IRB FAQ

The “IRB” or the "Institutional Review Board" means any board, committee, or other group formally designated by an institution to review, to approve the initiation of, and to conduct periodic review of, research involving human subjects. The primary purpose of such review is to assure the protection of the rights and welfare of the human subjects.

Research involving human subjects may not proceed until written approval is received by the investigator from the IRB. Investigators may submit a completed online IRB application through IRBManager, including consent document(s) and all supporting documents.

Exempt and Expedited Requests for IRB Review are usually processed within 10 business days.

For research needing Full review, investigators must submit an electronic copy to the IRB at irb@uccs.edu no later than ten (10) business days before the monthly IRB meeting. Typically Full reviews may take more than 25-50 business days to review and approve. The Board usually meets on the last Tuesday of the month during the academic calendar; summer meetings are scheduled if necessary.  The IRB committee meeting schedule is available online.

When in doubt, ask the Chair of the IRB. Otherwise, follow these general guidelines:

1. Exempt. The federal regulations provide for exemption from continuing review for certain kinds of research (e.g., reviews of existing data, documents, records, if the information is recorded in such a manner that subjects cannot be identified).
2. Expedited. Research that poses only minimal risk to adult human subjects and does not deal with sensitive or personal aspects of the subjects behavior may be granted an expedited review.
3. Full. Research involving more than minimal risk and/or vulnerable subjects must undergo a full IRB review. Vulnerable subjects include children under 18 years, prisoners, pregnant women, mentally/cognitively impaired persons, economically/educationally disadvantaged persons, and any subjects likely to be vulnerable to coercion or undue influence.

Note - Only the IRB can determine the level of review. Any project/activity involving human subject research have an IRB review. 

Once human subject research has been approved, it is the Principal Investigator's (PI) responsibility to do the following:

1. Risks to subjects are minimized.
2. Risks to subjects are reasonable in relation to anticipated benefits.
3. Selection of subjects is equitable.
4. Informed consent will be sought from each prospective subject or the subjects legally authorized representative.
5. Required elements of informed consent are present.
6. When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.
7. Whenever appropriate, there are provisions to protect the privacy of subjects and to maintain the confidentiality of data.
8. When some or all of the subjects are vulnerable research subjects, additional safeguards have been included in the study to protect the rights and welfare of these subjects.

When UCCS research involves human subject research participants, the IRB may consider research design under 45 CFR 46.111 and other ethical codes, such as the Nuremberg Code and the Declaration of Helsinki, to address the IRB's obligation to review the design or other aspects of a protocol/study that may affect the scientific quality of the research. IRB reviewers may ask questions about study design to better understand what researchers are proposing. The IRB reviews research to ensure that:

1. The study is designed to minimize the risks to subjects.
    
2. The potential risks of the research are justified by the potential benefits.

Additional information regarding scientific review may be found in the IRB Standard Operating Procedure Special Topics: XIV. Scientific Merit Review and in the Scientific Review Handout, both of which can be found on the IRB's resource page.

Report any changes in research activity related to the project including additional personnel. The PI must provide the IRB with all protocol and consent form amendments and revisions. IRB must approve these changes prior to their implementation. Submit an online Report of Change Form to the IRB through IRBManager.

• All advertisements recruiting study subjects must receive prior approval by the IRB. See our Advertisement Guidance on the IRB's resource page on tips for creating compliant advertisements for your study.
• The PI must promptly inform the IRB of all adverse and serious adverse events to subjects (within 5 days of the researcher becoming aware of the occurrence).
• When your study has been approved, it may be assigned an expiration date. UCCS IRB and federal regulations require review at least annually of all projects that are currently active. If you need to continue your project past the expiration date, you will need to request the project be renewed (before the expiration date). Submit an online Request for Continuing Review Form through IRBManager before your expiration date.
• Once you have completed your study/research, keep all records including signed consent documents on record for 3 years after the conclusion of your study.

