Green Post-It Note with the words Good Job handwritten on it.

Associate Director of Research Compliance earns certification

Jennifer Sutton, Associate Director of Research Compliance
Jennifer Sutton, Associate Director of Research Compliance

Associate Director of Research Compliance Jennifer Sutton recently earned the Certified IRB Professional (CIP) credential.

Administered by Public Responsibility in Medicine and Research (PRIM&R), CIP is earned by passing a 250-question exam that covers “information determined . . . to demonstrate a standard level of knowledge about human subjects research review under the rules and regulations of the United States.” To maintain certification, Sutton will complete Continuing Education Units (CEUs) and/or retake the exam in three years.

In addition, Sutton has been selected by PRIM&R as a Community Ambassador for the 2016 Advancing Ethical Research Conference, to be held November 14-16 in Anaheim, CA. According to PRIM&R, “Community Ambassadors are charged with aiding fellow attendees in meeting and connecting with each other.” Community Ambassadors assist fellow  attendees during the meeting, help coordinate onsite events, and attend networking receptions.


“Good Job” photo by NOGRAN s.r.o. via Flickr, used under Creative Commons license. Photo of Jennifer Sutton by Miami University Photo Services. 

 

Three people sit on a bench near a railroad track. Each of the people wears and orange vest and holds multiple clipboards and pens. A fourth person, who seems not to be affiliated with the other three is walking away from the bench, presumably after talking to one of the three seated people.

Office of Research Compliance updates procedures and materials

Many cups of water sit on a table. Someone is sitting in one of the chairs pulled up to the table.
Food taste tests, like this one for bottled water, are a Level 1 Research activity.

The Office of Research Compliance has refined administrative procedures for institutional review of human subjects research. There are now three levels of research, as described below.

  • Level 1 Research (formerly “exemption screening”) correlates to activities listed in one of the “exempt” categories in Federal regulations (45 CFR 46). These include:
    • Minimal risk surveys, interviews, or observations of public behavior with subjects over the age of 18.
    • Research with subjects under the age of 18 conducted in a normal classroom setting using materials collected as part of the normal curriculum.
    • Research with anonymous data or biospecimens that have already been collected, provided Miami researchers have not been involved in the design of the project or the collection of the data.
    • Food taste testing.

Download the Level 1 Research application form here. Guidance for completing the application form can be found here.

  • Level 2 Research correlates to activities that qualify for “expedited review” according to Federal regulations. Specifically, this is minimal risk research involving a vulnerable population or manipulated subjects. Review is conducted by a sub-committee of the Institutional Review Board (IRB).Download the Level 2 Research application form for general subjects here. Download the Level 2 Research application form for student (K-12 or post-secondary) subjects here.
  • Level 3 Research is that which a member of the Level 2 review IRB sub-committee has determined warrants further review. This research is subject to full IRB review and majority approval. No application form is required.

To aid researchers in complying with regulations and standards for ethical practice, the following consent templates are now available on the Research Compliance website:

  • Interviews
    • Formal — Use when meeting a subject at an agreed-upon location for an in-depth interview
    • Informal — Use when recruiting and interviewing at a public place, such as a city street or a zoo.
    • Skype/phone — Use when calling subjects on a member list or  when calling subjects who have responded to an online invitation.
  • Surveys
    • Online — Use when recruiting via email or online invitation, or when accessing an instrument in a computer lab.
    • Paper — Use when distributing a survey card to patrons or program participants.
  • Classrooms
    • Use of materials (FERPA) — Use when requesting to use assignments or grades for use in pedagogy research.
    • Observation — Use to request minor assent and parental consent.
  • Courtesy/debriefing card — Use to thank subjects and to provide contact information for post-participation follow-up.

Written by Jennifer Sutton, Associate Director of Research Compliance, Miami University.

Survey photo by Richard Masoner via Flickr. Bottled water taste test photo by tiarescott via Flickr. Both used under Creative Commons license.

A student researcher takes blood from the finger of a research participant who is walking on a treadmill. The students mentor supervises.

Changes to NSF and NIH policies and procedures are forthcoming

A researcher holds a bird that will be banded.
Researchers working with vertebrate animals need to be aware of recently increased scrutiny by the NIH.

