All research conducted by faculty, students or staff that involve human participants must be submitted for review. Studies initiated from an external/outside entity need not be reviewed unless Embry-Riddle is engaged in the study. The IRB Office must obtain a copy of the external/outside entity's approved IRB on file for the record. Engagement in research is defined as an institution's employees or agents as individuals who: (1) act on behalf of the institution; (2) exercise institutional authority or responsibility; or (3) perform institutionally designed activities. (OHRP Guidance Document) No research project which involves human participants may begin prior to receiving approval. This includes any recruitment activities and data collection.

If you are a faculty member, staff member, or student at Embry-Riddle and your research involves the use of human participants (either directly or through records), your research requires IRB review.

If you are from a different institution, but your research involves Embry-Riddle students, faculty or staff, then you must coordinate with a faculty member or administrative representative from Embry-Riddle and submit an IRB application for review.

A key question to ask in beginning the IRB process is whether the project is considered research. In general, research is defined by the Department of Health and Human Services as a "systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge" (45 CFR, Part 46).

Will your research make a broad statement to everyone? Will you publish your results in a nationally recognized journal? If so, and you are using human participants, your project will need IRB review. If you are unsure of whether or not your project requires IRB review, take this short survey.

Once you have decided to use human participants in your research:

  • Go to the Application and Instructions page and review the How to Complete the Online IRB Application Form page.
  • Complete the online IRB Protocol Application. It will be forwarded to your Faculty Advisor if you are a student, for his/her review and approval, and then forwarded to the IRB Office. Faculty and staff applications go directly to the IRB Office.
  • Include all relevant information (i.e., consent forms, assent forms, surveys, questionnaires, test instruments, advertisements, debriefing statements, contact letters, interview protocols, etc.)

If an instructor at any grade level wishes to recruit and involve students in his or her own classes in a research activity which will directly benefit the instructor (a dissertation research project, for example), the instructor should consider the following guidelines and premises that will govern IRB review of the research activity.

Instructors are in a position of authority over students in their classes, especially the power to determine a course grade. This compromises the absolute requirement that participation in research be voluntary, laying a veil of potential coercion over any in-class recruitment, regardless of how benign the instructors’ intentions might be. It is therefore always preferable for an instructor to recruit student participants from the general student population if possible (e.g., advertise in student-oriented media, post on campus bulletin boards, list-serves, or websites, broadcast to email addresses, etc.) or from classes or courses with which the instructor is not involved in determining grades.

If circumstances dictate that there is no good alternative to recruitment of one’s own students (and “it is so much easier to use my own classroom” does not equate to “there is no good alternative”), the major protection against the appearance and potential of coercion is maintaining the strict anonymity of participation – that is, the instructor must be insulated from knowing the identity of students who engage in the research versus those who do not. If this is not possible, then recruitment of one’s own students for one’s own research — or any research in which the instructor stands to gain a personal benefit — is simply not permissible.

Provision of incentives to students for participating in research activities, such as extra credit or bonus points toward a classroom grade, must be carefully considered in light of the requirement for anonymity. The Board recognizes the practice of incentivizing participation with a modest level of academic credit as a reasonable means of encouraging student participation in research. However, alternative opportunities to achieve the same extra credit based on a comparable commitment of effort to that required for the proposed research activity must be offered to any student who prefers not to participate in the research.

Extra credit may be offered only if it can be arranged such that the instructor/investigator is blinded to the identity of research participants versus nonparticipants who seek the credit through an alternative activity. This may be arranged by interposing a neutral third party or technological buffer in the credit confirmation process.

The IRB Office can provide assistance with the preparation of your IRB protocol application and can be reached at 386-226-7179 or email to teri.gabriel@erau.edu.

Research applications are reviewed at one of three levels, depending on risk to the human participants and on the Federal regulations that define the categories of review, which are exempt, expedited, and full board review. The Chair of the IRB determines what level of review is required. Whatever the level of review, the ethical treatment of human participants is always a requirement.