As a reminder, all changes are to be submitted and approved prior to implementation.

Minor changes can be made via a Request for Change, while more substantial changes might need a new protocol application. 

Minor changes have no impact on the original goals and protocols outlined in the original IRB application.  Examples of minor changes include, but are not limited to: 

• change of title
• minimal changes in survey instrument
• changes in any advertising or recruiting materials
• addition or deletion of collaborators and/or co-investigators
• change in faculty advisor
• adding additional sites for data collection. 

In addition, any research that increases the level of risk to the participant relative to the initial application must be submitted for a Request for Change.

More substantial changes would include changes in the purpose or process of the research project.  These will generally require a new IRB application. Examples might include, but are not limited to:

• a change in sampling population
• significant changes to survey instrument or interview protocols
• changes in the purpose or goal
• administration of a medical treatment/diagnostic of any kind

If a Request for Change is submitted and the reviewer determines that a new application is required, the IRB staff will request a new IRB application.  In the case of a new IRB application being requested, the Request for Change will be closed. 

Yes. "Generalizable" knowledge means more then formal publications and presentations. In a pilot study, the outcome has predictive value so the concepts or principles elucidated by the research can be applied to other circumstances, thus building upon knowledge base.

Visit the IRBManager page to learn about and access IRBManager. This page includes a link to the log-in page, a user-manual, and answers to some frequently asked questions. If you have any additional questions, contact the IRB at irb@ucc.edu.

Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains data through intervention or interaction with the individual, or identifiable private information regardless of its source.(adapted from 46.102(f))

Research means a systematic investigation (i.e., the gathering and analysis of information; including research development, testing and evaluation) designed to develop or contribute to generalized knowledge (46.102(l)).

The following activities are deemed not to be research

1. Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected.
2. Public health surveillance activities, including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority.
3. Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes.
4. Authorized, operation activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions.

Note- If your scholarly or journalistic activity fits solidly within #1 above you do not need IRB approval/review. If you have any doubts or questions, please contact the irb@uccs.edu. Numbers 2 through 4 apply only to activity performed by or on behalf of an authorized (Federal, State or local) government authority, and so are unlikely to apply to activity at UCCS.

Research means a systematic investigation (i.e., the gathering and analysis of information; including research development, testing and evaluation) designed to develop or contribute to generalized knowledge.(46.102(d))

Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains data through the following methods:

• intervention or interaction with the individual and using, studying, or analyzing the information or biospecimens; or
• Obtaining, using, studying, analyzing, or generating identifiable private information or identifiable biospecimens (adapted from 46.102(e))

1. Intervention: includes both physical procedures by which information or biospecimens are gathered (e.g., education program, drug treatment, venipuncture) and manipulations of the human research participant (i.e., exercise program, diet therapy) or the human research participant's environment (i.e., music, room light) that are performed for research purposes (adapted from 45 CFR 46.102).
2. Interaction: includes communication or interpersonal contact between investigator and human research participant.

Benign behavioral interventions are brief in duration (less than or approximately two hours, depending on surrounding circumstances), harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects, and the investigator has no reason to think the subjects will find the interventions offensive or embarrassing. 

Provided all such criteria are met, examples of such benign behavioral interventions would include having the subjects play an online game, having them solve puzzles under various noise conditions, or having them decide how to allocate a nominal amount of received cash between themselves and someone else.  Additional information can be found on the Secretary’s Advisory Committee on Human Research Protection (SACHRP) website. 

If the research involves deceiving the subjects regarding the nature or purposes of the research, this exemption is not applicable unless the subject authorizes the deception through a prospective agreement to participate in research in circumstances in which the subject is informed that he or she will be unaware of or misled regarding the nature or purposes of the research.

CITI Human Subject Training is required for all personnel including PIs and Co-PIs involved in human subject research. Faculty Advisors must also complete the training before submitting a student protocol for review. You can learn how to register for the required CITI training on the IRB's resource page website.

