SPECIAL GUIDANCE

In most cases, class projects involving human participants are not intended to contribute to generalizable knowledge and, therefore, do not need to be reviewed by the IRB. However...

IRB approval should be obtained using the IRB Application if:

• Personal information (e.g., opinions, behaviors, beliefs, feelings, etc.) will be collected from a human participant, regardless of the sensitivity of the data or if data will be collected through interaction,

AND

• The results of the classroom research project will contribute to generalizable knowledge and be shared publicly beyond the classroom (e.g., by publishing — including master’s theses; loading to a cloud or online database such as an e-portfolio; presenting outside the class; posting on social media or LinkedIn; poster presentations).

IRB review and approval are not required for human subjects classroom research in which the results stay within the classroom and are not presented or made available anywhere else. Even if IRB approval is not necessary, the research participants should be protected and treated with respect.

Students who plan to collect data from human subjects for their research project should contact the IRB Office (IRB@jcu.edu) BEFORE they begin their project. This applies to students in Communications, Exercise Science, Sociology, Political Science, and Business, among others. Some student research will require IRB review; others will not. It depends!

All students taking Research Methods in Psychology (PS301 or PS401) or Independent Research in Psychology must submit applications to the IRB to have their research projects reviewed and approved.

If you have any questions about students conducting research as a part of a course, please contact the IRB Administrator at IRB@jcu.edu.

Researchers who are in a position of authority over their participants must be particularly careful to avoid the appearance or possibility of coercion. The power dynamic between students and their instructors and mentors requires careful consideration. When researchers have a dual role as an instructor or mentor, it is essential that measures are taken to prevent any possibility of coercion. Although you may feel like your research is not coercive, students may feel pressured to participate.

The JCU IRB has developed the following guidelines for faculty members/instructors who wish to use their own students in a research project, regardless of the level of risk or type of research project. 

Researchers are asked to recognize that coercion to participate in a study, however benign, adds an increased level of risk to the participants. To mitigate this risk, the IRB suggests that the following procedure be followed:

1. For those studies where the class material will be used in the study, students should be notified early in the semester that they will be asked to consent to the use of their classwork/data in a research study (this step is especially important when the data includes reflection pieces or personal essays).
    
2. Consent materials should be distributed and collected by someone other than the instructor (an independent third party such as a colleague, graduate assistant, or department administrator).
    
3. Completed consent forms must be withheld from the instructor until grades have been posted at the end of the semester.
    
4. Surveys with Students:

• For one-time surveys distributed during class, written consent should be waived so that there is no record of who participated and who did not.
• The survey could be distributed during class and returned to an independent third party (department administrator, GA, other faculty, etc.) at a later time.
• Surveys completed during class should be distributed and collected by an independent third party, not the instructor.
• Completed surveys should be withheld from the researcher until after grades are posted.
• Anonymous online surveys using Qualtrics or Google Forms may eliminate some coercion.
• Identifiers such as handwriting and demographic data may make a survey identifiable and breach privacy.
• Peer coercion may be an additional factor for in-class completion of surveys.

Faculty members/instructors who wish to use their students in a research study are strongly encouraged to discuss their project with the IRB Administrator prior to designing the protocol to delay approval of the project. The IRB Administrator may be able to suggest other ways to mitigate coercion and/or increase privacy protection.

For more information on this topic, see also:

• Conducting Research with Your Own Students (Teachers College, Columbia University)
• Students as Research Participants (Syracuse University)
• The Many Faces of "Coercion" and "Undue Influence" (Advarra IRB)
• Swenson, E. V., & McCarthy, M. A. (2012). “Ethically conducting the scholarship of teaching and learning research.” In R. E. Landrum, M. A. McCarthy, R. E. Landrum & M. A. McCarthy (Eds.), Teaching ethically:
  Challenges and opportunities. (pp. 21-29). Washington, D.C.: American Psychological Association.

One of the primary ways the IRB evaluates projects is by the degree of risk to the privacy of the participant. The IRB considers these questions for research projects:

• Is there a risk of release of private information because the study population is too small and/or locally known?
• Who will have access to the data?
• How will the data be collected and maintained?
• How will the data be reported?
• How harmful will a breach of privacy be to a participant?

Because the JCU community is relatively small, the IRB is concerned with the collection of demographic information on campus that might identify a research participant. Therefore, researchers are encouraged to limit the collection of demographic data for those studies in which JCU students or employees are enrolled as research participants.

