Institutional Review Board

General Purpose

The Institutional Review Board (IRB) is a standing committee established to protect the rights and welfare of the human subjects that participate in research conducted by any person affiliated with the College. The function of this Board is to review research proposals submitted by investigator(s) and ensure that the proposals are in compliance with state and federal regulations (45 CFR Part 46).

Authorities and Responsibilities Delegated to the Committee:

  • Review and approve all research projects and modifications prior to the principal investigator(s) conducting research.
  • Determine when research is exempt or requires a review. Certain broad categories of research projects that involve human participants that do meet the definition under the regulations are “exempt” from IRB review.
  • Ensure IRB forms are developed, maintained and available in the designated committee area.

Composition:

The faculty members of this committee are elected by the faculty. The Committee is composed of five faculty-at-large with at least three graduate faculty members, and at least one faculty member representing each of the Schools. The chair will be elected from the graduate faculty members.

For AY Year ’22-’23:

  • Committee Chair: Christine Helfrich
  • Committee Secretary: Zane Pfefferle

Committee Members:

  • Kate Barlow
  • Michelle Balch
  • Anne Stuart
  • Linette Wilson

IRB Proposal Forms Update

The IRB Proposal forms are submitted electronically online. All new submissions and amendments must be submitted via this system as of 9/1/2022.

There are directions within the form itself to help with completion. The form cannot be submitted until it is complete.

New Project Proposal Form – Please click the link to begin your New Project Proposal Form.

IRB Amendment form – Please click the link to begin your Amendment form.

Engage Submission Directions– Please click the link for the Engage Submission Directions.

The Links to complete the CITI Human Subjects Research Protection Training and the Decision Charts are active below. Everyone involved in Human Subjects Research (students and faculty advisors) is required to complete training every three (3) years prior to being approved to start a research project. Once you have completed your initial training, you will only be required to complete the refresher course.

If you have any questions, please contact the IRB Chair, Dr. Christine Helfrich at christine.helfrich@aic.edu

 

IRB FAQS

The IRB Review & Approval Process

Are there WORD versions of the online forms I can use for my class assignments or to complete and get feedback from my chair/advisor before I submit the online form?

  1. There are word versions and samples of all forms on the IRB Webpage.
  2. You can also print a PDF version of your form before you submit it in Engage.

How long does the review and approval process take?

  1. You will hear back within 30 days regarding the review status
  2. Final approval takes 7-90 days, depending on scheduling, revisions and level of review needed.

How will I get approval or feedback?

  1. You will receive a notice from Engage if revisions are needed.
  2. You will receive an email with an approval letter.

How long do I have to make revisions and resubmit my proposal?

30 days

What Are the Levels of IRB Review?

There are 3 Levels of IRB Review that can be determined by the decision charts.

  • Exempt Review: Research can be approved as “exempt” if it is no more than “minimal risk” and fits one of the exempt review categories as defined by federal regulation 45 CFR 46. All human subjects research must still be submitted to the IRB to determine if it qualifies as “Exempt.” Exempt reviews are conducted by a member of the IRB board, and do not require a convened IRB committee meeting.
  • Expedited Review: Research can be approved as “expedited” if it is no more than “minimal risk” and fits one of the federally designated expedited review categories as defined by federal regulation 45 CFR 46. Expedited reviews are conducted by at least two (2) members of the IRB board.
  • Full Review: Research that presents more than minimal risk to subjects, involves vulnerable populations, or does not qualify for exempt or expedited review, will receive review at a fully convened IRB committee meeting.

How do I determine if my project is Exempt, Expedited or Full Review?

Use the 2018 Human Subjects Decision Charts which can be found on the IRB Webpage.

If I need my project approved quickly, should I request an Expedited Review?

No, an Expedited Review refers to the level of risk and must be completed by at least 2 members of the IRB Committee. While it does require a full committee review, it may take up to 90 days depending on the time of year and IRB workload.

What information do I need to include about Participant Recruitment?

