The information below is intended to provide helpful guidance for the completion of the IRB application.
Briefly describe the proposed study including 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.
Describe the research design and procedures to be used. It is 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.
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.
Besure to include the number of expected research participants.
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:
Examples of Mistakes:
4. Participant Recruitment
Describe how subjects will be recruited, selected, and, if part of the design, placed into groups.
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.
5. Informed Consent
Describe how informed consent will be obtained from each subject or the subject's legally authorized representative.
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:
The IRB may approve waiver of the requirement of a signed consent form, if it finds either:
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.
5a. Informed Consent Document
Attach an informed consent document that contains the following items:(Sample Consent Form)
A. General elements of informed consent:
B. Additional elements of informed consent. When appropriate, one or more of the following elements of information shall also be provided to each subject:
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
Describe how the data will be monitored to ensure the safety of the subjects.
Criteria for IRB approval: When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.
6a. Privacy and Confidentiality
Describe how the privacy of research subjects and the confidentiality of the data will be maintained. If Protected Health Information is to be collected or transferred, researchers must comply with the Privacy Rule associated with HIPAA.
Some studies require disclosure of information to other parties; describe any limits to confidentiality. If research is contemplated on a topic which is likely to be subject to legal proceedings, the federal government can issue a "Certificate of Confidentiality" which shields the data from required disclosure by the researcher.
List all individuals who will have contact with the subjects. List all individuals who will have access to data individually linked to subjects.
Criteria for IRB approval: When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data. When Protected Health Information is collected or transferred, researchers protect the privacy and security of such information.
7. Protection of Vulnerable Participants
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
Criteria for IRB approval: 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.
Section I Submissions to Other IRBs
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.
Section J Protected Health Information (PHI)
Read the definition of Protected Health Information and state whether or not you will be collecting or sharing such information during your research.
Section K Qualifying for Exempt Review
If you are requesting exempt review, answer questions 1 and 2 in order to determine if you qualify to do so. You protocol does NOT qualify for exemption if you answered “yes” for question 1B. It also does NOT quality for exemption if you answered “yes” to both questions 2A and 2B.
If you only answered “yes” to only 2A OR 2B OR you answered “no” for both 2A and 2B, answer questions 2C, 2D, and 2E. If you answered “yes” to questions 2C, 2D, and 2E your study does NOT qualify for exemption.
Read the description of Protected Health Information and state whether or not it will be collected for the project.
If your study DOES qualify for exemption, read all of the categories of exempt review and select the one in which matches the type of research you will be doing.
Section L Certifications/ Assurances
Review bullet number 1 and make sure that all personnel involved in your project complete the CITI Training course at https://www.citiprogram.org/Default.asp and list the dates of completion and the training numbers under the correct section of the application.
Read about Conflicts of Interest in number 2 and state whether or not there is an actual or perceived conflict of interest. If you answer “yes”, describe why.
Read and understand the investigator’s continuing responsibilities to IRB in number 3.
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.
If you have further questions, contact the IRB via email at firstname.lastname@example.org.