Felt pillow with "+1" appliqued on the face.

Use personnel form to add collaborators on an IRB protocol

Collaborators from another institution may be added to a Miami University IRB protocol using the personnel form. Miami requires persons engaged in research using humans as subjects to complete training using the CITI online system. Prior to submitting the personnel form to the Research Ethics and Integrity Office, the collaborator will need to complete the training or, if they have completed it at another institution, affiliate their CITI account with Miami University. Below are the steps to complete this process on CITI’s website:

  1. Log into your CITI account.
  2. On the home page, scroll down and select “Add Affiliation.”
  3. Select “Miami University (Oxford, Ohio).”
  4. Select “Courses.”
  5. Select “Humans as Subjects IRB Basic Course.”
  6. Complete any modules highlighted in blue including three electives

Once the additional modules are complete, our office will receive the completion report from CITI the next day.

For more information related to collaborating with researchers from other institutions, please visit the Research Ethics & Integrity website.

Image by Wicker Paradise via Flickr, used under Creative Commons license

Wires woven together to form connections

Informal networking events foster organic connections

Graphic depiction of network connections between several people.

One of the things we’ve heard frequently over the years from Miami’s more seasoned researchers is that they miss the days of the Old Miami Inn, where OARS would organize occasional get-togethers. It was an opportunity to hang out, with no particular agenda, but still manage to come away with new connections, and maybe even new collaborators.

Although we can’t bring back the Miami Inn, we are trying to revive the spirit of those informal gatherings with a series of program-free networking events. The first event took place last fall. Dubbed “Networking in the Club Lounge” for its location in Goggin Ice Center’s Club Lounge, it was a gathering of around 40 research-active faculty who enjoyed drinks and heavy appetizers on OARS while catching up with existing colleagues and getting to know new ones.

We are repeating that event again this fall. The Second Annual Networking in the Club Lounge event will be held this coming Tuesday, October 29, from 5:00 to 7:00pm. Registration is open through Monday.

In addition, we are organizing a series of no-host events at local restaurants. The first of these was held September 12 at Books & Brews in Oxford. It was sparsely attended, but the faculty who came were new to Miami and enthusiastic about their research and about meeting potential collaborators. We are hoping for stronger turnout at our next gathering, on Tuesday, November 12, from 5:00 to 7:00pm at Cru Gastro Lounge.  No registration is required. Menus and pricing are available on the restaurant’s website.

What are your thoughts about these informal opportunities for research networking? If you’re a Miami University researcher, please let us know in the comments.

Networking image by Gordon Johnson via Pixabay. Wire connections image via Max Pixel. Both used under Creative Commons license.

A Miami University laboratory

IRB and MREI establish procedures for collaborating with researchers from other institutions

A Miami University student intern takes measures the waist of a research study participant.

Researchers must satisfy the requirements all of the institutions involved. It is the responsibility of the principal researcher and external collaborators to meet the requirements. As a means for reducing regulatory burden, federal regulations and Miami policy allow for single IRB oversight for multi-institution projects. The procedures for establishing responsibilities are dependent on the nature of the research and funding sources. Miami’s requirements for documentation and approval are summarized in a decision tree.

The following describes the two most common situations. (“Principal investigator [PI]” refers to the person who has overall responsibility for the administration of the project).

The researcher is at Miami and the PI for the project is at another institution

It would be very unusual for a university or college not to have policies related to human subjects research oversight and an IRB. Miami researchers who are the PI on a project must seek Miami IRB approval. If Miami personnel are not the PI on a project and are not receiving external funds in support of the research, the Miami Research Ethics & Integrity program (MREI) may accept the review of the external collaborator’s (PI’s) IRB. This form may be used to register external IRB approval. The externally approved protocol will be examined to determine if the review process meets Miami standards or incurs a potential liability of which Miami should be aware of and manage.

Occasionally, a Miami researcher will propose a collaboration where Miami will wish to retain oversight for just the activities of Miami personnel. For example, the overall project is a biomedical clinical trial to be conducted at a medical center that could incur significant liability, but the activities of the Miami researcher are limited to data collection and analysis related to an anonymous online survey related to the study.

The PI is from another institution and the research is conducted at Miami

PIs who desire to conduct human subjects research at Miami University must have IRB approval from their home institution (or in the absence of such an IRB, a request can be made for the Miami IRB to conduct a review). To document adequate IRB oversight to Miami, external researchers must submit a copy of their protocol and a copy of the approval letter to the MREI program.

Miami’s IRB and the MREI program consider only the protection of human subjects; they do not grant authority for the PI to conduct the research at Miami. Therefore, the authority to conduct research must be obtained from the appropriate university official relative to the research to be conducted (e.g. Dean of the College, Dean of Students, Director of Clinical Training, Department Chair). It would be wise to reference this authorization when submitting your IRB approval materials to your home institution.

  • It is Miami policy that all human subjects research being conducted on a Miami campus be reviewed by an Institutional Review Board. That IRB review or exemption could be provided by the home institution of the researcher.
  • If the outside researcher is collaborating with a Miami employee and the Miami employee is functioning as a researcher, the Miami researcher must be listed as personnel on the external collaborator’s IRB-approved protocol or the Miami IRB must conduct a review of the protocol using the Miami procedures.
  • If no Miami personnel will be obtaining consent of subjects, collecting data, or have access to data with identifiers, then Miami is not engaged in research; therefore, Miami IRB approval or MREI program exemption is not required. However, we ask that external researchers send us a copy of the protocol and approval letter because we may be contacted about the project by potential subjects or the university administration granting access (see bullet below). Copies of the research description and the approval letter should be sent to the MREI program for our records.
  • Researchers must still obtain permission to use Miami facilities from the appropriate official (e.g. Dean of Student Affairs, Dean of a College, Department Chairs, Provosts Office). The IRB and the MREI program do not have the authority to grant or deny access to Miami facilities, staff, or students. Rather, the IRB or MREI program reviews and approves procedures.

Unless the Miami IRB has conducted a review and issued an approval letter, neither Miami University nor the Miami IRB can be referenced as approving of the research. MREI program’s acceptance of external review does not constitute Miami IRB approval.

Written by Neal Sullivan, Director, Miami University Research Ethics & Integrity Program.

Photos by Jeff Sabo, Miami University Photo Services.