FAQs

If non-compliance is identified during a routine review, the investigator may be asked to submit to the IRB specific changes to the protocol, informed consent, the eResearch application, or other study related materials.

If non-compliance is identified during a for cause review, the IRB of Record will craft a Corrective and Preventative Action Plan (CAPA) for the investigator which may include submission of a revised protocol, informed consent, or other materials.  ORCR will collaborate with the IRB to craft the CAPA plan and follow-up on required corrective actions.

For more detailed information, see ORCR SOP 101 (Not for Cause Routine Review) and ORCR SOP 102 (For Cause Review).

The Principal Investigator (PI) should plan on an initial 60-minute interview with an ORCR reviewer. This discussion will focus on areas of potential study risk. Interview questions may include but are not limited to: roles and responsibilities, recruitment, consenting process, study procedures, record keeping, data management, monitoring, and oversight. The scope of the review may vary and is tailored to the scope, nature, and complexity of the study.  Following the initial discussion, the ORCR reviewer will review study records with the study coordinator.  

Following the review, the investigator will have an opportunity to review a draft report to verify facts contained in the report. The IRB of record will also have an opportunity to review a draft of the report. The final ORCR report will be sent to the investigator, the IRB of Record, the Research Associate Dean, and Associate Chair for Research or Department Chair.

For more detailed information, see ORCR SOP 101 (Not for Cause Routine Review) and ORCR SOP 102 (For Cause Review).

Failure to register/update a trial/study or providing incomplete, false or misleading registration information may result in:

• Monetary penalties
• Withholding of federal research funds
• Return of grant funds to the sponsor
• Refusal of consideration by ICJME member (or other) journals

IRB approval is required for the study, but the IRB does not review the registration record in ClinicalTrials.gov.  Once registration on ClinicalTrials.gov is complete, add the NCT # to the IRB application.

Required Informed Consent Language for Applicable Clinical Trials:

Applicable clinical trials must use the unaltered consent template language provided below in the informed consent document:

• "A description of this clinical trial will be available on http://www.clinicaltrials.gov/(link is external), as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time."

Required Informed Consent Language for NIH and other Sponsor Requirements for Registration and Reporting

NIH funded clinical trials that began on or after 1/18/2017 must refer to ClinicalTrials.gov in their informed consent document (unless they are conducted under a grant submitted prior to that date, with no competing renewals on or after 1/18/2017).   Use the below language:

•  “This trial will be registered and may report results on www.ClinicalTrials.gov(link is external), a publicly available registry of clinical trials.” 

U-M IRB Informed Consent templates contain the above language.  Refer to IRMED Informed Consent Template and IRB HSBS Informed Consent Template

The federal Controlled Substance Act defines and classifies drugs and other substances into five (5) controlled substance schedules (I - V) according their potential for abuse and addiction. The substance's schedule dictates the application process to use and guidelines to follow for security, storage, etc.

Schedule I:  illicit drugs, compounds and their chemical precursors that have a high potential for abuse, no accepted medical use, and lack of accepted safety protocols for medical use.  They are typically used for drug abuse/addiction research or for analytical research.

​Schedules II-V:  drugs, compounds, and their chemical precursors that have accepted medical uses and a decreasing potential for abuse.

The Foreign Corrupt Practices Act

It is illegal for U.S. persons to offer or pay anything of value to a foreign official for the purposes of obtaining, retaining, or furthering business activities, per the federal Foreign Corrupt Practices Act (FCPA) anti-bribery provisions. For example, making payments to custom officials in exchange for their agreeing not to inspect goods or to release goods held at points of entry would violate the FCPA. For more information, visit the U-M Export Controls FCPA guidance.

Be Aware

Customs officials in any country, including the U.S., may inspect your belongings, including electronic content of computers, phones, tablets, and storage devices. They may take possession of these items for various periods of time—even permanently.  It is a best practice to only take items with you that are absolutely needed for your trip.

Some countries also have import regulations that specifically prohibit travelers from bringing into those countries encrypted laptops or other mobile devices. Violations of those countries’ prohibitions could result in confiscation of your device by customs authorities and/or fines or other penalties.

What If You Encounter A Problem While Overseas?

You are required to report a stolen or lost device or other IT Security Incident. The U-M Office of Global Engagement provides detailed information on General Emergency Protocols for U-M International Travelers.
 

When traveling out of the United States, everything you take with you is considered an “export,” under U.S. export regulations. Some of these exports will require an export license from the government. However, in many situations, you will not need an export license because either (1) the items or data you are taking are not controlled to your destination or sometimes (2) a license exception is available.

