ, and the EPA on the HRPP Policies webpage.
- Human Research Protection Program (HRPP)
- Incident Reporting (AE/ORIO)
- Information for the Public
- Informed Consent and Respecting Autonomy PDF- 2001 article arguing that the purpose of the informed consent signature requirement is to protect institutions and investigators; raising a question for IRBs about what role, if any, the signature requirement should play in the protection of human subjects. It proposes options to the requirement for a consent signature.
- Informed Consent Guidelines & Templates
- Institutional Not-for-Cause Compliance Review Programs (PDF) Article published by Terry VandenBosch and Ron Maio in the Jan/Feb 2011 issue of IRB: Ethics and Human Research 33:1, 15-17, a peer-reviewed bioethics journal published by the Hastings Center. Outlines issues in the start up of routine, not-for-cause research study review programs in research-intensive academic universities.
- International Compilation of Human Research Standards Webpage containing a downloadable document listing over 1,000 laws, regulations, and guidelines on human subjects protections in over 100 countries and from several international organizations compiled by the HHS Office of Human Research Protections (OHRP).
- International Ethical Guidelines for Biomedical Research Involving Human Subjects The Council for International Organizations of Mecial Sciences (CIOMS) guidelines (2016) reflect the conditions and the needs of biomedical research internationally, and the implications for multinational or transnational research in which they may be partners. CIOMS is an international, non-governmental, non-profit organization established jointly by WHO and UNESCO in 1949.
- International Human Subject Research Resources
- International Research Risks Report U-M Office of Human Research Compliance Review (OHRCR) report provides recommendations to mitigate the risks in conducting international research. (2011, pdf)
- IRB Amendment Process
- IRB Application Process
- IRB Authorization Agreement Flowchart Flowchart to identify when an IRB Authorization Agreement between U-M and other institutions or non-UM investigators is warranted.
- IRB Enrollment Definition (PDF) Reference document that defines the term "enrollment" as it pertains to human subject research studies at the University of Michigan.
- IRB Health Sciences and Behavioral Sciences (HSBS)
- IRB Metrics (PDF) Graphs depicting performance metrics and indicators (e.g., submission volume, review turn-around-time) for U-M Institutional Review Boards (IRBs) evaluating human subjects research protections.
- IRB Review Process
- IRB-HSBS Education
- IRB-HSBS Educational Sessions
- IRB-HSBS General Informed Consent Template (Word) Blank template with 2018 revised Common Rule key information and other required informed consent elements represented as section headers; includes instructions and recommended language. It is strongly advised that you modify this template to draft a project-specific informed consent document for your study for IRB review and approval. Last updated: 04/10/2024
- IRB-HSBS Standard Operating Procedures
- IRBMED Adverse Events, ORIOs, & Other Required Reporting U-M Medical School website that details the procedures and guidelines for reporting adverse events, other reportable information/occurrences, and unanticipated problems involving risks to human subjects. This is a good resource for all U-M investigators.
- IRBMED Educational Sessions IRBMED offers a variety of educational opportunities for the research community, both in-person and online.
- IRBMED webpage: sIRB and Multi-site Research (MSR) Guidance
- Maintaining and Updating ClinicalTrial.gov Records
- Newsletter Archive
- OISE: International Integrity Resources, NSF The Office of International Science & Engineering (OISE) provides resources to assist in developing training and oversight plans for the responsible and ethical conduct of research in international contexts and understanding international codes of conduct.
- Operations Manual - Contents Page
- ORCR Policies and Procedures
- Presidential Commission for the Study of Bioethical Issues: Moral Science Web page with links to mulitple reports and resources regarding a 2010 U.S Presidential Commission assessment into unethical research in Guatemala from 1946 to 1948. Includes reports of the fact-finding investigation of the past research studies and of the review of current research participant protection regulations, domestically as well as internationally, with 14 changes recommended to better protect research subjects.
- Protect Sensitive Data U-M Safecomputing website providing best practices for accessing, working with, and storing sensitive data. Includes information for managing your devices and reporting data breaches.
- Recruitment Flyer (Word) General outline to create and post a flyer seeking participation in a human subjects study. Includes instructions.
- Research Incentive Guidelines
- Research Study Participation - FAQ
- Reviewing Clinical Trials: A Guide for the Ethics Committee Created with the intention to promote human research protection of participants in clinical trials internationally. Edited by Johann P.E. Karlberg (Clinical Trials Centre, Univ. of Hong Kong) and Marjorie Speers of AAHRPP. Sponsored by Pfizer, an AAHRPP accredited pharmaceutical company, through a "non-binding" grant.
- Safely Use the Cloud U-M Safecomputing guidelines regarding use of U-M's Google services and sensitive university data, including research data.
- Saliva Collection Sample (Word) Last updated: November 2014
- SIDCER The Strategic Initiative for Developing Capacity in Ethical Review (SIDCER) is a network of independently established regional forum for ethical review committees, health researchers, and invited partner organizations with an interest in the development of ethical review.
- Single IRB-of-Record (sIRB) Process
- State of Michigan Act 328 of 1931 The Michigan Penal Code, an Act to revise, consolidate, codify, and add to the statutes related to crime and penalties for crime, including violation of state gaming or promotional activity laws.