Listed below are some important privacy-related definitions:

• Anonymous
  Data are anonymous if there are no identifiers connected to the data and the researcher is unable to link data to any one individual. Example: An online survey that does not collect identifiers would be an anonymous survey.
• Confidential
  Data are confidential if the researcher can link a data set to a particular participant but will protect the privacy of the participant from others. Example: A psychology student collecting behavioral data in the Dolan media labs from a member of the Psych Pool would be collecting confidential data; the privacy of the participant must be protected by the researcher(s).
• Identifiers
  Identifiers are types of data that can identify a research participant. Identifiers include gender, religion, birth month, salary range, city of origin, or ethnicity, especially if the participant pool is small. Focus groups or in-person interactions (such as those conducted in the psychology media labs) cannot be considered anonymous since visual recognition is an identifier. Dissemination of audio tapes is not confidential since voice recognition is an identifier.
• Privacy
  The federal Office of Human Research Protections online guidebook defines privacy as “control over the extent, timing, and circumstances of sharing oneself (physically, behaviorally, or intellectually) with others.” Loss of privacy is considered to be a risk factor.
• De-Identified Data:
  Data that previously contained identifiers, but which have been stripped, and no “code” linking the data back to identifiers still exists, such that the dataset cannot be “re-identified” by anyone.
• Coded Data:
  Data is NOT "de-identified" but is "coded” or “indirectly identifiable” if researchers have “coded” the data and stored the code separately from the research dataset, or the data provider has the “key” to “coded” data. Anyone can “re-identify” the data by linking the dataset to direct identifiers, even if the researchers do not.

Manner of Data Collection and Reporting

If the data are of a sensitive nature, the IRB would carefully examine the informed consent document to ensure that the participant is aware of the study design. Projects may collect data in a confidential manner but analyze and/or report it in an anonymous manner. Individual data sets can be re-identified in some cases; reporting aggregated data protects the privacy of the individual. Or the data may be collected and analyzed on an anonymous basis. Rarely are data collected, analyzed, and reported with the identity of participants disclosed. The consent form and IRB application should make these procedures clearly understood.

In some cases, the use of a consent form itself may lead to a loss of confidentiality.

Collecting Research Data with Electronic Surveys:

The JCU IRB has the following suggestions for setting up online surveys when a breach of privacy might cause harm:

• The survey should be posted on a host site (e.g., Qualtrics) that uses SSL Technology to encrypt responses. We are fortunate that John Carroll has an institutional subscription to Qualtrics, a powerful and easy-to-use survey platform. This means that anyone in the JCU community can set up a Qualtrics survey free of charge. Please contact Jay Tarby for more information about Qualtrics security, or contact the IRB Office for help with setting up a Qualtrics survey.
   
• By default, neither IP addresses nor emails will be automatically collected by Qualtrics. This means that you can collect data anonymously with Qualtrics. 
   
• If Google Forms is used to create a survey, make sure that it does NOT collect email addresses. The default setting for Google Forms is to collect the user's email.
   
• To further protect the privacy of survey participants, the collection of Identifiers (address, hometown, race, religion, sexual orientation, etc.) should be minimized and limited to only what is necessary for the study.
   
• If participants are invited to enter a lottery or raffle at the conclusion of their participation, email addresses should be collected and maintained separately from survey responses. Please see the IRB Office for tips and tricks for setting this up.
   
• The IRB Office has provided several informed consent templates for gaining electronic consent in a Qualtrics survey. Please see the IRB Forms & Templates page for these templates.
   
• The informed consent page should include this language: “There are risks to participating in Internet-based research with regard to potential breaches of privacy or anonymity. Be aware that some companies monitor employee internet usage.  Please be sure to close your internet browser once you have finished the survey to protect your privacy.  In addition, you can further safeguard your privacy by deleting the webpage history from your browser after closing the survey link.”

Gaining Informed Consent Electronically

Participants in a minimal-risk, online survey are unable to provide a written signature on an informed consent document. Instead, the landing page of the survey should provide all of the information necessary for a participant to make an informed decision whether or not to participate in the study. Researchers may use one of the available templates as a guide to writing this landing page.

Because participation is voluntary, the participants must be given the option to leave the survey. At the bottom of the landing page, the participant should be asked to answer “Yes, I agree to participate in the study” or “No, I do not wish to participate.” The submit button will forward the page to the start of the survey or will exit the survey.

A waiver of signed consent should be requested in Section 8.d.(ii) of the IRB Application.

Minimizing Risk

In order to make each question of an online survey voluntary, the IRB may insist that surveys do not have questions with required responses so that the participant is permitted to skip answering any question. An alternate method would be to require a response, but list “I choose not to answer” as one of the possible answers.

Informed Consent

The purpose of informed consent is to help investigators protect research participants by informing them about the nature of the research, including the procedures to be followed and any associated risks or benefits to participation. In compliance with federal regulations, the IRB carefully reviews informed consent documents.

There are several useful informed consent templates that investigators should use as a model when writing their documents. However, the IRB strongly believes that participants’ rights are best protected when investigators determine the appropriate tone, language, and format of the consent form based on what they believe will best convey study information that is accurate and understandable to their participants.

Bottom line:
Use templates, but tailor them so that they’re appropriate, informative, and understandable to your research subjects.

Regulations require that certain basic elements be included in informed consent. As a general rule, the following points should be considered when writing an informed consent:

• Include the basic required consent elements specified by the federal regulations.
• Use simple language. We suggest that it be written at no more than an 8th-grade reading level.
• Avoid technical and legal terms.

