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FAQs

Yes, but only for human subjects protections regulatory training.  The commonly accepted equivalents are:

The equivalent training must have been completed within the past 3 years and cover content similar to PEERRS content.  Certifications from CITI must include the following, at a minium:

For PEERRS credit in: Complete the following CITI modules:
Human Subjects - Biomedical
  • History & Ethical Principles 
  • Basic IRB Regulations and Review Process
  • Informed Consent
  • Research with Protected Populations - Vulnerable Subjects
Human Subjects - Social-Behavioral
  • History & Ehtical Principles
  • Defining Research with Human Subjects
  • The Regulations
  • Assessing Risk
  • Informed Consent
  • Privacy and Confidentiality

 

U-M may accept other human subjects protections training equivalents upon ad-hoc review.  To submit a certificate for a training equivalent and obtain PEERRS credit, complete the Request a PEERRS Human Subjects Certification Waiver webform.

Yes, if you are working on a U-M human subjects study.  

If you have completed an equivalent human subjects protections training course (e.g., from CITI or NIH) at your institution within the past three years, submit the training certificate to PEERRS to obtain a training waiver.  See Request a PEERRS Human Subjects Training Waiver for instructions.  

If you have not completed an equivalent training course:

  1. Establish a U-M Friend Account using your current email address.  This email address will be your login ID for PEERRS/My LINC.
  2. Request PEERRS access.  See the PEERRS Access Request Form for instructions.
  3. Upon confirmation that PEERRS access has been granted, select the applicable Human Subjects Protections course from the PEERRS website and log into My LINC to complete the course.

To receive PEERRS credit, the email address used for your U-M Friend Account must be the same email address used in the U-M IRB Application (HUM).

If you are the Principal Investigator on an award funded by the National Science Foundation (NSF), you are responsible for having and carrying out a training plan with undergraduate students, graduate students, and post-doctoral trainees working on the project.  This training plan must:

As the PI, you may choose to use PEERRS course as RCR pre-requisites, but per NSF regulations, online instruction (such as PEERRS) cannot be the sole method for RCR training.

Yes. It is not a requirement to hold PEERRS certification prior to sumbmitting a research transaction (e.g., PAF, HUM, TCP) for review by a U-M central office (e.g., ORSP, IRB Offices).  However, the required training must be completed before that transaction can be awarded or approved.

To receive PEERRS course credit, you must read every page in the course and pass/complete the certifaction test/activity.

Before you start

  1. My LINC works best with Internet Explorer or Safari web browsers.
  2. Turn off your web browser pop-up blocker to ensure that a course launches in a separate window.  Certification instructions also appear in pop-up boxes in My LINC.

When taking a course

  1. Click the NEXT button in the navigation bar to advance the course.
  2. Click NEXT twice, then OK after completing the certification test/activity.  Do not close the course until you see the Learning Activity Progress Detail page (3 clicks).
Who at U-M When Where
Office of Research and Sponsored Projects (ORSP) Prior to processing new awards and incremental funding (existing awards) eResearch Proposal Approval Form (PAF)
Institutional Review Boards (IRBs) Prior to approving human subjects studies eResearch IRB application (HUM) or IRB amendment (AME)
Export Controls Office (ECO) Prior to approving research activity using controlled technology or data eResearch Technology Control Plan (TCP) or TCP amendment

 

Other U-M offices may check PEERRS certification status as part of audit or misconduct investigations, including: University Audits, the Office of Research Compliance Review, and the UMOR Research Integrity program.  School/colleges may check student and trainee certification status if utilizing PEERRS courses as a part of their unit-based Responsible Conduct of Research curriculum. 

Topics covered each day of the course can be found on the Modules Map.
 

The Call for Intent to Submit process relates to the many Limited Submission funding opportunities that exist. There are at least 250 funding opportunities each year from various sponsors that are limited. We don't need to reserve competition dates for each opportunity if interest does not exist. So we prepare a weekly communication listing opportunities and asking for a show of hands to determine interest.  If interest exceeds the sponsor's institutional limit, the U-M Office of Research may hold an internal Limited Submissions Competition and announce it at a later date. 

We now communicate both the Calls for Intent to Submit and the Limited Submissions in a single communication.

To be informed of the opportunities we have identified, you can sign up for our Weekly Call for Intent and Limited Submission communication.  

Interested parties declare their interest for a Call for Intent to Submit and/or submit competition materials for a Limited Submission competition, through our InfoReady website.  

For questions, contact umorlimitedsubmissions@umich.edu.

