A laptop and a piece of paper on a table.

Miami transitions to online annual status reports for human subjects research

Screenshot of human subjects research online annual status report system. Text: Miami University. Human Subjects Research - Annual status report. This form is used to indicate a previously approved Level 2 (IRB) project is continuing, all personnel are appropriately trained and monitored, and data is secured. A link to this form is sent annually to the Primary Contact (PC) and Faculty Advisor (FA) (if a student project). Responses to the questions below are required and will indicate how records will be maintained. Submission of this form also serves as an assurance by the PC and FA that all personnel have completed the training and are competent given their assigned roles.
Annual status reports for human subjects research can now be submitted through an online system.

Due to changes in regulations for human subjects protections and Miami policy regarding what is commonly known as “Continuing Review,” Miami is transitioning to an online annual status report system. Approval will no longer lapse, and protocols will not be automatically closed unless no response is received to two annual requests for a report. Approval letters will no longer include expiration dates. However, the approval letters will include the date the next annual status report is due. It would be wise to have a personnel roster updated and available before beginning the online form. We will be transitioning next year to a system whereby all annual reports are requested and submitted during the summer break.

As has been the practice in the past, the Research Ethics and Integrity program will still accept the annual report Word template submitted by email attachment to humansubjects@miamioh.edu during this transition phase.


Laptop photo by Pixel.la Free Stock Photos via Wikimedia Commons, 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.

Students work on laptops in a classroom

Research Ethics and Integrity program offers updates for Miami research community

Students seated in a classroom
Using course evaluations for research requires approval from the Provost’s Office.

Use of institutional course evaluations for research

As a reminder, it is Miami University policy that use of course evaluations for research purposes requires approval from the Provost’s Office. Instructors do not have the authority to provide course evaluation information to researchers. It is implicit in the course evaluation system that the evaluation data is to be used for course improvement only. Most assessments of teaching methods employ data collection separate from course evaluations, which can include examination of submitted materials and/or test scores. An application must be submitted and approved prior to public use of normal course materials. A passive consent/notification process may be used for past students and their de-identified data (instructors remove identifiers from narrative responses) and an active consent process is used for current and future students. Read the policy.

Human subjects research: Level 1 screening — use of pre-existing data

This form is appropriate when Miami researchers are obtaining data that was collected by someone else or under the IRB approval of another institution. Data from Miami IRB-approved protocols being provided to new personnel, if de-identified, can be used for analysis under the original approval. If identifiers are included, the new personnel can be added using a personnel modification form. This form may be used for:

  • Research using data that is publicly available,
  • Data collected by non-Miami personnel, and
  • Research collected at another institution by current Miami personnel under IRB approval at that institution (e.g. transferring de-identified data)

Access the Level 1 application form.


Photos by Jeff Sabo, Miami University Photo Services.

Stylized illustration of concentric circles of binary digital data

New application available for human subjects research using pre-existing data

A stack of papers, organized with multi-colored, numbered sticky tabs.

All research projects involving human subjects, regardless of funding source, must submit an application to the Miami Research Ethics and Integrity Office (MREI). Some research requires IRB review and approval (Level 2 Form) and some research will qualify for administrative review and approval by MREI (Level 1 Forms).

To aid researchers, MREI created a new Level 1 application form that is specifically for the use of data existing prior to the proposed research activity. This data may have been collected by the Miami applicant prior to their affiliation with Miami or by another research team, under the IRB approval of another institution. This also includes research using data that is publicly available. This form is calledHuman Subjects Research Level 1 Screening: Use of Pre-existing Data and can be accessed directly from the MREI application page.

When a new use for data that was collected under Miami approval is proposed and the use does not violate the original consent agreement, if the approval is still current, new researchers can simply be added to the list of personnel using normal protocol modification processes. If the approval period for the protocol has passed, the new form can be used to receive approval to use de-identified data. If data will include identifiers, the project would require regular review and approval processes (either Level 1 or Level 2).

