The information below is intended to provide helpful guidance for the completion of the IRB application.
H. PLEASE ANSWER THE FOLLOWING RESEARCH SUMMARY QUESTIONS
Briefly describe the proposed study including a brief background, its purpose, and the research question. Please minimize technical language not readily understood by persons outside your discipline.
Criteria for IRB approval: The proposal is clear as to what the researcher wishes to accomplish. It is clear why the purpose is important enough to warrant participation of human subjects.
a. Describe the research design and procedures to be used. Make it clear what the participant will encounter: when, where, and how long. The proposal describes the population to be studied, how the population is to be approached, and what subjects will experience. Investigatory tools (surveys, questionnaires, etc.) are appended to the proposal.
i. Check ALL of the different procedures planned for the study.
b. Participant Recruitment
i. Describe from where the participant population will be drawn; include when, where, and how potential participants will be recruited. (If using existing data describe provide detail in this section as well.)
ii. Provide an estimate of the number of participants to be enrolled; for example, 90 participants will be recruited for group A, and 90 participants will be recruited for group B.
iii. Provide detail why the specific participants are being recruited (i.e.; the participants for this study will mostly benefit from the research).
iv. If placing participants in groups provide rationale.
v. Check all that apply.
vi. Check all that apply.
Note - If your study involves prisoners, pregnant women/fetuses, neonates, or children under the age of 18, you will need to complete the applicable addendum to the IRB application and submit it along with the application. Additionally, if your research involves traveling internationally, the applicable addendum will need to be completed and submitted along with the application to the IRB.
vii. Describe how participants will be in involved in the study. Include details how participants will be asked to interact with the procedures (i.e. participants will be asked to watch a video and complete a survey/questionnaire).
viii. Any recruitment materials to be used in the study should be listed and submitted as attachments for IRB approval.
ix. Describe how coercion or perceived coercion will be avoided (i.e., Potential subjects should not feel coerced into participating in research, nor must they fear the loss of some benefit to which they are otherwise entitled if they choose not to participate. A person in authority, such as a teacher recruiting students should take special precautions to ensure potential subject's decision to participate in research is not based on subtle pressures such as grades, monetary reward, or fear of loss of benefits).
If the research involves any subjects likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, and economically or educationally disadvantaged persons, describe the additional safeguards that have been included in the study to protect the rights and welfare of these subjects.
x. Describe how participants will be in involved in the study. Include details how participants will be asked to interact with the procedures (i.e. participants will be asked to watch a video and complete a survey/questionnaire).
Criteria for IRB approval: Selection of subjects is equitable. Equity requires that no group or class of persons should bear more than its fair share of the burdens of participation in research. Similarly, no group should be deprived of its fair share of the benefits of research, short-term or long-term; such benefits include the direct benefits of participation as well as the benefits of new knowledge that the research is designed to yield. In making this assessment the IRB should take into account the purposes of the research and the setting in which the research will be conducted and should be particularly cognizant of the special problems of research involving vulnerable populations, such as children, prisoners, pregnant women, mentally disabled persons, and economically or educationally disadvantaged persons.
When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, and economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these subjects.
c. List ALL materials used in the research that the research participants will receive. All listed items must be submitted as attachments for IRB approval.
d. This questions is asking about any medical equipment you plan to use to collect data from research participants. If you do not know of any risks or safety concerns, please mark NA.
e. Check the appropriate boxes (this question helps the IRB identify research using existing data).
f. Check the appropriate boxes
Criteria for IRB approval: Risks to subjects are minimized by using procedures that are consistent with sound research design and that do not unnecessarily expose subjects to risk, and whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.
3. Research Setting
This question helps identify where the research will take place, or how the researcher is using existing data. Make sure to list online sites as well.
Note - Most research performed outside of UCCS will require a letter of access; for example, if you are requesting to review records at a local school district you will need a letter of access from the school district providing details to the IRB what information is being provided to you for your research.
Note - If working with a school district, a letter of access will be required. See the guidance resources page for a list of local school district contacts.
a. Describe all benefits of the research. If the research does not benefit the research participant directly, be sure to address how the research benefits society and/or science.
b. Describe all risks (physical, mental, emotional, and legal) to the subjects. Note that all studies entail at least some risk (e.g. annoyance, frustration). If deception is to be used, describe what the deception will be and why it is necessary. Describe safeguards (e.g., medical consultation, counseling, etc.) that will be taken to reduce risks.
c. Describe how the risks are reasonable in relation to the anticipated benefits.
d. Describe safeguards (i.e. all research participants will be provided information for the counseling center on campus).
Criteria for IRB approval: Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research). The IRB should not consider possible long-range effects of applying knowledge gained in the research (for example, the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility.
Examples of research that may potentially involve more than minimal risk (mental or physical) include:
- Surveys or questionnaires that solicit information regarding personal or sensitive aspects of the subjects' behavior, including sexual practices, instances of child or sexual abuse suffered by the subject, criminal activities, drug and alcohol use, or studies of eating disorders.