Exempt

Research activities that fall into this category fit one of eight categories as designated by Federal regulations:

  • Research conducted in established or commonly accepted educational settings, involving normal educational practices including regular or special education instructional strategies and research on the effectiveness or on the comparison among instructional techniques, curricula, or classroom management methods. This exemption applies to minors.
  • Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior (including visual or auditory recording). This exemption applies to minors if the information obtained is recorded in such a manner that the identity of the participant cannot be readily identified.
  • Research involving benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal or written response (including data entry) or audiovisual recording if the participant prospectively agrees to the intervention. This exemption does not apply to minors.
  • Benign behavioral interventions is defined as “being brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the participant, and the investigator has no reason to think the participants will find the interventions offensive or embarrassing.” Examples include playing an online game, solving puzzles under various noise conditions, or having them decide how to allocate a nominal amount of received cash between themselves and someone else. [§46.104(d)(3)]
  • Secondary research using identifiable private information or identifiable biospecimens for which consent is not required if the identifiable private information or identifiable biospecimens are publicly available or information is recorded by the investigator in such a manner that the identity of the human participant cannot readily be ascertained directly or through identifiers linked to the participant and the investigator does not contact or reidentify the participant. This exemption applies to minors.
  • Research and demonstration projects that are conducted or supported by a Federal department or agency and that are designed to study, evaluate, improve, or otherwise examine public benefit or service programs. This includes internal studies by Federal employees, and studies under contracts or consulting arrangements, cooperative agreements or grants. This exemption applies to minors.
  • Taste and food quality evaluation and consumer acceptance studies, if wholesome foods without additives are consumed or 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. This exemption applies to minors.
  • Storage or maintenance of identifiable private information or identifiable biospecimens for which broad consent is required for potential secondary research use if a Limited IRB review is conducted. This exemption applies to minors.
  • Research involving the use of identifiable private information or identifiable biospecimens for secondary research use if broad consent for the storage, maintenance, and secondary research use was obtained; documentation or a waiver of informed consent was obtained; a Limited IRB review is conducted to determine that the research is within the scope of the broad consent and the investigator does not include returning individual research results to subjects as part of the study plan. This exemption applies to minors.

It is important to remember that a research activity qualifies as exempt if it meets the kind of activities listed above and only after review of the protocol application. If the project includes such activities but also involves participants that are considered "vulnerable" (i.e., children or prisoners) or other activities that are more intrusive, more personal, or more risky than the above, it most likely will not qualify as exempt.

Limited Review of Exempt Research

New Category of Exempt Review is required in some instances to ensure there are adequate confidentiality and privacy safeguards. Limited IRB review is required for “broad consent” in studies involving identifiable private information or identifiable biospecimens. Limited IRB review involves making and documenting the determination that adequate provisions are in place for protecting privacy and maintaining confidentiality.

Expedited

Research activities that fall into this category present no more than minimal risk to human participants and involve only procedures listed in one or more categories approved through Federal regulations:

  • Non-exempt 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 surveys, interviews, or human factors evaluation and any other research activity that poses no more than minimal risk to participants.
  • Minor changes in previously approved research during which approval is authorized.
  • Research for which Limited IRB review is a condition of exemption.

Full Board Review

Research that involves greater than minimal risk is reviewed by the IRB Committee.

Research that does not meet the requirements of ‘Exempt’ or ‘Expedited’ must be reviewed at a fully convened IRB meeting and can take anywhere from one month to three months to review.

The online IRB Protocol Application is forwarded to either the student’s faculty advisor or directly to the IRB office. It is reviewed to ensure the application is complete and that all questions are answered so that an IRB reviewer can understand the project. If the project is determined to be exempt, it is forwarded to the IRB Chair for final review and approval. If a project is determined to be expedited, it is forwarded to an IRB pre-reviewer who is a member of the Board. Upon the pre-reviewer’s approval, it is then forwarded to the IRB Chair for final review and approval. If it does not meet the requirements for "exemption" or "expedited" review, an IRB member will be assigned to be the primary reviewer, and it will go before the full IRB to be reviewed by the full IRB Board at a convened meeting.