Items That Require Export Control Review Before You Travel

Do not travel with any of the following items without first obtaining specific advice from the Export Control Program, as these items may require an export license:

• Devices, systems or software that are not standard, off-the-shelf products generally available to the public

• Devices, systems, or software that are specifically designed or modified for military or space applications

• Data or information received under an obligation of confidentiality

• Data or analyses that result from a project that has restrictions on the dissemination of the research results

• Classified information

• Export controlled information

Items That You May Be Able to Take With You

U-M employees and students may be able to use a “Tools of Trade” license exception to travel temporarily out of the U.S. and hand carry certain types of hardware, software and/or data. This license exception may be used by U-M employees and students traveling with personally-owned or U-M-owned hardware, software and data provided that the terms of the license exception are met.  This exception does not apply to items, technology, data, or software regulated by the International Traffic in Arms Regulations (ITAR). Please contact the Export Control Program if you would like more information on using this exception when traveling internationally.

If your hardware, software or data are not eligible for the “Tools of Trade” license exception, the Export Control Program will discuss other options with you.  There are other less frequently used license exceptions that may apply, and if no license exception is available, you may be able to work with the Export Control Program to apply for an export license.  

Items That Need to Be Properly Secured For Travel

Whether you are traveling with a personally owned computer, a U-M owned computer, or any other device, you must make sure that you properly secure your hardware, software and data for international travel.  U-M Safe Computing has detailed guidance to help you secure your devices before, during and after travel.

If you are traveling with any export controlled information or other sensitive data on your devices, you must encrypt your devices to protect the data from unauthorized disclosure.  Please remember that before you travel with any data or devices, make sure that these items are able to be exported out of the country and taken with you to your intended destination. Encryption software that is not commercially available on a mass market basis may be regulated or restricted from being brought into some countries. See Export Controls on Encryption Software for more specifics.

University employees and students travel internationally for many reasons, and different export control issues arise  depending on the nature of your travel:

• Attending an International Conference or Meeting

• Presenting at an International Conference

• Conducting Research Abroad

• Collaborating with Colleagues or an International Entity

• Teaching, Training or providing Other Services Abroad

When you travel internationally in your role as U-M employee or student, you must register your travel with the U-M Travel Registry. Registering travel with the U-M Travel Registry is also encouraged for personal trips. The U.S Department of State also allows you to record information about your planned trip so that they can assist you in case of an emergency.

If your destination is subject to U.S. embargoes, the U-M Travel Registry will automatically send your travel information to the Export Control Program, and you will be contacted to assure your travel complies with export regulations. If you are traveling to or through any other destination that is subject to other travel restrictions, you will need to talk to the Export Controls Program to ensure your travel complies with U.S. export control regulations.  

Destinations currently subject to the most comprehensive US embargoes include:

• Cuba

• Iran

• North Korea

• Sudan

• Syria

• Crimea region of Ukraine

Even if you do not need an export license to travel to your destination, you may need an export license to conduct certain activities in specific countries or to take certain items with you.

PLEASE NOTE: If you are planning to travel to Iran for a meeting or conference, you will need to obtain an export license prior to your trip. You should contact the Export Control Program immediately to allow time to apply for the license.

No. This is an often-heard misconception. The unit's cost-sharing is determined before the OVPR review takes place. Although the end result may be that the unit and OVPR each contribute the same amount toward the cost-sharing, matching is not automatic.

About $3 million in the Vice President's annual budget is specifically designated for cost-sharing. Most of the requests are for amounts in the range of $10,000 to $50,000. When requests for very large amounts of cost-sharing appear justifiable, the Vice President consults with the other executive officers to determine if other University funds can be made available for the requested purpose.

As defined in the FAR at 2.101, a micro-purchase is an acquisition of supplies or services using simplified acquisition procedures, the aggregate (total) amount of which does not exceed the micro-purchase threshold.

6-1.1: Click Update for each animal that will be administered LPS

--Provide the requested information regarding dosage and routes of administration.

--Note that animals administered LPS may be housed at ABSL1.

6.1: Each type of animal that you will be administering LPS to must have an entry in this list. Add entries, if needed, and be sure to provide the following information in the detail questions:

--Q5: Answer “yes” here.

--Q8: Answer “yes” here as well.

--Q8.1: Select LPS from the list. (If you do not see LPS in this list, check your response to Q13 of the detail questions for LPS in Section 4-2: it must be “yes”.)

Q4.2: Answer “yes” here.

Q4.3: Be sure to include in this response a description of your work with LPS.

4-2.1: Create an entry for LPS in this table

--Q12: Note that work involving LPS requires BSL2 containment/handling.

--Q13: If you will be administering LPS to your animals, answer “yes” here.

Be sure to answer "yes" to the option for Infectious Agents/Biological Toxins.

Visit http://research-compliance.umich.edu/irb-application-process Email: irb[email protected]. Phone: 734-936-0933. Please note that it must be accessed via U-M's eResearch Regulatory Management (eRRM) system: http://eresearch.umich.edu. Phone: 734-764-HELP (764-4357). A list of compliance contacts can be found here: http://research-compliance.umich.edu/sites/default/files/eccontacts_web.pdf.

Be sure to register your travel and check any policies here: http://global.umich.edu/travel-resources/ and http://research-compliance.umich.edu/international-travel-export-controls.