Additionally, if the study meets the definition of a clinical trial and is funded by NIH, Good Clinical Practice (GCP) Training is required for all personnel including PIs, Co-PIs, and Faculty Advisors (if applicable).  You can learn how to register for the required GCP Training on the IRB website.

NOTE – In order to qualify as a clinical trial, all the following must be true:

• The study involves human participants.
• The participants are prospectively assigned to an intervention.
• The study is designed to evaluate the effect of the intervention on the participants.
• The study effect is evaluating a health-related biomedical or behavioral outcome.

FERPA data include educational records of any kind that may personally identify a student, such as name, address, ID number, or another personal or indirect identifier.  In addition, a record is identifiable if it includes "other information that, alone or in combination, is linked or linkable to a specific student that would allow a reasonable person in the school community, who does not have personal knowledge of the relevant circumstances, to identify the student with reasonable certainty."  For more information about FERPA please click here.

If your research involves PII or FERPA, approval from the Office of the Registrar will be required in order to be able to obtain the data (prior to submission of your IRB application).  The approval received from the Office of the Registrar will need to be submitted with your IRB application.  Additionally, training might be required.  You may contact the Office of Registrar at 719-255-3361 or email datareq@uccs.edu with questions.

The majority of colleges, schools, centers, and departments within the University of Colorado Colorado Springs do not function as covered medical entities under HIPAA. UCCS is a covered entity that has chosen hybrid status. Therefore certain areas of the University have to comply directly with HIPAA. The UCCS HealthCircle Clinics are considered to be covered parts or covered healthcare components of the UCCS covered entity.

PHI may be involved if any of the following are involved:

• Accessing or collecting information from a medical record
• Adding information to the hospital or clinical record
• Creating or collecting information as part of health care
• Using information collected from the study to make health care decisions 

Please note that if your research involves PHI and is subject to HIPAA, a Privacy Board review is required prior to obtaining IRB approval. See UCCS IRB SOP 19 for additional guidance. 

If you have questions about how HIPAA may impact human subjects research contact composp@uccs.edu. 

A Letter of Access is a document obtained from the appropriate authority in order to gain access to a facility or organization. It should be requested during the application process and submitted along with the IRB application. Please keep in mind that the appropriate authority figure might be different than your assumption. For example, a captain in the military cannot provide access to a military facility and the principal of the school is not always the person that can provide access to a school. It might be the superintendent for the school district or another contact person.

Recruitment materials that are seen or heard by prospective participants to solicit participation in a study are considered part of the consent process and must have IRB approval prior to their use. These items include flyers, informed consent, recruiting messages/emails, etc. Please note that it is NOT acceptable to recruit/confirm participation for particular participants prior to the submission and approval of the IRB application. 

NOTE: The IRB has received complaints from individuals in the general population who believe their privacy was invaded because they received correspondence from unfamiliar investigations. When contacting subjects directly (e.g., via mailed letter or emailed message), the introductory paragraph should explain the right to access and include a general statement regarding how the investigator obtained the potential participants’ contact information (e.g., “I am contacting members of the XXX association regarding….” Or “You are receiving this questionnaire because you previously agreed to be contacted for further research studies.”)

Yes, the IRB may approve a research proposal in which an investigator will obtain information or biospecimens for the purpose of screening, recruiting, or determining eligibility of prospective subjects without an informed consent, as long as one of the following conditions are met:

• The investigator will obtain information through oral or written communication with the prospective subject; or
• The investigator will obtain identifiable information or identifiable biospecimens by accessing records or stored identifiable biospecimens.

Note that this is not a waiver of consent, but rather an exception to the requirement. If the information obtained is more than minimal risk, the informed consent will be required prior to screening. Possible inquiries eligible for screening include, but are not limited to, asking if the subject is married, asking if they are within a certain age range, or requesting a standard blood draw.

