- What ethical principles guide the IRB?
- What types of projects need review?
- What is a human subject?
- What is research for the purposes of the IRB?
- When should I come before the IRB?
- I'm a UDC student working on a project, do I need IRB approval?
- Who constitutes the IRB?
- What if I want to do research involving children or adults with a dimished mental capacity?
- I want to use UDC students, how should I proceed?
- Help, I think something has gone wrong with my research project? What do I do?
- I want to use non-native English speakers in my research, how would this work?
- What if I disagree with my findings? Can I appeal?
The rationale for ethical principles to guide research involving human participants has a long history, growing out of such violations of human rights and welfare as the Nazi experimentation on Jewish captives and the U.S. Public Health Service 40-year Tuskegee experiment on untreated syphilis among African American men. There are links on this website to the various codes for the ethical conduct of human participants' research promulgated since 1945. The most recent version of the regulations is based on the Belmont Report (1978), which was adopted in 1991 by the U.S. Department of Health and Human Services (DHHS) to establish rules for institutions engaging in research. These rules were codified as Title 45 Part 46 of the Code of Federal Regulations (45 CFR 46), generally known as the Common Rule. Promulgated by 16 federal agencies that conduct or regulate human participants' research, the policy sets forth three quintessential principles for the ethical conduct of research involving human participants: Respect for Persons, Beneficence, and Justice.
Respect for Persons -- Recognizes personal dignity and autonomy of individuals with special protections for those with diminished autonomy (children, prisoners, elderly, disabled, pregnant women)
Beneficence --The obligation to protect human beings from harm by minimizing risks and maximizing benefits
Justice--The burdens and benefits of research must be distributed fairly
- Research projects involving living humans
- Research project involving the collection of private information about people, including:
- Student tracking over time
- Health data
- Opinions on sensitive topics
- Student projects (graduate or undergraduate) that involve human subjects
Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains
(1) Data through intervention or interaction with the individual, or
(2) Identifiable private information.
The Office of Human Research Protections (NIH) defines research as systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.
When in doubt, please bring your research project before the IRB even if you think it's exempt or not research. The IRB is here to insure that you and your project are following federal guidelines for ethical research and if the IRB doesn't know about your project, it can't guide you.
Your faculty advisor should be helping you in this regard. Generally, projects that are due in the same semester do not have a timeframe by which to both be able to do the research properly and obtain IRB review. If you find yourself in this situation, please choose a non-Human Subjects research project.
If you have a research project that has a multi-semester duration, or is for a master's thesis or project or a capstone course, you should apply the semester before graduation to ensure that you have enough time to both obtain IRB approval and be able to do your research and write it up properly. UNDER NO CIRCUMSTANCES, should you proceed with your research without IRB review and approval. You not only violate UDC guidelines but you violate federal regulations as well.
Once you have determined that you have enough time to do the research, and your project is human subjects' research you can apply to the IRB. Please see the application guidance for directions. Please also note that your research will not be reviewed without your faculty advisor's signature signaling that he or she has read the project proposal and approves.
Each IRB shall have at least five members, with varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institution. The IRB membership is qualified through the experience and expertise of its member and the diversity of its membership by race, gender and cultural backgrounds. The IRB will contain a variety of professions and fields. Each IRB shall include at least one member whose primary concerns are in scientific areas and at least one member whose primary concerns are in nonscientific areas and the IRB will have a "community member" whose views and opinions represent those not affiliated with the university.
As the mission of the IRB is to promote sensitivity toward others in regards to the research endeavor, members shall, in addition to possessing the professional competence necessary to review specific research activities, be able to ascertain the acceptability of proposed research in terms of institutional commitments and regulations, applicable law, and standards of professional conduct and practice. The IRB shall therefore include persons knowledgeable in these areas. If a project is proposed to the IRB that involves a vulnerable category of subjects, such as children, prisoners, pregnant women, or physically or mentally disabled persons, the IRB will seek expert guidance as needed. These "experts" may not vote with the IRB as they are not regular members. No IRB member may participate in the IRB's initial or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the IRB.
a. What do I need to have prepared to submit to the IRB?
The researcher who wishes to work with children or individuals with a diminished mental capacity must include in their IRB application: an assent form for the children or individuals with disability to complete, a consent form for the parents/guardians and a detailed protocol of how both the assent of the research participants and the consent of the parents or guardians be obtained. These forms should be written in age-appropriate language, be accessible to individuals with disabilities, and where appropriate be translated into a language other than English by a certified translator.
b. What is an assent form and how is it different from a consent form?
An assent form is how the subjects of the research (the children or individuals with mental disabilities) will agree to participate in the research project. The consent form is how the parental or guardian permission for all research involving children is obtained. Written permission from a teacher or principal is not sufficient. To assent to participate in research is the active agreement of someone other than a competent adult to allow something to happen (a child or someone with a mental disability). This is again more than just the absence of dissent, but it does not require legal competence. In other words, the person giving assent has to actively say YES to something and not just not say no.
