The Institutional Review Board at Northwest Florida State College is composed of faculty, administrators, and staff, and an external member (non-college affiliate). Office of Human Research Protection (OHRP) regulations for IRB membership stipulate that an IRB must have at least five members with varying backgrounds to promote complete and adequate review of the research activities and include at least one member who is not otherwise affiliated with the institution. The IRB must have at least one member whose primary concerns are in scientific areas and at least one member whose primary concerns are in nonscientific areas. Prior to serving on the IRB, all members must complete external training provided by a qualified organization preparing them for their role as an IRB member at NWFSC.

The IRB Committee of NWFSC will consist of the following institutional and external personnel.

• IRB Chair (Vice President of Academic Affairs OR Associate Director of Institutional Research)
• IRB Member (3 Internal, 1 External)

The IRB may invite individuals with competence in special areas to assist in the review of issues, but these individuals may not vote with the IRB.

The IRB Chair will decide if the research is exempt from review, can be reviewed through the expedited process, or requires full committee review.  Working with the wider IRB, the chair will determine how and when requested reviews will be completed and will provide leadership for all reviews.  The Chair will be responsible for communicating with the researcher as to the results of a review.

All projects must be reviewed and re-approved by the IRB Chair once a year for the duration of the project (see Review of Approved Projects Form).

The IRB Chair ensures the orderly and efficient management of the review process.  The Chair will arrange meeting times and locations, ensure all procedures are followed, track the process, maintain all records and record/distribute minutes of meetings. 

NWFSC’s IRB adopts the following definitions below and, when applicable, adopts the Office of Human Research Protections’ (OHRP) definitions found in the 2018 Common Rule (45 CFR 46).

• Research.  The systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities [45 CFR 46.102(l)].
• Human subject.  A living individual about whom an investigator (whether professional or student) conducting research obtains (1) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (2) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens [45 CFR 46.102(e)(1)].
• Intervention.  This includes both physical procedures by which information or biospecimens are gathered (e.g., venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes [45 CFR 46.102(e)(2)].
• Interaction. This includes communication or interpersonal contact between investigator and subject [45 CFR 46.102(e)(3)].
• Private information. This includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (e.g., a medical record) [45 CFR 46.102(e)(4)].
• Identifiable private information. This is private information for which the identity of the subject is or may readily be ascertained by the investigator or associated with the information [45 CFR 46.102(e)(5)]
• Identifiable biospecimen. This is a biospecimen for which the identity of the subject is or may readily be ascertained by the investigator or associated with the biospecimen [45 CFR 46.102(e)(6)].
• Protocol. The formal design or plan of an experiment or research activity; specifically, the plan submitted to an IRB for review and to an agency for research support. The protocol includes a description of the research design or methodology to be employed, the eligibility requirements for prospective subjects and controls, the treatment regimen(s), and the proposed methods of analysis that will be performed on the collected data.
• Risk. The probability of harm or injury (physical, psychological, social, or economic) occurring as a result of participation in a research study. Both the probability and magnitude of possible harm may vary from minimal to significant. Federal regulations define only “minimal risk.”
• Minimal Risk. Indicates probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests [45 CFR 46.102(j)].
• Informed Consent.  A person’s documented, voluntary agreement, based upon adequate knowledge and understanding of relevant information, to participate in research or to undergo a diagnostic, therapeutic or preventive procedure.  Investigators must obtain legally valid informed consent from each subject or from the subject’s legally authorized representative (power of attorney, or authorized court appointed guardian/representative) when participating in human subject research.
• Assent.  An agreement by an individual who is unable to give legally valid informed consent to participate in research.  When potential research subjects are not competent to give legally valid informed consent, respect for a person’s autonomy mandates that the investigator obtain their voluntary assent to participate, in addition to obtaining the informed consent of a parent, guardian or other legally authorized representative.  Assent is generally required when the research subjects are children between the ages of 7 and 18 or are intellectually or emotionally impaired subjects who are not legally competent to give their informed consent
• HIPAA (Health Insurance Portability and Accountability Act).  The Privacy Rule, at 45 CFR parts 160 and 164, establishes a category of health information, defined as protected health information (PHI), which a covered entity may only use or disclose to others in certain circumstances and under certain conditions. In general, the Privacy Rule requires an individual to provide signed permission, known as an Authorization under section 164.508 of the Privacy Rule, before a covered entity can use or disclose the individual’s PHI for research purposes. The Privacy Rule is a response to public concern over potential abuses of the privacy of health information. PHI is a subset of what is termed individually identifiable health information.