Also, HIPAA requirements will still apply, if applicable. Those working with the Lane Center should contact the Privacy Officer before accessing any medical records to ensure compliance.

All research involving humans carried out by students, faculty, or staff, whether funded or unfunded, sponsored or unsponsored, on or off campus, is covered by the Standard Operating Procedures (SOPs) of the UCCS Institutional Review Board for the Protection of Human Subjects.

Incentives that are provided in research should be appropriate and researchers must take great care to ensure there is no undue influence on participation. For research requiring participants to undergo a minor inconvenience or discomfort, no payment or a modest payment amount is usually adequate. Participants are often compensated based on the complexity of the study, the type and number of procedures to be performed, the amount of time involved, any travel required, and the anticipated level of discomfort or inconvenience.  With this in mind, researchers need to justify the payment amount to the IRB based on these variables. The ethical principal of justice should be kept in mind while determining the payment amount.

The use of Amazon Mechanical Turk for recruiting purposes continues to grow. The compensation for tasks completed through Mechanical Turk is typically very small, usually less than $1. When using Mechanical Turk for recruitment, the same considerations for participants are the same as any other human subjects research. 

Additionally, the following should be considered:

• Inform the potential participant if compensation is contingent on certain conditions.
• Make sure that the complexity of the task and expected time to complete the task is reasonable and communicated clearly in the consent process.
• Lotteries and raffles present ethical concerns as it may violate the principle of justice and create concerns of undue influence if the prize is large as compared to the amount of participation in the study. They should be avoided.

Additional guidelines for compensation in research can be found in the SOP Special Topics XXXIV: Subject Payment for Participation in Research and on our Compensation Guidance found on the IRB's resource page.

Using Qualtrics is convenient, but there also some situations and settings you should be aware of. The IRB has issued guidance for using Qualtrics in research available on the IRB's resource page.

If you are considering providing diagnostic test results to participants or use test results to alter care, there are things that should be considered in advance such as the Clinical Laboratory Improvement Amendments of 1998 (CLIA). Additional information is available in Special Topics: XXXI. Lab Certification (CLIA) of the University of Colorado Colorado Springs Standard Operating Procedures (SOPs). If you have questions, please contact the IRB at irb@uccs.edu for assistance and guidance.

Researchers may serve as participants in their own studies. Note typically UCCS considers this type of research (self-experimentation) as human subject research and requires the same review and approval as research that recruits other people as participants.

Though self-experimentation may not raise the conventional ethical concerns outlined in the Belmont Report, all human subject research should undergo ethical review to assure the safety of participants involved and the integrity of the research at the university.  While researchers may be aware of the risks of self-experimentation, they may also be more willing to accept risks that are ill-advised. An IRB review allows a neutral third party to raise concerns and/or propose measures to promote the welfare of researchers.

The Common Rule also require that informed consent be obtained from all research participants unless certain conditions are met. The IRB recommends researchers provide a consent document based on the template provided at the UCCS IRB website with the IRB application which will serve as the basis for documentation of informed consent when the experimentation involves the researcher.

The IRB has issued a guidance document for Deception and Incomplete Disclosure on the IRB's resource page.

Off-campus research participants have several options available apart from walking.

1. If a participant would like to bike, they may do so. There are several bike racks available around campus. More information about biking to campus and a map of bike racks can be found on the Parking and Transportation Services Bike to Campus page. Visitors are not required to register their bike, but they may wish to discuss the bike’s presence with Parking. It is strongly advised that participants lock their bikes before leaving it anywhere on campus.
2. Participants can park in the 500 series lots around campus for free and take the shuttle or walk to different parts of campus. An interactive and printable map is available.
3. Parking offers coupon codes for parking, usually at the department level. Go through your research support personnel to see if a system is already in place or reach out directly to Parking to discuss individual researcher parking needs if you believe you’ll be getting many off-campus participants.