 

Below is a summary of changes in policy and procedure being implemented at the National Science Foundation (NSF) and the National Institutes of Health (NIH).

National Science Foundation (NSF)

The NSF Policy Office has a long history of being responsive to the grant community. In response to comments from investigators and research administrators, the NSF is making a number of changes in its policies pertaining to preparation and award administration. Full details can be found in the Proposal and Award Policies and Procedures Guide (PAPPG)but the changes that will have the most impact Miami University researchers are summarized below:

New proposal types and clarification on proposal types

  • Letters of Intent, preliminary proposals, full proposals, and invited proposals, oh my! Guidance on what to include in these different types of NSF proposals will now be outlined in the revised PAPPG. Special attention is given to what needs to be included in the new, separate section on Collaborator & Other Affiliation Information.
  • Look for two new proposal types to be implemented:
    • Research Advanced by Interdisciplinary Science (RAIS): RAIS will replace NSF INSPIRES to promote interdisciplinary science and education.
    • Grant Opportunities for Academic Liaison with Industry (GOALI): The GOALI program is expanding beyond Engineering to promote university-industry partnerships focused on solving basic research questions. Look for this cross-cutting program in many of the NSF Directorates.
  • Historically travel grants have supported international travel for students supported by NSF funds, while supplements — such as those for Research Experiences for Undergraduates (REUs) — have been used for domestic travel. Going forward, however, NSF travel grants will cover both foreign and domestic travel for students.

Defining participants

According to NSF policy, it is up to the institution, not the NSF program officer, to classify participant support. At Miami, we use the NSF definition of participant support recently adopted by the Office of Management and Budget (OMB): “Participant support costs are direct costs for items such as stipends or subsistence allowances, travel allowances, and registration fees paid to or on behalf of participants or trainees (but not employees) in connection with meetings, conferences, symposia or training projects” (PAPPG).

The revised PAPPG will aid in clarifying the difference between an undergraduate participant (such as an REU student) and an undergraduate researcher. However, if you are uncertain how to classify any student, please contact your OARS representative for assistance.

Finally, just a note on food for participants. If a participant receives funds for individual meal compensation, those funds should be budgeted under “Participant Support.” Funds for meals provided for conferences/workshops, should be budgeted under “Other.” Contact your OARS representative if you need assistance making this distinction.

Changes to NSF forms

  • The 4,600 character limit will be removed from the Project Summary. Instead, the Project Summary will be limited to one printed page using appropriate font size and type.
  • Guidance on “Collaborator & Other Affiliation information” will be updated in the revised PAPPG.

Financial considerations

  • NSF has adopted a 10% de minimis facilities and administration (F&A) rate for foreign subcontractors. Domestic subcontractors may used their Federally-negotiated F&A rate or may use the 10% de minimis rate, if they do not have a negotiated rate.
  • Use of an F&A rate less than the institution’s negotiated rate is considered by NSF to be cost share, which is unallowable for a majority of NSF programs. Using the NSF budget template provided by OARS will ensure you are using the correct F&A and fringe benefit rates.
  • NSF guidance on implementation of the Department of Labor’s Fair Labor Standards Act (FLSA) can be found in their list of frequently asked questions (FAQs).

Additional information

A final draft of the revised PAPPG will be posted to the NSF website in October 2016, with changes to be implemented January 2017.

If you’d like to learn more about NSF grant administration and programs, consider registering to attend the upcoming NSF Grants Conference being held November 14-15 in Pittsburgh, PA.

National Institutes of Health (NIH)

A number of changes have recently come out of the NIH Office of Extramural Research. Many of these changes have an impact on post-award accounting and reporting. The most helpful things for grant writers are the new NIH Guide to Grants and Contracts and the General Application Guide for NIH. These new guides offer streamlined overviews of NIH programs, open solicitations, and step-by-step instructions on preparing NIH proposals and reports.

Other changes to NIH policy and programs include:

New funding programs

The Precision Medicine Initiative (PMI) program was announced by President Obama during his 2015 State of the Union address. The focus of this initiative is to take fundamental research and apply it to a specific cohort of individuals to produce individualized care. Funding programs for PMI can be found here.