A Limited Submission is a funding opportunity in which the sponsor sets an institutional limit for the number of proposals it will accept. The sponsor limits the number of proposals accepted per institution (e.g. only one proposal from the University of Michigan).

In order to participate, the University must organize to submit our most competitive proposal. This requires an internal competition. The process is critical extra submissions can result in the rejection by the sponsor.

To be informed of the opportunities we have identified, you can sign up for our Weekly Call for Intent and Limited Submission communication.  We now communicate both the Calls for Intent to Submit and the Limited Submissions in a single communication.

Interested parties declare their interest for a Call for Intent to Submit and/or submit competition materials for a Limited Submission competition, through our InfoReady Limited Submissions website.   For questions, contact umorlimitedsubmissions@umich.edu.

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Your Unit Administrator takes care of that through eResearch. Our Blue Pages pull from the eResearch data warehouse so the work is seamless for us and reflects your updates. If you are that individual and don't know how to do this, you can call 4-HELP  and touch 3 to get open a ticket and get instructions on how to make the changes. 

If so, then be sure to select the option on this page for research involving human-derived substances. Note that BSL2 containment/practices is required for all work involving human-derived substances.

 

 

If your IACUC protocols include EITHER transgenic animals, OR administration of rDNA, infectious agents, biological toxins, or human- or certain animal-derived substances to any kind of animals, be sure to select those options on this page. That work must be represented in your application.

If you are no longer conducting work that is described in a currently approved IACUC protocol, let us know when you submit your new IBC application. Otherwise, we will contact you for clarification before assigning your application for review.

 

If so, then be aware that creating an application is NOT the same as amending your registration.

Once your IBC application is approved, your current IBC registration will be withdrawn:  be sure that your new application includes any work from your current registration for which you wish to maintain approval.

What if I’m no longer working with the recombinant DNA that is described in my current registration?

If you are no longer conducting work that is described in your current IBC registration, let us know when you submit your new IBC application. Otherwise, we will contact you for clarification before assigning your application for committee review.

The U-M Office of Research maintains a list of publications and news sources. All U-M faculty and staff receive Michigan Research. If you know of other newsletters that we should list, please contact orsp-communications@umich.edu

The University of Michigan Office of Research (UMOR) coordinates the U-M Human Research Protections Program (HRPP) with collaboration from the following offices and more:

For a complete list, see the HRPP Operations Manual, Part 2 - Organization

AAHARP is interested in your awareness of and knowledge about key concepts and policies, including, but not limited to:

  • Human Subject Regulations such as, the Common Rule (45 CFR 46), FDA regulations, the Belmont Report, and Conflict of Interest policies
  • Human subject protections and the procedures you use to implement them such as elements of informed consent, strategies for minimizing risk, adverse event and unanticipated problems
  • The strength and effectiveness of the HRPP, including education and training, adequacy of resources for researchers, researcher accountability, HRPP structure, and perceptions of the HRPP

The specific questions the AAHRPP site visitors ask will depend upon your role within the U-M HRPP.  Review the interview guide for your role to prepare for the AAHRPP site visit.

The site visitors are peer reviewers assembled by AAHRPP based on their expertise and experience in a similar research setting.  See the list of site visitors for 2016. We will share site visitor biographies with the selected interviewees upon AAHRPP confirmation.

AAHRPP, the Association for the Accreditation of Human Research Protection Programs, Inc., is an independent organization that reviews and accredits institutions engaged in human subjects research to protect the rights and welfare of the research participants.

AAHRPP accreditation bolsters the university’s reputation as a leader in human subjects research.  Research sponsors and other research partners increasingly consider AAHRPP accreditation before pursuing collaborations, or providing funding, for research.

U.S. export control regulations also identify certain countries that are subject to a comprehensive embargo or targeted sanctions.  

Definitions: 

  • Comprehensive embargoes prohibit all exports/imports and other transactions without a license or other U.S. government authorization.  
  • Targeted sanctions are prohibitions on trade in specified goods, technologies, and services with specific organizations (including foriegn governments) and persons.

Resources:

The list of countries per regulation (i.e.,  ITAR, EAR, and OFAC) and the sanctions change.  Use the following links to the federal resources to obtain the most current information.

The software U-M uses for the Restricted Party Screening process simultaneously searches the following restricted party lists, which are also combined in the U.S. government Consolidated Screening List.  The links below go to the federal web pages that further explain the purpose for each list and contain links to download the list.