If you will be paying for your participant’s parking, you should include this information in your Informed Consent document as well as in your IRB application.

The IRB issued guidance for people whose research includes Finger or Heel-sticks can be found on the IRB's resource page.

The Kraemer Family Library has collected a number of open repository resources for researchers who need or want to upload their data.

If your study is NIH funded, consider checking out the NIH Data Sharing Webpage for more information about data sharing policies.

Our Research Data Security & Management guidance document available on the IRB's resource page helps outline some of the best practices and important things to know about data security in research.

Because the University of Colorado Colorado Springs (UCCS) is a Division II NCAA member, it and its student-athletes must follow the rules and regulations of the NCAA in addition to the Common Rule and other regulations for research involving human subjects. Research on student athletes has several special considerations, such compensation and privacy concerns. Please keep in mind that you will need to have your research project looked over UCCS Athletic Compliance to ensure that it is compliant with NCAA regulations, and other potential issues, before you send it to the IRB.

Please review the the Student Athlete Guidance available on the IRB's resource page. This information is also available in the Researcher Manual.

Any research that involves participants in any EU nation should follow the rules set by the General Data Protection Regulation (GDPR). This includes any individuals who are NOT EU citizens. We have also posted a GDPR Guidance document on our website.

A federal law, called the Genetic Information Nondiscrimination Act (GINA), generally makes it illegal for health insurance companies, group health plans, and most employers to discriminate against you based on your genetic information. This law generally will protect research participants in the following ways:

• Health insurance companies and group health plans may not request genetic information that we get from this research.
• Health insurance companies and group health plans may not use genetic information when making decisions regarding your eligibility or premiums.
• Employers with 15 or more employees may not use your genetic information that we get from this research when making a decision to hire, promote, or fire you or when setting the terms of your employment.

Be aware that this federal law does not protect against genetic discrimination by companies that sell life insurance, disability insurance, or long-term care insurance, nor does it protect against genetic discrimination by all employers (U.S. Military).

NOTE – If you have plans to return clinically relevant research results, please see the IRB Standard Operating Procedures, Topic XXXI. Lab Certification related to the Clinical Laboratory Improvement Amendment (CLIA). Also see the IRB Sample Standard Language Consent form document for recommended language.

The use of DEXA equipment requires permission. Please get in touch with the CU radiation safety team to obtain any required approvals for the use of the DEXA/DXA machine on campus via email radsafety@colorado.edu or 303-492-6523.

Additionally, your consent document will need to explain the risks and, briefly, the process of the scans. Consider the following language for your consent document:

As part of this study, we will perform <insert number> DEXA scan[s] of your <insert body area>. DEXA is a way of looking inside the body by using X-rays. X-rays are a type of radiation.

Your natural environment has some radiation in it. This DEXA will give you about the same amount of radiation that you would get from your environment in <multiply the number of scans by two > days. 

If you are pregnant or believe you may be pregnant, consult with your care provider before participating in this research.

Courses sometimes require students to interview, observe, or interact with human subjects for a class project.

The purpose of these course projects is usually to provide:<

• Hands-on experience in social, educational, or psychological processes
• Opportunity to practice the research methods of a discipline.

The goal is usually not to develop or contribute to generalized knowledge. Therefore, the IRB does not consider them to be research. The IRB encourages faculty to discuss human subject protection issues with their students when assigning these kinds of classroom projects.

Due to potential increases in risk, you must submit classroom projects involving certain populations for IRB review. This includes projects involving:

• Children
• Pregnant women or neonates
• Prisoners
• International Populations

Tips for Classroom Research are available on the IRB resource page.

Additional information regarding Classroom Research may be found in the IRB Standard Operating Procedure Special Topics: XXVIII Student/Classroom Research Projects.

The IRB must review student-initiated/conducted research activity if it:

• uses human subjects and
• is designed to develop or contribute to generalized knowledge

This includes graduate and honors theses, dissertation research, and capstone projects. Student and their faculty advisors are equally responsible for obtaining IRB approval.