- Stress testing, drug and alcohol use by the subjects for research purposes, and studies where subjects are asked to do more than moderate physical exercise that could result in injury to the subject.
Examples of Mistakes:
- Risks involved in the procedure are not mentioned in the proposal. For instance, if the following risks are involved in the course of research, they must be explicitly mentioned:
- sensitive questions which may cause discomfort;
- expenses incurred by subjects;
- possible injury to subject;
- questions about illegal activities;
- questions/situations which may uncover suspected child abuse which would then be reported;
- retaliation which may occur when results of study become public.
- Risks are understated or benefits (if any) are overstated, coercive, or excessive. For instance, a researcher describes subjects as greatly benefited by knowing they have contributed generally to scientific knowledge.
- Risks are not reasonable in relation to the expected benefits. For instance, by answering questions, participants risk prosecution by law enforcement officials.
- Steps which could be taken to minimize risks are not taken. For instance, a researcher does not provide referral to a psychologist when very disturbing reactions to questionnaires or interviews may occur.
- Proposal involves risk or benefit which accrues unfairly. For instance, when a proposal offers a treatment (benefit) to participants in the study, the narrowing of the population of the study to exclude some particular group must be justified (such as women or ethnic groups).
5. Informed Consent
a. Will you be requesting a waiver of written documentation (i.e., a waiver of a signature)? If so, complete this section.
Note - A waiver of written documentation might be utilized for a phone or internet interview study for a minimal risk study. Another example would be where the principal risk to the participant would be harm from breach of confidentiality, such as a study involving illegal activity.
Note - (45 CFR 46.117 (c) (1 or 2) An IRB may waive the requirement for the investigator to obtain a signed consent form for some or all subjects if it finds either:
(1) That the only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject's wishes will govern; or
(2) That the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context.
In cases in which the documentation requirement is waived, the IRB may require the investigator to provide subjects with a written statement regarding the research.
b. Will you be requesting an alteration of informed consent (i.e., no consent or the consent is being altered to omit some of the required elements)? If so, complete this section.
If you will be conducting research with college students that could potentially be 17+ years old (under the age of 18), you can request a waiver. Suggested verbiage is: "Pursuant to 45 CFR 46.408 (a) and (b), I request that parental permission be waived as these minor students are nearly 18 years of age, are enrolled in a university where they are expected to be treated and to conduct themselves as adults, and where their parents have endorsed them to be enrolled and to conduct themselves as adults."
Note - An alteration of informed consent might be utilized in a retrospective records review.
Note - With sufficient justification, the IRB may approve a consent process that does not include or alters some or all of the elements of informed consent, provided that it finds and documents specific requirements. If requesting an alteration of consent, justify such in accordance with the criteria established under 45 CFR 46.116(d)(1-4) [waiver of consent ] or 45 CRF 46.117(c)(1 or 2) [waiver signature]
c. Describe how informed consent will be obtained from each subject or the subject's legally authorized representative.
d. Indicate the time commitment to participate. Make sure to include follow-up visits, if required.
e. Complete as indicated.
f. If the research involves minors (children under 18), complete this question.
g. Describe how result will be shared with participants, if applicable. If there are no plans to share results, indicate the same.
Note - 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).
Criteria for IRB approval: Informed consent will be sought from each prospective subject or the subject's legally authorized representative. Except as provided elsewhere in this policy, no investigator may involve a human being as a subject in research covered by this policy unless the investigator has obtained the legally effective informed consent of the subject or the subject's legally authorized representative. An investigator shall seek such consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence. The information that is given to the subject or the representative shall be in language understandable to the subject or the representative. No informed consent, whether oral or written, may include any exculpatory language through which the subject or the representative is made to waive or appear to waive any of the subject's legal rights, or releases or appears to release the investigator, the sponsor, the institution or its agents from liability for negligence.
There are three types of Informed Consent:
1. Written Consent. A Consent Form signed by each subject is normally required for protocols submitted for either expedited or full reviews. It is also required when subjects include vulnerable populations. Projects qualifying for exempt review normally require only the subject's oral consent to participate unless the research intends to audio- or video-tape the subject.
2. Assent. Projects involving children (up to 17 years, unless emancipated) may undergo full review. In addition to written consent forms for parents, these proposals require written assent forms from children aged 6 to 18. "Assent" means a child's affirmative agreement to participate in research. Minors aged 15 to 17 cannot give adult consent but are normally asked to sign an assent form using the same language and information contained in their parents' consent form. Any projects involving minors require a signed consent form from either the child's parents or legal guardians before approaching the child for assent. Certain studies may be exempt from the permission requirement (e.g., if the research is designed for conditions or for a subject population for which parental or guardian permission is not a reasonable requirement to protect the subjects (e.g., neglected or abused children; Source 45CFR 46.408). Proposals of research to be conducted in an educational or other institution must include a letter of approval from the school district, hospital, or other institution.
