IRB Procedures at FPG

last updated: October 25, 2007

This document describes the IRB submission process and local pre-IRB review at FPG Child Development Institute. It also provides basic guidelines and links to the Office of Human Research Ethics (OHRE). Researchers (or their designees) who are preparing applications, modifications, renewals, adverse event reports, or study terminations should read the OHRE procedures on the OHRE web site [http://ohre.unc.edu/]. Note that OHRE updates the forms frequently, and expects researchers to use the most recent version for any NEW application, and for all modifications, renewals, and other forms (consents, SSN forms, and so forth). Researchers may open an “old” document and the “new” form and cut & paste the content to “update” an application as needed.

If a PI or anyone preparing an IRB submission has questions that are not addressed on this site, she or he should contact one of the co-chairs of the FPG local Pre-IRB review committee, Drs. Barbara Davis Goldman and Noreen Yazejian.

Researchers can check the status of their submissions through “My Research at Carolina” using their ONYEN. Go to http://ohre.unc.edu/yourirb.php for information about this form and a link to the files. Researchers may also call the IRB office directly at 966-3113. If you are calling about a study which has already been submitted or approved, be sure to have your study number handy.

For other questions, please contact Marie Huff. Marie provides administrative support to the FPG local Pre-IRB review committee and is our chief liaison to the campus IRB boards (e.g., Behavioral IRB and Biomedical IRB), although the local co-chairs may also call on behalf of a specific study too.

 

WHAT'S NEW
... or JUST NECESSARY?

  • NOTHING needs to be submitted to document ethics training through the CITI (Collaborative IRB Training Initiative) online Ethics course UNLESS research staff are NOT already in the UNC database. Do make sure that the names of individuals on the application match their names in the CITI database, or provide relevant information (changed to married name, using middle rather than first name, and so forth). Make sure that ANYONE on your project with access to identifiable data or in direct contact with participants is certified in ethics and listed in the personnel section on the 1st page of the application.
  • A copy of your grant proposal should accompany new applications.
  • An updated application MAY be necessary when submitting a modification; see directions on the Modification form, and if desired, discuss with local co-chairs.
  • An updated application needs to accompany ALL renewals, whether or not you have submitted modifications since your last IRB approval. You do NOT need to submit copies of last year’s approval forms—they can be confusing for the IRB staff. All modifications already approved need to be integrated into the application at renewal if you have not done so at the time of the modification. Delete any underlining that may have been used to show the modification before re-submitting the updated application.
  • The most recent forms MUST be used for all new applications, renewals and modifications. Some older studies may also be required to switch over to the current format at renewal. The current versions can be accessed from the OHRE website. Researchers can cut and paste information from forms saved from previous submissions into the new forms.
  • In addition, despite “just-in-time” procedures, some funders (and this varies from agency to agency, and possibly with the size of the grant) will not even award the grant (not just send the money) without IRB approval, so you may need to submit an application and get approval in advance of final decisions. On occasion, very short notice of possible “fundability” has been provided to researchers, with the requirement of IRB approval within an extremely short timeline. It is strongly recommended that researchers begin preparing an IRB application soon after grant submission, so they do not miss an opportunity for funding because they do not have IRB approval. Researchers may obtain approval based only on a description of the entire project, but it may be more comfortable for the IRB if researchers can provide more concrete information and relevant consent forms, or whatever, for the first thing they would do, if funded, and indicate clearly that they will provide additional information and forms as modifications for approval prior to use.
  • A new separate form must be used for participants who need to provide their Social Security numbers (SSN) to be paid their incentives. This form and relevant guidance is on the OHRE website underneath the consent forms.
  • Unless you have requested and have approval to do otherwise, researchers MUST use photocopies of the “stamped as approved” consent forms and letters.
  • Researchers should note the fairly recent introduction of an OHRE “Determination” form that may be submitted when documentation from the IRB is needed that planned activities that resemble “human subjects research” do not actually meet the federal definition of such work, and thus do not need IRB approval. This form is on the website under “Forms”
  • Please attach a note to your submissions telling the local Pre-IRB review co-chairs whom to contact with questions, with phone numbers and email addresses if not on the forms.
  • Note that FPG has combined the “cover sheet” that is sent to the IRB office AND the local form documenting specific grant support (tie-in) into ONE document. This new form is in the IRB section of the FPG Portal Kiosk.