After your application is reviewed, you will receive a determination from the IRB Office.

The IRB reviews the purpose, procedures, and participant populations to be used and determines if the benefits of the activity outweigh the risks to the participant. Issues considered in the analysis include:

  • Whether risks to participants are minimized.
  • How participants are approached so that they can readily refuse.
  • How privacy, confidentiality and informed consent will be handled.
  • What physical and psycho-social risks, stresses, and discomforts participants will be asked to endure.
  • Whether vulnerable populations (i.e. children, prisoners) are to be included.
  • Whether additional safeguards have been included in the study to protect the rights and welfare of any participants likely to be vulnerable to coercion or undue influence such as prisoners or children.
  • How sensitive the information is.
  • Whether risks to participants are reasonable in relation to anticipated benefits, if any, to participants, and the importance of the knowledge that may reasonably be expected to result.
  • Whether diverse populations are included.
  • How data will be handled after the completion of the study.

The scientific merit of the activity is considered only if it has an impact on the risk-benefit analysis. For example, will the number of participants proposed allow the results obtained to be statistically significant? Is there a less risky way to achieve the same results?

The IRB also evaluates advertisements, approach letters, consent/assent forms or information statements, telephone scripts, and debriefing statements to determine if they are accurate, explanatory, and written in simple, lay language appropriate for the intended participants.

Since the fundamental requirement for research conducted using human participants is that an individual participates voluntarily, the consent process is one of the more important parts of the research project. The process must assure that the potential participant understands the study and its risks and benefits and can certify his or her willingness to participate or decline to participate in the study. Sample consent forms are available on the Informed Consent page.

In the case of minors, an assent form is to be used in addition to the consent form from a parent or guardian. Sample assent forms are available on the Informed Consent page.

What about informed consent for anonymous surveys?

In general, common survey research, where there is no more than minimal risk and anonymity is provided, a signature on the consent form is not needed. The survey itself must contain relevant information about the study. In this case, submitting the survey is an indication of consent. If the survey is being sent and returned through the Internet, participants should be alerted to how confidentiality is being protected. Researchers can block identifying information or arrange to have surveys returned by mail. If identification (through IP or email address) is possible, then steps taken to ensure confidentiality should be explained.

More information about informed consent and a sample consent form for survey research can be found on the Informed Consent page.

Research applications are reviewed at one of three levels, depending on the level of risk to the human participants and on the federal regulations that define the categories of research, which are exempt, expedited and full board review. The determination of what level of review is required is determined by the IRB Chair. Whatever the level of review, the ethical treatment of human participants is always a requirement.

The IRB may determine there is insufficient information to approve or disapprove an application. If this is the case, the IRB will ask the investigator to provide additional information. When the information is received by the IRB, the application is reconsidered. The IRB may determine that the risks of the proposed activity outweigh the benefits and will withhold approval. The IRB will work with the investigator toward a compromise to reduce the risks and gain approval to carry out the research.

No. Whenever an application is received, it is evaluated by the IRB Office. Some research will be exempt from formal review. Research that is considered to be of minimal risk to participants is usually reviewed by one designated Board member, if no additional concerns apply, such as specially protected populations. Research that falls into the category considered to be of more than minimal risk is reviewed by the full board.

The usual turnaround for a completed application that does not require full board review varies depending upon the level of review and whether or not the application needs further clarification. If the application is reviewed through the exempt or expedited process, you will receive either a determination form or a request for more information approximately two weeks after the submittal date. If your application is reviewed by the full board, you will receive a determination after the meeting. At this time, you will receive either an approval letter or a letter requesting more information about your application. If you receive a letter requesting more information, you can expect approval unless there are further questions.

To be safe, investigators should submit the IRB application with necessary documents as early as possible.

