Frequently Asked Questions

The Institutional Review Board

  • What is an Institutional Review Board (IRB)?

    An Institutional Review Board (IRB) is a group of people formally designated to review and monitor research involving human subjects. The purpose of the IRB is to protect, before and during the research study, the rights and welfare of humans participating as subjects in the research.

    The IRB has the authority to approve, disapprove, and require modifications to research projects involving human subjects. In addition, the IRB must review and approve or disapprove the investigator for the research. Once approved, the IRB must monitor the progress of the ongoing research and, if necessary, terminate a research project.

  • Who has access to IRB Records?

    Only investigators, study staff, and authorized IRB members and staff have access to the materials provided to the IRB.

  • What criteria does the IRB use for reviewing protocols?

    An IRB may approve research only after it has determined that the following requirements, as described by federal regulations, have been satisfied:

    1. Risks to subjects are minimal;
    2. Risks to subjects are reasonable in relation to the anticipated benefits and the importance of the knowledge that may be gained;
    3. Selection of subjects is reasonable in view of the purpose of the research and the setting in which it will be conducted;
    4. Informed consent will be sought from each prospective subject, or the subject's legally authorized representative, that provides the appropriate information and is understandable to a lay person;
    5. Informed consent will be appropriately documented in a written consent form;
    6. When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects;
    7. When appropriate, adequate provisions exist to protect the privacy of subjects and to maintain the confidentiality of data; and
    8. Additional safeguards have been included in the study to protect the rights and welfare of vulnerable populations, such as children; prisoners; pregnant women; mentally disabled persons; or, economically or educationally disadvantaged individuals.

    If any of these requirements are not met, the IRB will either disapprove the study or recommend modifications that will ensure the study satisfies these requirements.

  • Who reviews my application if it goes through a full board review?

    Federal agencies that govern human subject research, such as the U.S. Food and Drug Administration (FDA) and the Department of Health and Human Services (HHS), require that the IRB have at least five members with varying backgrounds.

    For example, each IRB must include at least: one member who has no affiliation with the University of Denver other than their IRB membership; one member who is a non-scientist; and one member who is a scientist. To satisfy the requirement for at least one non-scientist, most IRBs include attorneys or clergy. To satisfy the requirement for at least one scientist, most IRBs include physicians and PhD level scientists.

IRB Terminology

  • What is the difference between "exempt" and "expedited" review?

    Research studies can be categorized by the amount of risk involved. If a research study involves little or no risk to the subject, the research is exempt from further IRB review. Exemption waives the need for further IRB review; however, it does not negate the need for the consent of subjects where applicable. If the research study presents no more than minimal risk, it may qualify for an expedited review if the involvement of human subjects falls into one or more categories approved by DHHS.

    An expedited review is conducted by a qualified member of the IRB. The member reviews the appropriate materials and determines to either approve the research or return it for modification. A research study may only be disapproved by a full IRB meeting.

  • Does "exempt" mean I don't have to apply to the IRB?

    No. Only the IRB may make the determination that research is exempt from IRB review. Therefore, the investigator must submit the Request for Exemption application to the IRB, which details the research.

  • What is "minimal risk"?

    "Minimal risk" means that 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.

  • What is the definition of "research"?

    "Research" is defined as a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. (45 CFR 46.102(d)).

  • What is the definition of a "human subject"?

    "Human subject" is defined as a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information. (45 CFR 46.102(f)).

  • What is "informed consent"?

    "Informed consent" is an ongoing process. It starts well before any consent forms are signed and continues until the subject's participation is complete. If consent is to be informed, the subjects must genuinely understand the study. It involves meeting with a potential subject, finding out whether he or she is capable of giving consent, and discussing the purpose, risks, and benefits of participation. The informed consent process is different from the consent form. The consent form formalizes the agreement to participate and should be designed to document the process. Obtaining informed consent is not just giving a prospective subject a consent form and getting it signed.

  • What is a "medical device"?

    A "medical device" is defined as a diagnostic or therapeutic article that does not achieve any of its principal intended purposes through chemical action within or on the body. Such devices include diagnostic test kits, crutches, electrodes, pacemakers, arterial grafts, intraocular lenses, and orthopedic pins or other orthopedic equipment.

  • What is the difference between "confidential" and "anonymous"?

