Institutional Review Board

Complete the IRB Research Application to begin the review process.

• You'll provide basic information about your research project, who's involved, what and who you're planning to study, and how you will execute your research project.
  • Students may submit a research proposal as a Co-Investigator if they have a faculty member identified as the Principal Investigator (PI).

After you submit your form, it is automatically routed to the IRB, and you'll hear from them within seven working days regarding the next steps you need to take.

• DO NOT begin your research project until you receive IRB approval.

• IRB Research Application
• IRB Expedited Research Application
• IRB Continuing Review/Progress Report Form
• IRB Protocol Deviation/Violation Report Form
• IRB Project Amendment Form
• IRB Conflict of Interest Disclosure Form
• IRB Informed Consent Form - PENDING
• IRB Parental Informed Consent Form - PENDING

• Additional Verification Procedures
• Adverse Event Reporting Procedures
• Amendments Procedures
• Appeal Procedures
• Continuing Review Procedures
• Cooperative Activities Procedures
• Grievances Procedures
• Informed Consent Policy
• Initial Review Procedures
• Record Requirements Policy
• Reviewer Assignment & Voting Procedures

Mid's IRB makes a good-faith effort to manage internally sponsored surveys and those requested by external organizations. Below is a survey schedule based on an internal review. This is a living schedule that is subject to change at any time.

• Coming Soon!

Mid Michigan College (Mid) holds a Federalwide Assurance (FWA) through the Office for Human Research Protections (OHRP). Under this Assurance, Mid considers all human subject research to be governed by federal regulations, regardless of funding, if any of the following conditions are met

• The research is funded or sponsored by Mid.
• The research is conducted by or led by any Mid employee (except when conducted at another institution with which there's an IRB Authorization Agreement as detailed in Mid's FWA).
• The research is conducted by or led by any Mid employee using any Mid property or facility.
• The research uses Mid's non-public information to identify or contact human research subjects or potential subjects.
•  Sometimes, students might engage in course-related activities like questioning, participating in minimally physically demanding classroom exercises, observing, and/or interacting with others. It's the course instructor's responsibility to submit a Help Desk ticket to help determine if these activities require Institutional Review Board (IRB) approval. If there is any uncertainty, instructors are encouraged to complete an Exempt Review Application along with the protocol, consent forms, cover letters, and/or questionnaires for IRB guidance.
  • The IRB at Mid reviews all human subject research projects and programs following specified procedures, applicable federal regulations, and sponsor rules and guidelines. The IRB offers ongoing advice and guidance to those involved in human subject research.
  • The IRB has the authority to approve, disapprove, modify, or approve studies based on considerations relevant to human subject protection. Even after IRB approval, research can be subject to further review by the Director of Institutional Research, but cannot be approved without prior IRB approval.
  • The IRB can request progress reports from investigators and oversee study conduct. The IRB can suspend or terminate study approvals or impose study restrictions if deemed necessary for the protection of the subjects.
  • The IRB is allowed to observe the informed consent process by any investigator or authorized personnel, especially when the consentee is from a vulnerable group.
  • Lastly, the IRB has the authority to access and duplicate records for any approved research, regardless of where these records are kept. Where possible, the IRB will provide notice of intent to access or copy records to minimize inconvenience or disruption to ongoing research.

IRB Chair Responsibilities

• The IRB Chair is the Director of Institutional Research and holds the authority to approve all IRB-related items.

IRB Vice Chair Duties

• The Vice Chair, a voting member of the IRB, oversees meetings in the Chair’s absence. Appointed by the Chair, the Vice Chair can also sign all IRB action items when the Chair is unavailable.

IRB members do not receive financial compensation, though service may count toward faculty contract committee duties.

An IRB member is considered to have a conflict of interest if they, their spouse, or dependent child

• Are investigators or co-investigators on the protocol under review.
• Hold a significant financial interest in the study's sponsor or the sponsor's agent, where the study's outcome could impact the financial interest's value.
• Serve as an officer or director for the sponsor or agent of the sponsor of the study under review.
• Identify themselves as having a conflicting interest for any other reason.

Each IRB member is responsible for recognizing and avoiding any conflicts of interest, whether personally or by their position, related to matters before the IRB. If they believe they have a conflict with a proposal they're reviewing, they must inform the IRB Chair immediately so a new reviewer can be assigned. To prevent delays, potential reviewers should quickly examine assigned proposals to identify any conflicts.