For certain minimal risk studies, the use of a “study information sheet” may be more appropriate than collecting written signatures of participants on a standard informed consent document. Please contact the IRB Administrator to learn more about when the use of an information sheet is appropriate.

Visit the IRB Forms & Templates page for templates and sample documents.

Assent:

A minor (child) is a person who has not attained the legal age of adulthood, which is 18 in the state of Ohio*. A minor can assent but cannot legally consent to treatments or procedures involved in research.

Out of respect for children as developing persons, children should be asked whether or not they wish to participate in the research. The IRB must determine for each study whether all or some of the children are capable of assenting to participation. Federal regulations do not require that assent be sought from children starting at a specific age; therefore, determination by the IRB will be made based on such factors as the nature of the research and the age, maturity, status, and psychological state of the child participants. Note that the basic consent elements required for an adult consent are not required to be included in a child assent.

Assent for children should be written using simple language that the child can understand. Generally, the IRB suggests the following types of assent be used based on a child’s reading ability:

• Oral Script: A simple oral script can be read to young children who are not proficient at reading but are still capable of giving assent.
• Written Assent: A written and signed assent form can be given to older children/minors who are proficient readers and capable of comprehending concepts such as a research study, voluntary participation, benefits, and risks.

NOTE: The JCU IRB hesitates to specify an exact age range where an oral script versus a written and signed assent is appropriate. In some instances, assent cannot be obtained (e.g., babies and toddlers), and only parental permission is necessary. Each situation and child is different, and therefore, the JCU IRB, in conjunction with the principal investigator, will make the appropriate determination on a case-by-case basis.

*In the United States, the legal age of adulthood is a matter of state and local law. Please see https://www.hhs.gov/ohrp/regulations-and-policy/guidance/faq/children-research/index.htmlfor more information about research with children.

Federal Regulations, 45 CFR 46, §46.102 (i), use the following to define a research protocol as “minimal risk”:

“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.”

According to the regulations, non-exempt human subject research protocols that present no more than minimal risk to the research participants may be reviewed by the IRB with Expedited review procedures. Exempt or Expedited review processing at JCU can take up to three weeks from the time an application is submitted.

Any research that presents more than minimal risk to the participants will most likely be reviewed by the fully convened IRB. At John Carroll University, full board reviews usually require 4-6 weeks, and even longer if significant revisions are necessary. Researchers who plan greater than minimal risk research should plan accordingly for a possibly lengthy review period.

If you have any questions about IRB review categories or processes, please contact the IRB Administrator in SIH 331d, x1527.

The IRB looks closely at the use of concealment and deception in research projects because of the possible increase in harm to the human subjects.

Concealment definition: Information is withheld from the participant before the decision to consent or during the experiment. Justification can be made that the results of the study may be tainted if the participant were fully informed of the research question or design.

Deception definition: False information is deliberately given to the participant either before or during the experiment.

The JCU IRB will usually require the following for experiments involving concealment or deception:

1. The justification for the use of concealment/deception
2. Alternatives to the use of concealment/deception that were considered and why they were rejected
3. Recognition of the risk of using concealment/deception
4. Methods of minimizing risk and dealing with any resulting mistrust or harmful effects after the experiment.
5. A debriefing statement and possibly a re-consenting process allowing for the opportunity to withdraw the data from the study

If you have any questions about the use of concealment or deception in your study, please contact the IRB Administrator.

In special circumstances, the Federal government will issue what is called a “Certificate of Confidentiality” to protect the privacy of research subjects. These certificates are granted to investigators and protect them against the “compelled disclosure of identifying information about subjects of biomedical, behavioral, clinical, and other research.” Thus, it protects investigators from being forced to reveal the identity of participants in their research project in legal proceedings.

This formal protection can be granted when the research is of a sensitive nature, such that the protection is judged necessary to achieve the research objectives. A research project is considered sensitive if it involves any of the following categories:

1. Information relating to sexual attitudes, preferences, practices, or gender identity;
2. Information relating to the use of alcohol, drugs, or other addictive products;
3. Information pertaining to illegal activity;
4. Information that, if released, could reasonably be damaging to an individual’s financial standing, employability, or reputation within the community;
5. Information that would normally be recorded in a patient’s medical record, and the disclosure of which could reasonably lead to social stigmatization or discrimination;
6. Information pertaining to an individual’s psychological well-being or mental health; and
7. Genetic information.

Investigators conducting research that warrants this kind of protection may apply for a certificate. Certificates are granted by representatives from different research funding agencies (although funding is not a prerequisite). More information can be found at “Certificates of Confidentiality – Privacy Protection for Research Subjects: OHRP Guidance” or the National Institute of Health’s Information Kiosk on Certificates of Confidentiality.

In circumstances where the Investigator requests participants to divulge sensitive information, such as illegal activities, and where the information will be linked to the participant’s identity, the IRB may require an Investigator to apply for a Certificate of Confidentiality to ensure that participants are more fully protected.

If you are unsure whether you should obtain a Certificate of Confidentiality for your research, please contact the IRB Administrator.