- The Common Rule (45 CRF 46)
- FDA IRB Regulations 21 CFR 56.111
- The Belmont Report
- Nuremberg Code
- Declaration of Helsinki
- NIH Guidelines for Human Subjects
- Regulations for Requesting or Disclosing Health Information (HIPAA Privacy Rule)
Resources For Students
IRB forms are downloaded as Word files or PDF; type in your responses, add your project description, consent forms, and debrief forms, and then save either as a Word document or pdf and send to email@example.com Proposals are processed M-F 8 am-4 pm during the academic year. Over breaks and holidays, proposals may be processed on a non daily basis. Full board reviews take approximately 10 workdays to complete initial reviews.
- Proposal Form for Research with Human Participants (login required) Attention! The IRB is using a new proposal form starting May, 2013 in order to improve documentation for meeting federal regulations. Any questions, please email IRB. (Please do not submit the form until ethics training is completed. Completion of ethics training is mandatory. You note the completion of training in Section III of the proposal form.)
- Protocol Modification Form for Research with Human Participants (If the modification involves new research team members, you must document that they have completed ethics training.)
- IRB Continuation Proposal Form Use a Continuation form when approved projects are continuing beyond their approved duration. Because researchers may not continue a project beyond their approved time without receiving IRB approval for the continuation, it is best to submit a continuation form at least 10 days prior to the project's expiration date.
If you would like to view sample consent and debrief forms, the IRB provides some models that you could follow:
Model IRB Consent Forms (login required)
Online Ethics Training
These sites provide free online ethics training. The first site, “Ethics Training Module,” must be completed before initiating any human research at Grinnell College. The other two sites are highly recommended as they provide additional training and cover a broader range of ethical topics.
- Ethics Training Module – REQUIRED TO ENGAGE IN HUMAN SUBJECTS RESEARCH. Just click the link above and you will be taken to the CITI training site. The Grinnell College IRB requires that researchers complete training in the responsible and ethical conduct of research before initiating any human research at Grinnell College. Though the IRB will accept such training from a variety of sources (e.g., National Science Foundation), the College has a subscription to provide this training through the Collaborative Institutional Training Initiative (CITI).Instructions for registering with CITI are located here for Faculty/Staff and students. (login required)
- Human Participant Protections Education – National Cancer Institute (2 hours)
- Informed Consent Checklist – Stanford University
- Guidelines for Writing Informed Consent Documents – NIH
- Human Subjects Regulations Decision Charts – OHRP
Additional Ethics Links
- American Psychological Association (APA) Ethics Website
- American Educational Research Association (AERA) Research Ethics Page
- American Anthropological Association (AAA) Ethics
- American Sociological Association (ASA) Code of Ethics
- Ethical Standards for Research with Children – SRCD
- Guide for Psychological Research
- Ethics of Research on Vulnerable Populations – Case Western Reserve University
Resources for Faculty/Staff
- Faculty Handbook Appendix IX Concerning Research Oversight
- Online Addendum to Faculty Handbook Appendix IX Concerning the IRB
- Annotated References for Class Discussion
Online Additional Ethics Training
These sites provide links to advanced ethics training courses requiring a fee to complete.
Institutional Review Board Frequently Asked Questions (FAQs)
These FAQ pages were modified with permission of Claremont Graduate University, 2011.
What is research?
A key question to ask in beginning the IRB process is whether the project is considered research. In general, research is defined by the Department of Health and Human Services as a "systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge" (45 CFR, Part 46).
A good rule of thumb for determining whether or not a particular project qualifies as research is to consider whether the results will be published or presented in some form or forum outside of the institution; if yes, then it is research. However publication is not the critical determinant. If the activity is one in which you conduct because of your professional position, then it may be research. If you intend to share the information with others beyond the purpose of the activity, then it may be research. In-house evaluations and assessment are not considered research that requires IRB review.
Data used for institutional purposes would not normally be considered research in this context.
What about research projects that are part of Grinnell coursework?