All students conducting research must have a faculty advisor. Also, the student and faculty advisor are both required to complete IRB training.

Identifiable data is information that can be linked back to a participant. This data can be used to tell who that person is. Identifiable data includes, but is not limited to:

• video and audio recordings
• photographs
• real names
• IP addresses
• physical addresses
• emails
• phone numbers
• grades
• enrollment status

Identifiable data comes with risks. This is especially true if you’re researching a topic with inherent social or legal risk, such as political opinions or criminal activity.

Whenever possible, do not collect identifiable information from your participants. If you must collect this information, contact the IRB and see if you need IRB approval.

Yes, you should still obtain consent for classroom projects even when the IRB doesn’t consider them research. Ethically speaking, you should get consent from participants in any project, research or not. It is best if a third party obtains consent. Participants always have the right to know important details of your project. This includes things like:

• what they are being asked to do
• that participation is voluntary, and they’re allowed to withdraw at any time
• any risks and benefits involved

Additionally, you should tell participants that they are in a classroom project, not a study or research project.

You cannot present classroom projects in any outside conference or publication. This includes online mediums, such as blogs. If you think you’d like to present your research, you should submit an IRB application and get approval. The IRB can’t issue retroactive approvals. That means that if you need approval, you must get it before any data is collected.

Presenting a project outside of the university suggests that it is contributing to generalized knowledge. This includes presenting at a conference, publishing in a journal, etc. Any project presented outside the university requires IRB approval.

You can present your project at an internal (UCCS-sponsored) event, such as Mountain Lion Research Day, without IRB approval. However, you should not describe your project as “research” on any documents, posters, or during verbal presentations.

Students should not collect information from individuals that they supervise or direct. This includes TAs collecting data from students in their classes and lab supervisors from the students in their labs.

Researchers may want to use their students or subordinates as human research participants. However, these students and subordinates may be at higher risk of undue influence or coercion. Researchers should be careful to eliminate or reduce those risks.

No matter how well-intentioned the investigator, students or subordinates may feel compelled to participate. They may believe their grades/review will negatively suffer if they don’t. They may believe not participating will damage their relationship with the investigator. For these reasons, the IRB generally will not permit an investigator to use his/her own students or subordinates as research subjects.

First, ensure you’re asking your students to participate because they are a representative sample for your research question, not because they are a convenient and accessible sample.

If you invite your own students or subordinates to participate in your research, please pay attention to the following:

• The research must present no more than minimal risk to subjects.
• The recruitment should involve only indirect methods. This may be recruiting via an IRB approved flyer/ad or IRB approved communications sent out to a larger group. You should not recruit your students or subordinates individually or face-to-face.
• A disinterested third party should obtain consent from your students or subordinates. For example, an investigator wants to administer pre- and post-tests to determine the efficacy of a curriculum. A colleague could obtain consent forms and administer the tests while the investigator is not present. A teaching assistant for the class from which subjects are recruited does not qualify as a disinterested third party.
• If the research is conducted within a classroom setting, the instructor should be blinded to the identity of the participants. Also, researchers cannot analyze data until final grades have been posted.

Please know the IRB does not allow researchers to force students to be research participants. Additionally, researchers may not pressure students to participate by making them feel bad or ostracizing them in any way.

If you want to require research participation as part of students' grades, you must provide an equitable alternative assignment. For more detailed information, see SOP Special Topics XXVI. Subordinates as Human Research Participants.

All academic units collect routine data about class or program effectiveness. This includes FCQs, exit/senior interviews, and student perceptions of a class or academic program. These kinds of activities do not require IRB review.

However, assessments of students' personal lives (such as dating behaviors, drug/alcohol use, mental health, social life) may involve an element of risk to subjects and/or investigators. In these cases, IRB review is recommended.

