Essential IRB Components
This reference guide provides essential definitions, requirements, and procedures for risk level assessment, human subjects training, and informed consent that apply to all research studies requiring IRB review.
- Risk level determines the IRB review process - minimal risk studies may qualify for expedited review
- All study personnel involved in research design, IPA staff, or anyone handling Personally Identifiable Information must complete human subjects training before conducting research
- Informed consent is required for human subjects research, with specific elements mandated by federal regulations
Risk Level
Minimal Risk
Definition: The probability and magnitude of harm or discomfort anticipated in the research are not greater than those ordinarily encountered in daily life or routine procedures.
Review Process: - Studies deemed minimal risk that fit into one of OHRP’s (Office for Human Research Protections) seven designated expedited review categories undergo expedited review - Expedited review is conducted by an IPA IRB representative designated by the IPA IRB Chair - Reviews are conducted on an ongoing basis without waiting for full board meetings - Expedited review cannot be requested - it is determined by the IRB based on risk level
Non-Minimal Risk
Definition: Research that does not meet minimal risk criteria - poses more risk than encountered in daily life, or does not fit expedited review categories.
Additional Criteria: - Studies collecting both PII and sensitive information are likely considered non-minimal risk - Sensitive information: Information that (1) poses criminal or civil liability to respondent OR (2) could jeopardize employability, financial standing, or reputation
Review Process: - Referred to full IRB Board for monthly meeting review - Any submission type can be considered non-minimal risk
Vulnerable Populations
Definition: Groups whose ability to provide voluntary, informed consent is compromised relative to a free, functioning adult.
Federally Protected Categories: - Children/Minors: Defined according to local laws and regulations - Generally requires assent from minors and permission from parents/guardians - Prisoners: Any individual involuntarily confined or detained in a penal institution, including those awaiting arraignment, trial, or sentencing - Pregnant women/fetuses/neonates: Risk assessment depends on whether intervention targets improvement of woman and/or child welfare
Additional Protections: - Additional populations may be considered vulnerable based on local context - Inclusion of vulnerable populations may elevate the risk level of the study but not necessarily make it non-minimal risk
Human Subjects Research Training
Definition of Human Subjects Research
Systematic investigation including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge and that involves living individuals about whom an investigator obtains information either: - (a) through intervention or interaction - (b) identifiable private information
Training Requirements
Required Training: US federal regulations require human subjects training for all study personnel. IPA recommends CITI Social, Behavioral, and Educational Research (SBER) Basic course.
Who Must Complete Training: 1. ALL principal investigators 2. Any IPA research staff on the project 3. Any other research staff (such as university-based research analysts or field staff) who handle or view data with more than 10% Personally Identifiable Information (PII)
Timeline and Validity: - Must be completed before conducting human subjects research - Certificate issued immediately upon completion - Valid for three years - Refresher course required for continued research after expiration
Informed Consent
What is informed consent?
Informed consent in research is the process of providing potential participants with all necessary information about a study. This allows them to make an informed decision about whether to participate. Researchers must obtain participants’ informed consent before involving them in research.
Why is informed consent important?
This requirement is founded on the principle of “respect for persons”—one of three core ethical principles governing human subjects research described in the Belmont Report. Respect for persons requires that individuals receive treatment as autonomous agents and “be given the opportunity to choose what shall or shall not happen to them.” It also requires that persons with diminished autonomy – such as children, prisoners, and cognitively impaired adults – receive special protections.
What does informed consent look like in practice?
“Informed consent” is simultaneously (1) a process, (2) a decision, and (3) a form or script.
Process
The informed consent process is a dynamic interaction wherein: - Researchers provide information, such as risks and benefits, about the study which may affect a potential subject’s willingness to participate - Researchers facilitate the potential subject’s understanding of that information by inviting them to ask questions, re-explaining anything they found confusing, etc. - Researchers emphasize and protect the voluntariness of a subject’s decision about whether to participate
This process should not feel like a dry, esoteric, one-sided lecture. Instead, it creates an opportunity for an engaging, honest discussion about the risks and benefits of the research with a potential participant. Enumerators need training to verify whether respondents have questions and to check for understanding of key elements. IPA encourages researchers to think innovatively about the best way to deliver the information required in an informed consent.
Decision
At the end of this process—once the potential subject understands all relevant information—the subject will decide whether to participate. The decision to participate in research is not a binding agreement—a subject is always free to withdraw their consent.
The decision to participate in research is not a binding agreement—a subject is always free to withdraw their consent.