In IRB meetings, matters usually progress through three stages: discussion, deliberation, and action (which includes voting). Members with real or perceived conflicts of interest may stay in the meeting, at the discretion of the IRB Chair, during the discussion to provide necessary information. However, they must leave the room during deliberation and voting.

• The IRB meeting minutes will note by name the absence of any member who leaves the meeting due to a potential conflict of interest during deliberation and action.

Further Guidelines

• Investigators cannot participate in selecting IRB members.
• The Conflict of Interest Form and the Report Form for Financial Disclosure, requires investigators to disclose any vested interest in commercial enterprises linked to their research. They must detail safeguards to prevent bias in participant recruitment and consent.
• The IRB receives any financial disclosures related to human subject research from the Grants Office.

Experts may be consulted if specialized knowledge is required.

The IRB functions administratively through the Office of Institutional Research. This structure provides for administrative coordination for the IRB with the various academic and administrative units at Mid.

The IRB advises and makes recommendations to the Provost, to policy and administrative bodies, and to any member of the Mid community on all matters related to the use of human subjects in research.

All IRB members, regardless of employment status with Mid Michigan College, are covered under the college’s liability insurance.

IRB meetings are scheduled approximately four times a year.

The place and time of meeting, agenda, and study material to be reviewed are distributed to IRB members at least seven days prior to the meeting.

Although convened meetings of the IRB are open to the public, materials submitted for review, discussions of protocols, and individual votes are considered confidential and should not be discussed outside of the meeting context. If during an IRB meeting the Chair moves the meeting to executive session then any visitors will be asked to leave the room until the executive session has ended.

The IRB Chair appoints members and alternates for a three-year term. Members can resign by notifying the Chair, who can also terminate appointments. If a member cannot attend meetings for an extended period due to conflicts, the Chair should be notified to appoint a replacement. Members may be removed for excessive absences or inability to fulfill duties, with the Chair appointing replacements as needed. Terms may be extended by mutual agreement with the Chair.

At Mid Michigan College (Mid), the Institutional Review Board (IRB) consists of at least five voting members. 

The IRB is made up of members with diverse backgrounds and specialized knowledge to ensure thorough and adequate research evaluation. Members should not only be able to understand the research but also have the competence to make informed judgments regarding the acceptability of the research following Mid's regulations, relevant laws, ethical standards, and professional practices. Consultants with additional expertise may be brought in to review certain proposals.

The IRB must include both men and women, with at least one member focusing primarily on scientific areas, one focusing on non-scientific areas, and at least one member not otherwise connected to Mid, either directly or through immediate family.

No one is excluded from serving on the IRB due to sex, race, color, sexual orientation, gender identity, religion, or national origin.

Current Members

• Dr. Karolina Achirri, Director of Institutional Research (Chair)
  
• Dr. Stevens Amidon, Assistant VP of Academic Services (Co-Chair)
  
• Jessica Chemberlain, Social Sciences Faculty
• Amy Fisher, Dean of Business & Professional Studies
• Jason Howard, Director of TRIO SSS
• Dr. Scott Mertes, Provost
  
• Svetlana Overbaugh, Business Faculty
  
• Anthony Sassin, English Lectureship
• Dr. Richard Smith, Associate Dean of Off-Campus & K-12 Operations
• Jeremiah Wagner, Biology Faculty

Upon initial appointment and every three years thereafter, IRB members must complete formal training provided by the National Institutes of Health online tutorial [https://phrp.nihtraining.com/index.php]. Completion certificates are submitted to the IRB Chair, who logs training dates and keeps record of the certificates. Additional educational resources are available on the Institutional Research website [http://www.monroeccc.edu/institutionalresearch/index.htm].

Institutional Review Boards (IRBs) review research studies to ensure that they comply with applicable regulations, meet commonly accepted ethical standards, follow institutional policies, and adequately protect research participants.

Some people may also call IRBs Independent Review Boards or refer to them as Ethics Review Committees.

IRB reviews help to ensure that research participants are protected from research-related risks and treated ethically, a necessary prerequisite for maintaining the public’s trust in the research enterprise and allowing science to advance for the common good.

The IRB is an administrative body established to protect the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of the institution with which it is affiliated.

