About the IRB
- What is the purpose of the IRB?
- Why do we need an IRB?
- Does my project need IRB approval?
- I see that some projects are exempt. Does this mean that I get to avoid the IRB?
- As a faculty advisor, what is my role in terms of the IRB process?
Specific Research Scenarios and Questions
- What exactly is "minimal risk" and what do I need to know about it?
- I have an opportunity to work at a different institution with an investigator whose study has already been approved by that organization's IRB. Am I good to go?
- I have an opportunity to engage in a project that involves gathering data from participants from other countries. Are there any special considerations?
- Are there special issues when collecting data via an anonymous internet survey?
- What is the difference between "confidential" and "anonymous" data?
- Reviewers are always demanding rewrites, especially on my consent forms. Why?
- Some of the formal comments are simply wrong-headed. Do I have to comply?
- Why are reviewers so picky about using templates?
- Why are there are so many different templates? Which do I use?
- Do I always need to obtain informed consent?
- When can I change the informed consent requirement?
- Do I have to use the official informed consent template for my study?
- I work with children as subjects. What is the difference between consent and assent?
About the IRB
The goal of the Pacific University IRB is to assist investigators at Pacific University in their efforts to protect the rights and welfare of individuals who participate in research conducted at or under the auspices of the University and to ensure Pacific University's compliance with federal regulations regarding the protection of human subjects.
As needed, the IRB will work together with investigators to ensure that both goals noted above are met to our satisfaction. This can be done in the planning phase (i.e., each school and/or college has an IRB representative who will be happy to work with investigators as they plan their proposals) or during the review process (preferably the former). To aide investigators in the planning phase of their research, the IRB has provided investigators with a list of links to the ethical guidelines for several different disciplines. The IRB urges all investigators to familiarize (or refresh, as the case may be) themselves with the ethical guidelines of their disciplines as they prepare their proposals.
During the review process, the IRB only comments on the scientific merit of the research if the merit is not in balance with the risk posed to potential participants. That is, the IRB does not review the scientific merit of research studies per se; however, the IRB does evaluate the risks to human subjects in light of the potential benefits of the study, which requires consideration of the scientific merit of the study.
The Pacific University IRB is required by federal policy for human subjects' protection. This federal policy is known as "The Common Rule". The Common Rule, along with similar regulations from the Food & Drug Administration (FDA), requires an institution that is conducting research to assure the federal government that it will provide and enforce protections for human subjects of research conducted under its auspices. The Common Rule was first promulgated by the U.S. Department of Health and Human Services in 1974 and extended to 16 U.S. governmental agencies in 1991.
The Common Rule is based on the ethical principles articulated in The Belmont Report (issued by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research). The three basic principles are:
- Ensuring that individuals can make informed choices about their participation in research and protecting those individuals with diminished autonomy;
- Ensuring that the potential risks of a study are minimal or are justified by the potential benefits; and
- Ensuring that the selection of research participants is fair and not based simply on their easy availability, their willingness to participate, or other considerations not directly related to the problem being studied.
Federal regulations require that any project or proposal involving research ("a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge") with living individuals 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, must be reviewed by the Pacific University IRB. Personnel affiliated with Pacific University (e.g., faculty, students, or staff) who plan to conduct research utilizing human subjects must work with the Pacific University IRB to ensure that the project is properly registered and/or reviewed.
The Pacific IRB is registered with the Office of Human Research Protections in the DHHS and is thus subject to periodic audits to verify that we are in compliance with all relevant federal regulations. To uphold this charge, Pacific University policy requires all faculty, students, or staff involved with human subject research activities to work directly and conscientiously with the IRB at the following times:
- Before research is initiated;
- During research if the protocol requires continuing review;
- During research if the research protocol needs to change;
- During research if an adverse event occurs; and
- After research ends in order to close the file.
To further assist you in learning if your project needs IRB approval, please use the Request for Determination of IRB Jurisdiction form. If you have questions, please feel free to write us at email@example.com.
Not quite. All research plans involving human subjects must be documented to ensure compliance with applicable federal regulations. An independent evaluator who is familiar with human subjects research regulations and interpretations must first determine whether the "exempt" criteria apply, and then the exemption must be granted formally. At Pacific, this evaluator is the IRB chairperson(s). Thus, a proposal will be written and submitted to the IRB so a valid and documented determination can be made. If the proposal documents that exemption criteria are met, a single member of the IRB can recommend granting an exemption.
It is critical to understand that the IRB focuses exclusively on the participants' treatment. Therefore, the experience and/or status of the investigator is fundamentally irrelevant to the evaluation of submitted proposals; if a project meets the regulatory definition of human subject research, it is the duty of the IRB to verify the plans are in complete compliance with all applicable laws and policies.
For a project that meets the regulatory definition of human subject research, the IRB responsibility is externally dictated: to evaluate research proposals so as to ensure compliance with applicable federal regulations. When students are conducting research, their advisors must occupy an active, integral, hands-on role throughout the proposal development process as they teach and direct their students' human subjects research practices. Indeed, the faculty advisor should act as an extension of the IRB and thoroughly evaluate all student proposals before allowing them to be submitted for formal review and pass along only those s/he expects to be fairly readily approved. Submitting proposals with known or suspected weaknesses burdens the IRB's limited resources and delays the aggregate review process. The faculty advisor also serves as the conduit between his/her students and the IRB.
