Education
IRBMED offers presentations on topics important to researchers conducting human subjects research, invites special speakers to present to the UM community, and provides workshops on IRBMED processes throughout the year and upon request. In addtion to the IRBMED offerings, UM offers other research education opportunities.
- Consultations
- Other UM Human Subjects Research Education (PEERRS, HIPAA, etc.)
- Workshops
Workshops
We list full descriptions of each workshop below the table. We provide workshops on upon request at department, study team, or unit meetings.
Workshop Registration System: You can register for the sessions one of two ways:
1. To register you can click the requested date; or
2. Visit the registration site at: https://www-a1.lsa.umich.edu/es_conf/app/default.asp?confid=2. To find IRBMED Workshops, click on the "Search" button. Under Sponsor, click on "IRBMED" and at the bottom, click on "Click Here to Find Sessions". You can view the sessions either alphabetically by Title or by Date by clicking on the Header. Click on the session "Title" to register. You will need to register for each session individually. The site is secured by your Level 1 (Kerberos) log in. This new registration system allows for self-management of Workshop registrations. After you register, if you need to cancel your attendance at a session, you can log back into the system and cancel your registration. The system also allows for ‘wait-listing’. If a workshop is full, a registrant has the option of being put on a waitlist and if someone cancels their registration, wait-listed staff will be moved into a full registration and they will be notified via email of their new status.
Room locations can be found at: https://ummcweb29.mcit.med.umich.edu/hos/contactinfo/Directions.cfm or by clicking on the room number below.
Title/Content |
Date, Time, Location |
2/24/12, 2:30-4:00, B1 C111 UH |
|
Regs 101 / 102 |
2/10/12, 8:30-11:00, B1 C111 UH |
Regs 103 |
2/10/12, 12:00-2:30, B1 C111 UH |
Regs 104 / Apps 103 |
2/24/12, 8:30-11:00, B1 C111 UH |
Regs 105 |
2/24/12, 12:00-2:00, B1 C111 UH |
Regs 106 |
2/10/12, 3:00-4:30, B1 C111 UH |
IC 101 |
|
Apps 101 Click here for Apps 100 powerpoint. (Please view prior to attending either Apps 101 or 102.) |
3/6/12, 9:00 – 11:00, UH Cafeteria, Dining Room D |
Apps 102 Click here for Apps 100 powerpoint. (Please view prior to attending either Apps 101 or 102.) |
2/28/12, 10:00 – 12:00, Arbor Lakes Bldg 3, Rm 3550 |
Trials and Tribulations in Human Subject Research. In this workshop we take an historic view of ethical issues that led to the current regulations and on-going concerns about conducting research involving human subjects, from the Bible to the concerns of today.
Continuing Education Information: Not Offered
Basic Federal Regulations on IRB review (when IRB review is required and what the IRB must consider to approve the research). We cover investigator and IRB responsibilities stemming from federal regulations for human subjects research. Attendees will learn:
- How federal regulations define human subjects research (i.e., when you must receive IRB approval or exemption determination prior to commencing research)
- Investigator-to-IRB reporting responsibilities
- Other IRB responsibilities under federal regulations and their impact on investigators
- Helpful tips for communicating information to the IRB
Continuing Education Information: Not Offered
Regulations and Special Considerations for Vulnerable Populations. In this workshop we provide an overview of the different regulations and ethical considerations for vulnerable populations: Children, Prisoners, Pregnant Women and Fetuses, Neonates of uncertain viability and Nonviable neonates, Cognitively or Decisionally Impaired Adults, Students, and Patients and Employees of the Researcher.
- Limits on what a local IRB is allowed to approve under the federal regulations
- Importance of risk level
- Informed consent
We will discuss federal regulations that apply in these situations, including when researchers must contact the IRB, when IRBs must contact DHHS, and the additional responsibilities investigators have when involving these populations in a research study.
Continuing Education Information: Not Offered
Regulations 104 / Applications 103
Guidance, Reporting and eResearch Forms: Adverse Event, Unanticipated Problem, and Other Reportable Information and Occurrences. We cover the reports and forms that federal regulations and institutional policies require be submitted for IRB review. Attendees will learn:
- How to apply the IRBMED web-based guidance
- Unanticipated problems involving risks to subject and others and the difference between these problems and adverse events
- What reports are required regarding audits, inspections, protocol deviations and exceptions, accidents, complaints, subject incarceration, wards of the state, summary and annual reports, letters from oversight entities, voluntary holds, and unanticipated problems involving risks to subjects or others.
- How to determine which timetable to use
- How to determine which form to use
- How to fill out the forms and information to provide
- Information to provide in reporting
- Helpful tips for avoiding common mistakes
Continuing Education Information: Not Offered
Writing a Study Specific Adverse Event Reporting Plans and Data and Safety Monitoring Plan for Minimal to Moderate Risk Studies. All studies benefit from having a plan that addresses the safety of subjects and/or the safety of subjects' data. Complexity of a plan depends upon the risks involved in the research. The IRBs standard AE reporting guidance and timetable are written in accordance with the most stringent federal requirements—those that cover interventions involving drugs, biologics, or devices. All studies under IRB's oversight are required to follow that plan unless a study specific plan is submitted and approved. A study specific plan may be more appropriate when either:
- A protocol includes specific criteria for reporting to an oversight body in addition to IRBMED (e.g., a sponsor)
- A study is minimal or minor over minimal risk and therefore a less stringent plan would provide adequate subject protections
We will discuss federal guidance and regulations that apply, how the nature of the research relates to the content of the plans, and IRB requirements.
