Once you have decided to use human participants in your research:
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.
Research activities that fall into this category fit one of six categories as designated by federal regulations.
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:
The human participants are elected or appointed public officials or candidates for public office; or
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.
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.
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.
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:
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:
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.
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 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 in the Application & Instructions section.
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 need to complete the Modification of Approved IRB Application form and submit it along with any necessary documents to the IRB Office via email to email@example.com. 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 firstname.lastname@example.org or call 386-226-7179 if you have questions about what kinds of changes require new applications.
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. 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:
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.