Researchers who wish to submit a proposal to the IRB for review must complete and submit an IRB Protocol Form as well as a certificate of completion from a human subject research protection course. When applicable, researchers, who are currently enrolled in graduate school, must also submit an IRB approval letter from the IRB at their graduate institution. The Northwest Florida State College IRB will only review research protocols that have been approved by the researcher’s advisor/committee and their graduate institution’s IRB.

When completing the Protocol Form, researchers must select one of the three types of IRB review that they believe their study falls under. The IRB reserves the right to change the review category based on its interpretation of federal guidelines and the descriptions and materials provided.

Once completed, the principal investigator must electronically 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 have completed a human subject protection training course. 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 (see the Informed Consent Template on the NWFSC’s IRB website).

A submission checklist is also available to assist researchers with submitting complete proposals. The items on the checklist are as follows:

• Completed IRB Protocol Form with Signature(s) (required)
• Human Subjects Protection Course Certificate(s) (required)
• IRB Approval Letter from Graduate Institution (when applicable)
• Informed Consent Form(s)
• Supplementary Materials (surveys, questionnaires, etc.)
• Recruitment Materials (flyers, emails, etc.)
• Other documents (debriefing forms, letters of support, etc.)

• The three types of IRB review are: Exempt, Expedited, and Full Board Review, 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). The description of the three types of review are as follows:

EXEMPT

• Research, conducted in established or commonly accepted educational settings, that specifically involves normal educational practices that are not likely to adversely impact students’ opportunity to learn required educational content or the assessment of educators who provide instruction. This includes most research on regular and special education instructional strategies, and research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods [45 CFR 46.104(d)(1)].
• Research that only includes interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording) if at least one of the following criteria is met:
  • (i) The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects;
  • (ii) Any disclosure of the human subjects’ responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, educational advancement, or reputation; or
  • (iii) The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination required by §46.111(a)(7) [45 CFR 46.104(d)(2)].
• Research involving benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal or written responses (including data entry) or audiovisual recording if the subject prospectively agrees to the intervention and information collection and at least one of the following criteria is met:
  • (A) The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects;
  • (B) Any disclosure of the human subjects’ responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, educational advancement, or reputation; or
  • (C) The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination required by §46.111(a)(7) [45 CFR 46.104(d)(3)(i)].
• For the purpose of this provision, benign behavioral interventions are brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects, and the investigator has no reason to think the subjects will find the interventions offensive or embarrassing. Provided all such criteria are met, examples of such benign behavioral interventions would include having the subjects play an online game, having them solve puzzles under various noise conditions, or having them decide how to allocate a nominal amount of received cash between themselves and someone else [45 CFR 46.104(d)(3)(ii)].
• If the research involves deceiving the subjects regarding the nature or purposes of the research, this exemption is not applicable unless the subject authorizes the deception through a prospective agreement to participate in research in circumstances in which the subject is informed that he or she will be unaware of or misled regarding the nature or purposes of the research [45 CFR 46.104(d)(3)( iii)].
• Secondary research for which consent is not required: Secondary research uses of identifiable private information or identifiable biospecimens, if at least one of the following criteria is met:
  • (i) The identifiable private information or identifiable biospecimens are publicly available;
  • (ii) Information, which may include information about biospecimens, is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained directly or through identifiers linked to the subjects, the investigator does not contact the subjects, and the investigator will not re-identify subjects;
  • (iii) The research involves only information collection and analysis involving the investigator’s use of identifiable health information when that use is regulated under 45 CFR parts 160 and 164, subparts A and E, for the purposes of “health care operations” or “research” as those terms are defined at 45 CFR 164.501 or for “public health activities and purposes” as described under 45 CFR 164.512(b); or
  • (iv) The research is conducted by, or on behalf of, a Federal department or agency using government-generated or government-collected information obtained for nonresearch activities, if the research generates identifiable private information that is or will be maintained on information technology that is subject to and in compliance with section 208(b) of the E-Government Act of 2002, 44 U.S.C. 3501 note, if all of the identifiable private information collected, used, or generated as part of the activity will be maintained in systems of records subject to the Privacy Act of 1974, 5 U.S.C. 552a, and, if applicable, the information used in the research was collected subject to the Paperwork Reduction Act of 1995, 44 U.S.C. 3501 et seq. [45 CFR 46.104(d)(4)].
• Research and demonstration projects that are conducted or supported by a Federal department or agency, or otherwise subject to the approval of department or agency heads (or the approval of the heads of bureaus or other subordinate agencies that have been delegated authority to conduct the research and demonstration projects), and that are designed to study, evaluate, improve, or otherwise examine public benefit or service programs, including procedures for obtaining benefits or services under those programs, possible changes in or alternatives to those programs or procedures, or possible changes in methods or levels of payment for benefits or services under those programs. Such projects include, but are not limited to, internal studies by Federal employees, and studies under contracts or consulting arrangements, cooperative agreements, or grants. Exempt projects also include waivers of otherwise mandatory requirements using authorities such as sections 1115 and 1115A of the Social Security Act, as amended.
• (i) Each Federal department or agency conducting or supporting the research and demonstration projects must establish, on a publicly accessible Federal Web site or in such other manner as the department or agency head may determine, a list of the research and demonstration projects that the Federal department or agency conducts or supports under this provision. The research or demonstration project must be published on this list prior to commencing the research involving human subjects [45 CFR 46.104(d)(5)].
• 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 46.104(d)(6)].