It is very important to have a well thought out plan for research and have all documentation in place before proceeding. However, if you need to add additional materials to an already approved EXEMPT or EXPEDITED IRB application, you can modify the application. Complete the Modification of Approved IRB Application form and submit it along with any necessary documents to the IRB Office via email to teri.gabriel@erau.edu. This will then be sent along with the original application to the IRB Chair for consideration. For IRB projects that were reviewed through the full IRB review process, a new IRB application must be completed.

Substantial changes in the focus, procedures, or participant population of the research will require submission of a new application.

Inquire to the IRB Office, email teri.gabriel@erau.edu or call 386-226-7179 if you have questions about what kinds of changes require new applications.

"Exempt" research does not expire. "Expedited" research does not expire, but a Progress Report must be submitted to the IRB Office one year from the date of approval. Research reviewed by the full IRB at a convened meeting expires one year from the date of approval. To continue the research, a new IRB application must be submitted.

Embry-Riddle's IRB can review "Exempt" research using Veterans as participants. All non-exempt research must be conducted by the Department of Veterans Affairs, Office of Research Oversight.

The Department of Veterans Affairs (VA Office of Research Oversight (ORO)) is the primary office within the Veterans Health Administration (VHA) responsible for providing oversight of research program compliance with 38 CFR 16. Any research considered "non-exempt" must be reviewed by the ORO.

The principal investigator (PI) is ultimately responsible for the conduct of research, including ensuring that an investigation is conducted according to the approved protocol and the applicable regulations. The PI is also responsible for the rights, safety and welfare of the participants.

Yes, research can be conducted outside the US but there are additional requirements:

"Federal regulations for protecting research with human subjects, supplemented by guidance from the Office of Human Research Protections (OHRP), are quite specific about the requirements for review when U.S. agencies fund research conducted abroad." Quoted from the CITI Training module on International Research. OHRP under the US Department of Health & Human Services has a compilation of Human Research Standards that can be found at http://www.hhs.gov/ohrp/international/index.html.

An entity similar to an IRB needs to review and approve the research before it can be reviewed by Embry-Riddle's IRB.

An additional CITI Training module must be completed by all investigators under the Human Subjects: Researcher - Basic Course titled International Research. 

See the additional CITI Training modules required for research using children CITI Training Course/Module Requirement. 

“Children” are persons who have not attained the legal age for consent to treatments or procedures involved in research, under the applicable law of the jurisdiction in which the research will be conducted (45 CFR 46.402(a)). Children are persons with diminished autonomy and need extra protection. Therefore, Subpart D of the HHS regulations at 45 CFR part 46 provides additional protections for children participating in human subjects research.

The IRB must determine that all requirements of subparts A and D have been met. If the research involves pregnant minors, then the requirements of subpart B must be met and if the research involves incarcerated minors then the requirements of subpart C must be met.

Subpart D’s additional protections include:

a. requiring IRB review of some research activities involving children that would be exempt if the research subjects were adults;

b. use of parental permission and child assent instead of the procedures for obtaining informed consent used for research involving adults;

c. additional conditions for certain research activities involving children who are wards of the State or any other agency, institution, or entity

Parental Permission and Child Assent: Subpart D uses parental permission and child assent instead of the procedures for informed consent used for research involving adults. In general, one or both parents or a guardian must be provided with the information ordinarily required for informed consent, so that they may decide whether to allow the child to participate, and children capable of assent must also express their willingness to participate. Subpart D allows for various conditions and waivers of parental permission and child assent, depending on the nature of the research activity and the maturity of the child.

Categories of Approvable Research: Subpart D requires the reviewing IRB to identify the level of risk, the potential for direct benefits to the subjects, and other specified features of the research during the approval process.

Yes. However, permission, in writing, must be obtained from the applicable command. The written authorization should include reference to the non-existence of any conflicting military branch IRBs.

Note: Some branches not only have branch-specific IRBs but also may have base or region IRBs as well.