Investigator Submissions to the IRB

An investigator shall submit his/her completed research packet that will include; a cover letter describing the nature of the submission and under what mechanism the investigator is seeking approval (i.e. exempt, expedited, or full board review) to the IRB Chairman (email format is acceptable), an IRB initial Application for Non-Exempt or Application for Exemption, the study protocol, informed consent/assent document(s) (if applicable), the principal investigator’s CV, a current certification in the protection of human research subjects for all investigators/key personnel involved in the conduct of human subjects research. The summarized items and links to the forms are listed below. The preferred method of submission is electronic. All documents should be submitted as a Word document either (*doc or *docx) or as a PDF (preferred) to kristye.palmquist@medicalcityhealth.com.

Non-Exempt Studies

Principal investigators submitting studies not qualifying as exempt are required to complete and submit an Application for Non-Exempt (provide link to form) in addition to the study protocol, patient informed consent (assent of a minor for projects involving minors from ages 7-17), Financial Disclosure Form (provide link to form), and for IND, IDE, HDE, HUD the FDA approval letter with the approved indication(s) for IND’s the FDA form 1572 and Investigator’s Brochure. The entire submission should be submitted to kristye.palmquist@medicalcityhealth.com. If you should have any questions please call Kristye Palmquist at (972) 566-6060.

  • All documents must be submitted on letter head (ICFs, protocols, etc.)
  • All submissions should be submitted by 4:00 pm of the deadline date (No Exceptions)
  • Investigators are encouraged to submit their studies to the IRB as early as possible so that potential deficiencies can be addressed

The following links provide forms needed for submission as well as templates for various forms that may be required depending on the nature of the research proposal. All non-exempt studies will require an informed consent document, assent for minors for studies involving children and HIPPA authorization. For subjects in clinical trials it is recommended that subjects be given an I.D. card that identifies the study they are participating in, the name of the principal investigator and their contact information Patient ID Card Template.

Please note: HUD devices will not receive exempt approval from the IRB Chair and are required to be reviewed by the full board at initial submission. An informed consent document is not required for use of a HUD unless research information is being gathered to support a premarket application. However, the IRB will determine if a consent document is required for each HUD submitted.

Exempt Studies

In order for a study to be considered exempt, it must fall into one of the six categories of research considered to be exempt (45 CFR46.104b). Please refer to IRB Submission Forms and click on the Exempt Categories document for a complete listing. If your research project falls under 1 of these 6 categories, please complete the Application for Exempt Review and submit this to kristye.palmquist@medicalcityhealth.com, along with any supporting documentation (please refer to Submission Checklist for Exempt Review) for additional guidance on what documents will need to be submitted.

Annual Review and Study Closure

If you are requesting an annual review (study continuation), quarterly review or study closure, you must complete the Progress Report form (can be downloaded from the IRB Submission Forms and completed electronically) and submit the most recent IRB-Approved informed consent document in a clean version (not stamped). If you have revisions to your informed consent documents since last approved or to your protocol, then ensure you include a track change version of each document and/or summary of changes. This Progress Report Form will be used to review and evaluate the progress of the research project. After completing the forms, please submit to kristye.palmquist@medicalcityhealth.com. If you should have any questions, please contact Kristye Palmquist at (972) 566-6060.

Chart Review Studies – Retrospective versus Prospective Studies

There are typically two types of chart reviews, retrospective and prospective, with each having its own requirements for approval by the IRB. A guidance document regarding retrospective and prospective chart reviews can be found here. In addition, a template for preparing a medical record review study can be found here.

Waivers

An IRB may waive or alter the requirement of informed consent under 45 CFR 46.116(d), provided that the IRB finds and documents that all of the following four conditions are met. The investigator may apply for a Waiver or Alteration of Informed consent by completing the appropriate section in the IRB application.

  1. The research involves no more than minimal risk to the subjects;
  2. The waiver or alteration will not adversely affect the rights and welfare of the subjects;
  3. The research could not practicably be carried out without the waiver or alteration;
  4. If the research involves using identifiable private information or identifiable biospecimens, the research could not practicably be carried out without using such information or biospecimens in an identifiable format; AND
  5. Whenever appropriate, the subjects will be provided with additional pertinent information after participation.

An IRB may waive the requirement for the investigator to obtain a signed consent from each subject, although consent (e.g. verbal consent) must be obtained from all subjects. In order for the IRB to grant a Waiver of Documentation of Consent as defined under 45 CFR 46.117(c), the following criteria must be met and documented. The investigator may apply for a Waiver of Documentation of Consent by completing the appropriate section in the IRB application.

