Frequently Asked Questions
1. I’m not sure whether my project is “research on human subjects.” How do I know if I need to apply for approval?
You should complete the IRB Quiz (Does My Project Require an IRB Application?) to determine whether you need to submit an application.
2. What do I need to include in my application?
In addition to the application form, you should submit your consent form or the script you’ll use to secure oral consent. Depending on the type of research you are conducting, you should also include any other materials you might be using in the research, such as
- recruitment notices or advertisements,
- a debriefing statement in the case of research involving deception,
- survey instruments,
- psychological tests (other than standard, commercially available instruments),
- interview scripts or forms, or
- oral-interview scripts.
Applicants should note two matters related to the application process:
A. The online application must be initiated and submitted in one sitting; it cannot be saved and then completed in stages. Of course, the application form, informed-consent documentation, surveys/questionnaires, and other materials can be prepared ahead of time and then uploaded at the time that the application itself is completed.
B. All IRB applications by students must be approved by a faculty research advisor prior to IRB review. Though the online system includes an automated step during which a student's advisor formally approves the application, a student investigator must discuss his/her research and draft IRB application with a research advisor before submitting the final IRB application. An advisor's review of research and application materials will likely improve the IRB application, allowing more rapid approval of the application by the IRB itself.
3. How quickly can my application be approved?
Academic year: Applications are distributed to reviewers each Thursday during the term. Normally applications will be reviewed in a week, but if there’s a problem or the reviewer needs additional information, it may take longer. Please note that the IRB goes on hiatus in December. If you plan to collect data in December, you should submit your application by the end of fall term.
Summer: Applications are reviewed during the summer but only once a month. If you are facing a deadline to begin data collection, you should alert the IRB chair. The IRB will try but cannot promise to accommodate your schedule.
4. Can I start gathering data before my application is approved?
No, you may not gather data until your application is approved.
5. What kinds of projects will the IRB not approve?
Most research projects at Carleton are approved by the IRB, as is or with some modifications suggested by the IRB. Projects that pose a high risk of harm to subjects are most likely to go to full review and may not be approved. Risks might include the risk of emotional trauma (for example, by asking people to recount traumatic experiences) or risk of criminal liability (for illegal drug use, for example). High-risk projects can be approved as long as the investigator has taken steps to reduce the risks as much as possible, and the study is well-designed to make a significant contribution to the scholarship.
6. Do I need to use a consent form to document consent?
Most projects require informed consent, but if using a consent form is impracticable, you can secure consent orally. Standard practice requires following an informed-consent script and then noting that the subject gave oral consent - for instance, at the beginning of an audio-recorded interview, in clear notes from a focus group, or with a check box at the beginning of an on-line survey.
7. Do I have to keep my subjects’ identities confidential?
Normally it is important to protect your subjects’ privacy, for example by assigning identification numbers or pseudonyms to participants. Researchers must also keep electronic and paper documents secure, for example in a locked file cabinet or a password-protected electronic file.
However, some research projects can’t be conducted without revealing subjects’ identities. In these situations, you must fully explain and justify this need for the purpose of research (i.e. using photos and names simply to enhance the entertainment value of a public presentation would not, in most cases, be allowed). Subjects must consent to have this information made public. If the project involves collecting sensitive information, the IRB will weigh the risk of making public this information against the value of your research project and determine whether the benefits of doing the study outweighs the risk of harm.
The IRB can provide helpful guidance in choosing appropriate processes and tools for securing your research data. See Question #8!
8. How can I secure my research data, such as my human subjects' identities or their responses to survey questions?
Any IRB application must include an honest assessment of whether your data may be harmful to your research subjects if used inappropriately. Making this assessment requires understanding the life cycle of your data - from the inception of your project and the collection of data through the storage of data and the publication or presentation of results.
Good data-security practices that protect your research subjects include:
- Do not capture more information than you need to answer your research question. Do you need, for instance, your respondents' email addresses and names? Collecting too much information makes you and your subjects vulnerable to identity theft.
- Pay attention to cultural issues regarding the sensitivity of information, especially when working in a region or country with which you are not familiar. In this case, it is best to assume that all data are sensitive and act accordingly.
- Immediately remove all names and contact information from your working data files - qualitative and quantitative. Simply replacing names in a digital file is usually not enough! Even when specific names are not present in the data, identities can be determined (and stolen!) from other pieces of information such gender, birthplace, age, or activities. An identity thief can combine data from other sources to build complete profiles of your subjects. Note that Social Security Numbers should never be used as unique identifiers, nor should similar data such as driver's license numbers or student ID numbers.