The recruitment materials/ flyers,etc must contain the following information:

  • Clearly state that this is a research study
  • Purpose of the study
  • Eligibility criteria
  • Voluntary nature of participation
  • What participation will involve (basic procedure and time commitment)
  • Benefits to participation, if any
  • Contact information (name, number/email) to get in touch if interested

Do I need to get IRB approval to conduct research on activities that are part of my regular educational activities?

Yes, but it will almost always be Exempt and you can request waiver of consent. It is best practice to provide an information sheet to students.

If my research will be using an online survey, do I need a consent form?

You may include a statement about providing informed consent at the beginning of the survey with the option for respondents to give consent and continue or deny consent and be exited from the form.

If I conduct research interviews via Zoom, do I need a special consent form?

If you record interviews that will be transcribed by an individual, you need to share that information with research participants and include how the transcriber will maintain confidentiality.

When do I need to file an amendment?

An amendment must be submitted whenever there is ANY change to the protocol. This may include:

  • Adding Investigator(s)/staff to the project
  • Removing Investigators/staff from the project
  • Changing the Recruitment Process
  • Changing the Inclusion criteria or number of participants
  • Changing the Study Protocol
  • Requesting extension of approval dates
  • Adding/removing study sites
  • Adding/changing consent form
  • New information indicates that risks to subjects have changed
  • A new Conflict of Interest is present

I completed my original IRB Proposal Form using the old Paper Format, do I have to enter it online in order to complete an amendment?

No, but the amendment must be completed online.

 

Principal Investigators, Co-Investigators & Students

Why does a Committee Chair/Advisor need to be listed as a Co-Investigator? What if the Chair/Advisor will not be involved in data collection?

As an institution AIC can only support research that is conducted by individuals who are both employed by AIC and have Human Subjects Protection Certification.  Although the advisor is most likely not collecting data or interacting with research participants, they are overseeing the work of their student and thus fully responsible for the research that is done.

If I am advising a group of student researchers, who should be listed as the Principal Investigator?

There are two options: 1) The faculty member/advisor may be designated as the PI and the students can be included as co-investigators, or 2) One student may be designated as the PI and the other students and the advisor can be included as co-investigators. The IRB asks that whichever method is chosen, the PI remains consistent. A change in PI requires an amendment.

 

Human Subjects Protection Training

Who needs to submit a Human Subject Research Protection Certificate?

Everyone listed as an investigator on the IRB Proposal. This includes faculty who are advisors or committee chairs as they are responsible for the student’s research conduct.

How often do I need to be recertified for Human Subjects Protection Training?

Every three (3) years.

If my Human Subjects Protection Training Certificate has expired, can I continue my research until I update my certification?

No. You may not participate in ANY research activity with an expired certificate. You must notify the IRB immediately and submit an Amendment to update your certification information.

What if I am collaborating with someone who does not work at an Institution where they can get CITI Training? Can someone who is not an AIC employee or student access CITI training though AIC?

No. AIC only provides CITI training to individuals affiliated with the College. Free training is available to anyone through the U.S. Department of Health & Human Services, Office for Human Research Protections (HHS.gov) Human Research Protection Training at: https://www.hhs.gov/ohrp/education-and-outreach/online-education/human-research-protection-training/index.html

 

Collaborating With Other Institutions & Individuals

What do I need to do if I am a faculty member working on a research project that has been approved by another institution's IRB?

The AIC faculty member should submit a New Project Proposal for Exempt Review listing themself as the PI, regardless of their role on the project. The investigators from the other institution should be listed as Co-Investigators for our records. This is because we are responsible for the AIC faculty members research conduct.

What should I do if I need permission from someone else at a different site to conduct my research? For example, if I am conducting research within a school setting and I need permission from the district superintendent or the school principal?

The AIC Investigator should submit a New Project Proposal. Answer the question regarding other needed permissions “YES” and provide the requested documentation. If permission cannot be granted before AIC approves the proposal, the proposal will be reviewed by the IRB and granted Preliminary Approval until the permission is provided in writing from the other institution.

Does AIC have a Federal Wide Assurance (FWA) to assume responsibility for community organizations conducting research?

No, the Principal Investigator must be an AIC employee or student.

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