Current interpretation of guidelines suggest that research is held to a higher standard than instructional activities and requires research to be objectively reviewed whereas instructional activities of similar nature need not undergo review by the IRB. Because classroom-based projects will not usually be published nor contribute to the generalized knowledge, they need not go through the IRB process. Nonetheless, professors who use research projects or exercises as part of their teaching methods or those who teach research methods courses are expected to cover research ethics and to teach ethical research procedures before their students undertake such activities. Professors are also responsible for the ethical research behavior of the students in their courses even when students fulfill class projects off campus. In this context, students and faculty members are responsible for adhering to the IRB principles in their course projects. Feel free to contact the IRB for any questions that you may have.
The interpretation of the Code of Federal Regulations is that if a class project is designed with the potential to contribute to generalized knowledge, whether intended for publication or not, then the researcher should seek IRB approval prior to conducting the research. When a teacher elects not to have their class projects receive IRB review, the IRB recommends that the teacher act as an IRB Chair and require their students to submit materials for the teacher's review, that the teacher store and document the projects, so that should a participant find that the course activity harmed them in some way, the teacher has the necessary documentation of the student researchers' activity and materials.
Do studies that focus on quality improvement and quality assurance activities require IRB approval?
Quality Improvement and Quality Assurance activities conducted solely for the intent of maintaining or improving quality of services provided by an institution are not considered research activities. However, if the data collected are generalizable and are to be shared outside of the institution through discussion, presentation, or publication, the activity qualifies as research. In instances such as this, the research use of the data collected must be reviewed. Nevertheless, in all activities the principles of ethical practices should be observed.
Do evaluation projects require IRB approval?
Evaluations are systematic studies of programs (or of products or personnel) to determine impact and/or for improvement purposes. If the information generated from the evaluation is being used only for program administrators or staff, and is not intended for dissemination or publication, there is no need for IRB review. If there is a possibility that a publication or presentation may emerge from an evaluation study, IRB review is necessary. Please be aware that the agency for which the evaluation is being done, may require IRB approval.
May a researcher who is teaching a course conduct research on students enrolled in his or her class(es)?
If an instructor wishes to recruit and involve students in his or her own classes in a research activity which will directly benefit the instructor (a dissertation research project, for example), the instructor should consider the following guidelines and premises that will govern IRB review of the research activity.
Instructors are in a position of authority over students in their classes, especially the power to determine a course grade. This compromises the absolute requirement that participation in research be voluntary, laying a veil of potential coercion over any in-class recruitment, regardless of how benign the instructors’ intentions might be. It is therefore always preferable for an instructor to recruit student subjects from the general student population if possible (e.g., advertise in student-oriented media, post on campus bulletin boards, list-serves, or websites, broadcast to email addresses, etc.) or from classes or courses with which the instructor is not involved in determining grades.
If circumstances dictate that there is no good alternative to recruitment of one’s own students (and “it is so much easier to use my own classroom” does not equate to “there is no good alternative”), the major protection against the appearance and potential of coercion is maintaining the strict anonymity of participation—that is, the instructor must be insulated from knowing the identity of students who engage in the research versus those who do not. If this is not possible, then recruitment of one’s own students for one’s own research—or any research in which the instructor stands to gain a personal benefit--is simply not permissible.
Provision of incentives to students for participating in research activities, such as extra credit or bonus points toward a classroom grade, must be carefully considered in light of the requirement for anonymity. The Board recognizes the practice of incentivizing participation with a modest level of academic credit as a reasonable means of encouraging student participation in research. However, alternative opportunities to achieve the same extra credit based on a comparable commitment of effort to that required for the proposed research activity must be offered to any student who prefers not to participate in the research.
Extra credit may be offered only if it can be arranged such that the instructor/researcher is blinded to the identify of research participants versus nonparticipants who seek the credit through an alternative activity. This may be arranged by interposing a neutral third party or technological buffer in the credit confirmation process.
What does the IRB consider when reviewing research?
Issues considered in the analysis include:
- Which level of review should the proposal receive;
- Whether risks to participants are minimized;
- How participants are approached so that they can readily refuse;
- How privacy, confidentiality, and informed consent will be handled;
- What physical and psycho-social risks, stresses, and discomforts participants will be asked to endure;
- Whether vulnerable populations (e.g. prisoners, children) are to be included;
- Whether additional safeguards have been included in the study to protect the rights and welfare of any participants likely to be vulnerable to coercion or undue influence such as prisoners or children;
- How sensitive the information is;
- Whether risks to participants are reasonable in relation to anticipated benefits, if any, to participants, and the importance of the knowledge that may reasonably be expected to result;
- Whether diverse populations are included so that all benefit or all take the risks;
- How data will be handled after the completion of the study.