- Lock away paper and/or backup copies of your data in a location that can only be accessed by researchers working directly on your project.
- Set passwords on your computer(s) and any digital files that include sensitive information. Additionally, set your computer to go to a password-protected screensaver (or to go blank) when it is idle for some time. This is only a minimum security step! A determined intruder can readily bypass these passwords.
- Set up a working firewall on your computer.
- Verify that any computer on which you will work is free of any spyware, trojan malware or viruses.
- For very sensitive material, follow all of the steps above and work from a separate, more secured account on your computer and do not access the internet from that account.
- When the project is complete, be sure to securely destroy all original data. While shredding paper is one obvious way to destroy some kinds of data, digital data require more attention. Carleton's ITS Help Desk can assist you in securely destroying digital data. Deleting files is not a secure way to destroy digital copies of your research data or working files.
Given the importance of data security, you might want to consult some other excellent resources on research data management and security:
- Talk with Paula Lackie at plackie or x5607 about your plan.
- Georgia Tech’s Scholarly Communication & Digital Curation Office offers excellent advice on properly protecting your research data.
- The Inter-University Consortium for Political and Social Research (ICPSR) provides a nice primer on safely preparing quantitative & qualitative data for archival purposes.
- The University of Edinburgh's MANTRA site offers a full course in data management for students and advanced researchers.
9. Do I need IRB approval if I’m analyzing data collected by someone else?
Many research projects involve “secondary data analysis”, or analyzing data collected by some other institution or agency. (The US Census is one example). The Carleton IRB follows the common practice: The use of these existing data, when they have been stripped of any identifying information about the human respondents and made publicly available, do not constitute "research with human subjects" under the federal common rule (45 CFR Part 46). Consequently research using these data does not require IRB review.
Carleton's policy does not apply to data that includes identifying information (typically acquired only through special application to the archiving body) or research projects that merge one or more datasets in a manner that allows individuals to be identified. These projects will still require IRB approval.
Some examples of data archives where publicly available data meets these requirements and does not require IRB approval:
- Inter-University Consortium for Political and Social Research (ICPSR)
- National Center for Health Statistics
- National Center for Education Statistics
- National Election Studies
- Roper Center for Public Opinion Research
- LAPOP (The Latin American Public Opinion Project)
- U.S. Bureau of the Census
- Luxembourg Income Study (LIS)
- iPOLL Databank
This is not intended to be an exhaustive list of public-use data sites. Data made available though Carleton’s Library and other internet data sources may also fall under this policy if the site where the data has been made available satisfies the following criteria:
- It includes a ‘responsible use statement’ or other confidentiality agreement for the authors to protect human subjects.
- The initial data collection was approved by an IRB that meets the federal common rule ((45 CFR Part 46) criteria for an IRB (including non-US research oversight bodies that meet common rule standards).
- The dataset and documentation as distributed do not include information that could be used to identify individual study participants.
Investigators who intend to use existing data from on-line or other sources and who have questions about whether this policy applies should email the Chair of the IRB and include the following information: 1) the name of the dataset, 2) the URL of the data archive site (or other information on how the data can be obtained), and 3) a brief abstract describing the dataset and its possible use.
10. I want my students to do a research project as a class assignment. Do I need IRB approval?
Many student projects assigned as part of Carleton coursework bear superficial resemblance to Research, and might even be considered "research" at Carleton, but do not qualify as Research projects under the federal definition. Such is the case with some course assignments that mimic research but are intended only to teach students the basics of systematic investigation. For example:
- Students in an introductory sociology course might be asked to administer questionnaires or conduct brief interviews using other students as subjects, not with the intention of contributing to generalizable knowledge, but to teach the student interviewers about how to conduct sociological research.
- If you do a straw poll of people in Sayles about their favorite ice cream flavors, with no assumption that this is generalizable to a larger group, you are not doing research.
In such cases, course instructors (but not students) may decide on their own that the planned activities do not constitute Research under the federal definition and need not submit applications, or have their students submit applications to the IRB--provided that the subjects will be legal adults capable of giving informed consent and that the experiments present no more than minimal risk to the subjects.
If an instructor is not certain whether a planned activity constitutes Research, he/she should contact the IRB chair to discuss this question.
Even if a planned student project is clearly not Research by the federal definition, it is always acceptable for the instructor to require that students submit a formal application in order to teach them about the ethical treatment of human subjects and the workings of a review committee such as the IRB.
