Frequently Asked Questions
The main ethical principles involved in IRB review are as follows:
- risks to participants are minimized
- risks to participants are reasonable in relation to the importance of the knowledge that may result
- selection of participants is equitable with special considerations given to populations vulnerable to coercion
- informed consent is obtained and documented
- data collection is adequately monitored to ensure the safety of participants
- adequate provisions exist to protect the privacy of participants and to maintain the confidentiality of their data.
The federal guidelines define research as “a systematic investigation designed to develop or contribute to generalizable knowledge." A systematic investigation is the opposite of a disorganized, random venture. In other words, researchers need to have constructed a research plan with ideas about what they want to learn and how best to do that. Both qualitative and quantitative researchers may use systematic investigation.
To generalize is to derive general conclusions from particulars. Therefore, the essential consideration is whether it is the researcher's intent to contribute to a body of knowledge or whether the results were replicable. Usually this means publication or presentation – but not necessarily. You might present on something and have no real agenda to generalize it – you simply are talking about your experience and what you learned from it.
Scholarly research activities, including pilot studies, which involve human participants and which are intended to develop, test, or advance the body of knowledge in your field require IRB review. If you are planning to conduct research with animal participants, then you should submit an application to the RIC IACUC, not the IRB.
The activities listed below are research activities, but are not governed by the federal law and do not require IRB review:
- research activities that are categorized as journalism or oral history
- research on deceased persons, for example, conducting interviews to write a biography about a deceased person
- quality assurance research
- publicly available data, like census data, labor statistics
(Contact the IRB if you are uncertain as to whether the data qualifies as “publicly available.”) - data collection or evaluation designed for purposes of improving services or teaching or for developing new services or programs
- research activities done in the context of a classroom and that are intended solely to teach the course material
(For example, students in a social sciences research methods class may ask people to complete an interview or survey in order to fulfill a course assignment. This activity does not require IRB review because its intended purpose is to be educational, not generalizable. Independent or directed scholarly research that contributes to the discipline, such as honors projects, thesis, or dissertations, require IRB review.)
When in doubt, contact the IRB Chair to verify whether or not your research activity is governed by this policy.
Researchers who are not affiliated with RIC may want to recruit RIC faculty, staff, or students to participate in a study. If no RIC administrator, faculty, student, or staff members serve as investigators, consultants, or otherwise collaborate on the research project, then the RIC IRB does not review the proposal and provides no official sanction of the research project. Researchers who are not affiliated with RIC should contact Sara Phillips in the Institutional Research and Planning Office to gain permission to collect data on campus.
Generally, Non-RIC investigators may use means of communication that are available to the general public (e.g., purchasing an ad in the student newspaper) to advertise their study, but are not permitted to use official RIC means of communication including the use of RIC letterhead, campus mail, or email. If a RIC employee will be involved with the research activities, contact the IRB Chair to determine whether a review is needed.
Cooperative research occurs when researchers from different institutions are collaborating on the same project and their IRBs also cooperate to avoid duplication of effort. Any institution located in the United States that is engaged in cooperative research must rely upon approval by a single IRB for that portion of the research that is conducted in the United States.
The reviewing IRB will be identified by the Federal department or agency supporting or conducting the research or proposed by the lead institution subject to the acceptance of the Federal department or agency supporting the research. The bottom line is that both institutions generally do not need to review the research.
Usually, one of the institutions will take the lead and provide review and the other will sign an Institutional Agreement Form if it is determined that the school is engaged in research. Please contact the IRB Chair for more information about the cooperative review process.
The decision of whether to review student research depends on the purpose of the project. Scholarly activities such as Honors Projects, Masters theses, and Dissertation projects are generally intended to produce generalizable knowledge; therefore they are required to undergo review.
Research activities done in the context of a classroom that are intended solely to teach course material do not require IRB review. For example, students in a social sciences Research Methods class may ask people to complete an interview or survey in order to fulfill a course assignment. This activity does not require IRB review because its intended purpose is to be educational, not generalizable.
The federal guidelines defines minimal risk as "...the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests."
In other words, "minimal risk" confers no greater risk than a person would encounter during their normal, daily activities. "Minimal risk" may vary from one person to the next as it is dependent on their routine activities; for example, what constitutes "minimal risk" may differ for police officers vs. nurses vs. college students.
Coercion is defined as "the use of force or intimidation to obtain compliance". In the research context, coercion occurs when a researcher uses undue influence to get a person to participate in a study.
