Institutional Review Board (IRB)

Graduate student at poster presentation

Overview

If you conduct research using human participants, Federal Law and College Policy mandate that participants be adequately protected from harm of any kind. This applies to all human participants in a study including whether or not they are members of the RIC community. Rhode Island College's Institutional Review Board (IRB) is a committee of faculty and staff members who are charged with the responsibility of reviewing research involving human participants to determine whether they meet Federal Guidelines regarding:

  • The rights, welfare, and privacy of participants
  • Whether the risks to participants are outweighed by the potential benefits of the knowledge gained
  • Whether informed consent is obtained from participants and documented by appropriate methods

Meeting Dates

The Committee typically meets on the 3rd Friday of the month, although other dates are required to accommodate holiday and vacation breaks. Applications must be completed and ready for review by the 1st of the month to be reviewed that same month. Please note that revisions are often needed before a proposal can be sent for review, so the application process should be started several weeks earlier to ensure that it is ready by the 1st of the month deadline.

Committee Members:

Dr. Emily Cook, Chair (2021-2024)
Dr. Jesse Capece, Prisoner Advocate and Social Work (2021-2024)
Dr. Christine Connolly, Marketing and Management (2020-2023)
Dr. Andrea Dottolo, Psychology (2021-2024)
Dr. Michael Giacalone, Student Activities (2020-2023)
Dr. Paul LaCava, Special Education (2019-2022)
Dr. Kevin O'Connor, Unaffiliated member (2021-2022)
Dr. Penni Sadlon, Nursing (2021-2024)
Dr. Jason Sawyer, Health and Physical Education (2019-2022)

IRB Information

A. Powers and Duties

1. Institutional Review Board (IRB)

a. Consonant with approved policy (as identified in the document entitled " Institutional Review Board Policies and Procedures Manual"), the Committee shall establish, publish, and implement procedures governing the use of human participants for research conducted by members of the Rhode Island College Faculty/Staff/Student Body. The Committee shall make policy recommendations to Vice President for Academic Affairs on matters within its purview. The Committee shall comply with all published regulations and policies of the U.S. Department of Health and Human Services (DHHS) pertaining to the protection of human participants for purposes of research.

b. The Committee shall evaluate proposed research projects and activities involving human participants solely for the purpose of insuring that research projects are in compliance with federal regulations and the policies and procedures of this Committee. The Committee shall make every effort to avoid infringement of academic freedom.

c. The Committee shall maintain continuing constructive communication with the principal investigator of a study or, in the case of student research, with the faculty research advisor.

d. The Committee shall maintain appropriate and informative records of its reviews of applications and active projects; of documentation of informed consent; and of other documentation that may pertain to the selection, participation, and protection of participants. The Committee shall also review circumstances that may adversely affect the rights or welfare of individual participants.

e. The Committee shall present an annual report to distribute to the Vice President for Academic Affairs and RIC faculty and staff.

f. The bylaws shall be periodically reviewed and updated to reflect current regulations, policies, and procedures.

2. Chair

The Chair shall:

a. Receive all research proposals that involve human participants and shall make them available to the assigned reviewers.

b. Make an agenda available to the members of the Committee prior to each meeting.

c. Allow principal investigators (PI) to attend meetings of the Committee so that the PIs may have the opportunity to explain their proposals under consideration.

B. Membership

The IRB shall consist of at least five (5) voting members.

1. Membership shall conform to federal requirements. Members shall be appointed by the Vice President of Academic Affairs upon recommendation of the Committee members to serve for staggered three-year terms.

2. No member of this Committee may take part in any reviews of any project or activity in which that member has an active role or in which there may be a conflict of interest.

3. The appointment of the Chair will be made by the Vice President for Academic Affairs.   

4. Members shall continue until their successors take office.

C. Meetings

1. The Committee shall meet, as necessary, at the call of its Chair, or upon written request of the Vice President for Academic Affairs or any four members, and in any case at least once a semester.

2. The Committee may take action only by majority vote in which a quorum of voting members is present.

3. All meetings shall be subject to such advance notice as may be specified by the Committee.​

What does the IRB look for in the application?

A summary of the main ethical principles involved in IRB review is that: (a) risks to participants are minimized, (b) risks to participants are reasonable in relation to the importance of the knowledge that may result, (c) selection of participants is equitable with special considerations given to populations vulnerable to coercion, (d) informed consent is obtained and documented, (d) data collection is adequately monitored to ensure the safety of participants, and (e) there are adequate provisions to protect the privacy of participants and to maintain the confidentiality of their data.

Does my project need to be reviewed? Do pilot studies need to be reviewed?

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. Examples: 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 (IRB@ric.edu) to verify whether or not your research activity is governed by this policy.

I'm a researcher at another institution who has approval from my IRB. I want to recruit participants from RIC. Do I need to be reviewed by RIC's IRB also?

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 Chris Hourigan (chourigan@ric.edu) 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 (irb@ric.edu) to determine whether review is needed.

I'm collaborating with someone at another university. Do we both have to get IRB approval?