11. Can I do research using my students as subjects?
Because of the inherent power differentials at play, faculty members are strongly discouraged from enrolling students or advisees in their research projects. Likewise, staff members and students are discouraged from conducting research on peers (whether students or not) over whom they have, could have, or seem to have authority. (For example, a staff member should not ask work-study students under her supervision to complete a research survey. The captain of a sports team should not ask other athletes on that team to participate in his comps research.)
IRB approval may be granted with a compelling justification or the employment of a mechanism ensuring anonymity of participation. We normally disapprove of offering students course credit or extra credit for participating in your research.
12. If my project was approved by an IRB at another institution, do I still need to get approval from the Carleton IRB?
When Carleton College plans to participate in collaborative (multi-site) research studies where there is an intention to contribute to generalizable knowledge, IRB application is usually required. For all such studies initiated elsewhere but involving Carleton, the IRB asks that the relevant administrative office on campus (Institutional Research, in most cases) submit to the IRB chair the following information in advance and then follow Carleton's procedure on Cooperative Research outlined below:
- Basic information about the study itself--its title, the sponsoring institution or organization, target subjects at Carleton, and the kinds of information to be gathered.
- Written assurance that the project has been reviewed, or that an ongoing project is being annually reviewed by a qualified, listed IRB at another institution. If this cannot be provided, then the Carleton IRB will conduct a review.
- A brief discussion of likely benefits to the college and to the subjects.
- A brief discussion of any inconveniences or risks to the subject pool at Carleton.
- Written assurance that subjects at Carleton will be told clearly that they are not required to participate, may decline to participate at any point, and may decline to answer specific questions without penalty.
To implement the federal regulation above, the IRB at Carleton has developed the following procedures for cooperative (multi-institutional) research:
If the project has already been reviewed by a qualified IRB at another institution, then the applicant should submit the application from that institution and the IRB's finding to the Carleton IRB. We need this information to determine whether the review was done in a way that meets Carleton's responsibilities for "safeguarding the rights and welfare of human subjects and for complying with" the federal policy."
However, it will not be necessary to submit the full application and IRB finding from another institution in the case of established national studies that are ongoing, such as the HENRI Faculty survey. In those cases, the local administrator of the project should send a letter to the chair of the IRB affirming that the project is being regularly reviewed by a qualified IRB at another institution. If in doubt, the local administrator should contact the IRB chair to discuss how much documentation will be needed.
If the project has not been reviewed elsewhere, then the Carleton IRB will conduct its own review in the usual way.
13. I’m conducting a survey and some of my subjects might be under 18. Do I need to get consent from their parents?
Many Carleton students are minors (under the age of 18). The federal Common Rule (45 CFR Part 46) requires that parental consent be secured before minors are surveyed for research purposes.
Some colleges treat their students as adults and waive the parental consent rule, but Carleton does not follow this approach. Instead, the Carleton IRB reviews projects which will include minors as subjects like any other projects. Many projects, such as many that use surveys to gather education-related information, are low-risk (that is, they don’t collect sensitive information) and are usually found to be "exempt" from IRB regulation - meaning in turn that they are exempt from the parental consent policy.
For non-exempt projects (including some that might use surveys to gather sensitive information), the Carleton IRB requires at least one parent's consent to the research on the minor child. The investigator must provide the parent with a concrete sense of the nature of the research being done on the child, and must particularly describe the risks involved (if any). The investigator should secure a signed letter or an electronic signature indicating consent. Simple failure to respond to a letter requesting consent cannot be taken as evidence of consent.
14. I’m doing research abroad but my research isn’t under the auspices of any university or research institution. Do I need to find a university to supervise my work?
No. We will simply ask you to find a local expert to consult with you, to make sure you're following local ethical guidelines. This could be someone at a local university who does similar research, or someone at Carleton who has done research in that country.
15. I have IRB approval for my project, but now I’m making some changes to my study. Do I need to reapply?
You should inform the IRB chair of the proposed changes via e-mail. If the changes are minor, the chair will simply archive the e-mail and tell you that you can proceed. If the changes are more substantial, your project will probably require a new review, which will require a reapplication. "Substantial" changes include (but are not limited to) a change of research topic, a change of the human-subjects population, a change of in the level of risk to the subjects, or a change in the research protocol (i.e., switching from interviews to surveys).
Note that if your project was approved more than a year ago, you will definitely need to reapply regardless of the scale of the changes to your study.
16. I received approval to do this research last year, but now I want to gather some more data. Do I need to reapply?
IRB approval is good for one year. If it’s been more than a year since your project was approved, you need to reapply.
17. What do I do if I have other questions about the IRB process?
Contact the IRB chair, Daniel Groll at email@example.com or 507-222-4219!