The assentee can assent to participate through an assent form which is typically less detailed than a consent form that will be given to the parent or guardian. However, no form will ever replace the thoughtful face to face discussion of assent with a child. In developing an assent document or protocol, the researcher must remember to develop a document that is both age-appropriate and study-specific. For example, you don't want to have a document with an 8th grade reading level to speak to a pre-schooler. The researcher should take into account the child's experience and level of understanding of an underlying condition and compose a document that is respectful of the child and conveys the essential information the child needs to make a decision. The assent form should:
- Include a brief statement of purpose;
- Describe procedures (including time commitment);
- Affirm the voluntary nature of the assent process;
- Describe pain or discomfort that may be experienced;
- Include a brief explanation of alternatives;
- Describe benefit or compensation, if any; and
- Offer to answer questions.
A copy of this same form should be included with the parental/guardian consent form to inform them of what has or will be discussed with their children.
c. What type of research can I do with Children?
You can do exempt research (educational/pedagogical for example) or for research that is not exempt, federal regulations identify four categories of research that may be allowable in children; these are codified at 45 CFR 46.404-407. Three of them may be approved by the local IRB; the fourth also needs special federal approval. Most of the research conducted under these categories is health-related. Special considerations are required for each of these categories as children are a protected class. Please consult with your IRB staff before applying for advice in this regard.
Explanations and what's required for IRB approval under each category is provided below:
- Research involving no more than minimal risk. (45 CFR 46.404). Exemptions under the federal exempt categories may be applied to research involving children with one exception. Research involving surveys, questionnaires and observation of public behavior can only be exempt if it involves observation of public behavior in which the investigator plays no part (in research in which no identifiers are recorded).
- Research involving greater than minimal risk but presenting the prospect of direct benefit to the individual subjects. (45 CFR 46.405) If the research has benefit to the subjects, an IRB can approve it even though the research subjects are children and even though there are greater than minimal risks involved. This is the category under which most clinical trials in children would be considered. For example, a study may provide access to a promising new therapy in children who have failed standard therapy for a serious illness.
- Research involving greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subject's disorder or condition. (45 CFR 46.406). The simplest examples are studies that add additional diagnostic tests to the management of children being treated for diseases. A second type of study is one in which some sort of physiologic test is being done outside of a therapeutic context. A third type is the Phase-I drug trial in a child with a serious illness who has failed standard therapy
- Research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children. (45 CFR 46.407). This subsection provides an avenue for approval of studies that still seem reasonable, but don’t meet the criteria in any of the three previous categories. The IRB cannot grant final approval for these; after giving its conditional approval, it has to forward them to the federal regulators for review by a special panel, for public comment, and for a "no objection" statement (or a refusal of same) from the Secretary of HHS.
Figure 1: Flowchart of the decision process on whether to use children in research (www.irb.uminn.edu)
Researchers at UDC or other universities often use students or other staff and faculty as their research subjects either through convenience or out of necessity for the research project. However, researchers need to be extraordinarily careful to avoid potentially coercive seeming behavior as the very nature of the relationship can give the appearance of coercion. For this reason, researchers should be aware of the potential for coercion that exists when a research subject is also a student, employee, colleague, or subordinate of the researcher.
Information about how students and colleagues will be recruited and how coercion will be avoided should be included in the information submitted to the IRB. Whenever possible, researchers should avoid using their own students if another population of subjects is equally suited to the research question, e.g., another class section not taught by the researcher, recruitment by another instructor, or blinded/coded data collected by an associate so that subjects are not identified to the instructor.
- Students should be given an opportunity to decline participation without jeopardy.
- Unless the research question is directly related to class material, or the study process is being used as a teaching opportunity, such as in a research methods class, the IRB discourages the use of class time to recruit subjects or class time used to complete study instruments, etc.
- Use of extra credit points as reward for research participation should be limited to specific circumstances where the research is closely tied to the course subject matter. The number of points awarded should not be sufficient to augment a student's grade by a whole step, e.g., from B to A.
- The use of financial rewards should also be limited to dollar amounts which are proportionate to the inconvenience of participation.
- Whenever possible, a teaching opportunity in the form of an "educational debriefing" should be employed. Students should know something about the IRB review process, the rationale for the study, the process of data collection, and intent of the researcher.
Federal regulations [45CFR46.103(b)(5) and 21CFR56.108(b)(1)] require the IRB to ensure that investigators promptly report "any unanticipated problems involving risk to subjects or others" (UPIRTSO). UPIRTSO is defined as as any problem or event which in the opinion of the local investigator was unanticipated, reflects new or increased risk to the subjects and was possibly related to the research procedures.