Completed applications and questions regarding methods or status of an application should be emailed to humansubjects@miamioh.edu.


Digital data image via torange.biz. Numbered notes photo by Denise Chan via Flickr. Both used under Creative Commons license.

The back of a raised hand.

Well-written consent forms ease IRB process

A pen lies on a piece of paper next to the printed words, "I Agree," and a checkbox.

Consent forms are an ethical requirement for conducting human subjects research. Knowing what to do and what not to do when creating a consent form will help prevent delays in IRB review and approval.

Do

  • Be concise. Briefly worded forms are more likely to be read
  • Use vocabulary and grammar appropriate for the subject population. Doing so makes it more likely for participants to understand the form. Most forms should be written at an 8th grade level. Reading level can be assessed using Microsoft Word for Mac or Windows, or an online tool such as Expresso or Readability Calculator.
  • Include the following elements of consent:
    • Brief introduction of the researcher(s) and their affiliation with Miami University;
    • Brief description of the research;
    • Duration of participation;
    • Brief description of procedures, distinguishing normal activities from research activities;
    • Statement of risks;
    • Benefits to society;
    • Extent of confidentiality;
    • Statement of voluntariness and explanation of withdrawal procedures;
    • Contact information for researchers, faculty advisor, and the Research Ethics & Integrity office;
    • IRB/exemption approval reference ID.

Don’t

  • Don’t imply the subject is committing to participation. A consent form is not a legal document and should not have the appearance of of a contract.
  • Don’t overuse the word “understand,” which has certain legal implications. A consent form is not a liability waiver or other legal document. “I understand the risks associated with this research,” is a statement commonly included in consent forms submitted to the IRB. But how can a subject know they understand the risks, let alone sign a document stating they do?
  • Don’t word a consent form in the first person from the viewpoint of the subject. In other words, avoid statements such as, “I will take part in an interview with the researcher where I will be asked questions . . . “
  • Don’t make a form overly long and/or redundant.
  • Don’t create a form that is coercive.
  • Don’t use a template without customizing it for your specific project. The Research Ethics & Integrity office has sample consent form templates available on its website. Any Miami researcher who uses these — or any other — templates should take care to edit them to provide specific information about their project. For instance, blanks in statements such as, “The purpose of this research is to ___________,” should be filled in.

Written by Jennifer Sutton, Associate Director of Research Ethics & Integrity, Miami University.

Raised hand image by Genusfotografen (Tomas Gunnarsson) via Wikimedia Sverige. “I Agree” image by Pixabay via Pexels. Both used under Creative Commons license.

Head-and-shoulders portrait of Ann Frymier

New IRB chair named

Two students fit a research subject with electrical leads.
At Miami University, the majority of IRB applications are submitted by graduate and undergraduate students.

Ann Bainbridge Frymier, a professor in the Department of Media, Journalism, and Film, has been appointed as the chair of Miami University’s Institutional Review Board (IRB).

IRBs exist to protect the rights and welfare of human subjects recruited by the institution’s researchers to participate in research activities. The IRB is responsible for reviewing researcher-submitted applications to ensure the proposed research activities comply with the federal Common Rule, the Belmont Report principles, and Miami University policies.

The chair is responsible for leading IRB meetings and coordinating timely responses to IRB applications and/or research ethics questions. In addition, at Miami, where the majority of IRB applications are submitted by graduate and undergraduate students, a significant function of the IRB chair is to educate students about incorporating ethics into their research through the IRB application and review process. The chair helps improve the quality of student research projects by working with students as they engage with the IRB.

Frymier, whose scholarship has focused largely on instructional communication, is especially suited to handling the educational aspect of the position. Beyond that, her other qualifications include being a tenured professor and an established researcher with an interest in research ethics.


Student research photo by Scott Kissell, Miami University Photo Services. Photo of Ann Bainbridge Frymier 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.