2. How do I know if I'm conducting research with human subjects?
3. How long will it take for me to obtain approval to do my study?
4. May I begin data collection upon department approval?
5. Do projects conducted by NIU students need IRB review?
7. Do I always have to obtain the informed consent of the research participants?
8. Do research participants always have to sign an informed consent document?
11. What do the terms "consent", "assent", and “permission" mean? Aren't they all the same thing?
12. My research will be done in another country. Do I have to obtain IRB review and approval?
17. Do I need IRB approval if my research is not externally funded?
20. What is the difference between "debriefing" and participant "follow-up"?
21. What is the difference between the terms "confidentiality" and "anonymity"?
Answer: IRB stands for Institutional Review Board for the Use of Human Subjects in Research. Any institution that receives federal funding to conduct research with human participants, such as NIU, is required to establish an IRB to review all research that directly or indirectly involves human subjects, and to set forth institutional policy governing such research. The primary responsibility of the IRB is to safeguard the rights and welfare of human research subjects. The confidentiality and human subject protection requirements are intended to protect research study participants from risks that may result from either a breach of confidentiality or any physical harm due to their participation in a study. The IRB is chaired by a faculty member and is directly responsible to the Vice President for Research. The membership, appointed by the Vice President for Research with the concurrence of the President, is composed of NIU faculty, staff, and community representatives who have no other affiliation with NIU.
All research that involves the use of new or previously-collected data from human subjects, from interviews to collection of bodily fluid samples, must be reviewed and approved by the IRB prior to initiation of the research.
2. How do I know if I'm conducting research with human subjects?
Answer: Research, as defined by federal regulations, means "a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge" 45 CFR 46.102d). Human subjects are living individuals about whom an investigator conducting research obtains (1) data through intervention or interaction with the individuals, or (2) identifiable private information. Regulatory requirements to protect human research participants apply to a much broader range of research than investigators sometimes realize, and researchers obtaining new data or using existing data are often unsure about how regulations apply to their research. Regulatory and ethical obligations to protect research participants apply, for example, to research that uses:
If you are uncertain whether your planned activities constitute research with human subjects requiring IRB approval, refer to the Screening Form on the IRB webpage or contact the ORC for assistance.
3. How long will it take for me to obtain approval to do my study?
Answer: That depends on the nature of your study and the characteristics of the people you intend to recruit.
Allow 5- 7 business days for projects that will undergo Administrative Review, typically ones that involve surveys and interviews given to adults, providing that you record the data in such a way that there is no possibility that the subjects can be uniquely identified by an outsider and that any disclosure of the their responses outside the research could not reasonably place the subjects at risk of criminal or civil liability or be damaging to the their financial standing, employability, insurability, or reputation.
Allow 7-10 days for studies that will undergo Subcommittee Review and 2-3 weeks for studies that will need to be reviewed by the convened IRB (Full-Board Review). A convened meeting of the full board is held approximately every two weeks. If changes to your protocol are requested then clearly the time could be longer. These time estimates do not include the time for departmental review prior to submission of your application to the ORC. The more lead time you allow, the better.
4. May I begin data collection upon department approval?
Answer: No. You must receive written approval from the IRB before beginning participant recruitment, data collection, or data analysis. A letter indicating your project has been approved will be sent to the address that you provide when you submit your application to the IRB.
5. Do projects conducted by NIU students need IRB review?
Answer: It depends on whether the student project is intended to be an educational exercise or a project that truly fits the definitions of research with human subjects (see #2 above and refer to the Screening Form). Educational exercises do not need IRB review if the data collection takes place inside the classroom and the information will not be shared outside the class. At the request of the instructor, the IRB may review educational exercises if the project involves a risky or sensitive topic and/or data will be gathered outside of the classroom, but IRB review of such projects is not required. IRB review is definitely needed, prior to the start of data collection, for theses and dissertations and for other projects for which the results will be disseminated in some way outside the classroom (for example, in a publication or at a professional conference). In certain circumstances, a project that starts out as an educational exercise/class project (that does not need prospective IRB review and approval) evolves into a thesis or dissertation (that does need IRB review and approval). The student and advisor should contact the ORC for more information as soon as the shift in emphasis is considered.
6. I've heard that the Federal regulations consider certain categories of research to be exempt. If my research fits into one of these categories, does this mean that I don't have to have it reviewed by the IRB?
Answer: No. NIU policy and the Federal Regulations are clear that it is not up to the investigator alone to determine if a project is exempt. NIU has assured the Federal government that the IRB has the responsibility for determining whether or not a project is exempt. "Exempt," as used here, does not mean that a project is exempt from review of any kind, nor does it mean exempt from ethical responsibility. But, rather, it means that it is exempt from review by the entire IRB at one of the semi-monthly meetings. At NIU, projects that fit into the exempt categories undergo Administrative Review, a process whereby an authorized Departmental Reviewer and the IRB Chair conduct the review. The IRB Chair, upon confirming that a project is exempt from Full Board Review, will issue an approval on behalf of the IRB.