Typically, school districts have their own policies and procedures with regards to conducting research within their district. Please see the Local School District Research Request Information handout on the IRB's resource page for local school district contact information.

Yes, unless specific criteria for the exception are met. There is a parental permission requirement for each of the four categories of allowable research. With this in mind, under certain circumstances the IRB may waive the requirements for obtaining parental or guardian permission if it reviews and documents the requirements under 45 CFR 46.116(f).

The specific example cited in 45 CFR 46.408(c) is a study of abused or neglected children. In that case, the IRB may waive the requirement for parental permission, provided that adequate other protections are in place to protect the rights and welfare of the child. Appropriate protections would be study-specific; for the example cited, there may be a person-appointed by a court or a child protection agency who would be an appropriate person to approve (or not) the inclusion of the child in the study.

It depends which of the 4 categories of review are determined (described above). Permission from one parent may be sufficient for research conducted under 46.404 or 46.405. Research conducted under 46.406 and 46.407 permission must be obtained from both parents, unless one parent is deceased, unknown, incompetent, or not reasonably available, or when only one parent has legal responsibility for the care and custody of the child.

There is no absolute regulatory or ethical standard for assent. 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." In short, it is determined by the IRB reviewing the protocol. However, some guidance is offered: "In determining whether children are capable of assenting, the IRB shall take into account the ages, maturity, and psychological state of the children involved."

Taking this guidance into account, UCCS's IRB typically requires researchers to obtain written assent from all subjects between the ages of 6 and 18 (or age of consent when the research is taking place) unless a clear justification of waiver or alteration of assent is provided and approved.

Although the regulations provide little guidance, there are best practices that the UCCS IRB expects researcher to follow. The essential elements of the consent information should be provided, at a level and to the extent that the child is able to understand it. A lot of the formulaic elements (like compensation) can be omitted, but one should include (see "IRB Assent Form"):
 

1. A statement of what the research is about.
2. What the subject is being asked to do.
3. What the risks are likely to be.
4. What benefits there might be.
5. Should discuss participation in the study with parents.
6. Invite questions about the study.
7. That participation is entirely voluntary.

There is no absolute regulatory or ethical standard for documentation of assent. 45 CFR 46.408(e) states: "When the IRB determines that assent is required, it shall also determine whether and how assent must be documented."

The IRB expects investigators to describe what they are doing about assent of minors in research, and how they're documenting it. In many cases, the researcher will be asked to use the UCCS "IRB Assent Form" template.

An oral assent process with less detailed documentation may also be acceptable, especially in studies of low risk.

A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes. (45 CFR 46.102(b)).

If your research meets the definition of a clinical trial, your reporting requirements are two-fold:

• Per 45 CFR 46.116(h), for each clinical trial conducted or supported by a Federal department or agency, one IRB-approved informed consent form used to enroll subjects must be posted by the awardee or the Federal department or agency component conducting the trail on a publicly available Federal web site to be specified by the sponsoring agency.  The posting can take place at any time after recruitment closes, but no later than 60 days after the last study visit by any subject.
• If the research is sponsored by NIH, registration and reporting of the clinical trial at ClinicalTrials.gov is required.  Additional information is available on the NIH Clinical Trial Overview and Registration website.  Additional information is available in Special Topics: XXXII IRB Policy for NIH Funded Clinical Trial Compliance of the University of Colorado Colorado Springs Standard Operating Procedures (SOPs).

Visit UCCS's NIH Clinical Trials page for more information. You may also want to read about clinical trials at ClinicalTrials.gov.

If you have plans to return clinically relevant research results, please see the IRB Standard Operating Procedures, Topic XXXI. Lab Certification related to the Clinical Laboratory Improvement Amendment (CLIA). Also see the IRB Sample Standard Language Consent form document for recommended language.

If you have questions that were not addressed in this FAQ or need further clarification on a topic please contact the IRB at irb@uccs.edu or 719-255-3903.