- Have all members of the research team completed ethics training and stated their qualifications to conduct the project.
The scientific merit of the activity is considered only if it has an impact on the risk-benefit analysis. For example, will the number of participants proposed allow the results obtained to be statically significant? Is there a less risky way to achieve the same results?
The IRB also evaluates advertisements, approach letters, consent/assent forms or information statements, telephone scripts, and debriefing statements to determine if they are accurate, explanatory, and written in simple, lay language appropriate for the intended participants.
Does my research require review?
If you are a faculty member, staff member, or student at Grinnell College and your research involves the use of human participants (either directly or through records), your research requires Grinnell IRB review. Please consult the information under the tab "Categories of Research" which presents exempt, expedited, and full board reviews. If you remain unsure whether your project requires IRB, please ask the IRB. If your project does require IRB review, all researchers involved with the project need to complete ethics training.
The web page of the Office of Human Participants provides a decision tree to help investigators determine if their project is research that requires IRB review.
What levels of risk are employed for research with greater or lesser degrees of risk?
Research applications are reviewed at one of three levels, depending on the level of risk to the human participants and on the federal regulations that define the categories of review, which are exempt, expedited, and full board review. The determination of what level of review is required is determined by the IRB staff, NOT the researcher. Whatever the level of review, the ethical treatment of human participants is always a requirement.
Research activities that fall into this category fit one of six categories as designated by federal regulations.
- Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as:
- Research on regular or special educational instructional strategies, or
- Research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
- Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless:
- Information is recorded in such a manner that participants can be identified, directly or through identifiers linked to the participants;
- Any disclosure of the human participants' responses outside the research could reasonably place the participant at risk of criminal or civil liability or be damaging to the participant's financial standing, employability or reputation.
- The human participants are elected or appointed public officials or candidates for public office; or
- Federal statute(s) require(s) without exception that the confidentiality of personally identifiable information will be maintained throughout the research and thereafter.
- Research involving the use of educational tests, (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior the is not exempt under bullet two of this section, if:
- Public benefit or service programs;
- Procedures for obtaining benefits or services under those programs;
- Possible changes in or alternatives to those programs or procedures; or
- Possible changes in methods or levels of payment for benefits or services under those programs.
- If wholesome foods without additives are consumed or
- If a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural; chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.
- Research involving the collection or study of existing data, documents, records, pathological specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that participants cannot be identified, directly or through identifiers linked to the participants.
- Research and demonstration projects which are conducted by or subject to the approval of federal government department or agency heads, and which are designed to study, evaluation or otherwise examine:
- Taste and food quality evaluation and consumer acceptance studies,
It is important to remember that a research activity qualifies as exempt if it is limited to the kind of activities listed above and only after review of the proposal. If the project includes such activities but also involves other activities that are more intrusive, more personal, or more risky than the above, it most likely will not qualify as exempt.
Research activities that fall into this category present no more than minimal risk to human participants, and involve only procedures listed in one or more categories approved through federal regulations.
- Recording of data from participants 18 years or older using noninvasive procedures;
- Video/Audio recording;
- Study of existing data;
- *Research on an individual or group behavior that involves no manipulation of the participants and is not stressful.
Full Board Review:
Research that involves greater than minimal risk is reviewed by the IRB board. Research that requires full board review includes but is not limited to:
- Certain types of research involving children, pregnant women, fetuses, and other vulnerable populations;
- Research involving prisoners;
- Research that involves deception;
- Survey research that involves sensitive questions or is likely to be stressful for the participants; or
- Collection of blood samples in minimal amounts.
How do I start the review process?
Once you have decided to use human participants in your research:
- Complete ethics training.
- Complete an IRB protocol application and submit it to the IRB;
- Include all relevant information (IRB protocol application, consent forms, surveys, questionnaires, test instruments, advertisements, debriefing statements, contact letters, interview
What will happen to my application?
Mail sent to IRB is processed initially by support staff who indexes the proposals and save documents to our IRB storage server space. A member of the board is assigned to examine the proposal for appropriate level of review. If it requires full board review, it is sent to all board members. If not, then the assigned member will give it exempt or expedited review.