The IRB is charged with the responsibility of reviewing, prior to its initiation, all research (whether funded or not) involving human participants. The IRB is concerned with protecting the welfare, rights, and privacy of human subjects. The IRB has the authority to approve, exempt, disapprove, monitor, and require modifications in all research activities that fall within its jurisdiction as specified by both the federal regulations and institutional policy. The IRB shall have at least five members of varying backgrounds in order to provide a complete and adequate review of human research and its institutional, legal, scientific, and social implications. The Board will also include at least one member who is not affiliated with the institution and one member who is not a scientist. The IRB has several consultants who advise the Board and are periodically involved in protocol review.

Reasonably, it takes a village to conduct a clinical trial. Among the many vital contributors to successful clinical research in the U.S. is the institutional review board – sometimes known as an independent ethics committee (IEC), an ethical review board (ERB), or a research ethics board (REB).

Under Food and Drug Administration (FDA) regulations, an IRB is an independent group of people who review and monitor biomedical and behavioral research involving human subjects. An IRB’s purpose is to protect the participant rights and welfare of human research. In accordance with FDA regulations, an IRB has the authority to approve, require modifications to, or disapprove research when it believes the participant’s rights or welfare are not properly protected.

According to James Riddle, Vice President of Research Services and Strategic Consulting at Advarra, “Probably the most important thing for an individual to know is that, at least here in the United States, there is an independent group of folks who are overseeing research, looking out for your best interest as a patient, somebody other than the sponsor.”

The IRB originated in several landmark efforts to instill ethical considerations into research, including the Nuremberg Code of 1945, stemming from Nazi atrocities in World War II. U.S.-based events that helped inspire the IRB include the Tuskegee Syphilis trial, in which Black men with syphilis were denied treatment. The National Research Act, signed into law in 1974, is the legislation that formally created the IRB. The Belmont Report followed in short order and set forth the basic ethical principles underlying biomedical and behavioral research conduct involving:

• Respect for persons
• Beneficence
• Justice

Today, the IRB’s structure and function is codified in 21 CFR Parts 16 and 56, enacted in 1981.

The people serving on an IRB is surprisingly diverse, as it may include lawyers, accountants, local church members, or any other community member who expresses interest in serving, applies for membership, and is accepted. IRB members may serve on a private IRB, through companies like Advarra, or the academic institution may administer their own IRB.

Both sponsors and independent researchers working on behalf of sponsors are subject to IRB oversight. Sponsors will submit their protocol and information about the investigational product (IP). They’ll also submit the template consent documents and any other materials patients will receive to explain the trial to them. Once these elements are approved, the IRB will turn to review the individuals conducting the research.

Each research site submits a short application to the IRB to verify that the investigator has the appropriate credentials, facilities, and staff to safely conduct the trial. The submission should also include:

• The investigator’s curriculum vitae and medical license
• Study information, including:
  • The clinic
  • Staff involved in the research
  • Expected number of participants enrolling in the trial
  • Prior experience with conducting trials in this particular disease modality or similar disease conditions

The IRB’s objective is to confirm that each investigator is qualified to conduct the trial per the already-approved protocol.

While the IRB does have the power to derail or even terminate a research project, researchers should understand while it is rare, and is never the IRB’s objective. Certainly not at Advarra.

“We want to see projects move forward, we want to see new cures hit the market, we want to see advancement in human health,” says Riddle. “So, what we are most likely to say to a sponsor is something like this: ‘Look, here are the federal regulations. Here’s where your protocol falls short, in our opinion. Take what we’ve said under consideration, update your protocol, and come back to us.’ If the sponsor disagrees with the IRB’s position, they are welcome to appeal the evaluation or ask for clarification. Very rarely is a protocol ever just killed.”

Once the protocol and investigators are approved and researchers start enrolling and consenting participants, staff will continue to send periodic reports to the IRB. The Board will want to know the number of participants enrolled and any problems stemming from the study. There is significant interaction between the investigators, the sponsor, and the IRB when the investigated drug or device uncovers new risk information. For instance, if new side effects appear, the IRB will decide how to communicate the information to participants. They will also make sure participants understand they can end their participation based on the new information.

While most of the heavy lifting occurs during research initiation, an IRB will continue to monitor trial activities as long as there are interactions between researchers and participants. In a typical clinical trial, this includes long-term follow up and data gathering, even beyond the point where participants are taking the IP. As long as there is still communication between participants and the investigators, the IRB will be active. This provides participants with the comfort of knowing that if at any point new risk information is revealed, the IRB will make certain they are informed and given the opportunity to exit the trial.