Tips and Tricks for a Successful IRB Submission and Review Process

Here are some tips for completing the Research Protocol to ensure that the IRB has the information it needs to review the study. Keep in mind that the IRB is reviewing the study to determine that it meets the criteria for approval. The more information the IRB has, the easier it can be to make the required determinations.

1. When completing the IRB application, remember to describe the entirety of the study. Imagine when completing the Research Protocol that you will give this to a future investigator who has never heard about the study before, and will help you conduct the research. If they read your protocol, could they complete all the study procedures without needing copious amounts of additional information? Is it clear who, in terms of collaborating institutions, is responsible for each research activity?

What am I supposed to write in my research protocol?

Many investigators are unsure exactly what to put in the Research Protocol. You can explore an example of what an investigator will write vs. what the IRB needs to see.

2. Be realistic with your enrollment size, feasibility of study, resources (financial, staffing, physical space, materials needed, etc), amount of time study will take, use of vulnerable populations, etc.

3. Use lay language – The IRB application should be written in a way that all can understand. The IRB recommends writing in a narrative form, explaining the specifics of what the participant will experience if they take part in the study, from beginning to end. If the Research Protocol is written in too technical of a manner (i.e., it’s not clear what you are doing), it may unnecessarily go to the Convened IRB. TIP: Have a non-scientist friend or family member read the protocol and consent forms…do they understand?

Here is an example of an overly technical description of study procedures vs. how the IRB would recommend study procedures are written:

Speaking Different Languages

• • • Prior to surgery, the labial keratinized tissue will be measured at the mid aspect of the tooth to be extracted as follow:
    • -Gingival width; Distance from the Free Gingival Margin (FGM) to the Mucogingival Margin (MGJ) measured at the midbuccal aspect of the tooth
    • -Vestibular depth (using a bilateral retractor and a UNC 15mm probe)
    • -Alveolar ridge: width measured on the CT scan at 5mm apical to the bone crest in the mid-mesial-distal aspect of the tooth to be extracted
    • -The vertical distance of the line connecting neighboring Cemento-Enamel Junctions (CEJ) to the buccal FGM (measured just prior to surgery)

    IRB (for the same procedures):

    Prior to the surgery measurements will be taken:

    • • • -Pre-Operative measurements will be taken of teeth, gums and bone before tooth extraction after the patient has been numbed
          • • Gums will be measured by placing a periodontal probe (a small ruler) on top of the tissue
            • Gum thickness will be measured with a thin needle and rubber stopper

            4. Use pictures in your application documents, if possible (e.g. graph in Research Protocol of what surveys are given to which participant groups and when, picture in the consent form of the device used, etc.)

            5. If you’re collecting prospective data from participants, you need to think about your recruitment process.

            • Recruitment materials may be an email, letter, or script and must be included for IRB review. Providing participants with a recruitment document prior to consent gives them the opportunity to decide if they even want to participate in the type of research being conducted before having to go through the entire consent process.
            • In most research studies, initial contact with a potential participant through an email or letter is customary. Cold calling or showing up at someone’s house to recruit them should be well-justified in the Research Protocol, if such methods are necessary for the study. In some international settings, this type of recruitment is the norm. The IRB will honor any local customs or procedures so these should be described in the protocol.
            • If you are using an established organization, site, or group to assist you with recruitment please include the names of these organizations/groups and confirm that you have approval from the leaders/administrators of the groups to assist you with recruitment (e.g. the moderator of a list serve agrees to send your recruitment email out to their list; the administrator of a social media group agrees to post your recruitment message to the group board; the leader/administrator of a company agrees to give the PI a list of their employee emails to use for recruitment purposes, etc.).

            6. Think about your consent process:

            • • If you are recruiting participants into the study, you must obtain consent. Consent is not just a signature, it is a process involving a discussion with the participant. The IRB wants to see a well thought out process described in the IRB application, not just a means to get a signature.
              • Give potential participants time to review the consent, ask questions, talk over their decision to participate with family and friends, etc.
              • For Exempt and NHSR studies that involve interactions with or data collection from participants, a signature on the consent form is not required per the regulations. However, if an investigator wants to collect a signature, they may. The Exempt consent template includes all the required elements of consent for this type of research. In this type of research, it is often typical for consent to be either a verbal yes/no or indicated by completion of an online survey, questionnaire, etc. The process of consent still applies but the signature requirements are not as stringent and the consent form is not as long.
              • For Expedited and Convened IRB studies, a full consent form that includes Key Information must be used. There are few, but some in special cases, exceptions to this so if you have concerns about using the full form, talk to your IRB Review Specialist.
              • Adapt the consent process to your study. Are you working with a vulnerable population, will you ever interact with participants, are you meeting with participants before the study? If it is not practicable to obtain a signature, explain why and write in your protocol that you’re requesting a waiver. Below are two such waivers that can be requested:
              • Waives the requirement to obtain a signature
              • Waiving the entire or part of the consent process
              • Consent still obtained via verbal yes/no, ticking a box, etc.
              • Study must be:
                • Minimal Risk,
                • Could not be carried out without the waiver, and
                • Does not adversely affect the rights and welfare of individuals
                • Waiver can be applied to all study participants or a particular cohort
                • Where appropriate the study teams should provide additional information to subjects about their participation
                • Study team should track consent on their own end via a spread sheet or other device
                • A waiver of consent is often seen is secondary data analysis studies, where there is not contact with the participant
                • May be requested for studies where obtaining a signature is not practicable, where the only link between the participant and the study is the consent, the study is minimal risk, or where a signature is not in alignment with cultural norms
                • Depending on the type of data/data source, consent should have been obtained from the original study to conduct future research with the data
                • Examples: Online survey, study that seeks to collect completely anonymously data, study with vulnerable populations, like prisoners, where the risk is the participant’s association with the study
                • • Final thoughts on consent: remember that practicable is not synonymous with possible. Although it may be inconvenient to meet with participants to obtain consent (i.e. because their appointment schedule doesn’t match the PI’s work schedule, the consent process will lengthen their appointment, the consent is long, etc.), the investigator should be obtaining consent when they can. Being impracticable would be if the investigator never interacts with the participant (online survey/medical record review/secondary data analysis only) or if the participant is not in the same physical location as the investigator (interview via phone or Zoom).

                  7. Plan ahead if you plan to travel to conduct your research. You cannot begin human subjects research before obtaining Harvard and in-country IRB approval, even if you’ve booked your flight! Be sure to discuss your project with in-country collaborators to check on any special approvals or permissions needed before you arrive.

                  8. Report if things happen (which they do sometimes!). Reportable Events include unexpected events that may be out of your control or reports from local IRBs, sponsors, DSMB, etc. It is not intended to be punitive, the intention is to utilize the IRB’s resources to resolve or respond to the issue. You must adhere to the IRB’s Prompt Reporting Requirements. Keep in mind that reportable events may not be limited to huge problems. Reportable events could be a DSMB report or new information that has come to light because of routine study or data monitoring. Sometimes events reported are out of the study team’s control. The IRB will work with you to resolve any reports of new information; the report is not meant to penalize the researchers! Keep these things in mind when completing this section. (Link to RNI instructions)

                  9. Explore reliance agreements with collaborating institutions – Are you already on the personnel roster of an existing study? You may be able to join that study rather than submit a new application through the HLC IRB. See our website for more instruction on ceding review to another IRB. Note: Reliance agreements can only be executed if the study is considered non-Exempt research.