Ethics and Institutional Review Board (IRB) Guide

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IRB General Information

All research submitted to the PCRF must have been conducted with the approval by an institutional review board or animal/human subjects protection committee. 

An Institutional Review Board (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. (See: What is the Institutional Review Board (IRB)?)

The IRB is charged with the responsibility of reviewing, prior to its initiation, all research (whether funded or not) involving human participants. IRBs are concerned with protecting the welfare, rights, and privacy of human subjects. IRBs have the authority to approve, disapprove, monitor, and require modifications in all research activities that fall within their jurisdiction as specified by both the federal regulations and institutional policy.  For more information visit the U.S. Department of Health & Human Services Office for Human Research Protections at https://www.hhs.gov/ohrp/. 

The PCRF understands that obtaining IRB approval for some EMS providers can be a challenge.  We are proud to offer novice researchers mentorship and assistance in getting proposed prehospital research projects through an ethics approval process. We understand that some EMS agencies may not be affiliated with an institution that has a standing “Institutional Review Board” (IRB).  We have partnered with our affiliate, the International Academies of Emergency Dispatch to offer this service.  

Here is a list of concrete to-do steps to get your project moving along the ethics approval process if your institution does not have an option you can access:

1. Mentoring

The process of getting your project reviewed by an approved by an IRB can be challenging, especially if you have not completed an application before.  The PCRF is proud to offer mentoring services by experienced EMS providers who have performed and support research.  Please contact David Page, PCRF Director, to be paired with a mentor: dpage@mednet.ucla.edu or (651) 705-6505. 

2. IRB Online Training

The National Institutes of Health Office of Extramural Research offers a course on Protecting Human Research Participants. Registration is free to those working with or in member organizations.  This type of training is required by institutional review boards prior to submitting any research projects.  The PCRF encourages all of its members, affiliates and workshop participants to complete this training prior to any research activities.  Be sure to print or save the certificate of completion.  Your IRB and your workshop facilitators may require it.

The CiTi training is found here: https://about.citiprogram.org/en/course/human-subjects-research-2/ 
Click on Register and declare yourself as part of an ‘organization’, if you do not see your organization listed, and you are participating in PCRF activities, please list UCLA as the organization you are affiliated with.  
  
While there are many great modules (do as many as you wish), the IRB will care that you at least complete the Human Subjects Research (HSR): “Social-Behavioral-Educational (SBE) Basic”.  This is online entirely and should be 1-3 hrs to complete unless they changed something.  Make sure you keep the certificate of completion as you will be asked to include it with your application to the IRB (screenshot or PDF will suffice).

3. Research 101 Online Training

We also recommend you complete our “Research 101” course online (4hrs): https://info.psglearning.com/fisdap-research-101 

4. IRB submission

Once you have completed the training please review the documents linked here.  If you do not have an IRB within your department the PCRF has created a relationship with the IRB out of the International Academies of Emergency Dispatch (IAED).  This IRB is a federally approved IRB  (IORG0005364 - IRB #00006450) with the U.S. Department of Health and Human Services (HHS), Office for Human Research Protections (OHRP). https://www.hhs.gov/ohrp/ 

 

The IRB consists of 9 members with multidisciplinary expertise/professions. The current Chairman of the IAED’s IRB is Jerry Overton. The main role of the IRB is to review research proposals with an aim to ensure three major things:

I. Respect and Protection for Persons:
Treat individuals as autonomous agents with regard to goals, opinions, decisions, and self-determination, and protect persons with diminished autonomy.
II. Beneficence:
Efforts made to secure the person’s well-being—Do no harm while maximizing possible benefits.
III. Justice:
Guarantee fairness in the distribution of resources or what has deserved: to each person an equal share, according to individual need, individual effort, societal contribution, and merit.

