Frequently Asked Questions

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.

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

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.

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.

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.

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.

"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.

"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)).

"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)).

"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.

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.

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.

Depending on the nature of the study, IRB review may take one day or as long as one month. The IRB may request additional information from the investigator which could lengthen the process.

For federally-funded projects that are reviewed by expedited review, your approval is valid for one year from the date of approval.

Projects that are classified as more than minimal risk, your approval is valid for one year or less, as determined by the full board.

For non-federally funded projects that are reviewed by expedited review or are classified as exempt, a two-year time period is applied to the study. These studies are not issued expiration dates, but rather the IRB will request a status report on the study at the end of the two-year period to confirm if the study is still active or has been completed.

No - research can only begin once you have written approval from the IRB.

Under 45 CFR 46.103, the IRB must review and approve all non-exempt human subject research. Failure to obtain IRB approval before conducting research could result in the researcher being unable to use data and other information collected through the research process.

Yes. An investigator needs to inform the IRB that the study is being terminated or closed. The IRB will continue oversight of the study for follow-up purposes.

The Principal Investigator (PI) must be listed along with all other research staff and faculty.

Yes. Under 45 CFR 46.111, the IRB must determine risks, potential benefits, informed consent and safeguards for human subjects. According to the OHRP -IRB members should receive and review a protocol summary and a status report on the progress of the research including:

1. the number of subjects accrued
2. a summary of adverse events
3. unanticipated problems involving risks to subjects or others
4. any withdrawal of subjects from the research or complaints about the research since the last IRB review
5. amendments or modifications.

Yes.

Yes, but depending on if the study is federally funded or may be more than minimal risk, it must be reviewed at least on an annual basis.

Yes. All research studies that involve human subjects are subject to IRB review, irrespective of funding.

For a University researcher to participate in a research project at another site, the project needs to be reviewed by the IRB as well as by the other institution's IRB. Changes in protocol or consent forms required by the other IRB should be brought to the attention of the DU IRB.

Pilot studies and feasibility studies, including those involving only one human subject, require the same scrutiny as full-scale research projects. Pilot studies should be identified as such in applications to the IRB. Ordinarily the data collected from subjects in a pilot or feasibility study are not used for study findings.

If students are conducting human subject research as part of a class assignment, or to satisfy a degree requirement, the IRB must review the proposed research. When students conduct research as part of a course of study, a faculty member ultimately is responsible for the protection of subjects, even if the student is the primary researcher and actually directs the project.

As a general matter, there is no retrospective IRB review. However, you should submit the Human Subjects Research (HSR) Determination Form (formerly Appendix E) to HSRrequest@du.edu for review and include an explanation for why you did not think you need IRB approval. Based on the information provided, the IRB will conduct a review. The research may not qualify as human subjects research or may be exempt from IRB review. If the research is not exempt, the research would have required IRB approval in advance and, therefore, the research is not in compliance with federal regulations.

Therefore, if there is any chance that the chart review could turn into a research project, and even publication, you should submit an application to the IRB for approval in advance. Quality assurance activities or evaluation projects designed for self-improvement or program evaluation, not meant to contribute to "generalizable" knowledge, do not need IRB.

Yes. However, the research may qualify for an expedited review if it involves materials (data, documents, records, or specimens) that have been collected, or will be collected, solely for non-research purposes.

Research conducted by University investigators in foreign countries remains under University purview and guidelines.

While human subjects in foreign countries merit the same level of protection as subjects in the United States, acceptable practices vary from place to place. Different traditions and institutions may require different research protocols, particularly in informed consent, recruitment practices, and documentation.

Research projects must have been approved by the local equivalent of an IRB before they are presented to the DU IRB. Where there is no equivalent board or panel, investigators must rely on a review panel of local experts or community leaders to provide approval. The IRB requires documentation of this "local approval" before it will grant approval and the completion of Appendix G: International Research form. Researchers should describe what if any, knowledge or experience they possess regarding the language and culture of the country in question. Researchers proposing international research should allow additional time for this review process.

No. After a research project has been approved by a foreign country's review panel, the research must be submitted for approval to the DU IRB. The DU IRB will independently review the research.

Yes. Research on human subjects must include a prior review by the IRB, including those studies involving only a few subjects.

Yes, the IRB will need to review the project. The research may be exempt from IRB approval if the research involves the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by an investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects. Additionally, if the data is not publicly available, you must submit documentation that the original researcher has provided permission.

Courses in research methods and class assignments that involve research with human subjects do not require IRB approval if the class exercise does not seem to qualify as "true research": when, for example, the results are not intended for publication, will not advance work in another area, or will not contribute to generalizable knowledge. The IRB reviews research for risk assessment and provisions for informed consent.

Yes. For a University researcher to conduct a research project at another site, the project needs to be reviewed by the DU IRB.

Yes. Research on human subjects must include a prior review by the IRB, including those studies that do not involve any risk.

All personnel listed on the protocol that will have contact with participants involved in the study are required to complete the Human Subjects Protections Training. Human Subjects Training is available on through CITI Program.

Yes, anyone contacting the human subjects in any way needs to complete training.

Your consent form should have a detailed account of compensation for injury, if any, as well as what a subject should do in the event of a complaint. Complaints and injuries should be dealt with promptly. Where a participant has a question about their rights in the study, they should contact the IRB. The IRB should also be informed of any complaints or dissatisfaction on the part of the subjects through completing the Reportable New Information (RNI) Form.

You must send this modification to the IRB for review and approval through completing the Amendment Application. While a minor change may not need full board approval, the IRB does need to review and approve such a change.

As stated above, changes to a study must be received and approved by the IRB before they are implemented. Subjects enrolled and actively participating in the study should be informed of the change if it might relate to the subjects' willingness to continue their participation in the study (21 CFR 50.25(b) (5)).

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.

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.

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.

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.

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."

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

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.

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.

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.

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.

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.

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.

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).

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.

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

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

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.

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.