FREQUENTLY ASKED QUESTIONS
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.
- Create a protocol in Axiom Mentor.
- The pre-protocol questionnaire will help to determine whether your study requires IRB review and, if so, what level of review it is likely to need.
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 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.
After your application is reviewed, you will either receive a notification 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.
- 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.
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.
- 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.
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 if the 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…”, but the 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 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.
- 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.
- Substantial changes in the focus, procedures, or participant population of the research may require submission of a new application.
- Call the IRB at (909) 607-9406 if you have questions about what kinds of changes require new applications.
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 recommend 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.)