Expedited and Full Board Categories
The expedited study category includes certain proposed minimal risk research and minor changes to approved research. The following categories of research may be reviewed through an expedited review procedure:
- Clinical studies of drugs and medical devices only when specific conditions are met.
- Collection of blood samples by finger stick, heel stick, ear stick or venipuncture following specific guidelines.
- Prospective collection of biological specimens for research purposes by noninvasive means.
- Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves.
- Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for nonresearch purposes (such as medical treatment or diagnosis). (NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human subjects).
- Collection of data from voice, video, digital or image recordings made for research purposes.
- Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation or quality assurance methodologies. (NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human subjects.)
- Continuing review of research previously approved by the convened IRB under specific conditions.
- Continuing review of research, not conducted under an investigational new drug application or investigational device exemption where categories two (2) through eight (8) do not apply but the IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified.
The Full Review category includes research that is nonexempt and not eligible for expedited review. Reasons for full board review may include:
- Not meeting one of the regulatory definitions of minimal risk;
- Not falling into a category for expedited review or criteria for approval of an expedited review are not met;
- Local policies require full board review.
The ACIRB full committee meets once a month during the academic year to review proposals. Materials to be reviewed at a full committee meeting must be submitted two full weeks (fourteen calendar days) in advance of the meeting to allow time for pre-review, distribution to ACIRB members, and adequate time for review prior to the meeting. Following pre-review, proposals will be scheduled for review on the next available meeting agenda. Only submissions that require full board review are reviewed by the full committee. Evidence-based practice/quality improvement projects and research that qualifies for exempt or expedited review are not reviewed at meetings of the full board.
- For projects requiring full review, the investigator(s) will be notified of project status (e.g., approved, modifications required, disapproved, tabled, etc.) within seven business days after the ACIRB meeting.
Expedited and Full Board Reviews
Expedited review is conducted by a subset of the ACIRB for certain proposed minimal risk research and minor changes to approved research.
If a submission falls under the expedited classification, two ACIRB members, one of whom is the chair, will be assigned to complete the review.
Research that is not eligible for expedited review must be initially reviewed by the full board. Complete submissions identified for full review will be put on the agenda for an ACIRB meeting. The ACIRB Meeting Schedule page provides information about application submission deadlines for each scheduled meeting.
The submission will be assessed based on the items that follow.
Risks
The Code of Federal Regulations (CFR) 46.111(1) and (2) provide specific information about risks to subjects. Considering the following question may help you develop research procedures that avoid putting your participants at more than minimal risk if they participate in your study:
What risks do you anticipate for those involved in your research?
- Mental health such as stress and embarrassment
- Physical health such as medical burdens
- Social wellbeing such as risk to employment
Your study will be reviewed according to the following items:
- Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result (achieved from research interventions).
- Risks to subjects are minimized by using procedures that are consistent with sound research design and which do not unnecessarily expose subjects to risk.
- When possible, risks to subjects are minimized by using procedures already being performed on the participants for diagnostic or treatment purposes.
- The research proposal addresses the likelihood of harm and magnitude of harm (encompassing potential physical, psychological, social and/or economic risks to the subjects).
- The research is likely to achieve its proposed aims.
- The importance of the knowledge expected to result is clear.
Subject Selection
CFR 46.111(3) provides specific information about subject selection. Considering the following may help you develop research procedures that help to ensure subject selection is equitable in your study:
- Unpack any assumptions and address the biases you bring to your research
- Clearly define your participant inclusion/exclusion criteria
- Mitigate potential barriers to participation in your research
- Justify your data procedures keeping in mind participant characteristics that may prevent participation
- Engage communities as partners in data analysis to avoid misinterpretations
- Ensure equal participant access to your research benefits
Consider how your study procedures will ensure the equitable and fair treatment of people in your research by considering:
- Participant recruitment and samplings
- Data collection and reporting
Your study will be reviewed to determine subject selection is equitable (in relation to):
- Objectives of the research
- The setting in which the research is to take place
- The special problems of research involving special populations
- Recruitment methods
- Inclusion/exclusion criteria
Informed Consent/Assent (For research other than Exempt)
If your study is classified as nonexempt (expedited or full review categories), providing and documenting informed consent is required unless you have been granted a waiver or alteration of informed consent or documentation of consent.
One of the easiest ways to do this is to provide participants with a written document, but there are other options available to you:
- Electronic form and signature capture
- Preamble to a survey with an overt action that signifies consent (e.g., clicking on a link)
- Others – check with your advisor or the ACIRB if you have questions
For more information, review the Informed Consent and Providing Information to Participants page. The ACIRB Participant Informed Consent template on the Form & Templates page may also be a valuable resource.
Your submission will be assessed according to the following items regarding informed consent/assent:
- Adequate provisions are in place for seeking informed consent from each prospective subject (“subject), or the prospective subject’s legally authorized representative (“subject’s LAR”).
- The proposed consent process provides the subject/subject’s LAR with sufficient opportunity to consider whether to participate.
- The proposed consent process minimizes the possibility of coercion or undue influence.