    Anonymous data can never be linked to the subject (directly or indirectly) either because the name/identity of the subject is never obtained by the investigator, or because there is no code linking the data to the subject's name/identity.

    Confidential data is recorded so that the information is not immediately identified with the subject who supplied it, but such a link is possible. Confidential data is usually "coded". That is, the subject is assigned a unique identifier that will be used to identify the data. The code identifies the data, and the subject's identity is kept separate from the code and data. Coded data is not anonymous.

IRB Processes

Do I Have to Go Through the IRB?

Training & Education

While Your Protocol is Active:


  • Who keeps the informed consent?

    Informed consent is drafted by the investigator, reviewed and approved by the IRB and must be kept by the investigator and on file with the IRB.

  • What's the difference between an assent form and a consent form?

    Assent is the agreement of someone not able to give legal consent to participate in the activity. Study subjects who cannot give consent, but who are able to participate in the process to some degree can do so through the assent process. For older children, for example, the assent process can be similar to the consent process used with a competent adult. For a younger child, the process may be less detailed.

  • How can I get informed consent if the survey is conducted online?

    A survey on a web page should include the elements of informed consent. As with a survey that is not on a web page, a reply is considered to be implied consent. If confidentiality is necessary, the survey could be printed and mailed back to the investigator. Where subjects are to reply via e-mail, they should be told that in the cover letter that the confidentiality of their response cannot be guaranteed.

  • Do I have to get consent of everyone participating in a study?

    The regulations generally require that the investigator obtain informed consent from subjects or where warranted from a legally authorized representative of the subject. There are circumstances where consent can be waived (see 45 CFR 46.116) however waiver of consent requires IRB approval.

  • How do I obtain consent from children?

    45 CFR 46.408(a) requires that "adequate provisions are made for soliciting the assent of the children, when in the judgment of the IRB the children are capable of providing assent." The section goes on to state that "[i]n determining whether children are capable of assenting, the IRB shall take into account the ages, maturity, and psychological state of the children involved."

  • How can I get signed consent forms for the surveys that will be mailed to research participants and still maintain confidentiality?

    There should be a cover letter that accompanies the survey and which contains the elements of informed consent.

  • I'm doing research with a group of children. Is it possible not to have parental consent?

    Under 45 CFR 46.404-407, researchers are required to obtain parental consent in order to do research on children. However, pursuant to 45 CFR 46.116, there are certain situations where consent can be waived (i.e. where waiving consent would be in the best interest of the child). Waiving consent must be specific to the study and must detail what protections will be put in place for the children in the study.

  • Can I obtain informed consent by telephone?

    In general, under 45 CFR 46.117, written informed consent is required to comply with federal regulations and standards. Where an investigator feels that written consent is not feasible or otherwise not warranted, the investigator can apply for a waiver of consent through the IRB. The investigator should be detailed as to why written consent is not warranted. Generally, however, written informed consent is necessary.

  • Who should be present when the informed consent interview is conducted?

    Under 21 CFR 50.27(b), a third person is not required to witness the consent interview unless the subject or representative is not given the opportunity to read the consent document before signing. The person authorized to conduct the consent interview should have adequate information about the study to answer questions that may arise.

    Federal regulations do not specify who this "authorized" individual should be. If someone other than the clinical investigator conducts the interview and obtains consent, this person should be authorized by the clinical investigator and the person so delegated should have received appropriate training to perform this activity.

  • How do you obtain informed consent from someone who speaks and understands English but cannot read?

    Study subjects are given a copy of the consent to refer to and clarify the parameters of the study. Under 21 CFR 50.20 the consent document must be in language understandable to the subject. Where the subject is English-speaking, and the consent interview is conducted in English, the consent document should be in English. Where a large number of subjects are non-English speaking, the PI should submit a translated consent form for IRB review. A copy of the translated consent document must be given to each subject who requires it.

  • Does a witness to the consent interview have to be there the entire time or only to witness the signature of the participant?

    Under 21 CFR 50.27 (b) (1) there is no requirement for a witness' signature where the subject can read and understand the consent process. A witness becomes necessary under 21 CFR 50.27(b) (2) where the subject has not had the opportunity to thoroughly read and understand the consent document. At that point, a witness is necessary to attest to the fact that the consent was presented in a certain manner that the subject understood.