Coercion to participate may be overt or subtle. An example of overt coercion would be an offer to give a prisoner better cell conditions or special privileges to participate in a study. The prisoner does not have direct control over his/her environment and is dependent on others to provide a suitable environment; consequently, offering improvements in exchange for participating in the study is overtly coercive.
An example of more subtle coercion would be a supervisor asking employees at the end of a staff meeting to answer a survey before leaving the meeting. This situation might be coercive because some staff members may participate in order to please the supervisor rather than out of any inherent interest in the study. In those instances when coercion may occur, it is best to remove the authority figure from the recruitment process and to find another person to recruit participants.
Before involving a person in research, an investigator needs to obtain and document the legally effective informed consent of that person (45CFR46.116). Historically, documenting consent would mean a written signature on a paper consent form. With more and more research being conducted online, many researchers are unsure what constitutes a valid consent process in online studies. The Office for Human Research Protections (OHRP) has guidance that states that electronic signatures may be used to document informed consent. The RIC IRB has consulted that document as well as other resources to provide recommendations for the online consent process that needs to be followed at RIC. Please see Online Consent Recommendations for that guidance.
One of the main ethical principles of research is that participation is voluntary. When a faculty member recruits his/her own students and/or offers extra credit, the potential for coercion exists (see above). Whenever extra credit is offered to participate, the instructor must provide a reasonable variety of alternative opportunities for credit that take an equivalent amount of time and effort.
If a questionnaire takes 10-15 minutes to complete, then having students to read a journal article and write a review of it as an alternative assignment does not constitute equivalent effort. Also, having students attend an hour-long event on campus is not equivalent to a 10-minute survey. The IRB carefully examines such requests to ensure that there are a variety of activities that reflect an equivalent amount of time and effort.
Deception in the research setting occurs when an investigator either (a) withholds information about a study from participants or (b) provides inaccurate or misleading information to participants.
An example of Situation A would be a researcher who is studying prejudicial beliefs. If the participant knows the purpose of the study, she may change her behavior to look more favorable to the researcher. In this case, it would be reasonably acceptable for the researcher to withhold that information and to say that she is studying "people's opinions about others" to prevent the participant from changing her behavior.
An example of Situation B would be a researcher who is studying people's reactions to disappointment. The researcher might give the participant a task and then provide bogus feedback which indicates that they performed poorly on the task. Anytime misinformation is given to a participant, the IRB must carefully examine the potential risks to the participant's well-being. Such deception may be permitted in some circumstances, but not others.
Anytime deception is used, the researcher must indicate in their application how the participants' rights and safety are not jeopardized and must provide a debriefing session which informs the participant of the deception and attempts to undo its effects before the participant leaves the study situation. It is never permitted to withhold information about procedures and risks that might influence a person's decision to participate in the study.
You will receive an approval notice from the IRB Chair. You will also receive copies of your consent form that have the official, approval stamp with the expiration date (if applicable). You must use the stamped forms when recruiting and consenting your participants. Do not begin any research activities until you have received both the approval notice and the stamped, approved materials because doing so would actually be illegal.
Approval of projects that are considered more than minimal risk and were reviewed by the full board are approved for one year. In certain circumstances, the approval period may be less than a year if the level of risk warrants more frequent reviews of the study. Expedited and Exempt protocols submitted after January 2019 have no expiration date and do not need to be reviewed on a yearly basis.
If you continue to be engaged in research with human participants – whether collecting data for new participants or collecting follow-up data from existing participants – you must submit a Renewal Protocol form in TOPAZ 30 days before the approval expires.
Please note that you are responsible for being aware of this renewal date and will not be given a reminder. If the approval period expires, you must immediately cease any data collection and submit a new application. You can resume data collection only after the new approval is given.
The IRB Chair reviews exempt and expedited protocols over the summer that are minimal risk. Generally, the IRB does not review protocols that need full board review over the summer.
All investigators (faculty, staff, students) are required to complete the CITI online training before submitting an IRB proposal. Training must be renewed every 5 years. Instructors of courses should have students submit IRB proposals only if the student is engaged in a scholarly research activity (e.g., honors project, masters thesis, dissertation, etc).
The IRB should not be used solely as a teaching tool or classroom assignment for students to learn about research ethics. Instructors who teach research ethics in their courses may wish to have their students complete the CITI training as a classroom assignment, or instructors can contact the IRB Chair for suggestions for other classroom activities or assignments on research ethics.