Form updates

  • The new Forms D are in effect for proposals submitted on or after May 25, 2016. The new forms include:
    • A new section on authentication of key biological and/or chemical resources in order to meet requirements for rigor and reproducibility.
    • New questions regarding enrollment of human participants (enrollment type, dataset source, participant location, etc.)
    • A PHS Assignment Request Form to help determine under which institute or center a proposal should be reviewed
  • Newly specified font types including Arial, Garamond, Georgia, Helvetica, Palatino Linotype, Times New Roman, and Verdana. All font types should be 11 points or larger.

Compliance issues

eRA Commons and technical/financial reporting

  • As of June 12, 2016, eRA Commons usernames are required for primary mentors on Mentored Career Development proposals. If you need to register a PI, co-PI, investigator, sponsor, or mentor with eRA Commons, please contact your OARS representative.
  • While registration is not required for undergraduate students, graduate students, and postdoctoral candidates at the proposal stage,  once a project is funded and work by those personnel is supported by NIH funding, they must be registered with eRA Commons so that PIs can complete technical (annual and close-out) reports. Contact your OARS representative to register individuals with eRA Commons.
  • New guidance on completing the Research Performance Program Report (RPPR) will be published this October. The new guidance will cover completing and submitting the Final Progress Report (FPR), the Final Invention Statement & Certification (FIS), and the Final Federal Financial Report (FFR). Please remember that all financial reports must be submitted by Miami’s Grants & Contracts office, and should not be submitted by the PI.

Additional information

If you’d like to learn more about NIH grant administration and programs, consider registering to attend the upcoming NIH Regional Seminar being held October 26-28 in Chicago, IL.


Written by Tricia Callahan, Director of Proposal Development, Office for the Advancement of Research & Scholarship, Miami University.

Treadmill research photo by Scott Kisssell, Miami University Photo Services. Bird photo also by Miami University Photo Services.

Two students work in a chemistry lab.

Office of Research Compliance offers RCR training

Two students in lab gear listen as their professor explains something in about equipment in a chemistry lab.

The Office of Research Compliance will offer two Responsible Conduct of Research (RCR) trainings this spring — one for faculty, graduate students, staff, post-docs, and other personnel, and another for undergraduates.

NSF, NIH, and the contractual obligation of researchers

Principal Investigators granted research funds from an agency requiring RCR training are required to have completed the training within 180 days of notification of this requirement.
Graduate and undergraduate students, post-doctoral scholars, and other research personnel who are supported or whose research activities are supported by funding agencies requiring RCR training must complete the training.

The principal means of formal training is a series of interactive sessions, each focusing on a particular topic of RCR. The Office of Research Integrity is the central resource for the nine topic areas identified as important to research activities:

1. Research Misconduct
2. Data Acquisition, Management, Sharing and Ownership & Collaboration
3. Mentor/Trainee Responsibilities
4. Human Subjects & Animal Welfare
5. Conflict of Interest and Commitment
6. Publication Practices and Responsible Authorship & Peer Review

The nine core areas are addressed through outside-of-class short case study readings, video vignettes, speaker presentations, and small group discussions.

RCR training for  faculty, graduate students, staff, post-docs, and other personnel

Participants must attend all four sessions in the RCR training series to receive training credit. Each lasts about 50 minutes and is limited to 30 people. Topics for the sessions include:

  • Introduction to research misconduct
  • Data management and collaboration
  • Mentor-mentee relationships
  • Ethical conduct
  • Research with animals and humans
  • Conflicts of interest
  • Time management
  • Publication practices.

Dates: Tuesdays, April 12, April 19, April 26, May 3
Time: 10:00 am – 10:50 am
Location: 134 King Library (AIS classroom)

RCR training for undergraduates

For undergraduates involved with NSF/NIH research who will have limited ability to effect the research results, we will conduct a single evening session lasting about 50 minutes. This session will cover the topics relevant to typical undergraduate involvement with research (e.g., data collection and integrity). Substitution of this 50 minute session for the full series for undergraduates is at the discretion of the PI/faculty advisor.

Date: Wednesday, April 13, 2016
Time: 4:00 pm to 4:50 pm
Location: 134 King Library (AIS classroom)

Registration for all RCR training

Please visit the Research Compliance website to register for either training.


Photos by Scott Kissell, Miami University Photo Services.

