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IRB Process and Forms

Steps in the Process
Researchers who wish to submit a proposal to the IRB for review must submit a certificate of completion from a human subject's research protection course. 
 
When applicable, researchers must also submit an IRB approval letter from their graduate institution. The
Broward College IRB will only review research protocols approved by the researcher's advisor/committee and their graduate institution's IRB. 
 
Researchers wishing to conduct human subject research at Broward College must complete and submit an IRB Protocol Form.  When completing the Protocol Form, researchers must select one of the three types of review that they believe their study falls under.  However, please note the IRB reserves the right to change the type of review based on federal regulation. The IRB will make the final determination as to the type of review a study requires. 
  
Below are descriptions of the three types of review to assist you in your selection.  
 
Types of Review:
There are three types of IRB review: Exempt*, Expedited**, and Full Board***, as stipulated by the Office for Human Research Protections (OHRP), Code of Federal Regulations, Title 45, Part 46 Protection of Human Subjects (45 CFR 46).
  • *Even if you deem your study to be exempt, you must still submit an IRB Protocol Form and supporting materials to the IRB and the IRB will make the final determination. 
  • **Expedited review consists of a review by the IRB Chairperson or by one or more experienced reviewers designated by the Chairperson from the members of the IRB in accordance with the requirements set forth in 45 CFR 46.110.
  • ***Full Board review can only occur at convened meetings of the IRB. Therefore, Full Board review is not available during the Summer Term (June, July, and August). Exempt and Expedited reviews are available during the Summer Term. 
Exempt

​a. Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods (45 CFR 46.101(b)(1)).​
b. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless: (i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (ii) any disclosure of the human subjects' responses outside the research that could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation (45 CFR 46.101(b)(2)).
​c. ​Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph (b)(2) of this section, if: (i) the human subjects are elected or appointed public officials or candidates for public office or (ii) Federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter (45 CFR 46.101(b)(3)).
d. ​Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects (45 CFR 46.101(b)(4)).
e. Research and demonstration projects which are conducted by or subject to the approval of Department or Agency heads, and which are designed to study, evaluate, or otherwise examine: (i) Public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs (45 CFR 46.101(b)(5)).
f. Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are consumed or (ii) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture (45 CFR 46.101(b)(6)).

 

Expedited

Clinical studies of drugs and medical devices only when condition (I) or (II) is met:​ ​
I. Research on drugs for which an investigational new drug application (21 CFR Part 312) is not required. (Note: Research on marketed drugs that significantly increases the risks or decreases the acceptability of the risks associated with the use of the product is not eligible for expedited review.) II. Research on medical devices for which (i) an investigational device exemption application (21 CFR Part 812) is not required; or (ii) the medical device is cleared/approved for marketing and the medical device is being used in accordance with its cleared/approved labeling.
b. Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:
I. From healthy, nonpregnant adults who weigh at least 110 pounds. For these subjects, the amounts drawn may not exceed 550 ml in an 8 week period and collection may not occur more frequently than 2 times per week; or ​II. From other adults and children, considering the age, weight, and health of the subjects, the collection procedures, the amount of blood to be collected, and the frequency with which it will be collected. For these subjects, the amount drawn may not exceed the lesser of 50 ml or 3 ml per kg in an 8 week period and collection may not occur more frequently than 2 times per week.
c. Prospective collection of biological specimens for research purposes by noninvasive means.​ ​
d. Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. Where medical devices are employed, they must be cleared/approved for marketing. (Studies intended to evaluate the safety and effectiveness of the medical device are not generally eligible for expedited review, including studies of cleared medical devices for new indications.)​ ​
e. Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for non-research purposes (such as medical treatment or diagnosis).​ ​
f. Collection of data from voice, video, digital, or image recordings made for research purposes.
g. Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies.​ ​

 

Full Board

​Studies involving more than minimal risk and/or a vulnerable population [“children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons” (HHS, para 1)].