Specific Research Scenarios and Questions
According to the federal regulations, minimal risk "means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests" (45 CFR 46.102(i)).
One of the primary considerations for the IRB when it is reviewing a research proposal is the level of risk that is present for subjects. The concept of minimal risk provides a benchmark that allows the IRB to assess how much risk is present, as well as to determine if the proposal needs additional scrutiny because of the potential risk. In fact, the IRB is required to make a determination as to whether each research proposal presents no more than, or greater than, minimal risk to human subjects.
It is important for investigators to understand that every research study presents at least minimal risk (the risk present in daily life) to its subjects—there is no such thing as a "no risk" study. For example, in a minimal risk research study using an online survey, the investigator should not state that there is "no risk to participation"; rather, he/she should state that "there is no additional risk to participation beyond that which would be experienced in daily life or during completion of any survey instrument."
For a more thorough discussion of minimal risk, and some helpful case studies, visit this resource from the Office of Human Research Protections.
I have an opportunity to work at a different institution with an investigator whose study has already been approved by that organization's IRB. Am I good to go?
Almost. Since you are formally connected to Pacific, federal regulations require that we bear equal responsibility for ensuring the welfare of research participants, so we must be clearly informed about the study. An accelerated route is available that may involve submitting the proposal and supporting materials from the other institution (e.g., copies of proposal, IRB correspondence and federal registration information). Contact the IRB office for additional guidance.
I have an opportunity to engage in a project that involves gathering data from participants from other countries. Are there any special considerations?
Definitely. The primary consideration is that the investigator must effectively and persuasively document that the proposed methodology complies with all of the ethical considerations (formal and informal) of both nations. Demonstrating a detailed and accurate understanding of the cultural norms for the other society, particularly as it relates to obtaining informed consent, is essential. One of the most efficient ways of demonstrating this is to have a local (foreign) IRB review and approve the study plan. To properly address all of these variables, please fill out the International Research form and append it to the IRB template you use for your project.
The primary issue is to assure participants are granting truly informed consent. Since we are immersed in our fields, jargon and high levels of writing are quite natural and understandable to us. This is absolutely not true for folks outside the field, and this is the population from which we are recruiting! Materials must effectively and completely disclose everything participation will involve. Most importantly, risks and rights must be explicitly acknowledged. The proposal forms list the required consent criteria.
Another factor is that all contributions to science, particularly writing, demand certain qualities throughout the entire science process—logic, clarity, precision, and honesty. If the writing is ineffective, it may easily give rise to concerns about the capability of the investigator to conduct the project properly. Also understand that these documents represent the university to the external community (both the public as well as federal auditors)—and we must be concerned about our reputation and quality for myriad reasons.
The vast majority of projects we see involve methods where participant identities are known to the investigator (regardless of whether or not individuals can be linked to specific data) and this information is vigorously protected and not released to any party—this is "confidential." Investigators also must consider, anticipate, and have plans for situations where it may be necessary to break confidentiality. For example, if child abuse is known or strongly suspected, investigators are required to notify the appropriate authorities; also, if a participant is believed to be a threat to himself/herself or others, the investigator generally should notify appropriate authorities. The conditions under which the investigator will break confidentiality must be described in the proposal and the informed consent.
Data can be described as "anonymous" only if participant names are withheld and completely unavailable to the investigator(s). Precise terminology use in this context is essential.
Yes. The main issues are anonymity and whether informed consent is obtained. As noted elsewhere, there are a number of specific requirements for informed consent, but modifications are allowable under some circumstances. For internet surveys, it is recommended to incorporate a modified consent process whereby the participant has to actively select an "I agree" button to grant consent and begin the survey; this can still allow for truly anonymous data collection. The critical issues are to:
- Show the consent gateway in the survey form (not just in the template hardcopy format)
- To ensure all relevant and required elements of consent are presented
- To explicitly list all specific inclusion and exclusion considerations
- To provide Pacific and investigator contact information and instruct respondents to print and/or note for their own records (if using anonymous methodology)
- To specify how non-responses to items will be handled (e.g., Can the survey always offer a "decline to respond" choice for each item? Will a non-response negate the participant's entire survey, in effect a withdrawal from the study, or just negate that item? Will exiting the interface be equivalent to full withdrawal of all data, or will data up to that point be kept?)
- To explain what types of information, other than responses to formal questions, will and will not be obtained by the investigator (e.g., IP addresses, time stamps)
- To acknowledge that internet privacy and security cannot be guaranteed
If gathering participant identity information can be avoided, it often is very helpful. If such content is necessary, the proposal must explain in detail how confidentiality will be protected effectively.
No. Investigators may rebut any review comments that they believe are invalid. The rebuttals should strive to provide these justifications with synthesized evidence and in a collegial tone.