Visit the Responsible Conduct page: http://research-compliance.umich.edu/responsible-conduct-research-rcr-training as well as the PEERRS Portal: https://research-compliance.umich.edu/peerrs-portal/  

Unfortunately, we cannot accept résumés and applications for graduate programs or research opportunities. Find application materials on the Rackham graduate programs website or follow the employment application procedures on the University of Michigan careers/job postings site. Do check the eligibility requirements for any programs you see. Many summer research opportunities are only available to U.S. Citizens.

Your first point of contact should be your department's research administrator. You can find that person here: Find a Research Administrator (Blue Pages).

Jobs and internships are arranged through the academic department or posted on http://careers.umich.edu.

We do not keep research publications for loan or purchase. If published, it may be available via the National Institutes of Health PubMed Central or our U-M library. For citations, please use standard citation methods.

You can look up your ORSP Project Representative here. 

Your first point of contact should be your department's research administrator. You can find that person here: Find a Research Administrator (Blue Pages) You can use our Project Representative lookup table here. 

Check the U-M Library's http://funding.research.umich.edu for funding databases. There, you can arrange a consultation with a librarian who can help you with resources. If applying for funding, your next point-of-contact should be your department's research administrator. You can find that person here: Find a Research Administrator (Blue Pages). 

Research and internship opportunities are available for enrolled students. You can find graduate program application materials on the Rackham website (http://rackham.umich.edu). For undergraduate admissions go to http://admissions.umich.edu.

Media may contact [email protected].

The U-M Office of Research has a Research Development team dedicated to sharing external funding opportunities through a monthly newsletter called Research Blueprint, along with the new Research Commons website (currently in the "soft launch" phase and under development).   If you would like to share any internal funding opportunities or to be added to the newsletter distributions list, please email at [email protected].

Yes, but only for human subjects protections regulatory training.  One commonly accepted equivalent is the basic or refresher courses for either biomedical or social-behavioral human subjects protections from the Collaborative Institutional Training Initiative (CITI).

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 minimum:

U-M may accept another (non-CITI) course as a human subjects protections training equivalent upon ad-hoc review.  

To request a waiver for equivalent training, submit a certificate showing the course completion date and a list of course topics through the Request a PEERRS Human Subjects Certification Waiver form.

Yes, if you are engaged (i.e., interacting with the participants and/or their identifiable data) on a U-M human research study you may need to complete the PEERRS Human Subjects Research Protections (HSP) course or show proof of equivalent training.

  At U-M, HSP training is tracked only for those non-UM investigators who qualify to be listed on the IRB application; otherwise training requirements and oversight are handled by the investigator's local IRB.

If you have completed an equivalent human subjects protections training course (e.g., CITI) 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 at:   https://friend.weblogin.umich.edu/friend/.  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 Human Subjects Research Protections course from the PEERRS Portal and log into My LINC to complete the course.

For your PEERRS credit to display in the U-M IRB application (HUM), the email address used as your U-M Friend Account Login ID and the email address associated with you in the IRB application must be the same.

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:

• Explain the nine Responsible Conduct of Research (RCR) components as it applies to the research discipline (e.g., engineering, botany, biomedical research)
• Include face-to-face instruction

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 the certifaction test or complete the attestation.

Before you start

1. My LINC works best with Internet Explorer or Safari web browsers.
2. Turn off your web browser's pop-up blocker to ensure that the PEERRS course will open.  Courses display in a separate window.

At then end of a course:

Click the exit button to close the course.  The Exit button is located under the menu icon.  Exiting the course transfers the completion information and assessment/attestation results to the My LINC database and records your credit in the course.

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 (ORCR), and the OVPR 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 [email protected].

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 its most competitive proposal, requiring an internal competition. The process is critical; extra submissions can result in the rejection by the sponsor.

To learn more, contact [email protected].

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. 

The Blue Pages pulls its data from eResearch. If you find the information here is not up to date, your unit liaison can update it in the Reviewer and Unit Liaison Workspace of eRPM. Here are links to ITS's step-by-step guides:

• Manage Department Information
• Unit Liaison Home Workspace

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.

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For questions on the Award Managment Functionality project, please contact [email protected] or 734-936-1284.

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After review, testing, and communications, we plan to launch August 2018. The timeline includes:

• User Acceptance Testing (UAT) - June 2018
• Training - July 2018
• "Go Live" - August 2018

ORSP in conjunction with Sponsored Programs, ITS-eResearch, and the research units is developing new award management functionality in eRPM with the goal to:

• Streamline the award management processes;
• Create greater flexibility in the relationship between PAFs and Awards (AWDs);
• Increase the visibility of award details and related items (e.g., individual funding commitments, compliance factors, required deliverables);
• Provide consistent award data between eRPM and U-M’s financial system (M-Pathways); and
• Enhance the “big picture” view of sponsored awards at the University of Michigan.