PLEASE BE AWARE:

  • As part of the centralized IRB process under the OHRE, research participants should now be referred to the Institutional Review Board at 919-966-3113 or by email to IRB_subjects@unc.edu. NOTE: This wording should be used on the consent template under, "What if you have questions about your rights as a research participant?" If previously approved forms designate the Behavioral IRB specifically, revise that before resubmitting.
  • Please continue to review all documents for participants (consents, letters) very carefully prior to submission. The IRB now requires all typographical errors (spelling, punctuation, formatting) noted to be fixed and the documents returned to the IRB before approval is given.
  • All investigators, new employees, and students involved in research should complete the CITI ethics training course IF they will have direct contact with participants (in person, on the telephone, or via email) or access to identifiable data.. You may access the CITI training course via the following link: http://ohre.unc.edu . Select "Required Education" to link to the CITI website. You will need your PID and will provide a password of your choice (be sure to record this password and the email address you are using in a safe place for subsequent log-in and future reference). Be sure to save both the electronic and paper copies of your documentation from CITI. You can also link to the database at CITI to check your records if questions arise in the future.
  • All investigators, staff, and students with direct contact or access to identifiable data need to be included on the listing of personnel on the original application or added later via a Modification. Modifications should also be submitted to note when individuals who had been on the study have left.

IRB procedures related to GRANT PROPOSAL PREPARATION

Note: Most NIH, NSF, ACF and DOE grant proposals now use "Just in Time" (JIT) procedures for IRB review and approval, making it unnecessary for researchers whose work involves human participants to submit an IRB application at the time of grant submission. Researchers are typically allowed to wait until they are notified that their proposal is in the "fundable range" category. However, some competitions do NOT follow JIT procedures, so researchers should ALWAYS check the RFP or Program Announcement, which supersedes any generic guidelines. In addition, some funding agencies will not even award the grant without IRB approval, so you may need to submit an application and get approval in advance. On occasion, very short notice of possible “fundability” has been provided to researchers, with the requirement of IRB approval within an extremely short timeline. You also need to follow specific procedures for the UNC Internal Processing Form and the respective face sheets (i.e., ED-424 for DOE and PHS-398 for NIH) to indicate the status of your IRB. Again, please ASK if you are not sure what to do, or contact FPG’s Business Office or the Office of Sponsored Research (OSR).

General Guidelines

  • IRB materials submitted for local Pre-IRB review should include the recently revised cover sheet that includes information about funding as well as the study..
  • Check your spelling and grammar, especially on the letters to participants and consent forms. IRB policy is that anything that goes out from the University to participants should be spelled and phrased correctly. Approval is not given until all typos noted in the IRB’s response are corrected and returned to the IRB.
  • Make a special effort to write letters of invitation and the information that you provide in the standard consent forms at appropriate reading levels (depending on the sample being recruited). Avoid jargon. It may be useful to have someone outside your area of expertise review your letters and forms to help spot such jargon. In most cases, researchers should follow the templates provided on the OHRE website, but do not need to include sections/statements that do not apply to a particular study. If those forms are not deemed appropriate by the researchers for the specific study or sample, alternatives can be offered with accompanying explanation.
  • After approval, keep organized files of all IRB materials which have been approved for each project, so that it is easy to know exactly how many modifications were approved each “IRB year” (between renewals) for each study, and their exact content. Given the high likelihood of minor revisions, called “minor stipulations” and multiple versions prior to final approval, this is not always an easy process. Be sure that all staff know exactly which paper and electronic files are the most recently approved versions.

Modifications

Researchers wishing to alter an approved protocol in any way, such as a change in the approved number or type of participants, adding or dropping measures, or adding or dropping staff, should submit a modification (see OHRE forms: Submissions after initial approval).

