Welcome to the Colorado College IRB web page. The below information should be reviewed in the order in which it appears for greatest effectiveness. Everything you need is on this page (except for consent information; see link on left for information about the consent process).
NEW IMPORTANT INFORMATION: IRB proposals can no longer include participants under age 18 unless the study is specifically of children (say, in school) and all studies involving children will involve a much more rigorous process. If your study does not absolutely require the inclusion of children, your application must indicate that you will only use participants ages 18 or older, and your consent form must include a sentence at the end, "I affirm that I am 18 years of age or older." Contact Amanda Udis-Kessler if you have any questions about this change.
- Not if you are only carrying out a class project that won't be presented beyond your class (but you do need to submit an application if your research will be published (including being electronically archived or bound as a senior thesis in the library) or presented publicly (including certain Venture Grant projects that involve interviews, surveys, etc.)
- Not if you are not interacting with living people (e.g., if you are only analyzing texts or carrying out ecological research)
- Not if you are only asking people professional questions (that focus on their areas of expertise) rather than personal questions (that involve getting private information from them); personal questions require approval, professional questions don't
- Not if you are only carrying out non-participant observation in a public place (the Worner quad, Acacia Park, etc.) and not interacting with the people you observe
- In all other cases, you do need to submit an IRB application (for one exception, see the section on Venture Grants below)
Please be aware that your proposal will NOT be reviewed if it is missing any of the following elements:
- Faculty sponsor's email of approval (unless it is a Venture Grant project that is NOT for a thesis; those are reviewed without faculty sponsor input. If your Venture Grant will be used to collect senior thesis data, your thesis advisor does need to approve the IRB proposal)
- A debriefing form or script if you will be using deception (most common in psychology and marketing studies)
- Your consent form or script, built using one of the templates on the consent forms page
- Your interview questions, survey instrument, experiment process, or other materials showing clearly what the participant will encounter and what they will do
- An answer to the question of how you would report an incident of harm of one occurred. Please be aware that you need to answer this question even if you are sure no harm will occur. A typical and good answer is that you would report an incident of harm to your advisor and to the chair of the IRB.
- Those that do not put participants at more than minimal risk of physical, legal, financial, employment, reputational, emotional/psychological, or any other kind of harm; projects with low risk levels of harm can be approved but the less potential for harm, the easier the approval
- Those that only involve adults (people 18 or over)
- Those that only involve people who are completely free and able to refuse participation in your research (so not people under 18, prisoners, undocumented immigrants, people with developmental disabilities, or members of politically disadvantaged groups)
- Those with well-designed processes to gain consent of participants
- Those that only use the following research methods: educational tests, questionnaires/surveys, interviews, focus groups, non-participant observation, or collection of data from voice, video, digital, or image recordings
- Those in which the research focuses on individual or group characteristics or behavior (e.g. perception, cognition, motivation, identity, language, communication, cultural beliefs/practices, or social behavior)
- Those that take place in educational settings and that focus on normal educational practices
- Those that involve the study of already collected data, documents, or records that are publicly available
- Those in which individual participants cannot be identified by name or, if they can, being identified does not put them at risk of harm
- Those that, if an organization is the topic of study, have already been approved by the organization in question
- The probability and magnitude of harm or discomfort anticipated in the research are not greater than the harm or discomfort ordinarily encountered in daily life or while taking routine physical or psychological tests.
- For example, an interview study that addresses past experiences of depression is within the category of minimal risk if the questions are expected to cause no more harm than would a session with one’s therapist or counselor
- An appropriate consent process must include:
- Voluntariness (the complete freedom of the participant to refuse to participate if they want),
- Information (about the research, provided on the consent form), and
- Comprehension (the consent form is written in language the participant can understand fully so that they are completely capable of deciding whether or not to participate)
- A process that uses either:
- An appropriate consent form for participants who can read and sign their names, or
- A verbal consent script in the participant’s native language for participants who cannot read and sign their names (or who, for cultural reasons, would not do so, such as participants in some tribal or ethnic groups)
- In cases where photography or videotaping will be used, a release form for use of photograph/videotape
- Information about laws relating to consent, as well as a variety of consent form templates, can be found in the consent section of the IRB website.
Complete proposals including copies of data collection instruments, consent forms, and a confirming email from your faculty sponsor are due VIA EMAIL to the Chair of the IRB when they are fully prepared, and will be reviewed on a rolling basis during the entire year (including the summer, though please note that summer review may take longer). You will be notified about the IRB decision regarding your proposal within several days of submitting your proposal. A turnaround of one to two days is not unusual but cannot be guaranteed.
The best way for researchers to make sure they have enough time to go through the application, receive approval, and still have time to do research is to do an exemplary job of filling out the application (see the tips link above) and to send the proposal in as early as possible.
