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Frequently Asked Questions

All research conducted by faculty or students 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. Refer to the Determining Whether or Not Your Project Needs IRB Review Chart.

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

  • Go to the Application & Instructions page and download the How to Complete the Online IRB Application Form.
  • 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 applications go directly to the IRB Office.
  • Include all relevant information (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 – this 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 via email to teri.gabriel@erau.edu.

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 review, which are exempt, expedited, and full board review. The determination of what level of review is required, is determined by the Chair of the IRB, NOT the researcher. 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 six categories as designated by federal regulations.

  1. Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as:
    • Research on regular or special educational instructional strategies, or.
    • Research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management models.
  2. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless:
    • Information is recorded in such a manner that participants can be identified, directly or through identifiers linked to the participants;
    • Any disclosure of the human participants’ response outside the research could reasonably place the participant at risk of criminal or civil liability or be damaging to the participant’s financial standing, employability or reputation.
  3. 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 bullet two of this section, if:Research involving the collection or study of existing data, documents, records, pathological specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that participants cannot be identified, directly or through identifiers linked to the participants.
    • The human participants are elected or appointed public officials or candidates for public office; or
    • Federal statute(s) require(s) without exception that the confidentiality of personally identifiable information will be maintained throughout the research and thereafter
  4. Research and demonstration projects which are conducted by or subject to the approval of federal government department or agency heads, and which are designed to study, evaluate or otherwise examine:
    • Public benefit or service programs;
    • 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
  5. 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

It is important to remember that a research activity qualifies as exempt if it is limited to 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.

Expedited
Research activities that fall into this category present no more than minimal risk to human participants and involve only procedure listed in one or more categories approved through federal regulations.

  • Recording of data from participants 18 years or older using noninvasive procedures
  • Video/Audio recording
  • Study of existing data
  • Research on an individual or group behavior that involves no manipulation of the participants and is not stressful

Full Board Review
Research that involves greater than minimal risk is reviewed by the IRB Committee. Research that requires full board review includes but is not limited to:

  • Certain types of research involving children, pregnant women, fetuses, and other vulnerable populations
  • Research involving prisoners
  • Research that involves deception
  • Survey research that involves sensitive questions or is likely to be stressful for the participants, or
  • Collection of blood samples in minimal amounts
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 meets the requirement for 'exemption', it is forwarded to an IRB pre-reviewer who is a member of the Board. Upon the pre-reviewer's approval. It is forwarded to the IRB Chair for final review and approval. If a project meets the requirements to be 'expedited', it follows the same process except that two IRB members pre-review the application before it is sent to the IRB Chair for final review and approval. If it does 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 in the Application & Instructions section.

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 in the Application & Instructions section.

What about informed consent for anonymous surveys?

In general, on common survey research, where there is no more than minimal risk and anonymity is provided, a separate 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 can be found in the Application & Instructions section.

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 review, which are exempt, expedited, and full board review. The determination of what level of review is required is determined by the IRB Chair, NOT the researcher; 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. As indicated in question number 8, some research will be exempt from formal review. Research that is considered 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' IRB application or change an already approved 'Exempt' IRB application or extend the dates for the project of an already approved 'Exempt' IRB application, you need to complete the Extend Protocol Extension/Change Request 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 Expedited or 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 via email to teri.gabriel@erau.edu or call 386-226-7179 if you have questions about what kinds of changes require new applications.

Approval is valid for one year even if it is a multi-year project. To extend a project that was reviewed through the 'Exempt' review process ONLY, complete the Exempt Protocol Extension/Change Request 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. Only EXEMPT research can be extended. Full IRB reviewed and Expedited reviewed research cannot be extended beyond one year; a new IRB application must be completed.
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. 

“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. Investigators conducting HHS-supported research must comply with the requirements of subpart D, as well as other subparts.

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. conditions for IRB approval of proposed research activities in three categories depending on the level of risk and other specified features of the proposed research activity;
  • d. review by the Secretary for research that an IRB finds not approvable under any of the three categories; and,
  • e. additional conditions for certain research activities involving children who are wards of the State or any other agency, institution, or entity

Altering the Exemption: Subpart D widens the range of research activities requiring IRB review by reducing the scope of the exemption in 45 CFR 46.101(b)(2) regarding research activities involving education tests, survey or interview procedures, or observation of public behavior, if the subjects are children. The exemption of research activities involving survey and interview procedures is eliminated. The exemption is also narrowed for research involving observation of public behavior, by eliminating the exemption of any research involving observation of public behavior if the investigator will participate in the activities being observed.

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. Depending on the level of risk and other specified features of the research activity, there are three categories under which the IRB can approve research involving children.

  • a. Wards: Subpart D also sets additional conditions for research involving children who are wards of the State or any other agency, institution, or entity if the research is approved under two of the categories of approvable research: it limits the kind of research activities approved under these two categories in which children who are wards can participate, and it requires the appointment of an advocate to act in the best interests of the child.