Department of State (ITAR):

  • Nonproliferation Sanctions - Parties that have been sanctioned under various statutes regarding weapons proliferation. Note:  the Federal Register is the only official and complete listing for nonproliferation sanctions determinations
  • AECA Debarred List - Entities and individuals prohibited from participating directly or indirectly in the export of defense articles, including technical data, and defense services

Department of Commerce (EAR):

  • Denied Persons List - Individuals and entities that have been denied export privileges. Any dealings with a party on this list that violate the terms of denial are prohibited.
  • Unverified List - Individuals and entities who the U.S. Bureau of Industry and Security (BIS) has been unable to verify in prior transactions. The presence of a party on this list does not necessarily mean that the transaction cannot go forward, but it is a "red flag" that must be resolved prior to proceeding with the export. 
  • Entity List - Parties whose presence in a transaction can trigger a license requirement supplemental to those elsewhere in the Export Administration Regulations (EAR). The individual listing specifies the requirements and policy for each party.

Department of Treasury (OFAC):

  • Sanctioned Program and Country InformationDetails the export controls restrictions (e.g., embargoes, targeted sanctions) to specific individuals, organizations, and countries
  • Specially Designated Nationals ListDetails individuals and companies owned or controlled by, or acting for or on behalf of, sanctioned countries. It also lists individuals, groups, and entities, such as terrorists and narcotics traffickers designated under OFAC sanction programs that are not country-specific.  Export Adminstration Regulations (EAR) require a license for exports or re-exports to any party on this list whose entry contains the following suffixes:  SDGT, SDT, FTO, IRAQ2, or NPWND.

Any interaction with foreign persons or entities should undergo Restricted Party Screening (RPS).  For example:

  • Sponsored Research - When accepting funding from an international entity or when working on an export-controlled research project (screening conducted by ORSP or U-M Export Controls, initiated with the PAF)
  • Visitors to U-M - Visiting scholars and corporate relations visitors prior to coming to U-M (screening conducted by your department or by U-M Export Controls, upon request)
  • International Travel - When meeting potential foreign collaborators or speaking at a foreign university or institute (screening requested by you, conducted by U-M Export Controls)
  • International Shipping - Sending equipment overseas for fieldwork or sending samples or data to international recipients (screening requested by you, conducted by U-M Export Controls, or by OTT when initiated by an outgoing Materials Transfer Agreement)

Restricted Party Screening (RPS) is a service provided by the U-M Export Controls program that verifies whether an organization (e.g., company or university), individual, or country has had its export privileges restricted or revoked per the U.S. Departments of State, Commerce, or Treasury and is listed on any of the federal restricted party lists.  RPS is required by the federal government and is a critical component of U-M's efforts to prevent violations of U.S. Export Control laws.  U-M uses a software program that checks all of the federal lists simultaneously.  Because restricted party screening may be complicated, U-M recommends that you email the U-M Export Control Officer to request screening, as opposed to reviewing the multiple lists yourself.

Bridging eligibility years run from 9/1/XX – 8/31/XX. The initial year is based on when the research faculty member first becomes eligible for bridging. Here is an example of how bridging eligibility is determined/tracked.

The eligibility for bridging support renews every five years following the first year of eligibility.  If you are within the five-year block of your last bridging award, but not all funds available (based on appointment and years of service) were previously used, you may be eligible for additional support.

Job aids and tools that don’t require training or interaction, will be made available on the ORSP website, under the "Navigate" portal page.  However, the course has been designed for intense in-person interaction and much of the content will be experienced in-person.

The design of this course was developed in collaboration with representatives from Office of Research and Sponsored Projects, Sponsored Programs, and various schools/colleges/units on campus. See Design Team Roster.

The Navigate: Fundamentals course was designed in response to extensive research and survey feedback that revealed a need for training of those who need it most: brand new research administrators who support faculty and the research community.

The research and survey results also revealed opportunities to improve and restructure training.

As a result, the new training program will include two tracks/tiers:

  1. basic concepts for newcomers in research administration to obtain introductory knowledge (Fundamentals).
  2. in-depth analysis and specialized knowledge for more seasoned research administrators (Advanced & Specialized).  

For more information, visit the Navigate Portal

We anticipate offering the Fundamentals course twice per year - once in the fall, and once in the spring. Learn more about current offerings on the Navigate: Fundamentals course page.

Due to space limitations, there may be more applicants than open slots for the course. For those applicants not selected for the course, once a future course application is made available, they may be given additional consideration and priority during the selection process.

There is a limited number of spots available (up to 30) for participation in this course. The application allows the selection team to identify potential participants, gather pertinent personal and unit information from applicants, assess an applicant’s interest in the program, assess the potential needs and benefits for schools/colleges/units, maintain campus-wide representation, and balance in the selected cohort.

