CGU is committed to the ethical treatment of research participants, to IRB procedures that comply with current federal regulations and with CGU guidelines and standards, and to help 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. 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 by the IRB or its designated representative.
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 are designed to be published in a research journal or presented to an audience of academics or professional researchers in a forum outside of the institution. Data used for institutional purposes such as quality improvement, customer satisfaction, or market segmentation 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 a classroom research project involving human participants is designed and intended to meet publication standards and contribute to generalized knowledge. In that case, such projects may be considered for IRB review. If a study not originally so designed becomes part of a dissertation, a paper submitted to a research conference or a journal, that implies that a shift from classroom project to research is occuring, and the researcher should submit the study for retrospective IRB review. A study determined to be exempt at this time may proceed, but one determined to need expedited or full board review must have been designed originally to comply with IRB standards for approval, or the study can not be used for research purposes.
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 research 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.
Once you have decided to use human participants in your research:
Complete an IRB protocol application and submit it to the IRB located at 135 East 12th Street and firstname.lastname@example.org;
Include all relevant information (IRB protocol application, certification of training in human subjects research proptection, 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 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 and members of the Board, NOT by the researcher. Whatever the level of review, the ethical treatment of human participants in accord with the Belmont Principles 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; AND
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 that 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 a study can be determined exempt only by the IRB after it has reviewed the proposal. If the project includes activities that would be qualified as exempt 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 do not satisfy criteria for exemption, present no more than minimal risk to human participants, and involve only procedures listed in one or more categories approved through federal regulations. Some examples of studies approved under expedited review include:
Research that involves temporary deception, for which consent is confirmed following a debriefing;
Survey research that probes highly sensitive topics or is likely to be stressful for the participants; or
Collection of blood samples in small amounts.
Note that the judgment of the expedited reviewer may be that even if a study is prima facie elligible for expedited review, the reviewer may refer the study for discussion by the full board.
Full Board Review:All 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;
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.
Yes, this is permissible. In general, if you offer participants compensation--also called an incentive or honorarium, and whether the compensation is in cash, tokens (such as a gift card), or in kind, such as undergraduate psychology course credit for participating in research--the compensation should be in line with the amount of time spent, distance travelled, discomfort experienced, or comparable metrics of contribution and inconvenience; or in line with local practices (where applicable). If your study involves a risk of adverse consequences, the amount of compensation may reflect that, but it may not be so large as to constitute an undue influence--that is, it should not be so large as to plausibly persuade a person to take more than minimal risks that a person would not otherwise consider taking.
The points above regarding compensation in general apply to variable compensation. Giving different compensation based on metrics of differential participation is permissible.
If elements of chance are introduced, there is one additional consideration that applicants may be advised to consider. This complication does not bear on the research participants but on the researchers.
If a study distributes compensation in the form of a prize based on a random drawing, where entry to the drawing is in return for participation in the research, that drawing fits the definition of a lottery in the State of California, as covered in Penal Code (PEN) Sections 319-29 (see below.) This law discourages lotteries by classifying the operation of a lottery (but not participation in it) as a misdemeanor. This law carves out a few explicit exceptions to this prohibition, as do some other statutes; for example, the California Lottery is excepted by GOV 8880.2. Conducting a lottery strictly for research purposes is not one of those exceptions, and a lottery that uses the internet but is based in California is also not an exception. For studies conducted outside of California, laws regarding lotteries vary State by State, and the researcher would need to investigate the relevant statutes.
California PEN 319 was enacted in 1872 and stands unchanged, defining a lottery as “any scheme for the disposal or distribution of property by chance, among persons who have paid or promised to pay any valuable consideration for the chance of obtaining such property…whether called a lottery, raffle, or gift enterprise, or by whatever name the same may be known.” Cash or a gift card is property, and participation in a study is a “valuable consideration” to a study's PI. However, IF participation in the study is not required as a condition of entering the random drawing, the drawing does not meet the definition, and operating it is not a misdemeanor.Therefore, if anyone who learns about the drawing is able to enter it without having to participate in the study, the ban does not apply--this is equivalent to stating that "no purchase is necessary to enter." If information distributed about the study states that someone can enter the drawing without participating in the research--equivalent to the familiar "no purchase is necessary to enter"--the operator's risk of penalty under this statute, which is not high for small studies and small prizes, reduces to nil.