For more on IAED’s Research programs visit: http://www.emergencydispatch.org/Science and https://www.emergencydispatch.org/sites/default/files/downloads/marketingkit/ResearchBrochure.pdf 

For anyone who submits to the IAED IRB, the requirements are:

  • Complete the CITI IRB training for researchers and attach the completion certificate to the application
  • Complete the official IAED IRB forms
  • All files should be submitted with file names that include the author’s name, a short title of the project, and year
  • All submissions should be made to Dr. Isabel Gardett or Dr. Chris Olola; 

Once you have completed the forms linked here, please attach them with a cover letter and e-mail them to Dr. Isabel Gardett: Isabel.gardett@emergencydispatch.org 
Isabel Gardett, PhD
Director of Academics, Research, and Communications
International Academies of Emergency Dispatch
110 S. Regent St, SLC, UT 84111
801.359.6916 ext. 262
Isabel.gardett@emergencydispatch.org 

Here are some tips:

  1. Read the IRB Cover Page and Application carefully and follow all instructions
  2. Do not leave anything out, be complete
  3. Check for spelling/grammatical errors
  4. Ensure that your Study Title is the same on all forms you submit to the IRB (Cover Page, Application, Consent Forms, etc.)
  5. Study Dates: 

    • Start Date: your project cannot begin until after you receive IRB approval. Do not submit application materials with a start date that is before your submission date or with a start date that does not allow adequate time for IRB approval (minimally 3 weeks). “ASAP” is not a date, dates must be in mm/dd/yyyy format. 
    • End Date: the end date of your project is not the last day you collect data; it is the date by which you expect your project to be completed. Dates must be in mm/dd/yyyy format.
  6. Study Design: The design section should explain all of your interactions with human subjects. 

    • Include date, time, and place study is being held; 
    • Include how you have access to participants, how you will contact participants, everything participants will be asked to do, etc. 
    • The procedure needs to match the purpose of your study and should be written in the future tense. 
    • The number of subjects, the maximum number (not a range) of subjects should be the same on all forms you submit to the IRB (Cover Page, Application, approval letter from a cooperating organization). 
    • Conflict of Interest can occur if one of the researchers is in a position of authority over research subjects (employer, teacher, counselor, etc.), if this is the case, you must explain how you will protect the participants. 
    • Study procedures must be complete and easy to understand by someone outside of the researcher’s field, do not use jargon, include full name before using acronyms, etc.
  7. Recruitment: Advertisements and recruitment material are considered a part of the informed consent process. Submit all scripts with the proposal; provide verbatim scripts of what you will tell subjects in a telephone recruitment call, email, poster, etc. IRB reviewers ask the question: “What information are the subjects getting (or not getting) that would help them decide to participate (or not) or to continue to participate, and is this information being given as soon as possible?”
  8. Risks, you are aiming for minimal risk. There is no such thing as a NO risk study. Boredom, restlessness, participants may feel singled out. Possibilities of financial risk, social harm, etc.

    • Efforts to minimize risk, did you shorten the survey to alleviate possible boredom? How will privacy be protected? Etc.
  9. To ensure confidentiality, you want to ensure that participants cannot be identified by their behavior, responses, or demographic information (especially with a small subject pool). 
  10. Compensation; if compensation is offered, it must not be so large as to seem influential. Compensation amounts should be clearly identified in the application and the consent forms and should explain what must be done to earn the compensation. 
  11. Consent, in explaining how consent will be obtained, “Informed Consent Form will be given to participants” is not a sufficient explanation. Describe how and when potential participants will have the opportunity to answer questions. Who will distribute and collect the consent forms? Will there be a deadline for returning consent forms?
  12. Consider the reviewer a reasonably educated person, NOT a clinician. Write using simple lay language and well-described concepts. Be sure to define scientific and clinical terminology.
  13. Include well-defined inclusion and exclusion criteria and explain how determinations of eligibility will be made (e.g., medical records, participant self-report, participant’s physician).
  14. Ask colleagues to share recently IRB-approved consent forms as a model for your forms.
  15. Include copies of all study documents (e.g., data collection instruments, recruitment materials, waiver requests).
  16. Have someone else proofread your submission. Ask them to look for inconsistencies.
  17. Be ready to quickly respond in full to requests during the review process. Know the submission deadlines for the next IRB meeting.
  18. Foster a constructive working relationship with your IRB contact person through polite and professional communication.