  1. The only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject’s wishes will govern; or
  2. The research presents no more than minimal risk* of harm to subjects and involves no procedures for which written consent is normally required outside of the research context; or
  3. If the subjects or legally authorized representatives are members of a distinct cultural group or community in which signing forms is not the norm, that the research presents no more than minimal risk of harm to subjects AND provided there is an appropriate alternative mechanism for documenting that informed consent was obtained.

In cases in which the documentation requirement is waived, the IRB may require the investigator to provide subjects with a written statement regarding the research.

A Waiver of HIPAA Authorization allows researchers to use HIPAA Protected Health Information (PHI), such as names, dates of birth, etc. in their research study. The HIPAA "minimum necessary" rule always applies. The criteria that must be satisfied for a Waiver of HIPAA Authorization are: The investigator may apply for a Waiver of HIPAA, by completing the appropriate section in the IRB application.

  1. The use or disclosure of the requested information involves no more than a minimal risk to the privacy of individuals based on, at least, the presence of the following elements:
    1. An adequate plan is in place to protect the identifiers from improper use and disclosure
    2. An adequate plan is in place to destroy the identifiers at the earliest opportunity consistent with conduct of the research (absent a health or research justification for retaining them or a legal requirement to do so) AND
    3. Adequate written assurances that the PHI will not be reused or disclosed to (shared with) any other person or entity, except as required by law, for authorized oversight of the research study, or for other research for which the use or disclosure of the PHI would be permitted under the Privacy Rule.
  2. The research could not practically be conducted without the waiver or alteration; and
  3. The research could not practically be conducted without access to and use of PHI.

Examples of research studies where a request for a Waiver of HIPAA Authorization may be appropriate include:

  1. Research on using existing health information, e.g., medical records research and chart reviews
  2. Research where a waiver of informed consent is also being requested, e.g., survey research via phone

If you are requesting any type of waiver, please send a letter to the IRB Chair stating what type of waiver you are requesting and the reason for the requests.

All of these forms and templates may be found on the IRB Forms page. All submissions and correspondence need to be submitted electronically to kristye.palmquist@medicalcityhealth.com.

The timeline for the approval process is as follows:
IRB receives submission > Review of materials (expedited approval 7-10 days) > Full board review > If no changes, approval letter sent to PI > With changes, letter sent to PI with outlined changes > Once changes are received & reviewed final approval may be given as short as 2-3 days or up to 3 weeks following full board review

IRB Contact Information

Kristye Palmquist
IRB Research Coordinator
(972) 566-6060
kristye.palmquist@medicalcityhealth.com

Allan Naarden, MD, FAAN
IRB Chairman
(972) 566-4718

Department of Clinical Research Contact Information

Joseph Zerwekh, PhD
Director, Clinical Research
(972) 566-6953
joseph.zerwekh@medicalcityhealth.com

IRB Fees

The MCD IRB will charge the following fees for studies submitted on or after June 1, 2018.

  • The fee for initial review is $2,500 to offset the MCD IRB costs for reviewing and processing submitted protocols. These studies are also subject to the continuing review fees below.
  • All sponsored studies that are reviewed by the MCD IRB by full board or expedited review will be subject to a continuing review fee of $750. Continuing review fees will be assessed on renewal submissions and at the time of study closure.
  • All sponsored studies that are reviewed by the MCD IRB by full board or expedited review will be subject to an amendment review fee of $250 per submission (revised protocol of ICF, addition or removal of investigators, sponsor advertisements, investigator brochures, etc.). Individual submissions may contain multiple amendments for a single study (e.g. a revised protocol and ICF would be considered a single amendment submission).
  • The administrative fee for a Waiver of Oversight to an external IRB (e.g. a commercial IRB) for grant (State or Federal) or industry-sponsored studies is $1,000. This fee covers administrative fees and supplements the MCD IRB cost for processing submitted protocols. Studies under the oversight of an external IRB will not be charged continuing review fees, adverse event report reviews, or amendment review fees.
IRB Review Fee Policies

IRB fees are non-refundable and will be billed at the time services are completed.

IRB fees are due within 30 days of invoice. Protocols with outstanding invoices may be subject to suspension of enrollment and/or withholding of continuing review at the discretion of the MCD IRB and/or the Department of Clinical Research.

In exceptional circumstances, some studies may receive a waiver or discount of these fees.This will be based on the nature of the study and the extent of funding provided by the sponsor of the study. Examples where a waiver of fees may be appropriate include certain humanitarian device studies or expanded access and compassionate use studies where only minimal funding is provided by the sponsor. Fee waivers or discount requests will be reviewed on a case-by-case basis and will be determined by the MCD IRB.