- State of Michigan Act 382 of 1972 The Traxler-McCauley Law-Bowman Bingo Act licenses and regulates the conduct of bingo and other forms of gambling, including charity games, raffles, etc.
- State of Michigan Charitable Gaming Division Raffle Guide (PDF) Outlines the State of Michigan charitable gaming policy, including definitions, licensing requirements (if applicable), and more. (REV 8/28/19)
- Strategies for Protecting Human Research Subjects Globally PDF - Summary report from the "Roadmap for Success in International Research" conference (Aug. 2004). Describes issues in the conduct of international research from the point of view of researchers and federal research regulatory offices. Recognizes the need for training in international human subjects issues including; providing information and tools to help researchers, regulators, and Institutional Review Board members implement the very best procedures to protect study participants globally.
- Subject Payments Over $100 Sample (Word) Contains language informing subjects about U.S. tax implications if total payment for human subject participation in research in a calendar year is greater than $600, plus other standard compensation language.
- Summary of changes to secondary use applications IRB-HSBS tip sheet outlining key changes to the secondary use application and related processes implemented for the HRPP Flexibility Initiative.
- Tip Sheet: Exemption #1 Provides the full definition and explanation of exemption category #1 (educational exemption) under the 2018 Common Rule, including examples of the types of studies that qualify/do not qualify for this exemption.
- Tip Sheet: Exemption #2 Provides the full definition and explanation of exemption category #2 (surveys, interviews, educational tests, and observations of public behavior exemption) under the 2018 Common Rule, including examples of the types of studies that qualify/do not qualify for this exemption.
- Tip Sheet: Exemption #3 Provides the full definition and explanation of exemption category #3 (benign behavioral intervention) under the 2018 Common Rule, including examples of the types of studies that qualify/do not qualify for this exemption.
- U-M Assessment: eResearch Compliance with 21 CFR Part 11 PDF - Internal assesment report of eResearch, the University's research administration system, compliance with the Food and Drug Administration Electronic Records and Signature policy (21 CFR, Part 11).
- U-M FDA Electronic Signature Certification Certification letter to the Food and Drug Administration (FDA) regarding U-M electronic signature authority under U-M SPG 601.24 Delegation to Authority to Bind the University to comply with per FDA Regulatory Guidance, part 11
- U-M Federalwide Assurance The University of Michigan's Federalwide Assurance outlines the specific terms the university will follow to protect human research subjects. U-M's FWA number is 0004969.
- U-M Policy: IRB Approval for Classroom Assignments PDF - 2004 memo to U-M faculty from the Provosts and Vice President for Research defining when classroom assignments involving questionnaires, interviews, or other interactions with individuals qualify as human subjects research and, therefore, require IRB approval prior to adminstration of the assignment.
- U-MIC Presentation: Collaborator Agreements, IAA, IIAs, and CIAs Download the University of Michigan IRB Colllaborative (U-MIC) presentation (with audio) explaining the Collaborator Agreement process (~3 minutes)
- Units Supported by IRB-HSBS
- Waivers of Informed Consent Guidelines
- World Bank Countries and Economies The World Bank provides comprehensive national data for developing countries around the world. Including topics such as; Agriculture & Rural Development, Aid Effectiveness, Climate Change, Economic Policy & External Debt, Education, Energy & Mining, Environment, Financial Sector, Gender, Health, Infrastructure, Labor & Social Protection, Poverty, Private Sector, Public Sector, Science & Technology, Social Development & Urban Development. (Available languages include English, Spanish, French, Arabic, and Chinese).
- World Health Organization Country Information A webpage listing all the countries which are members of the United Nations and the World Health Organization. Includes population statistics, information on national health systems, mortality, disease burden, and the health profile of each country.
- World Medical Association: Medical Ethics Manual Webpage - Provides a basic universally-used curriculum for the teaching of medical ethics. Introduces medical ethics and explains why it ought to be studied, with topics such as: the principal features of medical ethics, how the World Medical Association (WMA) decides what is ethical; ethical issues arising from the physician/patient encounter, physician/colleague interactions, physcians/society concerns; and medical research ethics.
Enterprise
Enterprise
As the nation’s largest public research university, the Office of the Vice President for Research (OVPR) aims to catalyze, support and safeguard U-M research and scholarship activity.
The Office of the Vice President for Research oversees a variety of interdisciplinary units that collaborate with faculty, staff, students and external partners to catalyze, support and safeguard research and scholarship activity.
ORSP manages pre-award and some post-award research activity for U-M. We review contracts for sponsored projects applying regulatory, statutory and organizational knowledge to balance the university's mission, the sponsor's objectives, and the investigator's intellectual pursuits.
Ethics and compliance in research covers a broad range of activity from general guidelines about conducting research responsibly to specific regulations governing a type of research (e.g., human subjects research, export controls, conflict of interest).
eResearch is U-M's site for electronic research administration. Access: Regulatory Management (for IRB or IBC rDNA applications); Proposal Management (eRPM) for the e-routing, approval, and submission of proposals (PAFs) and Unfunded Agreements (UFAs) to external entities); and Animal Management (for IACUC protocols and ULAM).
Sponsored Programs manages the post-award financial activities of U-M's research enterprise and other sponsored activities to ensure compliance with applicable federal, state, and local laws as well as sponsor regulations. The Office of Contract Administration (OCA) is also part of the Office of Finance - Sponsored Programs.