Please treat initial contact with the IRB chair in a formal and professional manner, as you would the cover letter you sent along with a job application. Sending an extremely casual or informal email to the IRB chair signals that you may be equally casual about your obligations to the participants in your study. Unless you know the chair personally, please do not begin your email "Hey, Amanda" or in other equally informal ways.
Please note that the IRB is instituting a new policy about the timing of Venture Grant-related IRB proposals. The IRB must receive IRB proposals tied to Venture Grant applications by 5 pm the final Wednesday of the block before the Venture Grant proposal will be turned in. In the past, it was acceptable to turn in an IRB proposal and a Venture Grant proposal simultaneously. Now students must complete the IRB process first. If the Dean's Advisory Committee does not have evidence of a student's approved IRB proposal when they review the Venture Grant application, the Venture Grant application will be tabled until the following month. Also please note that all inquiries about whether a Venture Grant project is exempt from IRB review must similarly be received NO LATER THAN 5 pm of the final Wednesday of the block before the Venture Grant proposal will be turned in. This deadline is strongly recommended beginning at the end of block 7 of the 2012-2013 academic year, and will become a requirement during block 1 of the 2013-2014 academic year.
- If you will be interviewing people, surveying them, observing them, or otherwise obtaining personal or private information from them, you have two sets of obligations: first, to the local social structure, and second, to the CC IRB.
- Regarding the first obligation, you may not carry out human subjects research while off-campus unless you have gone through whatever official channels have been established at your study site and have been approved for research there. It is your responsibility to work with your program director or the faculty member teaching your course to determine what the local obligations are so that you can meet them.
- You should begin these preparations before you leave CC, if possible, by communicating with your program director or faculty member to obtain background information that will leave you better prepared when you arrive onsite.
- Once you are at the study site, you will need to continue your process of finding out the local specifics of human subjects research permission. Remember that you must do this proactively; it is not an excuse if the proper channels are not immediately made available to you. Track them down.
- If you have questions or concerns and your program director or faculty member is not helping you, contact Heather Browne (firstname.lastname@example.org) at the CC Off-Campus Study Office.
- Regarding the second obligation, as the rest of the CC IRB website points out, CC requires you to demonstrate that your research falls within legal and ethical bounds as defined by the US federal government; you will demonstrate the appropriateness of your research by completing and submitting a CC IRB application, and having the IRB approve it. Everything you need to know about the IRB process and the issues underlying it can be found on this page, the CC IRB homepage (except for a couple of items on linked pages; see the top of this page for a list of those other items).
- It is strongly recommended that you familiarize yourself with this webpage before you leave for your study site, as this will save you time once you are there. You will be able to go through the entire IRB process at your study site as long as you have access to email and a printer there. You may find it helpful to print documents (as well as this webpage) before leaving, as well as saving a copy of the IRB application form on your computer.
- Your program director or faculty member off-campus should review your IRB application form to make sure that you have done a thorough job on it, as this will speed up your IRB approval.
- If you are studying off-campus during the fall semester, you should plan to submit your IRB application no later than the end of block 1. If you are studying off-campus during the spring semester, you should plan to submit your IRB application no later than the end of block 5.
- If you plan to use your off-campus research for a thesis project, be aware that your thesis advisor needs to review and approve your IRB application before you send it to the IRB (along with your program director or onsite faculty member).
- If your Venture Grant project involves collecting personal information from people (as opposed to asking only questions of expertise or professional questions), you need IRB approval in order to receive Venture Grant approval and funding. Please see the above bullet points for more clarification. Many Venture Grant projects that involve interacting with people do require IRB approval because you are required to present your findings publicly. To determine whether your Venture Grant proposal requires IRB approval send a detailed paragraph explaining your project along with a finalized list of questions you will ask participants to the IRB chair for review.
- The IRB is in the process of developing one other IRB exemption for Venture Grant applicants, specifically for projects that are intended to address topics of personal interest rather than to contribute to academic literature or to benefit the applicant academically. You will still need to run your project by the IRB to see whether you are eligible for this "journalism exemption" and the main questions you need to answer are as follows: Are you collecting data for academic credit? Are you collecting data for a course in which you will receive a grade? Are you collecting data for a senior thesis (whether for a major or minor)? If none of the above hold, what do you plan to do with the data you collect? If you send an email to the IRB chair answering these questions with regard to your Venture Grant proposal (do NOT send the proposal itself), the IRB can determine whether you are eligible for the journalism exemption.
- All non-IRB questions related to your Venture Grant go to the Dean's Advisory Committee, not to the IRB. The IRB is not able to answer Venture Grant questions.
- Do not send a draft of your Venture Grant proposal to the IRB. The IRB does not review Venture Grant materials, only IRB applications.
- If your Venture Grant research will be taking place abroad, please be sure to review the section immediately above.
- As noted toward the top of the page, if your Venture Grant information collection is for your senior thesis, your thesis advisor must review and approve your IRB proposal before the IRB will review it. If your Venture Grant information collection is simply for your own education, you do not need a faculty member to sign off on the application.