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A-Z Index and Glossary

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  • HCFA

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    Health Care Financing Administration

  • HHS

    Department of Health and Human Services

  • HIPAA

    Health Insurance Portability and Accountability Act

  • Horizon 2020

    The University of Michigan is registered in the European Commission system for the Horizon 2020 funding program, with the European Union as the sponsor. Our Participant Portal PIC Number is 999843603.

    Please work with the ORSP Project Representative working with Foreign Government Sponsors if you have questions. 

     

  • HPSCRO

    Acronym for the Human Pluipotent Stem Cell Research Oversight compliance program

  • HRPP Operations Manual

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    The HRPP Operations Manual details the policies and processes that the govern Human Subject Protection Program at the University of Michigan.  This manual is a reference for U-M investigators, students, and staff conducting research and the IRB members reviewing and approving research.

  • HRSA

  • HSIP (Human Subjects Incentives Program)

    Human subjects often are paid a fee for their participation in research projects. Protocols for the use of human beings in research, teaching, or testing are reviewed and approved, according to federal, state and university policies. (See: Human Research Protection Program). For payment policies and details on paying subjects, see Standard Practice Guide 501.7-1. Also see the University's Human Subject Incentive Program (HSIP) at http://www.finance.umich.edu/treasury/hsip or email subject-incentives@umich.edu.

    See also: Research Subject Fees

    • Budget and Cost Resources
    • Paying research subjects: Human Subject Incentives Program (HSIP) Human subjects often are paid a fee for their participation in research projects. Protocols for the use of human beings in research, teaching, or testing are reviewed and approved, according to federal, state and university policies. (See: Human Research Protection Program). For payment policies and details on paying subjects, see Standard Practice Guide 501.7-1. Also see the University's Human Subject Incentive Program at http://www.finance.umich.edu/treasury/hsip or email subject-incentives@umich.edu
  • HUD

    Department of Housing and Urban Development. See: http://www.hud.gov/.

  • Human Subjects Protections

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    U-M is guided by ethical considerations to ensure that human subjects involved in research are protected from harms as outlined in federal, state, and university policies.