EXPEDITED

• Clinical studies of drugs and medical devices only when condition (I) or (II) is met:
  • 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.)
  • 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.
• Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:
• From healthy, non-pregnant 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
  • 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.
• Prospective collection of biological specimens for research purposes by noninvasive means.
• 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.)
• 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).
• Collection of data from voice, video, digital, or image recordings made for research purposes.
• 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 REVIEW

Studies involving more than minimal risk and/or a vulnerable population [(i.e., children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons (45 CFR part 35 subparts B, C, D, and E)].

Note: even if a researcher deems their study to be exempt from review, they must still submit a Protocol Form and supporting materials to the IRB.

The Chairperson and/or the Committee will make the final determination. After selecting the type of review, researchers must complete the Protocol Form.

The IRB convenes twice per year (once in fall/once in spring).  Other called meetings will be scheduled as needed to review research requests or other issues. Researchers should allow four weeks to receive a response about the status of their proposal from the IRB.

IRB members review research protocols, informed consent forms, IRB approval letters and materials from researchers’ graduate institutions, stimulus materials/instruments, recruitment materials, etc. An Expedited review procedure consists of a review by the IRB Chairperson or by one or more experienced reviewers designated by the Chairperson from among the members of the IRB in accordance with the requirements set forth in 45 CFR 46.110.

There are four possible IRB actions: 1) approve research, 2) require modifications in order to secure approval, 3) disapprove research, and 4) suspend or terminate previously approved research. The IRB will provide researchers with a formal letter regarding the status of their proposal. If a study has been approved, researchers will receive an approval number from the IRB. An expiration date will be provided for all approved protocols. IRB approval is typically granted at intervals within one year, contingent upon the level of risk associated with the research. If a study will require modifications, researchers will receive a formal letter from the IRB with the specific modifications needed to secure approval. Researchers must make all changes specified by the IRB for their study to be approved. If the IRB decides to disapprove research (must be voted on during a convened meeting), it will include in its written notification a statement of the reasons for its decision and give the researcher an opportunity to respond in person or in writing (45 CFR 46.109(d)). The researcher has the right to appear before the IRB at a convened meeting to appeal the decision. Requests to appeal research disapproval before the convened IRB must be received in writing two weeks prior to a meeting being scheduled.

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 occurs while conducting a research project, the researcher must submit an IRB Adverse Event Form to the IRB as soon as feasible. For more information regarding reviewing and reporting unanticipated problems and adverse events see http://www.hhs.gov/ohrp/policy/advevntguid.html.

Federal regulation requires the IRB to review any proposed changes to research protocols. Researchers wishing to make changes to their approved IRB protocols must first receive permission from the IRB. Researchers should complete and submit an Amendment Form to the IRB prior to implementing any changes to their approved protocols.

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. No research may be conducted passed the expiration date unless the study has been reviewed and renewed by the IRB.

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 to the IRB.

Records relating to approved research must be retained for at least 3 years after the completion of the research project. All research materials, consent forms, questionnaires, data, etc. must be retained for at least 3 years and may be subject to review by the IRB, if deemed necessary.

Any violation of the policy and or procedure will be reviewed by the IRB Committee and the Vice President for Academic Affairs (or designee). The IRB has the authority to suspend or terminate approval of research that is not being conducted in accordance with the IRB’s requirements or that is associated with unexpected serious harm to subjects (45 CFR 46.113). A suspension or termination of IRB approval of research may occur at any time during the period for which IRB approval had already been granted. At any time during the approval period, if further participation is deemed to not be in the best interest of the College, the Vice President for Academic Affairs (or designee) may suspend or terminate the research and the researcher will be notified immediately. In all cases, the College will take the necessary action(s) to maintain the integrity of all research projects being conducted at and through Northwest Florida State College to ensure that the rights and welfare of all research subjects, as well as the College, are sufficiently protected .