Form / Script
The exchange of information—between researchers and the potential subject—that occurs during the informed consent process can take place in either a written or verbal format (or both). The following approaches are most common at IPA: - An enumerator reads aloud a written form or script to the subject (face-to-face or by phone) - The research team provides a written form for the subject to read (on paper or electronically) and keep for future reference
The format used often depends on specific research logistics. For example, phone surveys make it impossible to provide subjects with written paper forms, so enumerators read the consent aloud by phone.
Regardless of how researchers conduct the informed consent process, they must also decide how to document a subject’s decision. Consent may be documented in one or more of the following ways: - The subject may provide a signature (or thumbprint) - The subject may click a button or checkbox indicating their consent (e.g., if completing an online survey) - The subject may express their consent verbally; in this case, researchers must have some system for documenting the subject’s response
If the IRB determines the research is greater than minimal risk, subjects typically must provide a signature documenting their consent.
What should be included in a consent form/script?
Federal regulations require that certain key elements be included in an informed consent. The IPA IRB has developed two resources to help research teams prepare good consent forms: - A checklist of required elements (this is what IPA IRB looks for when evaluating a submitted consent form) - A template consent form (this provides a sample structure and language to cover all required elements in the checklist)
You do not need to use IPA IRB’s template to develop your consent, but every relevant element on the checklist must be present. Using the template is a shortcut to ensuring that all requirements in the checklist are met. If you do not wish to use the template, it is still to your benefit to check your consent against the checklist before you submit, as IPA IRB uses this checklist each time it evaluates whether a submitted consent meets the proper standards.
Alteration or waiver of consent
In some circumstances, researchers may request that required elements of the consent process be waived (“alteration of consent”). In even rarer circumstances, researchers may request that the requirement to obtain subject consent be waived entirely (“waiver of consent”).
In either of these circumstances, all the following criteria must be met in order for the alteration or waiver to be granted by the IRB: - The research involves no more than minimal risk to the subjects - Researchers could not practicably carry out the research without the requested waiver or alteration - If the research involves using PII or identifiable biospecimens, researchers could not practicably carry out the research without using such PII or biospecimens in an identifiable format - The waiver or alteration will not adversely affect the rights and welfare of the subjects - Whenever appropriate, researchers will provide subjects or legally authorized representatives with additional pertinent information after participation
The following are examples of circumstances where researchers might request an alteration or waiver of consent: - Waiver of parental consent (most often requested for school-based research) - Studies involving deception (i.e., leaving out information or misleading subjects about some element of the study)
Researchers must request the IRB’s permission for any alteration or waiver of consent. To do so, describe your rationale for the requested alteration or waiver in the consent section of the protocol.
Studies involving children
For studies involving minors, researchers typically must seek both: - Child assent: permission from the child themselves - Parental consent: permission, given by the parent, for the child’s participation
“Assent” is not, and cannot substitute for, consent—legitimate consent can only be given by adults.
A child assent form/script should be written in language understandable to the child’s age group. For children age 14+, it is typically fine to use IPA IRB’s standard consent template to develop the assent. For children age <14, researchers should consider how best to communicate key information to those children such that they can make an informed choice about whether to participate in the study.
Waiver of child assent
The IRB can waive the requirement to obtain child assent if the child cannot reasonably be consulted about their participation in the research, such as young children.
Waiver of parental consent
The IRB can waive the requirement to obtain parental consent only in the following circumstances: - All criteria for a waiver of consent are met (see section above); OR - Parental permission is not a reasonable requirement to protect child subjects, such as neglected or abused children, or children living on the street without family
Even if the IRB determines that it may waive the parental consent requirement, the IRB may require additional measures to protect child subjects, such as: - Obtaining consent from school officials, such as the child’s teacher for school-based research - Sending parents an “information sheet” which provides information about the study, as well as instructions for how to withdraw their child from participation using an “opt out” procedure
Other considerations
Timing: In most cases, researchers should obtain subjects’ informed consent before each round of data collection. In some rarer cases, researchers may need to obtain consent before the intervention, even if no data collection occurs at that point. This applies when there is no baseline survey and the study intervention is the first research procedure subjects will participate in.
Language: Researchers must conduct the informed consent process in a language understandable to the potential subject.
Literacy: Researchers should consider the literacy level of the potential subject population when designing the consent process for their study. For example, if working with a largely illiterate subject population, researchers should conduct the consent process orally—providing only a written form for subjects to read would be inappropriate.
No exculpatory language: No consent may include language through which the subject waives any of their legal rights, or language that releases the researchers, sponsor, or institution from liability for negligence.