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.
What do I need to include in my application?
In addition to the application form, you must submit your Consent Form and the Data Security Form. Completing the Data Security Form will assist you in your assessment of the sensitivity of your data, as well as potential risks to your participants.
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.
All submitted materials must be in their final form. Do not submit drafts of consent forms, interview questions, etc. This is the #1 reason applications are rejected.
All IRB applications by students must be read and 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.
How quickly can my application be approved?
Academic year: Applications are distributed to reviewers each Thursday during the term. Applications will normally be reviewed in a week, but if there’s a problem or the reviewer needs additional information, reviews may take longer. Please note that the IRB goes on hiatus in December and over Spring Break. If you plan to collect data in December or early Spring Term, you should submit your application before the end of the prior 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.
Can I start gathering data before my application is approved?
No, you may not gather data until your application is approved.
How long do I need to store my research?
All research materials must be stored for at least three years following the conclusion of the project. This includes consent forms and participant contact information, raw data and analyses, and any other pertinent materials.
Students should make arrangements with their advisors regarding the long-term storage of their data.
What kinds of projects will the IRB not approve?
Most human-subjects research projects at Carleton are approved by the IRB, either “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 may 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.
How do I document consent, including “broad consent”?
If the project is ruled exempt, the IRB will not require you document your participants’ consent. However, it is usually good research practice to get your subjects’ consent even when it is not required.
If the project is not exempt, you normally will have to document consent. The Carleton IRB provides a consent-form template that researchers can use to develop a form for their own project. This form addresses the major considerations for obtaining consent, which include having each participant’s legal name and contact information, and enumerating the specific uses of their data to which they do (and do not) consent.
In some cases, a physical or electronic consent form cannot be used. For instance, this can occur when the sensitive nature of the research heightens the possibility of risk to the subjects if the consent forms might be compromised, or when the subjects cannot sign paper or electronic forms. In these cases oral consent can substitute for written consent. Standard practice requires reading 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.
The new common rule also created the idea of “broad consent,” by which subjects may consent to both to the immediate use by a researcher of the data being collected – for instance, through a survey and subsequent, secondary use by other researchers of that data. Note that under the old rule, use by researchers of data collected by others was and now still may be permitted as one type of research exempt from IRB oversight:
(4) Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
In addition, elements of informed consent may be waived where the research could not practicably be carried out without a waiver, as long as it involves minimal risk to subjects and waiving consent will not adversely affect their rights and welfare.
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.
How can I secure my research data, such as my human subjects’ identities or their responses to survey questions?
Every IRB application must include a completed Data Security Form. Completing this form requires an understanding of the kind(s) of data you will be collecting, how you will be collecting it, how you will be storing it, and managing it throughout its entire life-cycle, from the inception of your project to the publication and/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.
- Be mindful of secondary identifiers. Even if you use pseudonyms in reporting your data, a handful of secondary identifiers (e.g., age, educational status, occupation, and/or city of residence) can be enough to uniquely identify your participants. 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.
- Make sure all devices used for data collection and storage are password-protected. This includes laptops, tablets, mobile phones, and related devices. 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 and storage of your data and materials is no longer required, 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 (or at 507-222-4123), IRB Technical Consultant, about your plan.
- Georgia Tech’s Office of Research Integrity Assurance offers excellent advice on protecting sensitive 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.
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 (e.g., the US Census).
If these data are either not private or not identifiable, then your project is not “research with human subjects” as defined by the federal rule (sec. 102(e)), and you may proceed without IRB review. (For example, how many votes a candidate received in a public election is identifiable information about that candidate, but the information is public. What percentage of a county voted for a given party is a statistic based on private information about the voters, but that information is not identifiable.)
Please note that some projects merge one or more datasets in a manner that allows individuals to be identified. In such cases, you must treat the merged data as identifiable. If you are using private, identifiable data collected by others, you must submit an IRB application. Your project will likely be approved as long as (1) the research is within the scope of the “broad consent” given by the subjects and (2) you will adequately secure the data so that they are not made public.
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.
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 that they thus do not need to apply to the IRB for approval. Alternatively, course instructors may decide to have their students apply to the IRB as a pedagogical exercise, to obtain the IRB’s formal review of the research, or both.
Many such applications will be found exempt under category 1: “Research that only includes interactions involving educational tests (cognitive, diagnostic, aptitude, achievement).” However, researchers must consider whether any subjects will be minors, in which case parental consent might be required. See question 13 below.
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.
Can I do research using my students as subjects?
Because of the inherent power differentials at play, faculty members are discouraged from enrolling students or advisees as participants in their research projects. We normally disapprove of offering students course credit or extra credit for participating in your research. 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.)
However, pedagogically-oriented research inherently involves one’s students as participants, and the college recognizes the value and benefits of such research. Please see our established guidelines and protocols for further information.
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.
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). Parental consent is required before you conduct research on minors.
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 that will include minors as subjects like any other projects. 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.
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.
See the guidance for International Research.
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).
I received approval to do this research last year, but now I want to gather some more data. Do I need to reapply?
If you are continuing a project that was found to be exempt from IRB oversight, you need not reapply. For all other projects, IRB approval is good for one year. If it’s been more than a year since your project was approved, you need to reapply.
What do I do if I have other questions about the IRB process?
Contact the IRB chair, Justin London, Andrew W. Mellon Professor of Music, Cognitive Science, and the Humanities, at 507-222-4397 or 1 N. College Street, Northfield, MN 55057.