Continuing Education Information: Not Offered
Compassionate Use, Emergency Use, Humanitarian Use Devices, Orphan Drugs, etc. Covers physician and IRB responsibilities. We will discuss applicable federal regulations, including when physicians must contact the IRB, information that must be submitted, and what patients must be told. Attendees will learn about:
- Reporting forms and responsibilities
- How to determine if a planned use is emergency, compassionate, or humanitarian
- Procedures for interacting with the IRB
Continuing Education Information: Not Offered
IRBMED Templates and Guidance and Writing an Informed Consent Document for Research. Will review:
- Federal regulations about informed consent, parental permission and children's assent
- Federal regulations about informed consent waivers, exceptions, and alterations
- Federal regulations for recruiting non-English reading or speaking subjects
- The importance of version control in managing regulatory documents
- Working with eResearch to achieve compliance with federal informed consent regulations
Review how to turn the technical language of a scientific protocol into a lay-language document. Examples illustrate the necessary steps. We will discuss the research subject's point of view and how that influences needed content, as well as the federal regulations that must be considered. Attendees will learn:
- Helpful tips for achieving a population appropriate language level
- Content that counts—what's important to subjects
- Helpful tips for evaluating an informed consent document
- Regulatory requirements
Continuing Education Information: Not Offered
Initial Project Application. This workshop, designed for those new to eResearch, covers basic information about how to submit a new human subject’s research project to IRBMED. We recommend, but do not require, attending Regulations 101 prior to Applications 101.
Continuing Education Information: Not Offered
Amendments and Scheduled Continuing Renewal Applications. This workshop, designed for those new to eResearch, covers the process for submitting amendments and renewals to the IRBMED after a project's initial approval. We recommend attendees attend Applications 101 or have basic knowledge of eResearch prior to attending this workshop.
Continuing Education Information: Not Offered
Other UM Human Subjects Research Education
Investigator 101: This two-part program provides basic information on the topics of ethics in research and investigator compliance with federal regulations. Part 1 presents the history of research ethics and key ethical issues are explored in terms of application to research design and study execution. Regulatory compliance topics as they apply to investigators are presented in Part 2. Examined is the IRB approval process, obtaining informed consent, continuing review and proper study documentation and record retention practices. It can be viewed online at: http://tnemcirb.tufts.edu/?pid=57. You can also sign out a copy of the computer CD "Investigator 101" by emailing Monica Stiddom.
PEERRS
UM requies this web-based Program for Education and Evaluation in Responsible Research and Scholarship (PEERRS) be completed by anyone engaged in or associated with human subjects research. Key personnel--principal investigators, co-investigators, faculty advisors, study coordinators, and project managers--must complete PEERRs before the IRB can approve a study. Responsiblity for assuring all others complete PEERRS falls to the principal investigator. For more information, visit the PEERRS Web site.
On NIH applications where it asks for information about certifying your human subjects training, enter your PEERRS certification expiration date for the human subjects module and a one sentence description of PEERRS, such as, "PEERRS consists of educational modules and short tests covering basic rules, procedures and professional norms for the responsible conduct of research by anyone involved in research and scholarship at the University of Michigan".
Upon request, OVPR will consider a waiver of equivalency for investigators from other institutions who have completed human subjects courses like the UM PEERRS modules. Email peerrs@umich.edu to request a waiver and include:
1. Name and university/institution of the investigator
2. Role on UM study
3. Description of course completed and a link to it if available on the web
4. Electronic copy of the completion certificate (if available)
Email the peerrs@umich.edu if you have additional questions.
Michigan Institute of Clinical and Health Research (MICHR)
The Michigan Institute of Clinical and Health Research Education Program offers clinical research educational opportunities and resources to faculty and staff within UM. For more information, visit the MICHR Web site.
HIPAA Training for UM Researchers
The UM Health System offers a web based training module for those conducting research that involves Protected Health Information (PHI). For more information, visit the HIPAA Web site.
Statistics
The Center for Statistical Consultation and Research (CSCAR) is a service and research unit of UM, administratively located in the Office of the Vice President for Research. Its staff provides statistical services to faculty, primary researchers, graduate students and staff of the University. To learn more about educational opportunities about statistical analysis in biomedical and behavioral research, visit the CSCAR Web site.
OHRP Educational Activities and Materials
OHRP provide educational videos on a variety of topics regarding the Department of Health and Human Services (DHHS) regulations for the protection of human subjects of research described at 45 CFR part 46. Each video is approximately 20-25 minutes in length.
Currently Available Videos:
- Research Use of Human Biological Specimens and Other Private Information: http://videocast.nih.gov/ram/ohrp_kaneshiro.ram
- Reviewing and Reporting Unanticipated Problems and Adverse Events: http://videocast.nih.gov/ram/ohrp_carome.ram
If you have technical difficulties with viewing the videos, please see: http://videocast.nih.gov/faq/#topic4. For more information, please see: http://www.hhs.gov/ohrp/education/.
Advanced Human Subject Research Modules
Collaborative IRB Training Initiative (CITI): This nationally recognized web course provides advanced educational modules that supplement those in PEERRS. A certificate issued upon completion of each module. The courses are free, but there is a charge to obtain Continuing Education Credits if you want/need them. For more information, visit the CITI Web site. Click here for instructions on accessing CITI.
General Computer Education
IT Education Services: IT Education Services provides education and training programs for the UM community. Courses offered include Microsoft Word, Excel, and Other Programs. For for more information, visit the IT Education Services Web site.
Updated 1/31/12