7. Do I always have to obtain the informed consent of the research participants?
Answer: In general, yes, you do, but there are some limited exceptions. The IRB has the authority to waive some or all of the Federal requirements for informed consent in certain extenuating circumstances. (For more information refer to the Application for Alteration of the Requirement to Obtain Written Informed Consent.)
8. Do research participants always have to sign an informed consent document?
Answer: No. In certain research situations, all involving no more than minimal risk, the IRB can waive the requirement that you obtain the participants signature on a paper consent form. For example, if your participants cannot write, the IRB will authorize you to obtain consent orally.
In some situations the IRB might authorize you to obtain consent over the telephone or by e-mail. Sometimes the documentation requirement is waived if "implied" consent is sufficient. An example of this would be including a statement at the top of a survey or questionnaire informing participants that their completion and return of the survey implies their consent to participate. (For more information refer to the Application for Alteration of the Requirement to Obtain Written Informed Consent.)
The requirement to obtain written consent can also be waived if the risk to your participants would increase markedly because they signed a consent form (as in an interview or survey that addressed the participant's HIV status). You'd still need to obtain informed consent, but it could be obtained orally.
9. Do I need to prepare an informed consent process if my project qualifies for Administrative Review (i.e., exempt status)?
Answer: In general, yes. Regardless of the review category, the IRB is responsible for ensuring that basic ethical principles (functionalized in the regulations) are abided by in all research. While the exempt designation means that a project does not require review by the convened IRB or by Subcommittee Review procedures, it does not mean that it is exempt from the sound ethical principles set forth in the Ethical Principles and Guidelines for the Protection of Human Subjects of Research (a.k.a., The Belmont Report) (i.e., respect for persons, beneficence, and justice). The expectation that the informed consent of research participants be obtained is based upon the Belmont principle of respect for persons. Obtaining the informed consent of participants is required in most circumstances. In short, simply qualifying for Administrative Review does not determine whether consent or documentation of consent can be waived. NIU policies allow for some flexibility in the inclusion of the required elements and process for obtaining consent for these studies.
10. What should I do with the informed consent documents once the participants have signed them? Does the IRB need to see them?
Answer: No, the IRB does not need to see the consent forms that your research participants have signed. You, the researcher, are responsible for retaining the signed consent forms obtained from the participants in a secure location for a minimum of three years after the study is concluded.
11. What do the terms " consent “, " assent “, and "permission " mean? Aren't they all the same thing?
Answer: Sometimes the word "consent" is used to refer, loosely, to all three of these terms. When discussing research with human subjects, the term "consent" is used more precisely to describe the granting of legally-effective consent to participate in research by individuals who have reached the age of majority (in Illinois, this is age 18). When you intend to collect data from minors (in Illinois, individuals under age 18) who are capable of comprehending information about participation in your study, you must tell the children what to expect if they agree to participate in your research. You must make as certain as possible that the child understands that he or she has a free choice in the matter. The children must give you a positive affirmation of their interest in participating. This is their way of exhibiting "assent", or agreement. For younger children who are not yet able to read or write, it is generally most appropriate to achieve this via the use of an oral "script." For slightly older children who are able to read, this might be accomplished with a paper document, but is probably appropriate to supplement this with discussion. For children of middle- through high-school age, it is often appropriate to obtain the signature of the child, even if it is not legally effective. For most research involving children, it is necessary to obtain the signed "permission" of the parent or guardian in addition to the "assent" of the child. One individual cannot give legally effective "consent" for another and so the term "permission" is used to describe the agreement of a parent/guardian for their child/ward to participate in research. (Click here for more information on the assent process and information on the inclusion of children as research subjects.)
12. My research will be done in another state (or country). Do I have to obtain IRB review and approval?
Answer: Yes. If you are a member of the NIU faculty or staff, or an NIU student, you must get NIU IRB approval to conduct your research regardless of where the research will take place.
Moreover, you may also need to furnish proof that the project has been reviewed and approved by the IRB to the entity where the study will be conducted. You should also be aware of local and/or state laws that may impact the conduct of your research (e.g., legal age of consent is 18 in Illinois but may differ in other states or countries).
13. Is it true that I need IRB review even if I am not doing an "experiment", but I am only conducting interviews or surveys, using secondary data, or simply observing people?
Answer: Yes, As long as your research involves collecting data or information from or about living individuals, you need to have it reviewed by the IRB.