  • Can I videotape children in a classroom as part of my research project without consent since I won't be talking to the students?

    Yes. The parental consent form (parental permission form) and the child or youth assent form should include the following information: whether the tape will be used for studying the actions of children doing certain projects; whether the tape will be used for any other purpose; how will the tapes be kept confidential; where will the tapes be stored; when will the tapes be destroyed.


  • What is the goal of compensation and what are some common pitfalls?

    Compensation to research subjects is not a benefit of research. Rather, compensation is meant to offset the time and inconvenience of participation, as well as to serve as an incentive to participate.

    The federal regulations do not set limits on compensation to participants. However, both researchers and the IRB are tasked with ensuring that research subjects provide voluntary, informed consent that is free from coercion or undue influence.

  • What is a reasonable compensation for my participants?

    Compensation can take on many forms and can include monetary (cash, gift cards, etc.) and/or non-monetary (gifts, course credit, extra credit, etc.) payments to subjects.

    Your protocol (research plan) should clearly specify what form(s) of compensation would be provided to participants in your study and the amount of payment. For non-monetary items, please provide an approximate value.

    Compensation can also take the form of a lottery. When considering using a drawing or lottery form of compensation, researchers should ensure that there is a fair method for selecting winners. Compensation may be awarded or accrued by participants in response to various tasks in a study.

    For student subjects, reasonable levels of extra credit may be offered as compensation for participating in research. If extra credit is offered for participation, students must be provided with and informed of non-research alternatives involving comparable time and effort to obtain the extra credit in order for the possibility of undue influence to be minimized.

    Payments or compensation should not require subjects to spend their own money. For example, a gift card to a coffee shop would be acceptable if it was sufficient to purchase a drink or other items without spending further money. However, a 50%-off coupon for a coffee drink would not be an appropriate form of payment.

    The amount as well as schedule of payments to research subjects should be presented to the IRB at the time of initial review and under 21 CFR 50.20, the IRB should review the amount of payment and the proposed method and timing of the disbursement of payment to assure that the amount and method are fair to the subjects involved. (see also: FDA Guidance).

  • Disclosure of compensation to participants

    Research subjects should be accurately informed through the consent process about any compensation for participation. The consent form should clearly state what form of payment will be provided, the amount or value of the payment, and the timing of compensation. If or when questions or complaints arise regarding compensation, the consent form becomes the source document for the information that was provided to participants. The information about compensation should be clear, detailed, and consistent with your protocol.

    Some examples of consent form language include: “Financial rules require us to have your 87 number [or name, SSN, address] in order to compensate you for your participation. This information and your payment amount will be kept secure and confidential in our research financial records, our department’s financial office and the University’s financial office. This information will not be associated with the study name or the research data you provide as a participant.” and/or “If you are paid a total of $600 or more as a research subject in a calendar year, the University is required to report the payment to the Internal Revenue Service as miscellaneous income. DU will send you a form (IRS form 1099) in January documenting the payment total. This form is also sent to the IRS to report any money paid to you. You can use the form with your income tax return, as appropriate.” Based on your study and your subject population, this sample language should be modified and/or additional details can be provided during the consent process about how and where the information will be stored and who will have access to it.


  • How do I submit a protocol?

    IRBNet is the electronic submission system used by the DU IRB for accepting new protocols. ( Refer to the Review & Submission section for step-by-step instructions for completing and submitting IRB applications for review.

  • How do I create a consent form?

    Use the consent templates provided in the Forms & Templates section in IRBNet and on our Forms page.

  • I have an approved protocol—how do I do my renewal?

    All protocol renewals must be submitted through the IRBNet system. If your project is federally funded or is more than minimal risk, you must complete the Continuing Review Application and submit it for review prior to the expiration date.

  • I have an approved protocol but it has no expiration date. Do I need to renew the study?

    For protocols that are issued exempt status and for non-federally funded projects that are approved through the expedited review process, renewals are not required. Effective February 2018, the DU IRB policy was revised to no longer require continuing review reports for these type of studies due to changes in the Common Rule. Instead of expiration dates, “Next Report Due” dates were assigned to research projects. At the end of the two-year period, investigators will be contacted by the IRB to confirm whether the study is still active or has been completed.