Office of Sponsored Programs FAQs - Human Subjects

Research compliance including Human Subjects (red section)

FAQs about the Institutional Review Board (IRB) Process

 

Data collected without IRB approval cannot be used in theses, dissertations, or publications. This may ultimately prevent students from fulfilling graduation requirements, so students and instructors are urged to think ahead and plan when deciding whether or not to submit an IRB for student or class research.

1. What kinds of studies need IRB approval?

Any research conducted using living human participants must be submitted for review.

The Code of Federal Regulations (45 CFR 46.102 (d)) defines research as a systematic investigation (including research development, testing, and evaluation) designed to develop or contribute to generalizable knowledge. Federal Regulations (45 CFR 46.102), define a human subject as any living individual about whom an investigator obtains data through observation, interaction, manipulation of the environment, application of procedures or treatments, administration of therapies, communication, interpersonal contact, or physical procedures.

The submission of the IRB form entails filling out the Request for Human Subjects Review. The Office of Human Research Protections provides a useful chart to assist researchers with IRB questions concerning their research.

2. I am collecting data from my class to determine if students like a new teaching method. Do I need to go through the IRB to collect these data?

The federal guidelines define research as “a systematic investigation…designed to develop or contribute to generalizable knowledge”. The Department of Health and Human Services does not consider a study research unless you plan on disseminating the information you collect to a wider audience (e.g. through presentation or publication). To this end, if you are collecting data only to improve your course and will not be sharing the results (presenting them or publishing them), you do not need to fill out a Request for Human Subjects Review. If, however, you think you may want to present or publish your results, you need to submit a Human Subjects Review application. If you are collecting data from students in your class, it is imperative to make sure they know that refusing to participate will not affect their grades. Because collection of data from your class can be seen as coercive, it is essential to be cautious when asking students to participate.

3. What about student research?

The State University of New York at Fredonia does not require student projects conducted in courses to be reviewed if the purpose of these projects is only pedagogical in nature. If you have students who might present their research outside of the classroom or submit a paper for publication, they must go through the IRB. While the IRB does not require review of classroom projects, it is understood that instructors in these courses are providing the appropriate supervision of students, are teaching students the ethics of human research, and ensuring that students are not performing research that is at all questionable. Any student research proposal may be submitted to the IRB for approval, even if the data collected will not be published or presented outside of the classroom.

4. Is IRB review needed for class-related projects?

IRB review of classroom-related activities is not required when the collection of information from participants is exclusively for the purpose of class discussion or for the purpose of training in research or research methods.

Please note that even when IRB review is not required, any projects designed to collect information from human subjects should be careful to protect the rights of those subjects. In these cases, the instructor is responsible for educating students about the protection of human subjects and providing ethical guidance for all student projects.

Data collected for a class project may not be used for publication or presentation, unless the project was reviewed and approved by the IRB prior to recruitment and data collection. If there is any possibility of or intent to publish, present, or otherwise disseminate research data or findings outside the course in the future (e.g., for a Senior Paper, a Master’s Thesis, by the instructor), an application must be submitted for review and approval by the IRB prior to the start of recruitment and data collection. Students should discuss these limitations with their instructor or faculty advisor so that they can determine whether IRB review is necessary.

5. Do service-learning projects require IRB approval before students begin their service-learning?

The informal collection of information by students from respondents does not require IRB review.

If data collection and analysis are for instructional purposes only within the context of the course, without the intent of communicating it beyond the instructor and students of the course, IRB review is not required.

If a student research project intended only for class purposes develops into disseminated research, IRB approval must be obtained immediately. Please note that the IRB cannot grant retroactive approval.

IRB review is required only where there is the intent to undertake systematic investigation, produce a design or protocol for the research, sample a population, or report findings (either through a publication or a presentation outside of the classroom. IRB approval is not required for service-learning and community-based learning course projects (except in the case described above), however, this activity must still be planned and carried out in an ethical and legally responsible manner. Projects involving special populations (e.g., youth under age 18; prisoners, individuals with physical or mental disabilities; economically or educationally disadvantaged; institutionalized individuals; pregnant women) require additional safeguards. In these cases, researchers should contact the Human Subjects Administrator to determine whether IRB approval is required.

6. Are IRB applications required for students participating in the Study Abroad programs?

Yes-- if human subjects are involved and the primary objective is the development of new knowledge that will be shared publicly (i.e., thesis research).

No--if the primary objective is for the student researcher to learn research methods and procedures. If, however, this research poses more than no or minimal risk, or if the participants are members of vulnerable populations (i.e., children and/or impaired adults) or the research will be shared outside of the classroom, a Human Subjects Review form most be filled out and submitted.