- The information to be relayed during the consent process is in a language understandable to the subject/subject’s LAR.
- The information being communicated during the consent process does not include exculpatory language through which the subject/subject’s LAR waives or appears to waive any of the subject’s legal rights.
- The information being communicated during the consent process does not include exculpatory language through which the subject/subject’s LAR releases or appears to release the investigator, the sponsor, the institution, or its agents from liability for negligence.
Similarly, documentation of informed consent/assent as described in your study procedure will be assessed by reviewing:
- The provisions for documenting informed consent/assent are appropriate
Privacy/Confidentiality
Privacy “refers to protecting the individuals involved in research” (Poth, 2021, p. 64). Confidentiality “refers to protecting information or data shared with researchers” (Poth, 2021, p. 64). The submission will be assessed based on the items that follow:
- The research proposal describes adequate provisions for protecting the privacy of subjects.
- The research proposal describes adequate provisions for maintaining confidentiality of the data.
Some considerations regarding protecting participants’ privacy and confidentiality include:
- Assessing, communicating and taking all reasonable measures to maximize potential benefits and mitigate foreseeable risks to confidentiality. Taking care to not overstate benefits in your method of informing participants about your research is important when developing your study.
- Collecting only the information you need. By limiting the number of sensitive questions you ask, you can help protect the privacy of your participants. You should also avoid collecting personal information, if possible, or only collect the identifying information you need.
- Carefully planning the location of data collection. Avoiding noisy public locations is an important consideration. You should also ensure the safety of your participants when selecting a location for a private conversation.
- Explaining how the data will be used. Be up front about where and how your research will be shared and how it will be stored. Remove personal identifiers from the data as soon as possible and secure your master list if you are using one as part of your study.
- Becoming familiar with local privacy laws. If a privacy breach occurs, be sure to report this to the appropriate authorities.
- Presenting data in reports in a way that prevents individual participants from being identified.
- Collecting anonymous data whenever possible.
- Limiting the number of people who have access to the data.
If you have any questions about privacy or confidentiality concerns, be sure to talk with your advisor. The ACIRB is also happy to assist. Send an email to ACIRB@fenxiong.net with any questions.
Researcher Expertise
New researchers, and even those with some experience, may have questions about conducting a project or study. It’s important for you to recognize when you need help and to know who to contact. Completing human subjects protections training provides you with the basis for sound project or study development. Additionally, student researchers need to include a faculty advisor on the submission. Your submission will be reviewed to determine the following:
- The credentials and/or described qualifications of the research staff/ investigators are representative of the appropriate expertise needed to perform their responsibilities in the study. For student researchers, at least one faculty advisor is included on the study.
Research Setting
Obtaining study site cooperation is an important part of developing a research or project submission if you plan to conduct your project or study at a particular organization or location. See the Documentation of Cooperation page for more information. Some study designs (e.g., surveys, web-based interviews) do not require documentation of cooperation. All submissions will be reviewed to determine the following:
- The research setting (e.g., location of research, facilities, drug/device controls & accounting) supports adequate safeguards for protection of human subjects.
Vulnerable Populations
If your project or study design includes participants from vulnerable populations, your submission will be reviewed regarding the following item:
- Additional safeguards have been included in the study to protect the rights and welfare of subjects vulnerable to coercion or undue influence (e.g., children, prisoners, adults with impaired consent capacity, economically or educationally disadvantaged persons, etc.)
The Code of Federal Regulations (CFR) 46.111(8) provides specific information about this item. Because this is too broad of a topic to cover here, be sure to reach out to your advisor or ACIRB@fenxiong.net with any questions if your study or project design includes vulnerable populations.
Payment
If you will be offering payment of any kind to your participants, the proposed payment to participants and/or cost to subjects for participation will be reviewed to ensure appropriateness. Be sure to reach out to your advisor or ACIRB@fenxiong.net with any questions about payment as this may create additional considerations that affect your study or project.
Conflict of Interest
Conflict of interest is defined as: a set of conditions in which a researcher’s judgment concerning a primary interest (e.g., subject welfare, integrity of research) could be biased by a secondary interest [e.g., personal or financial gain] (Bankert et al., 2022, p. 924). In some cases, disclosure of any conflicts of interest are required (i.e., federal or government research). In other cases, identifying conflicts of interest, especially those involving financial issues is an important step to help manage them.
If PI/research staff conflict of interest is identified in a project or study, the conflict of interest will be reviewed in relation to human research protections to ensure they are appropriately minimized or managed (e.g., limit who obtains informed consent; add disclosure(s) in informed consent process; COI management plan appropriate, etc...).
Additional information about financial conflict of interest can be found on the HHS website.
References
Bankert, E. A., Gordon, B. G., Hurley, E. A., & Shriver, S. P. (2022). Institutional review board: Management and function (3rd ed.). PRIM&R.
Poth, C. N. (2021). Little quick fix: Research ethics. Sage.
Protection of Human Subjects, 46 C.F.R. § 116 (2019).
Protection of Human Subjects, 46 C.F.R. § 117 (2019).