The IRB and NOT THE RESEARCHER makes the determination of whether the unanticipated problem meets the criteria as a UPIRTSO. As the person most familiar with and ultimately responsible for the conduct of the study, the researcher should provide his or her informed opinion of whether an event meets UPIRTSO criteria. The IRB will then review the researcher's assessment of the event to determine if any changes to the approved study should be made as a result of the report.
a. What kinds of events constitute UPIRTSOs?
The following events meet the IRB's definition of UPIRTSO and should be reported within 10 calendar days of the event.
- Any event (including on-site and off-site adverse events, injuries, side effects, deaths or other problems) which in the opinion of the local investigator was unanticipated, involved new or increased risk to subjects or others, and was possibly related to the research procedures
- Any accidental or unintentional change to the IRB-approved protocol that increases risk or has the potential to recur either on a regular or occasional basis
- Any deviation from the protocol taken without prior IRB review to eliminate apparent immediate hazard to a research subject.
- Any publication in the literature, safety monitoring report (including Data and Safety Monitoring Reports), interim result or other finding that indicates an unexpected change to the risk/benefit ratio of the research. This can include scholarly literature, conference papers, general news articles, new or modified regulations (federal, state, local), or any other source.
- Any breach in confidentiality that may involve risk to the subject or others. This can include a computer virus or worm or other suspected hack as well as a break-in or other intrusion where research materials and logs were potentially compromised.
- Any complaint of a subject that cannot be resolved by the research staff or a complaint that goes directly to the IRB
- Any other possibly related event which in the opinion of the investigator constitutes an unanticipated risk
Unanticipated (unexpected) problems/events are those that are not already described as potential risks in the consent form, not listed in the Investigator's Brochure or not part of an underlying disease or syndrome of interest.
Anticipated (expected) problems are those that are already described as potential risks in the consent form, listed in the Investigator's Brochure or part of an underlying disease or syndrome of interest. These do NOT meet the IRB's definition of UPIRTSO and should be reported in summary form only at the time of IRB continuing review. For example, if death is an expected outcome, this event should be reported only at the time of continuing review. Problems/events that are unanticipated should be reported to the IRB within 10 calendar days only if in the opinion of the local investigator they are possibly, probably or definitely related to the research procedures.
- Reports of off-site events on studies that are now closed at this site should be reported as UPIRTSOs if the event meets the IRB's definition of UPIRTSO AND in the local investigator's judgment, this event may affect risk to subjects who have completed the study such as in the case of a computer hack or other breach of security regarding the research logs.
When the prospective subject is fluent in English, and the consent interview is conducted in English, the consent document should be in English. However, when the majority of anticipated study subjects are non-English-speaking people, and it is anticipated that the consent interviews are likely to be conducted in a language other than English, the PI should submit a translated consent form for IRB review as well as a certification that the translation was done correctly and appropriately. This certification can be a letter from a translator, or another individual fluent in both English and the native language who is NOT a relative of the PI.
A copy of the translated consent document must be given to each appropriate subject. While a translator may be used to facilitate conversation with the subject, routine ad hoc translation of the consent document may not be substituted for a written translation.
If the anticipated study population will only include a few non-English-speakers, a short form may be used to obtain informed consent.
a. How do you obtain consent from someone who speaks and understands English but cannot read?
Illiterate persons may have the consent read to them and "make their mark." The 21 CFR 50.27(b)(2) requirements for signature of a witness to the consent process and signature of the person conducting the consent interview must be followed, although a special "short form" consent need not be prepared. Investigators should be cautious when enrolling subjects who may not truly understand what they have agreed to do.
The Institutional Review Board evaluates a wide range of research, and OSP wants researchers to know there is an avenue to address disagreements regarding committee decisions.
Principal investigators wishing to raise concerns with IRB decisions should first clarify their understanding of the recommendations or requirements with IRB staff (202.274.7079). It is also recommended that researchers familiarize themselves with the specific regulation requirements related to the committee concerns. These references can most often be found on the IRB website.
If researchers are unable to address concerns through these methods, then a researcher may address controverted issues by meeting with the committee. Before meeting with the committee, researchers should describe their concern and forward any supporting materials to the IRB coordinator via IRBNet. The submission should be a scientifically based position outlining the specific concerns, provide references, scientific rationale, and/or supporting material.
The submission will be referred to the committee for discussion. The process may include meeting with the committee at its next meeting if requested and appropriate. The process will include communication with all the relevant parties to collect additional information as well as the transmittal of the findings, recommendations and resultant actions back to the researcher.
All communication concerning IRB submissions should be submitted directly to the IRB coordinator via www.irbnet.org, and not to individual committee members or to other UDC officials. Per federal regulations, 45 CFR 46.112 and 21 CFR 56.112, officials may not approve the research if it has not been approved by an IRB. These regulations prevent UDC officials such as the OSP Director, the Institutional Official, and the Associate Provost for Research from overruling a decision by the IRB.