After your application is reviewed, you will either receive a letter stating approval or an email requesting additional information and a revision. Researchers should plan the initial review to take up to 10 days.
If a revision is requested, the researchers not only submit the revised proposal form and project description but also include a letter stating responses to the revisions requests. Similar to a letter to an editor an author will send when their manuscript is reviewed, it is helpful for the researcher(s) to respond specifically to the points made in the revision request, drawing attention to how the issues raised in the review were addressed.
Is approval ever denied?
The IRB may determine there is insufficient information to approve or disapprove an application. If this is the case, the IRB will ask the researcher to provide additional information. When the information is received by the IRB, the application is reconsidered.
The IRB may determine that the risks of the proposed activity outweigh the benefits and will withhold approval. The IRB will work with the researcher toward a compromise to reduce the risks and gain approval to carry out the research.
Does all research go through the same review process?
No. Whenever an application is received, it is evaluated by a board member to determine which level of review is appropriate. Many research proposals will be exempt from complete review. In these cases, the board members checks that all information is properly documented for the records. Non-exempt research that is considered of minimal risk is expeditiously reviewed if no additional concerns apply, such as specially protected subject populations or above minimal risk. Expedited review involves evaluating the informed consent process, data storage, and study procedures. Non-approved expedited proposals and projects proposed to be of more than minimal risk is reviewed by the full board. Information can be found as to what level of review is likely to be required by consulting the IRB website's "Category of Research" or by contacting the IRB. Any proposal that is submitted whereby members of the research team have not completed ethics training will not pass review.
How long does the process take?
The usual turn around for an approved proposal that does not require full board review is within 10 days. The actual time varies depending upon the level of review and whether or not the proposal needs further clarification.
To be safe, researchers should submit the IRB application as early as possible in order for the review process not to interfere with the start date of the research.
How can I change my research after it has been approved?
You must notify the IRB if you wish to change any aspect of your research by submitting a modification proposal form that identifies the changes, along with an explanation of the changes made to your research.
Substantial changes in the focus, procedures, or participant population of the research may require submission of a new application.
How long is approval valid?
Approval is valid for the requested duration of the project listed by the researcher on the proposal form up until one year. For projects lasting more than 1 year, the researchers must submit a Continuing Review Form within a month prior to the expiration of the approved year. (See §46.103(b)(4) and §46.109(e) ). If the IRB questions the duration period, the researcher may be asked to revise the timeline. If the researcher finds that an extension of the approval period is needed, the researcher may submit a Continuing Review form requesting the extension along with an explanation for the need. Most extensions are granted; the concern of the IRB is that projects above minimal risk are justified to continue or that minimal risk studies are not wasting resources.
What are my responsibilities as the principal investigator?
The principal investigator (PI) is ultimately responsible for the conduct of research, including ensuring that an investigation is conducted according to the approved protocol and the applicable regulations. The PI is also responsible for the rights, safety, and welfare of the participants.
How do I obtain informed consent?
Because the central requirement for human participants research is that people participate voluntarily, the consent process is one of the more important parts of the research project. The process must assure that the potential participant understands the study and its risks and benefits and can certify his or her willingness to participate or decline to participate in the study. Under certain circumstance the IRB can waive or alter the informed consent process. Sample consent forms are available on the IRB website.
Information that must be provided to participants for informed consent can be found in federal regulations.
What about informed consent for anonymous surveys?
In some cases, a signed consent form is either inappropriate or unnecessary. According to Federal Regulations at 45 CFR Part 46.117c the IRB may waive this requirement if it determines either:
- There is a risk of breach of confidentiality and the only link between the participant and the research would be the consent document. In this case, the participant's wishes should be followed.
- The research presents no more than minimal risk of harm and involves no research that requires written consent outside the research context.
In general, on common survey research, where there is no more than minimal risk and anonymity is provided, a separate consent form is not needed. The survey itself can contain relevant information about the study. In this case, submitting the survey is an indication of consent. If the survey is being sent and returned through the Internet, participants should be alerted to how confidentiality is being protected. Researchers can block identifying information or arrange to have surveys returned by mail. If identification (through IP or email address) is possible, then steps taken to ensure confidentiality should be explained.