 

A student wearing a t-shirt that reads, Alcohol Research, holds a clipboard and a pen. He is smiling and talking to someone who cannot be seen in the photo.

Office of Research Compliance offers tips for submitting IRB applications

A student researcher measures the waist circumference of a research subject.

The following tips will help you successfully submit your IRB application.

Training

Please remember that the primary contact on the application needs to complete both the on-campus and CITI training prior to submitting an IRB application. If the primary contact is a student, the faculty advisor listed needs to complete both parts of the training. Other personnel listed on the application need to complete the CITI training only. If other personnel are from another institution, please provide a copy of their CITI training certification. The IRB and/or Research Compliance Office will request a copy of their training certification prior to approval.

Location permission

When conducting research outside Miami University’s campus, it is wise to receive permission from the property owner and/or management prior to conducting the study. Please provide a copy of this approval document (or email) when submitting your IRB application.

Additional documents

When your research project involves children, please remember to submit both a student assent document and a parental consent form with your application. Please review your application to make sure all your instruments are attached to the appendix.

Title

Please double check to make sure the title listed on the cover page matches the title on the research description and appendices.

Writing

It is always best to have someone else proofread your application prior to submission. As always, if you have questions regarding the application process please contact the Research Compliance Office at 513-529-3600 or humansubjects@MiamiOH.edu.

A young man walks on a treadmill attached to a desk. On the desk are a computer, a book, and a travel mug. Standing next to the desk, an undergraduate researcher wearing a white lab coat and blue exam gloves takes notes in a folder while speaking to the man on the treadmill. Behind the undergraduate researcher, her research mentor looks on.

Research compliance training offered this fall

A hand holds the feet of a small yellow bird between its first two fingers so that the bird sits on top of the hand. In the background a glass container with duct tape wrapped over its rim sits on a digital scale.

Animal Care Training

The Research Compliance Office (RCO) is making a change to online education requirements starting with the Fall 2015 semester. That training will now be provided by the Collaborative Institutional Training Initiative (CITI) at the University of Miami (FL), instead of by the American Association for Laboratory Animal Science (AALAS) Learning. CITI provides self-registration for all students and a single user-account for any person who also needs to complete the same research ethics program for humans-as-subjects research.

Detailed instructions on creating a CITI account can be found on the RCO website.

The basic course, “Working with the IACUC” is the required course. All other courses (see the RCO website for a list) are optional, but may be required by certain faculty for workers in their particular labs.


Human-as-Subjects Training

Principal investigators and faculty advisors new to Miami are required to attend a 75-minute program orientation session. Graduate students who will be listed as a principal investigator (PI) on an application must also attend the program orientation session. Fall 2015 times and dates are as follows:

  • Friday, September 11, 8:30am in 134 King (AIS)
  • Wednesday, October 21, 4:00pm in 134 King (AIS)
  • Saturday, October 31, 1:45pm at VOA West Chester
  • Monday, November 2, noon, Psychology Building
  • Thursday, November 19, 10:00am in 134 King (AIS)
  • Friday, December 4, 8:30am, location TBA

If you are interested in attending one of these sessions, visit the RCO website to register. Seats are limited to 40 people for general sessions.

Images by Miami University.

Two men work in a laboratory. In the foreground, a seated man wearing glasses, surgical gloves and a button-front shirt with the sleeves rolled up holds something in a container filled with clear liquid. Behind him, a standing man wearing a black golf shirt and surgical gloves holds a vial of blood. Various supplies and equipment are visible on the table in front of the men and in the background.

Jennifer Sutton earns Certificate in the Foundations of Human Subjects Protections Overview

Jennifer Sutton, Associate Director of Research Compliance
Jennifer Sutton, Associate Director of Research Compliance

 

Jennifer Sutton, Associate Director of Research Compliance, recently earned a Certificate in the Foundations of Human Subjects Protections Overview from the Public Responsibility in Medicine and Research (PRIM&R), a professional organization that seeks to advance the highest ethical standards in the conduct of biomedical, behavioral, and social science research.

To earn this certificate, Sutton completed PRIM&R’s online Ethical Research Oversight Course (E-ROC), attended the Advancing Ethical Research conference in 2013 and 2014, and participated in a full-day regional meeting in 2013. She now plans to work toward becoming a Certified IRB Professional (CIP).