14. The “unit of analysis” for my study is an entire community (or village, culture, ethnic group, etc.). Do I still need to obtain the consent of each individual?
Answer: In general, yes. But it might depend upon the circumstances of your study. For example, in some cultures one or more individuals customarily make decisions for the group (e.g., the “village elders”) and less emphasis is placed on individual autonomy than we are accustomed to in American culture. In such a situation it might be more appropriate for the leader(s) to consent on behalf of the group. If appropriate, this might be followed up with a more informal consent from individuals. Situations of this type would need to be evaluated by the IRB on a case-by-case basis. It should also be noted that in many circumstances involving research on cultures, groups, villages, communities, etc., the investigator should consider both individual and social group confidentiality protections with appropriate descriptions of the confidentiality protections provided in the consent process and in the IRB application.
15. If there is reason to believe individual identity may be deduced from the study location, can I seek confidentiality protection for the study location and the social group for which it is a part, e.g. community, village?
Answer: Yes. Although the federal regulations primarily focus on protections for individual research volunteers, it might certainly be appropriate to describe your plans for protecting the confidentiality of both the individuals and their community or other social unit. This information would need to be conveyed in the consent process as well as included in the IRB application.
16. I want to conduct a study that involves the use of deception. Is this allowed? What do I need to consider?
Answer: The use of deception in research is not prohibited by either the Federal Regulations or NIU IRB Policy. However, deception in research should be used with caution since it essentially violates the trust that the participant puts in the researcher. Deliberate deception of subjects may occur only in situations where withholding complete, accurate information about the nature of the study is necessary to ensure valid results. Deception should never be used to get research participants to do something that they would not do if the nature of the study or their participation in it were fully disclosed to them.
In most research that involves deception, a consent process is still needed. But, because some information is being withheld from the participants or is factually incorrect, the term "informed consent" cannot be used. Instead the process is simply referred to as a "consent process" and any hard-copy documentation is referred to using terms such as "information letter" or "consent document". It is expected that the investigator will prepare a debriefing statement and/or process in order to inform the study participants of the true nature of the project and/or their involvement in it upon completion of their participation. Once the participants have been debriefed, it is often desirable to give the participants the opportunity to confirm their voluntary, and now informed, consent to participate. Sometimes this is accompanied by the opportunity to redact or completely retract the information they have provided during the course of their participation. (Click here for more information about deception and debriefing).
17. What is the difference between "debriefing" and participant 'follow-up"?
Answer: Both terms refer to information that is provided to participants at the conclusion of their involvement in the research project. The term "debriefing" is used in studies involving deception to refer to the process by which the participants are presented with information that had initially been withheld from them regarding the true nature of the research.
Participant "follow-up" is used in studies that do not involve deception but it is felt that it is appropriate to provide the participants with some additional information relevant to their needs. This information is typically conveyed to the participants at the conclusion of their participation.
Examples might include referrals to:
18. Do I need IRB approval if my research is not externally funded?
Answer: Yes. All research involving human subjects conducted under the auspices of NIU must be approved by the IRB regardless of whether the research is externally funded and regardless of the funding source.
19. If I have approval to conduct research involving human subjects from another IRB, do I still need to get approval at NIU?
Answer: Yes. As a faculty member, staff, or student at NIU, your research must be reviewed by the NIU IRB. A copy of the approval of your research by another IRB can be included with your submission to the NIU IRB.
20. After I download the IRB form from the Internet and complete it, can I send it back to you by e-mail?
Answer: Sorry, but we are not yet set up to process protocols sent to us this way.
21. What is the difference between the terms "confidentiality" and "anonymity"?
Answer: Something that is truly anonymous has no known name or identity or known source. For research data to be considered anonymous, no identifiers of any kind (e.g., name, code number, etc.) are used that can link the data or information to the individual who provided it.
In contrast, research data that do have identifiers present that link individual participants with their data or information need to have appropriate provisions made to protect confidentiality. In this situation the researcher has been entrusted with private information and the confidence of the participants and the researcher is responsible for addressing how sensitive information will be protected.
22. Why aren't journalists required to go through the IRB review process? How does journalism differ from research with human subjects?
Answer: The definition of "research" refers to a "systematic investigation "designed to contribute to "generalizable knowledge". While it's true that journalists can engage in a "systematic" investigation, generally speaking, the end result of their interviews is simply reported (or quoted) and synthesis or interpretation of what was said is not offered and no attempt is made to generalize. This differs from a researcher who would attempt to analyze and synthesize the information in some way in order to be able to apply the newfound knowledge to others or for the benefit of others. It is, of course, possible for journalism students and faculty to engage in activities that would meet the federal definitions of research with human subjects, in which case IRB approval of the project would be required.