7. For research with school-age children, do both the parent and the child have to give consent?

Yes. Parental consent is required, and the child must also give their assent to participate. For very young children, this process could involve a brief description of the activity culminating with asking the child's willingness to participate. A short written consent form in simple language or with symbols or graphics is appropriate for most children; older children should be given a more extensive written consent form that is closer in format and language to the one given to the parents. There are details regarding child assent in the Campus Policy on the Use of Human Subjects.

8. How do I obtain consent if I’m doing an internet survey or phone survey?

For Internet-based surveys, it may be appropriate to use implied informed consent. Participants would still need to be presented with the consent information, but would be informed that their consent is implied by submitting the completed survey.

For protocols involving oral consent, the PI MUST communicate to the participant what the participant will be asked to do, the amount of time the participant will spend participating, the voluntary nature of the participation, the ability to withdrawn fro the study at any time, that the information collected will remain confidential and the PI MUST offer the participant contact information for the researcher and the Human Subjects Administrator.

9. Can I use advertisements be identify potential participants?

Yes. Samples of all advertisements, such as flyers, newspaper ads, radio and television announcements, bulletin board tear-offs, and posters, along with an explanation of other methods of recruiting participants, must be submitted to the IRB.

Advertisements should be submitted with the application or as soon as the principal investigator decides to use them. The content of advertisements MUST include the manes of the PIs conducting the research as well as their affiliations, the location where the research

  • names of the investigators conducting the research, identification of the university by name as the location of the research or the researchers main affiliation, and contact information for the researchers;
  • purpose of the research;
  • general eligibility criteria;
  • straightforward and truthful descriptions of benefits (e.g. research procedures are free of charge) and risks.

Advertisements should not claim, explicitly or implicitly, that the research is treatment or is superior to any current practice. Extravagant attention-getting devices such as extremely large, bold typefaces and dollar signs for payment information are prohibited. Advertisements should not pressure readers into participating.

10. What is required for off-campus research?

Research that is physically conducted on private property (schools, hospitals, community agencies, NGOs, businesses) requires documented approval from that site.

11. How do I apply for approval?

Your proposal will fit into one of three categories: Category I (exempt), Category II (expedited) or Category III (full board review. Distinctions for these categories can be found in the Campus Policy on the Use of Human Subjects. If you believe your study is exempt, fill out the Blanket Exemption Form and attach that to your application before submitting (note, this form is for faculty and staff only

12. Do I need to go through the IRB process if my project is exempt?

Yes. If the proposed research activity involves human participants and may contribute to “generalizable knowledge,” it still must be submitted and reviewed by the IRB before any recruitment or involvement of human participants. Exempt research is a classification determined by the chair of the IRB.

13. Where do I submit the form?

Completed forms should be taken to the Office of Sponsored Programs and should also be emailed to the Human Subjects Administrator on Campus (Dr. Judith Horowitz). You will be notified via email or any questions, if changes need to be made or if the project has been approved as is. All IRB requests will be archived in the Office or Sponsored Programs.

14. How long with the review take?

If your study falls into the exempt or expedited categories, the process will usually be completed in less than two weeks. If your study requires review by the full board (i.e. your study does not meet the expedited criteria), the review could take a month to 6 weeks.

15. Can I start collecting data before I receive approval?

Absolutely not! You must have approval before any data are collected.

16. How will I know that my research has been approved?

You will receive an email from the Human Subjects Administrator indicating that you have been approved. Please note that approvals will be good for one year from the date of approval unless you state on your application that the data collection will last longer than one year.

17. How long does a researcher need to keep records of the research?

Researchers must keep documents showing informed consent for three years after the conclusion of the research. Some agencies that sponsor research may have a longer retention requirement.

18. Federal regulations require that all researchers receive training. How do I meet this requirement at Fredonia?

At Fredonia, all faculty, staff, and students who wish to submit research for review by the Fredonia IRB must complete the online training program available at www.citiprogram.org. You will need to register for the course and select State University of New York at Fredonia as your institution. Once you have completed the training, please retain a copy of the training completion certificate for your records. You will need to attach this certificate along with any Human Subject proposals that you submit. The online training approval is valid for two years. After this, refresher courses must be completed.

19. What happens if I conduct human research without IRB approval?

You will place the university out of compliance with Federal requirements that regulate human subjects research. This can result in Federal or IRB actions that will prevent you, your Department/Division, or the university from conducting human subjects research. It will also jeopardize the Institution’s human research certification with the Office for Human Research Protections (the FWA).

Data collected without IRB approval cannot be used in theses, dissertations, or publications. This may ultimately prevent students from fulfilling graduation requirements, so students and instructors are urged to think ahead and plan when deciding whether or not to submit an IRB for student or class research.

 

If I have other questions, where can I look for answers?

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Office of Sponsored Programs

E230 Thompson Hall
State University of New York at Fredonia
Fredonia, NY 14063
(716) 673-3528 phone