Studies that vary the amount of compensation based on the level of participation or the performance or decisions of the research participant are not lotteries ifthe variation in compensation is intrinsic to the experimental design and is carried out in a systematic, non-random way. Such variations should be signaled when obtaining informed consent. If it is critical for the validity of the research to give participants the impression of randomized compensation (such as, “there is a one-in-xx chance that you will receive so many dollars…”, butthe researcher does not actually employ a random drawing to distribute these funds, that approach is fine if presented as a hypothetical, or it may be allowable as temporary deception, that is, as long as any false or misleading impression is addressed and removed in a post-study debriefing, when fully informed consent (permission to use the data) is obtained. If a study incorporates a drawing for a prize by chance, then the researcher runs the same type of risk described above.
The IRB may determine there is insufficient information to approve, disapprove, or exempt 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 review of the application is resumed.
The IRB may determine that an application does not meet the criteria for exemption, and that the risks of the proposed activity outweigh the benefits, or the protocol does not provide for suitably informed consent, or that other applicable aspects of the Common Rule are not complied with, and therefore approval cannot be granted. The IRB is always gives the researcher opportunities to modify or supplement the research plan appropriately to gain approval. Following such consultations, the IRB has denied approval outright in only a handful of cases.
No. Whenever an application is received, it is evaluated by the IRB staff to determine what level of review is appropriate. As indicated above, research may be deemed exempt from IRB supervision. 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. It is not necessary or advisable nor is there any specific procedure for an applicant to ask for a specific level of review, this is determined only after review of the complete application. The level of review may be revised due to amendments or for renewal purposes.
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.
Expedited or Full Board Approval is valid for one year even it it is a multi-year project, although a shorter approval period may be specified by the IRB. If the project was initially designed to go beyond one year and was approved with that assumption, an annual renewal can usually be easily expedited through a renewal application. The renewal process follows a similar timeline in granting approvals as an original IRB application. Exemption does not expire, but is contingent on maintenance of the study characteristics described in the original application. Any change in those characteristics requires that an amendment to the application be filed with the IRB so the determionation of exemption may be reconsidered.
The principal investigator (PI) is ultimately responsible for the conduct of research, including ensuring that an investigation is conducted according to the approved protocol, the applicable regulations, and the ethics and best practices of the relevant professional discipline. The PI is also responsible for assuring that the rights, safety, and welfare of the research participants are not compromised by the research.
The best way to protect private data is to not collect it in the first place--that is to avoid recording information that uniquely identifies the individual participants in the study when not needed in order to reach the research objectives. In this age of internet connnectivity and fast microprocessors, information such as personal names, email handles, physical addresses, dates of birth, birthplaces, and the like are readily searchable and easy to concatenate. Where recording such information is necessary for immediate research purposes, it should be separated as soon as practicable from the main data and linked to it, if needed, only by indirect "keys."
Digital files are subject to theft, loss, or invasion. Electronic data files (including video and audio) that include any identifiers or clues to identity, whether cloud-hosted or saved on hard media, should always be encrypted with a strong file-level password that only the investigator and other members of the research team trained in human subjects protection have access to. It is a good idea to change the encryption password before placing data files into more permanent storage. We recoomend multiple layers of protection, such as internet firewalls and drive-level and system passwords. Identifiable data that resides on paper, when not in use by the research team, should always be stored under lock and key, preferably double layers (a locked file cabinet in a locked room.)
No. The IRB does not as a rule advise or require the destruction of analytical data. But it does advise that whenever anonymity or confidentiality has been promised, any identifying information or clues about individual participants that have been kept in the study data should be erased or, if partial information is analytically useful, should be recoded to more generic categories, or unique individual values scrambled, or otherwise rendered non-identifying, as soon as the need to maintain information about individual participants is no longer present. After the recording of a confidential oral interview has been transcribed in writing, checked for accuracy and inclusion, and adopted as the primary data source for the study, the audio recording itself should be erased or irreversibly distorted or degraded so that no unique vocal cues to identity remain.