Human Research Frequently Asked Questions

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 the collection of bodily fluid samples, must be reviewed and approved by the IRB prior to initiation of the research.

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:

• Data from varied research methods including surveys, interviews and observation
• Private information, such as medical, family, or employment information, or residual administrative records including earnings and treatment histories that can be readily identified with individuals, even if the information was not specifically collected for the study in question;
• Tissue specimens, obtained for routine medical care would have been discarded if not used for research, or DNA samples, where samples or specimens can be linked to a living individual.

If you are uncertain whether your planned activities constitute research with human subjects requiring IRB approval, refer to the Screening Form on the IRB web page or contact the ORC for assistance.

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).

Yes, if you are a new faculty member, staff, or student at NIU and are the principal or lead investigator on the project, you must now obtain IRB approval from the NIU IRB. A copy of the approval of your research by another IRB can be included with your submission to the NIU IRB.

However, if you are a collaborator on a research project with researchers from one or more other institutions and are not the principal or lead researcher on the project, it may be possible for NIU to accept the review of the lead researcher's IRB. You will need to contact the Office of Research Compliance at 815-753-8588 or pwallace@niu.edu) so that the necessary agreement can be put in place.

It depends on whether the student project is intended to be an educational exercise or a project that truly fits the definition 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.

Yes, As long as your research involves collecting data or identifiable information that is not publicly available from or about living individuals, you need to have it reviewed by the IRB.

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 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.

Your completed and signed application should be submitted along with any relevant materials related to recruitment, the consent process, data collection materials, debriefing materials, counseling resources and anything else that the participants will see.

That depends on the nature of your study and the characteristics of the people you intend to recruit. Please keep in mind that the departmental reviewer is responsible for providing an initial determination of the review level that is needed.

Allow 5- 7 business days for projects that will undergo Administrative Review. These typically include studies that involve surveys and interviews given to adults, providing that you either record the data in such a way that there is no possibility that the subjects can be uniquely identified by an outsider or that any disclosure of their responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to their financial standing, employability, insurability, or reputation. There are several categories of this level of review.

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.

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 once the protocol has been reviewed, a determination was made that it is exempt from the federal regulations. 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 the federal regulations, will issue an approval on behalf of the IRB.

You will receive an email stating that you have been approved. Depending on the level of review, you may receive an attached approval letter and stamped consent documents.

Most departments have a person or two who are trained to conduct a preliminary review of a protocol to determine what level of review is needed and make sure the application is complete.

List of current Authorized Departmental Reviewers (PDF)

Please contact the main office of your department or the Office of Research Compliance, Integrity and Safety if you need further assistance to identify who your ADR is. If your department does not have an ADR, you may contact one from another department.

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.

You have several options. You may scan the application and all accompanying documents into a single file to email to the ORC, but be sure to get all signatures that are needed before doing so. You may also FAX the entire set of documents to the Office of Research Compliance, Integrity and Safety. Otherwise, campus mail and regular mail are still acceptable options.

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 (PDF) in certain circumstances. For example, depending on the nature of the study, it could be that a researcher requests to waive the statement about the purpose of the study (deception studies), the signature line (online studies), or the entire consent form (international studies). The IRB application asks specific questions about what the waiver request is for and why it is needed.>

No. In certain research situations, all involving no more than minimal risk, the IRB can waive the requirement that you obtain the participant's 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.

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.

The IRB will eventually want copies of any translated consent documents, but these aren't needed when the protocol is initially submitted. It is possible that changes will be requested for your documents, so it is in your best interest to wait to have the translation done after you have received approval. In addition, it is required that you provide the qualifications of the person who translates your documents.

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 is exempt from federal regulations, 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.

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.

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 a 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.

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 another social unit. This information would need to be conveyed in the consent process as well as included in the IRB application.

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.

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:

• Counseling for individuals experiencing emotional difficulties, substance abuse problems, etc.;
• Educational assistance for children with learning disabilities;
• A physician and/or nutrition counselor for persons with eating disorders;
• Support agencies/services for victims of physical abuse;
• Support agencies/services for low-income families.

If the change is fairly minor, you can send an email to the Office of Research Compliance explaining the requested change. You should include any modified documents and/or new documents as attachments to the email. Once the amendment has been approved (email notification), you may incorporate the change into your study. If the change changes your study dramatically, it is in your best interest to submit a new protocol.

The Office of Research Compliance, Integrity and Safety sends out emailed continuation documents to researchers about 1 month before the study approval expires (this is done annually). It is the responsibility of the researcher to complete the form and send it back with any necessary non-stamped consent documents with plenty of time for approval to be granted before the expiration date.

Once you have completed data collection, you will still need to continue to get annual approval for the project until all identifiers have been removed from the data. Once all identifiers have been removed, you can send an email to the Office of Research Compliance, Integrity and Safety notifying them that the study has ended, the total number of participants in the study and any problems that occurred. At that point, the study can be closed.

The Office of Research Compliance, Integrity and Safety has an Adverse Event form to complete when an unanticipated harmful event occurs in your study. This form can be accessed on the Applications page.

The IRB application requests that researchers explain both ethics training and hands-on training for conducting human subjects research. All new researchers (student or faculty) are required to complete the CITI training module (a link is available on the Training and Education page) for their ethics training. A researcher who has already submitted a protocol stating some other type of training may continue to use that training to complete this requirement on the application. All researchers must also receive training to conduct the hands-on component of human subjects research. This involves training both at NIU and elsewhere. For newer researchers, this may involve training from others that will take place prior to conducting the study being reviewed. This should be explained in the application.

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.

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.

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.

Research subjects may receive incentives or compensation for their participation. However, the level of compensation should not be so high as to cause a prospective subject to accept risks that he or she would not accept in the absence of the compensation. This same principle would apply to compensation offered to parents whose children are prospective subjects. Information about any compensation should be included in subject recruitment materials and informed consent/parental permission/assent forms. Compensation should not be described as a benefit of the study. The University will not reimburse purchases of gift cards to be used for compensation in research.

Guidance on NIU Controller's policy regarding incentives/compensation

The IRB at Northern Illinois University has discussed best practices for researchers who plan on collecting data from underage participants using one-on-one data collection techniques (e.g., interviews, and assessments). Although there is no set policy on how to carry out these types of studies, the content below provides suggestions based on the IRB's best practices discussion. These practices protect both the researcher and the participants. Please contact ORCIS (researchcompliance@niu.edu) if you have any questions.

If data collection is being carried out in a school/facility, find out if the school/facility has specific requirements. All researchers may be required to complete a background check.

Additional considerations (highly recommended if possible):

• Allow others (parents, teachers, etc.) to be present in the room
• Require two adult researchers to be present during every data collection interaction
• Conduct data collection in a room with a one-way mirror (to allow parents or teachers to observe).