    • 2016 AAHRPP Site Visitor List List of AAHRPP assigned site visitors who will interview U-M as part of the 2016 re-accreditation of its human research protections program
    • 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 Interview Guide for Administrators
    • AAHRPP Interview Guide for IRB Members and Staff
    • AAHRPP Interview Guide for Researchers and Research Staff
    • AAHRPP Site Visit Flyer Post this flyer with information about the upcoming AAHRPP site visit or share it with your unit
    • AAHRPP Tip Sheets Use these brief documents from AAHRPP to review the standards and elements that form an accredited human subjects protection program.  U-M IRBs and OHRCR 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).
    • 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 section of an IRB application.  Provided by IRB-HSBS.
    • Certificates of Confidentiality Process CoCs are issued by the: National Institutes of Health (NIH) by institutes under their purview Centers for Disease Control and Prevention (CDC) Food and Drug Administration (FDA) for studies that obtain an Investigational New Drug (IND) authorization or other FDA authorization
    • Charitable Gaming Raffle Guide (PDF) State of Michigan Charitable Gaming Division, Michigan Lottery guide outlines the requirements for conducting raffles, lotteries, and other games for non-profit or charitable fundraising use.
    • Child Assent Sample (Word) Sample language for obtaining consent from children ages 7-13.  Must be accompanied by a Parent Permission letter or consent form.
    • CIA World Fact Book Provides information on the history, people, government, economy, geography, communications, transportation, military, and transnational issues for 267 world entities. 
    • Cloud Computing & Information Security U-M Safecomputing website providing definitions of cloud computing, guidelines for proper use, and describes security and privacy concerns.
    • Commercial IRB Guidance Link to IRBMED's Central IRB Information (External IRBs) webpage.  This webpage includes "Working With" guidance documents for each of the commercial IRBs with which U-M or Michigan Medicine has a master agreement.
    • 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. 
    • Creating a Scheduled Continuing Review (SCR) (PDF) eResearch Regulatory Management (eRRM) system instructions to create and submit a continuing review for IRB re-approval or termination of a study.  Provided by ITS.
    • Creating an Adverse Event / ORIO (PDF) 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 Classification Levels U-M institutional data is classified into one of four classifications or sensitivity levels. Researchers should become familiar with these levels and consider whether additional procedures should be implemented to adequately protect and manage human subject research data.  
    • Data Classification Levels U-M institutional data is classified into one of four classifications or sensitivity levels. Researchers should become familiar with these levels and consider whether additional procedures should be implemented to adequately protect and manage human subject research data.  
    • Decision Trees: Exempt Human Subjects Research Decision trees displaying the criteria and potential review paths, including self-determination,  for exempt categories 1 - 4, 7 & 8 under the 2018 Common Rule. 
    • (PDF) Lists the components of the Department of Defense (DoD) and outlines policies and procedures for investigators conducting research subject to DoD oversight.  January 2012.
    • Department of Education (ED): Additional Requirements for Investigators U-M HRPP guidance document outlining the requirements for human subjects research funded by the U.S. Department of Education (ED).
    • DoD FWA Addendum Addendum to the University of Michigan's Federal Wide Assurance (FWA) for the protection of human subjects in research to comply with Department of Defense (DoD) specific requirements.
    • Engagement of Institutions in Human Subjects Research HHS definitions and examples of human subjects research terminology
    • eResearch Regulatory Management (eRRM) Training Website that contains job aids and other resources to learn how to use the eRRM system.  See the PI & Study Team menu for step-by-step system instructions.  See the Application questions spreadsheet to view all the questions by section and any related questions/sections based on "yes" answers.
    • 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.
    • Exempt Protocol - No Signature Sample (Word) Sample language for an informed consent document for an exempt study where a signature is not required to consent to participate
    • Exempt Protocol - Signature Sample (Word) Sample of informed consent language including a signature line to use for exempt studies where a signature is collected.
    • 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.
    • Focus Group Sample Word.  Last updated: November 2014
    • 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.
    • HRPP Guidance: Additional Requirements for Department of Defense (DOD) Research Summary of guidelines and requirements to conduct human subjects research sponsored by the U.S. Department of Defense (DOD).
    • HRPP Guidance: Additional Requirements for Department of Energy (DOE) Research Summary of guidelines and requirements to conduct human subjects research sponsored by the U.S. Department of Energy (DOE)
    • HRPP Guidance: Additional Requirements for Department of Justice (DOJ) Research Summary of guidelines and requirements to conduct human subjects research sponsored by the U.S. Department of Justice (DOJ)
    • HRPP Guidance: Additional Requirements for Environmental Protection Agency (EPA) Research Summary of guidelines and requirements to conduct human subjects reserach sponsored by the U.S. Environmental Protections Agency (EPA).
    • HRPP Organization Chart U-M Human Research Protection Program (HRPP) Organization Chart
    • 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.
    • HRPPMatrix2014 (PDF) Chart showing the structure of U-M's Human Research Protections Program (HRPP).
    • HRPPPlan-2004 The Plan for Insuring Adequate Protection of Participants in Clinical Trials, from Jan. 15, 2004, provides details on the history and purpose of the HRPP at U-M.
    • 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 Elements & Suggested Language PDF Outline of the federally required elements (e.g., description of subject involvement) that an informed consent doucment must include.  Includes suggested language and/or additional instructions.
    • Informed Consent Flyer - Template (Word) General outline to create and post a flyer seeking participation in a human subjects study.  Includes instructions.
    • Informed Consent Template - Clinical (Word) Template to modify for clinical research studies to be reviewed by IRB-HSBS
    • Informed Consent Template - Exempt (Word) Template to modify for exempt human subject studies that outlines the details of the research, and the benefits/risks to the subject.
    • Informed Consent Template - General (Word) Blank template with required informed consent elements represented as section headers; includes instructions and recommended language.  Modify this template to draft a project-specific informed consent document for your study for IRB review and approval.
    • 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 INternationla Organizations of Mecial Sciences (CIOMS) guidelines 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 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) 
    • Interview Project Sample (Word) Sample of the elements, procedures, and language used in an informed consent document for an interview. (Last modified, 2010)
    • 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 Metrics (PDF) Graphs depicting performance metrics and indicators (e.g., submission volume, review turn-around-time) for U-M IRBs. 
    • IRB Noncompliance/Complaint Review Process (PDF) Flow diagram of the IRB process to review complaint or concerns about noncompliance in human subjects research. 
    • IRB-HSBS Educational Sessions Educational sessions offered by the IRB-HSBS educational team for both IRB members and researchers.
    • IRB-HSBS Newsletters
    • IRB-HSBS Standard Operating Procedures
    • IRB-HSBS: Key Changes to the Common Rule IRB-HSBS general session presentation (updated 10/12/2017) explaining key changes in the 2018 Common Rule (Regulations for the Protection of Human Subjects ~ 45 CFR 46)
    • IRBMED Adverse Event, ORIO, & Other 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: Changes to the Common Rule Link to IRBMED's Seminar Series webpage containing two presentations explaining the changes to the 2018 Common Rule.  The presentations differ in content based on information known as of the presentation date.
    • Letter of Cooperation Samples (Word) Two sample letters for site approval cooperation between U-M and other institutions, organizations, etc.  Letters of cooperation must be on U-M letterhead and signed by an appropriate official.  These letters are uploaded into the Performance Site section of the eResearch IRB application.
    • Making Changes to Your Consent Document PDF.  Instructions to update an approved informed consent document and upload both "clean" and "track change" versions in eResearch Regulatory Management for IRB review.
    • MICHR Education and Mentoring Educational sessions for study coordinators.
    • 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. 
    • Online Survey Sample (Word).  Sample language for informed consent documentation for a human subjects study that includes a computer-based or computer-delivered survey.
    • Parent Permission Letter Sample (Word).  Sample of informed consent permission letter addressed to the parents of a child being recruited for participation in a human subjects study.  
    • 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.
    • Protection of Vulnerable Populations in Research Highlighted topic for IRB members and researcher review: Vulnerable Populations.  For additional information, see the Operations Manual, Part 7, Section IV.
    • 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.
    • Saliva Collection Sample (Word)  Last updated:  November 2014
    • Security & Privacy in the U-M Google Environment U-M Safecomputing guidelines regarding use of U-M's Google services and senstive university data, including research data.
    • 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.
    • SOP 101.0 Not-for-Cause/Routine Review Outlines the process and procedures that the Office of Research Compliance Review (ORCR) follows to conduct a routine, or "not-for-cause" review of a U-M human subjects research project. 
    • 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.
    • 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.
    • Teenager Assent Sample (Word).  Example of consent form assent language for use when children ages 13-17 are participants in a human subjects study.
    • 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) 
    • UMICH NPRM Comments Finalized comments on the notice of proposed rule making submitted by the University of Michigan on January 5, 2016
    • 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 PDF - 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.