This course was specifically designed for new research administrators (which we define as U-M staff who have from zero to about two years of working experience working in research administration at any institution).

Applicants must:

  • have from zero to about two years of working experience in research administration;
  • commit to satisfy all requirements of the course;
  • submit all application materials by February 10, 2017, including:
  • agree to attend all seven full-day, instructor-led sessions;
  • complete all assignments in between sessions;
  • complete capstone projects;
  • participate in program evaluations (pre-, mid-, post- and in-session evaluations).
  • The Navigate: Fundamentals course is not a replacement for the The Research Administrators Instructional Network (RAIN) program, which targeted research administrators with several more years of experience. 
  • The Navigate: Fundamentals course is developed for a different audience, and is meant to provide training for new research administrators with zero to about two years of working experience in research administration.
  • The Navigate: Fundamentals course was designed after extensive research and survey feedback that revealed a need for training of those who need it most: brand new research administrators who support faculty and the research community.
  • Participants are expected to attend all seven full-day, instructor-led sessions of the course. While we understand there are unavoidable situations that may result in a missed session, each session builds upon the previous, therefore a session cannot be made up in the current cohort.
  • Participants who miss a session will not receive a certificate of completion in current cohort. Those participants will need to make up the missed session(s) in a later cohort. Participants will have up to one year to complete the missed session to receive a certificate of completion. 

To cancel, contact the Training Team, via email ratraining-projectteam@umich.edu. You may withdraw from the course by February 28, 2017 (2 weeks prior to the start of the course) with a full refund. Cancellations received after February 28, 2017 are discouraged, and you forfeit your course fee of $400.

Participants should not expect that successful completion of this course will result in a raise, a promotion, or even a new position at U-M.  However, we hope that graduates of this course will be more efficient and better prepared to perform their job duties and support the complex research performed by our U-M faculty and staff.  We hope graduates view this as an excellent opportunity for professional development, and that supervisors and other hiring staff may be glad to see this on your resume as you advance your career in research administration.

  • Ensure the applicant/participant will be permitted time to attend all seven full-day, in-person sessions
  • Complete the Supervisor Statement of Support online form that will be coming soon and will be due by February 10, 2017.
  • Support the participant with tasks assigned in between sessions, including in-person meetings as necessary
  • Participate in training evaluations
  • Participants must commit to attend all seven full-day, in-person sessions 
  • Participants must complete assignments in between sessions outside the course schedule  (Time may vary. An additional average of two hours a week may be expected).
  • Complete capstone projects
  • Participate in program evaluations (pre-, mid-, post-, and in-session evaluations).
  • This newly designed instructor-led was expertly developed for RAs with newcomers to research administration (zero to about two years of experience). This course is not a replacement for the former Research Administrators Instructional Network (RAIN) course. The "Navigate: Fundamentals" course was developed for a different audience and is meant to provide fundamental training for those who need it most, at the beginning of their research administration careers.
  • This course will provide fundamental knowledge about the field of research administration, the research enterprise at the University of Michigan, and the high-level tasks performed at each stage of a sponsored project “Lifecycle.”
  • Research administrators work with difficult business, compliance, and financial challenges, and often undertake them with little or no experience. Providing training for research administrators during their first months in their career is integral to reducing faculty and administrative burden.

The Navigate portal is the new central destination for training and professional development for research administrators (RAs), navigating research administration at the University of Michigan. The Office of Research and Sponsored Projects and Finance - Sponsored Programs have partnered to improve the professional development resources available to RAs. A number of initiatives will come under this new program, including training, mentoring, and other resources.

  1. When the collaborating institution is unwilling to cede IRB oversight to U-M or U-M is unwilling to serve as the collaborator's IRB-of-Record.
  2. When the interaction/intervention with the human subjects is taking place at the collaborator's institution, the U-M may determine that IRB review at the collaborator's institution is necessary.

A study team needs to document IRB oversight of an external collaborator when:

  1. The project involves IRB-regulated research (i.e., project is reviewed by the full board or expedited review process), and
  2. The external collaborator is engaged in the conduct of human subjects research (e.g., obtain informed consent from subjects, interact or intervene with subjects as part of the research, obtain or analyze personally-identifiable subject data)  

Notes:  

  • Exempt or non-regulated projects are not considered IRB-regulated research; therefore documentation of IRB oversight for external collaborators is not required.
  • Collaborators are not considered "engaged in research" if they do not interact with subjects or the identified data, analyze deidentified data only, or assist with recruitment only.  For more information,"  see the OHRP Guidance on Engagement of Institutions in Human Subjects Research.

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