 
Instructions for Researchers:
Researchers wishing to conduct human subject research at Broward College must complete and submit an IRB Protocol Form.  When completing the Protocol Form, researchers must select one of the three types of IRB review that they believe their study falls under.  After selecting the type of review, researchers must complete Sections I-VI of the Protocol Form. 
 
 
The sections are as follows:
  
Section I General Study Information
Section II Study Summary and Rationale
Section III Study Design
Section IV Participants
Section V Risks and Benefits
Section VI Additional Documents
  
Once completed, researchers must sign and date the certification at the end of the Protocol Form.   All researchers working on the study (primary investigators and co-investigators) must submit a certificate of completion to show they completed a human subject's protection training course. The National Institutes of Health (NIH) offers a free online course on protecting human research participants at http://phrp.nihtraining.com/users/login.php.
  
Informed Consent Documents
Researchers are required to submit a copy of an informed consent form for each study submitted for IRB review, in addition to a copy of their IRB approval letter from their graduate institution, if applicable.  The Informed Consent Template below provides instructions and guidelines for creating an informed consent document.
 
 
To assist researchers with submitting a complete proposal packet to the IRB, please use the Submission Checklist.
  
 
Completed IRB Protocol Forms should be submitted electronically with required and supporting documents as attachments to irb@broward.edu, in one communication.  Please note the IRB reserves the right to request a hard copy of the Protocol Form and supporting documents, if deemed appropriate
 
 
 
Reporting Adverse Events
Federal regulation requires that any adverse events associated with participation in a research study be reported to the IRB.  The Department of Health and Human Services (HHS) defines an adverse event as follows:
 
“Any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject’s participation in the research, whether or not considered related to the subject’s participation in the research (modified from the definition of adverse events in the 1996 International Conference on Harmonization E-6 Guidelines for Good Clinical Practice).”
  
If an adverse event has occurred while conducting your study, you must submit an Adverse Event Form to the IRB, as soon as feasible at irb@broward.edu.
 
 
For more information regarding reviewing and reporting unanticipated problems and adverse events see the HHS Guidance on Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or Others and Adverse Events at http://www.hhs.gov/ohrp/policy/advevntguid.html
 
Amendments and Changes to Approved Research
Federal regulation requires the IRB to review any proposed changes to research protocols.  Researchers wishing to make change s to their approved IRB protocols must first receive permission from the IRB.  Researchers should complete and submit an Amendment Form to the IRB at irb@broward.edu prior to implementing any changes to their approved protocols.
 
 
Continuing Review of Approved Research
Federal regulation requires the IRB to conduct continuing review of approved research protocols set at a time interval appropriate to the level of risk associated with the research, but no less than annually.  One month prior to the IRB approval expiration date, the researcher must submit a Continuing Review Form to the IRB.  The IRB will notify the researcher in writing, 60 days prior to the approval expiration date, to inform the researcher that their study is subject to continuing review.  If the researcher wishes to continue conducting the approved research, even if only coding or analyzing data, the researcher must complete a Continuing Review Form and submit it electronically to irb@broward.edu.
 
 
The Continuing Review Form must be submitted one month prior to the IRB approval expiration date.  The timely processing of the form will ensure that there is no lapse in IRB approval.  No research may be conducted passed the expiration date unless the study has been reviewed and renewed by the IRB.
 
Research Closure
The completion or termination of a research protocol is a change in research activity that must be reported to the IRB. The closure of an approved research protocol means that no further research, data collection, follow-up, and coding of data or data analysis will be conducted.  Even if a study is no longer enrolling subjects, it remains active until data analysis, write-up of research results, and manuscript preparation that requires the use of personally indefinable information is complete.  Upon final completion of a research project, a Research Closure Form must be completed and submitted electronically to irb@broward.edu.
 
 
Retention of Research Records 
Records relating to approved research must be retained for a period of at least three years after the completion of the research project.  All research materials, consent forms, questionnaires, data, etc. must be retained for at least three years and may be subject to review by the IRB, if deemed necessary. This information should be included within the IRB Protocol Form and all Informed Consent Forms. 
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