The templates were designed to help the investigator completely address the issues critical to human subjects research ethics in a consistent and organized fashion, and to facilitate the reviewers' assessment that all salient issues are addressed. If investigators use the templates, then reviewers know exactly where to look for critical elements. Excellent writing that completely addresses salient issues presented in a consistent structure will greatly shorten the time to approval.
Investigators are encouraged to add sections or subsections deemed necessary or helpful to explain unique features of particular undertakings more effectively.
Some situations (e.g., protected populations) involve special circumstances and requirements; using the templates facilitates documenting that all such considerations are addressed.
With a few exceptions, no investigator may involve a human being as a subject in research covered by the applicable policies unless the investigator has obtained the legally effective informed consent of the subject or permission from the subject's legally authorized representative. An investigator shall seek such consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence. The information that is given to the subject or the representative shall be in language understandable to the subject or the representative. No informed consent, whether oral or written, may include any exculpatory language through which the subject or the representative is made to waive or appear to waive any of the subject's legal rights or releases or appears to release the investigator, the sponsor, the institution, or its agents from liability for negligence (CFR §46.116). Pacific's proposal forms list the required consent elements.
When can I change the informed consent requirements?
An IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent set forth above or waive the requirement to obtain informed consent provided the investigator persuasively documents that:
- The research could not practicably be carried out without the waiver or alteration;
- The research involves no more than minimal risk to the subjects;
- The waiver or alteration will not adversely affect the rights and welfare of the subjects; and
- Thenever appropriate, the subjects will be provided with additional pertinent information after participation.
An outright waiver of written consent may be granted if either (1) it would be the only record linking the subject and the research and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether s/he wants documentation linking the subject with the research, and the subject's wishes will govern; or (2) the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context. In cases in which the documentation requirement is waived, the IRB may require the investigator to provide subjects with a written statement regarding the research.
Do I have to use the official informed consent template for my study?
Generally, yes. Informed consent shall be documented by the use of a written consent form approved by the IRB and signed by the subject or the subject's legally authorized representative. A copy shall be given to the person signing the form (CFR §46.117). The templates were designed to address all of the required elements. However, if you create your own consent form that includes all required elements of consent, this is also acceptable.
Documentation of consent may be altered under some conditions; this must be justified clearly in the proposal. The consent documentation may be either of the following: (1) a written consent document that embodies the required elements of informed consent. This form may be read to the subject or the subject's legally authorized representative, but, in any event, the investigator shall give either the subject or the representative adequate opportunity to read it before it is signed; or (2) a short form written consent document stating that the required elements of informed consent have been presented orally to the subject or the subject's legally authorized representative. When this method is used, there shall be a witness to the oral presentation. Also, the IRB shall approve a written summary of what is to be said to the subject or the representative. Only the short form itself is to be signed by the subject or the representative. However, the witness shall sign both the short form and a copy of the summary, and the person actually obtaining consent shall sign a copy of the summary. A copy of the summary shall be given to the subject or the representative in addition to a copy of the short form.
I work with children as subjects. What is the difference between consent and assent?
Consent applies only to individuals deemed legally able to act independently in their own interests. Assent is similar in that researchers aim to ensure that the preferences of individuals are honored with regard to their participation in a research study. For non-autonomous participants, permission from a parent/guardian is required, but even if permission is obtained, it is common to not compel that person into participating as a subject unless s/he also agrees.
So, for autonomous individuals, informed consent is obtained. For non-autonomous individuals, researchers first obtain informed permission from the parent/guardian and then informed assent from the potential participant.
Obtaining assent is not legally binding but should be done to demonstrate respect to the individual. The following is targeted at child participants but offers important guidance for any participant not legally capable of granting consent.
- Take the time to explain to a child, at whatever age they can begin to understand, at an appropriate level of complexity, what is going on in the proposed study, why the study is being done, what will be done to them, and, that if they object, the activity will be terminated and that they will not be punished or scolded. As children develop, they gradually become the primary decision-makers for themselves. Obtaining assent can be viewed as a part of this development and should be an interactive process in which information and values are shared and joint decisions are made.
- When participants are not legally able to grant consent, a guardian/parental permission form shall be developed and used (not a consent form). It will contain the same content as standard consent forms.
- The child should be given an explanation of the proposed research procedures in a language that is appropriate to the child's age, experience, maturity, and condition. This explanation should include a discussion of any discomforts and inconveniences the child may experience if s/he agrees to participate.
- Unless formally waived by the IRB, child assent and parent permission must be obtained for each participating minor.
- For pre-reading children, a simple oral explanation of the study shall be offered to the child before any study-related procedures are conducted (provide the IRB with a script of this).
- For elementary school-aged children able to read independently, informed voluntary assent should be obtained without pressure from parents or investigators. An appropriate assent form may be used; if so, include it in the IRB proposal.
For middle school-aged children and older, a separate assent form to read and sign should be utilized. The assent form should be written as simply as possible and cover the following points:
- What the study is about;
- Why s/he qualifies for the study;
- The procedures that will be done;
- The potential benefits and the potential risks;
- The voluntary nature of the study;
- An assurance that s/he may withdraw from the study after discussing it (or not) with parents/guardians;
- An assurance that s/he will be treated the same whether or not s/he agrees to join the study; and
- An invitation to ask questions.