Many but not all modifications require the application form to be updated to show the modification. Currently, such changes should be underlined in the text, and it is recommended that researchers also highlight with yellow those areas for easy identification. Updating applications using the “Track Changes” function of WORD may be helpful. “Track changes” will show where additions have been made with underlining. At the time of renewal (or the next modification) the changes can simply be “accepted” to integrate the modified information into the application. Regardless of how you choose to show changes, once a particular modification has been approved, the underlining and/or highlighting showing that change needs to be removed prior to the next modification or renewal so that only what is being requested to be changed at that time is marked. Modifications can be done at the time of a renewal, but the modification form has to be submitted along with the renewal, the modification should be marked as above in the application updated at renewal, and the modification should be explained or described in the text of the renewal.  

Please note that the phrase “unanticipated problems” on the Modification form in the question “Is this modification being submitted in response to an unanticipated problem or adverse event?” has very specific meaning, and relates to increased risks to subjects rather than difficulties experienced by the researchers (as one would normally think). Only say “yes” if the reason for the modification is actually to reduce risk.

Local Pre-IRB Review Procedures

The local Pre-IRB Review committee reviews submissions prior to formal submission to the IRB to help both researchers and the IRB—we try to reduce the workload on the IRB, and thus reduce delays in approval for the researcher. New applications should go through local review. The process is also recommended for substantive modifications, especially those that will be reviewed by the full board, and for complex renewals. Local review is NOT required, but offered, and recommended.

Please help the local reviewers by asking other project staff or colleagues to review your application/modification and recruitment/consent materials BEFORE submitting for local review. This initial, informal review should be focused on the 4 Cs, clarity, internal consistency, completeness, and correcting spelling and grammatical errors.  This is especially important if PIs use IRB preparation as a learning tool for staff and students.

This section describes the steps of the local Pre-IRB review process, once you have drafted your submission. Please allow 2 to 4 working days to get initial feedback through the local Pre-IRB review committee, so one or more persons can help you by providing a thorough review. Responding thoroughly and promptly allows the reviewer to then get back to you quickly, and move on to local “approval.”

  1. Researchers should turn all IRB submissions in to Marie Huff. Researchers may turn in only two copies for review and possible editing. Always keep your own copy of the submission and forms and add a Post-it note to let the local chairs know whom they should contact to make any needed changes to the original documents.
  2. Marie will log the submission in and assign the review to one of the local co-chairs. Primary responsibility for reviews will typically rotate among the two co-chairs, but may be assigned based on the chair's availability or expertise in certain areas. If one of the co-chairs will be out of the office for 2 or more days, the co-chair will notify Marie and the other chair will cover.
  3. The local co-chair will review the submission, then …

a. If there are significant issues or questions, the co-chair will discuss them with the researcher (or designee) and have the researcher submit (or email) the revised documents to the local co-chair for re-review.
b. If there are minor changes, the co-chair will attach Post-it notes to the document(s), call or email the researcher, and either put the documents in campus mail for revision or complete the minor revisions over the phone or do them in person. Revised pages can be emailed by the researcher to the reviewer for substitution in the final document(s).

  1. After reviewing the revised document to be sure all needed changes have been made, the co-chair will sign, date, and return the submission to Marie.
  2. The researcher will then arrange for the necessary number of copies of the various materials to be made. Make sure that a copy for Marie’s files is prepared too.
  3. Marie will obtain the required departmental signature (for new applications only) and send the original and appropriate number of copies to the IRB via campus mail. Note: If researchers are concerned about meeting an IRB or grant proposal deadline, they can request Marie contact them when the proposal is signed and ready to go, and they can deliver the documents to the IRB office themselves. The IRB is now in Medical Building 52, a set of trailers on Mason Farm Road, across the street from the Ambulatory Care Center on Mason Farm Road. There is a drop box for after-hours deliveries. Anything needing urgent attention should be appropriately and prominently flagged, and it is best to alert appropriate staff, such as Joyce Hamlett, Behavioral IRB coordinator, about this too

last updated: October 25, 2007