Cooperative research occurs when researchers from different institutions are collaborating on the same project and their IRB's 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. Please contact the IRB Chair at irb@ric.edu for more information about the cooperative review process.

I'm a RIC student doing research. Does it have to be reviewed?

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.

What is meant by "minimal risk"?

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.

What constitutes "coercion"?

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.

I'm a faculty member who wants to give my students extra credit to participate in my study. Is this allowed?

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.

What constitutes "deception"?

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.

How do I know when my proposal is approved?

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.

How long is my approval good for?

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.

What happens when the approval period is over?

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.

Does the IRB review proposals over the summer?

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.

How can I learn more about research ethics? How can I teach about research ethics in my classes?

All investigators (faculty, staff, students) are required to complete the CITI online training before submitting an IRB proposal (www.citiprogram.org). 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 at IRB@ric.edu​ for suggestions for other classroom activities or assignments on research ethics.

Non-Compliance

Noncompliance is defined as a failure to comply with any of the regulations, laws, or organizational policies as well as not complying with any determinations of the IRB. Noncompliance may be serious or non-serious (minor), a one-time incident or continual. Serious, increases risk of harms to subjects, decreases potential benefits, or compromises the integrity of the research. Research conducted without prior IRB approval, or research conducted where subjects have not provided their informed consent (unless this requirement was formally waived by the IRB), always constitutes serious noncompliance. Noncompliance policies are outlined on the OSP website and noncompliance should be reported to the IRB as soon as it occurs: OSP Policies and Procedures.

Unanticipated Problems

Investigators must report all potential unanticipated problems to the IRB. Unanticipated problems are defined as any incident, experience or outcome that meets all of the following criteria:

  • Unexpected (unforeseen by the researcher or the research participant) in terms of nature, severity, or frequency, given the research procedures and the subject population being studied;
    and​
  • Related or probably related to participation in the research, or if the event or problem probably or definitely affects the safety, rights and welfare of current participants;
    and​
  • Suggests that the research places subjects or others at a greater risk of harm (including physical, psychological, economic or social harm) than was previously known or recognized.

Adverse Events

Investigators must report all adverse events to the IRB. Adverse Events are defined as any unexpected or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject’s participation in the research, whether or not considered related to the subject’s participation in the research. Adverse events encompass both physical and psychological harms. An adverse event would not be considered an adverse event if either of the following applied:

  1. the known or foreseeable risk of adverse events associated with the procedures involved in the research are described in the protocol-related documents, such as the IRB-approved research protocol, any applicable investigator brochure, and the current IRB-approved informed consent document
    Or
  2. the event is part of the expected natural progression of any underlying disease, disorder, or condition of the subject(s) experiencing the adverse event and the subject’s predisposing risk factor profile for the adverse event

How to Report a Potential Unanticipated Problem or Adverse Consequence

Investigators who experience any complaints, unanticipated problems, or adverse events must report this information promptly (typically, within 48 hours) to the IRB for evaluation. Please report this by either using the below form or by accessing TOPAZ and Choosing Create Interim Review Protocol under the Protocols Tab. The IRB Chair will review this report and will contact the investigator if more information is needed.

IRB Unanticipated Problems Report

For more information on Unanticipated Problems or Adverse Events you can go to 
https://www.hhs.gov/ohrp/regulations-and-policy/guidance/reviewing-unanticipated-problems/index.html#Q1​

Submitting an Application

CITI Training

Before submitting your application, investigators must have completed the Collaborative Institutional Training Initiative (CITI) program. The PI is responsible for ensuring that study personnel who work with human participants data have current CITI training certification. Certification must be renewed every 5 years. If this is your first time using CITI, register at their website and select Rhode Island College as your affiliation. You will then be able to select the coursework to complete. The required training module must be one of the following from Question 1, as appropriate for the research in this application: (a) Biomedical Research Investigator, (b) Social & Behavioral Research Investigator, (c) IRB Members, (d) Students conducting no more than minimal risk, or (e) Research with data or laboratory specimens only. Please see the attached guide for detailed instructions on how to register for CITI training. 

Submitting Your Protocol

Protocols must be submitted online using the TOPAZ system. See attached documents on how best to use TOPAZ. Once the protocol has been submitted, please plan on the reviews taking a minimum of 3 weeks, and plan accordingly. Reviews that require revisions or that require review by the full board will take longer.

Creating Your Consent Materials

Please use the examples below to ensure that your consent materials meet the federal standards for required information. It is important to use these as a guide and to make sure that you develop your consent using the template.

Examples of consents are available below in Spanish (Latin America) and Portuguese (European) to use as guides when translating your IRB documents. Please note, these are just examples and when translating your documents you should think of your specific audience and documents should be translated by a native language speaker or a certified translator.

Research Considerations During COVID-19 (updated 7/18/2021)

In response to the COVID-19 virus, in-person research at RIC has not been occurring since March 2020. As in-person research resumes, the Rhode Island College Institutional Review Board on Human Participants (IRB) has developed guidance for those planning on conducting research on-campus and off-campus. Please access this guidance HERE. Additionally, please click HERE for language to add to the consent if conducting in-person research.

Rhode Island College entrance

Committee Chair