3. Oral Consent. A statement of oral consent must include the elements of a Written Consent Form. The IRB should be provided with the oral statement and the rationale for requesting oral consent.
The IRB may approve waiver of the requirement of a signed consent form, if it finds either:
- The only record that links the subject to the research is the signed consent form, and the principal risk to the subject would be a breach of confidentiality. In this case, subjects must be asked if they want to sign a consent form that links them to the research.
- The research presents no more than minimal risk of harm to the subjects -- that is risk that is no more likely and not greater than that attached to routine medical or psychological examination -- and if the research involves no procedures for which written consent would be required outside of the research context. Such low-risk research may include completion of a questionnaire that does not contain sensitive material, or removal of a small volume of blood by venipuncture on a single occasion. If the research involves more than "minimal risk," then no waiver or alteration of informed consent is allowed.
In these cases, the IRB may require the investigator to provide subjects with information sheets to retain (e.g., an information letter that contains the information normally included in a consent form, but with no signature line).
Cultural Considerations: In some cultures an investigator may enter a community to conduct research or approach prospective subjects for their individual consent only after obtaining permission from a community leader, a council of elders, or another designated authority. Such customs must be respected. In no case, however, may the permission of a community leader or other authority substitute for individual informed consent.
In some populations the use of a number of local languages may complicate the communication of information to potential subjects and the ability of an investigator to ensure that they truly understand it. Many people in all cultures are unfamiliar with, or do not readily understand, scientific concepts such as those of placebo or randomization. Investigators should develop culturally appropriate ways to communicate information that is necessary for adherence to the standard required in the informed consent process. Also, they should describe and justify in the research protocol the procedure they plan to use in communicating information to subjects. When consent forms need to be translated into different languages, the IRB will need to see copies of those translated forms, along with evidence (through back translation) that the pertinent information has been included.
Criteria for IRB approval: Each required item is present, or an explanation is provided for any elements that have been omitted or modified. The IRB may waive or modify this requirement under certain circumstances. For projects where no written consent is obtained, provide a written assurance that the subjects will be informed of their rights (i.e., the right not to participate, the right to omit answers to any questions, and the right to withdraw from the study at any time).
6. Data Monitoring
a. Describe where the data will be physically stored.
b. Describe how the privacy and confidentiality will be maintained.
c. Complete as indicated. Please note that if a privacy or confidentiality agreement is required, you may need to contact OSPRI, as you might not have signature authority.
d. Describe plans for disposition of data at the end of the study. Make sure to indicate how long the data will be maintained.
Note - Records should be kept for 3 years after the completion of the research or after the funding has ended depending on which is longer.
e. Complete as indicated.
Criteria for IRB approval: When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.
I. Have you submitted this study to any other IRB?
If the protocol has been submitted to any IRB other than that of the University of Colorado Colorado Springs, explain the action taken on that protocol and attach a copy of the other IRB approval.
J. Will your research involve personally identifiable information (PII) or FERPA data?
FERPA (Family Educational Rights and Privacy Act) 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 visit http://www.uccs.edu/registrar/ferpa-the-family-educational-rights-and-privacy-act.html.
Note - If utilizing FERPA data from UCCS students, approval must be received from the Registrar's office prior to IRB approval.
Note - If utilizing data from another institution, follow their procedure to obtain information.
K. Will you be collecting Protected Health Information (PHI)?
In the research context, Health Insurance Portability and Accountability Act (HIPAA) establishes the conditions under which PHI may be created, obtained, used or disclosed by covered entities for research purposes. As defined by HIPAA, the term "covered entity" includes health care providers who engage in certain financial or administrative transactions electronically. Because the University's activities include both HIPAA covered and non-covered functions, the University has a status as a "hybrid" HIPAA entity.
If you are conduct research at a covered entity outside of UCCS the researcher must contact the covered entity directly and provide the UCCS IRB a letter of access and any supporting documents from the covered entity which may include HIPAA Authorizations and/or HIPAA Waivers approved by the outside covered entities Privacy Board.
If you are conducting research at a covered entity at UCCS; contact the IRB.
Note - Most of the HealthCircle clinics in the Lane Center are HIPAA covered entities.
L. Will this study involve food, drugs, or devices?
Check the appropriate boxes.
M. Certifications/ Assurances
Read about Conflicts of Interest in number 1 and state whether or not there is an actual or perceived conflict of interest. If you answer "yes", describe why and attach the COI Managment Plan, if applicable.
Read and understand the investigator's continuing responsibilities to IRB in number 2.
Make certain that the investigators and the faculty advisor read the Investigator Acknowledgments and the Faculty Advisor Acknowledgments and submission procedures BEFORE submitting the completed IRB Application.