CGU is committed to the ethical treatment of research participants and to IRB procedures that fully comply with current federal guidelines and standards. From an educational point of view, we seek to engage members of the community in issues related to the ethical treatment of participants in the research process and to prepare students for roles as researchers in other institutions. The information in this overview is intended to provide a beginning guide for submission of information to the CGU IRB. Fuller documentation and related federal guidelines are available on the IRB website and in the IRB handbook. An application that describes the proposed project and protections of research participants is an essential part of this effort. The IRB is available to advise and assist all faculty, students, and staff with this process.
Federal, state and university regulations require that the use of human participants in research be reviewed by and Institutional Review Board (IRB).
At CGU, the IRB is responsible for the following:
Reviewing research applications involving the use of human participants;
Providing certifications of review to funding agencies;
Receiving reports of adverse effects resulting from research with human participants;
Monitoring complaints from human participants;
Advising faculty, staff and students on human participants review.
If you are a faculty member, staff member, or student at CGU and your research involves the use of human participants (either directly or through records), your research requires human participant 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).
A good rule of thumb for determining whether or not a particular project qualifies as research is to consider whether or not the results will be published or presented in some form or forum outside of the institution. Data used for institutional purposes would not normally be considered research in this context.
What about research projects that are part of CGU coursework?
Because CGU classroom based projects that will involve research will not usually be published, they need not go through the IRB process. Nonetheless, professors who use research projects or exercises as part of their teaching methods or those who teach research methods courses are expected to have a section on research ethics and to teach ethical research procedures before the students undertake such activities. Professors are also responsible for the ethical research behavior of the students in their courses even when students fulfill class projects off campus. In this context, students and faculty members are still responsible for adhering to the IRB principles in their projects. Feel free to contact the Chair of the IRB for any questions. The Chair will gladly speak to any groups or individuals as requested.
Sometimes data from a classroom research project become part of a dissertation, a paper submitted to a conference or a journal. At the time that this shift from classroom project to research occurs, the use of the data has changed and the researcher is obligated to subject the research activity to IRB review.
Do studies that focus on quality improvement and quality assurance activities require IRB approval?
Quality Improvement and Quality Assurance activities conducted solely for the intent of maintaining or improving quality of services provided by an institution are not considered research activities. However, if the data collected are generalizable and are to be shared outside of the institution through discussion, presentation, or publication, the activity qualifies as research. In instances such as this, the research use of the data collected must be reviewed. Nevertheless, in all activities the principles of ethical practices should be observed.
Do evaluation projects require IRB approval?
Evaluations are systematic studies of programs (or of products or personnel) to determine impact and/or for improvement purposes. If the information generated from the evaluation is being used only for program administrators or staff, and is not intended for dissemination or publication, there is no need for IRB review. If there is a possibility that a publication or presentation may emerge from an evaluation study, IRB review is necessary. Please be aware that the agency for which the evaluation is being done, may require IRB approval.
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 subjects 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/researcher is blinded to the identify 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.
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 staff, 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.
Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as:
1. Research on regular or special educational instructional strategies, or
2. Research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless:
1. Information is recorded in such a manner that participants can be identified, directly or through identifiers linked to the participants;
2. Any disclosure of the human participants' responses 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.
Research involving the use of educational tests, (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior the is not exempt under bullet two of this section, if:
1. The human participants are elected or appointed public officials or candidates for public office; or
2. Federal statute(s) require(s) without exception that the confidentiality of personally identifiable information will be maintained throughout the research and thereafter.
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.
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, evaluation or otherwise examine:
1. Public benefit or service programs;
2. Procedures for obtaining benefits or services under those programs;
3. Possible changes in or alternatives to those programs or procedures; or
4. Possible changes in methods or levels of payment for benefits or services under those programs.
Taste and food quality evaluation and consumer acceptance studies,
1. If wholesome foods without additives are consumed or
2. 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 proposal. If the project includes such activities but also involves 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 procedures listed in one or more categories approved through federal regulations.
Recording of data from participants 18 years or older using noninvasive procedures;
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 board. 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
When the IRB receives your application it is reviewed to make sure the application is complete. Once it has been determined that the application is complete, it is sent to the IRB for review.
After your application is reviewed, you will either receive a signed copy of your IRB application along with a letter granting approval or a letter requesting additional information and revisions. If you received a letter requesting revisions to your application, your application will be re-reviewed and returned to you after you respond to the revisions requested.
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. Fuller information about each of these is available on the web and in the IRB handbook. 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 (e.g. prisoners, children) 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 statically 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 central requirement for human participants research is that people participate 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. Under certain circumstance the IRB can waive or alter the informed consent process. Sample consent forms are available in the IRB handbook and on the IRB website.
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 IRB handbook and on the IRB website.
What about informed consent for anonymous surveys?
In some cases, a signed consent form is either inappropriate or unnecessary. According to Federal Regulations at 45 CFR Part 46.117c the IRB may waive this requirement if it determines either:
There is a risk of breach of confidentiality and the only link between the participant and the research would be the consent document. In this case, the participant's wishes should be followed.
The research presents no more than minimal risk of harm and involves no research that requires written consent outside the research context.
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 can 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.
The IRB may determine there is insufficient information to approve or disapprove an application. If this is the case, the IRB will ask the researcher 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 researcher 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 staff to determine what level of review is appropriate. As indicated above, some research will be exempt from formal review. Research that is considered of minimal risk is usually reviewed by one designated Board member, if no additional concerns apply, such as specially protected subject populations. Research that falls into the category considered to be of more than minimal risk is reviewed by the full board. Information can be found as to what level of review is likely to be required by consulting the IRB website or by contacting the IRB staff.
The usual turn around for an approved 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 an approval letter or a letter requesting more information approximately two weeks after the submittal date. If your application is reviewed by the full board you can expect to hear from the IRB two weeks after the date of the monthly IRB 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, researchers should submit the IRB application as early as possible.
Approval is valid for one year even it it is a multi-year project. If the project was initially designed to go beyond one year and was approved with that assumption, an annual renewal will be easily expedited through a renewal application. The renewal process follows the same timeline in granting approvals as an original IRB application.
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.