Institutional Review Board (IRB)

Research may be classified as “Exempt” if it meets the criteria for one or more of the specific exemption categories defined by federal regulation (45 CFR 46.104). An exempt determination means the research is not subject to the full requirements of the Common Rule. However, the research must still be conducted ethically and may be subject to institutional policies. Please refer to the U.S. Department of Health and Human Services’ exempt decision chart to verify if your study qualified for exempt review.

Exempt research activities are characterized by an extremely low or non-existent level of risk and typically include:

• Research in Educational Settings: Research conducted in established or commonly accepted educational settings that involves normal educational practices, such as the comparison of instructional techniques or curricula. (Please note that work with minors, although potentially exempt, will still require a full board review.)
• Surveys, Interviews, and Observations: Research involving the use of educational tests, surveys, interviews, or observation of public behavior, provided the data is recorded in a way that subjects cannot be identified, or that any disclosure of responses outside the research would not reasonably place the subjects at risk.
• Benign Behavioral Interventions: Interventions with adult subjects that are brief in duration, harmless, painless, not physically invasive, and unlikely to be offensive or embarrassing. The intervention cannot involve deception unless the subject prospectively agrees.
• Secondary Data Analysis: Research involving the use of identifiable private information or identifiable biospecimens, if the data is publicly available or if the information is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained.

Expected Timeline: 1 week (except in instances where a full-board review is required)

An application for exemption is required in addition to the completed IRB protocol application.

Application for Exemption

IRB Protocol Application (docx)

An Expedited review is required for research that involves no more than minimal risk and falls into one of the nine federally defined expedited categories (45 CFR 46.110). 

Minimal risk is formally defined as “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.”

An expedited review is conducted by the departmental representative and the IRB Chair. It does not require a convened meeting of the full board.

Common examples of research eligible for expedited review include:

• Limited Blood Draws: Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture from healthy, non-pregnant adults who meet specific weight and age criteria, within defined frequency and amount limits.
• Non-Invasive Specimen Collection: Collection of biological specimens by noninvasive means, such as hair and nail clippings, deciduous teeth, and saliva.
• Non-Invasive Data Collection: Collection of data through noninvasive procedures routinely employed in clinical practice, excluding procedures involving general anesthesia or sedation. This includes data from voice, video, digital, or image recordings made for research purposes.
• Research on Individual or Group Characteristics: Studies on perception, cognition, motivation, identity, and cultural beliefs where the investigator does not manipulate subjects’ behavior and the research will not involve stress to subjects.

Expected Timeline: 2-4 weeks

IRB Protocol Application

A Full Board Review is the most rigorous level of review and is the default method for protocols that do not qualify for Exempt or Expedited status. It is required for any research that presents greater than minimal risk to participants.

The protocol is reviewed by the entire board at a convened monthly meeting where a quorum is present. Investigators planning research that requires full board review must adhere to strict submission deadlines to be included on the meeting agenda.

Full board review is required for research that:

• Exceeds Minimal Risk: Involves procedures that may cause significant physical or psychological harm, discomfort, or stress. This includes studies with experimental drugs or devices, novel medical procedures, or interventions that could have adverse effects.
• Involves Vulnerable Populations: Includes participants who are members of populations specifically protected in federal regulations, such as prisoners, children, pregnant women, and individuals with impaired decision-making capacity. Research with these populations often requires full board review even if the risk level would otherwise be considered minimal.
• Involves Significant Deception: Uses deception that may cause participants to experience negative emotional or psychological outcomes.
• Deals with Highly Sensitive Information: Collects data on illegal behaviors or other sensitive topics where a breach of confidentiality could result in significant social, legal, or financial harm to the participant.

The primary investigator (PI) for the project must attend the full board meeting to discuss their proposal. The PI will be invited to the next meeting by the IRB Chair.

Expected Timeline: 4-8 weeks

IRB Protocol Application (docx)

Once you submit your research protocol to the IRB, it undergoes a structured review to ensure compliance with federal regulations and institutional policies. The specific path it takes depends on the study’s level of risk.

1. Administrative Pre-Review: All submissions, regardless of review level, first go to the IRB office staff for an administrative pre-review. During this step, an IRB coordinator or specialist checks the submission for completeness to ensure all required forms are present, signatures are in place, researcher training (e.g., CITI) is current, and all supporting documents (consent forms, surveys, recruitment flyers) are included. If the package is incomplete, the IRB staff will contact you with a list of required revisions or missing items. The formal review process does not begin until a complete application is received.
2. Review Path Determination: After passing the pre-review, the protocol is assigned a review level (Exempt, Expedited, or Full Board).
   • Exempt & Expedited Review: Submissions that appear to meet the criteria for Exempt or Expedited review are assigned to one or more experienced IRB reviewers (often the departmental representative and or IRB Chair). These reviews happen on a rolling basis as submissions are received.
   • Full Board Review: Submissions involving more than minimal risk and/or vulnerable populations are scheduled for review at the next convened full board meeting.
3. The Official Review: This is the core evaluation of your study’s ethical framework.
   • For Exempt/Expedited Studies: The designated reviewers will assess your protocol to confirm it meets the criteria for its assigned level and that all ethical considerations are appropriately addressed. The reviewer makes a final determination.
   • For Full Board Studies: Before the meeting, the complete protocol is distributed to all IRB committee members. During the convened meeting, a primary reviewer presents a summary of the study. The full committee then discusses the research, focusing on the criteria for approval, such as risk/benefit analysis, equitable subject selection, and the informed consent process. The discussion concludes with a formal vote.
4. Communication of the Outcome: Following the review, you will receive a formal written notification of the IRB’s decision. There are four possible outcomes:
   • Approved: Your study is approved as submitted. You may begin your research immediately upon receiving the official approval letter.
   • Approved with Conditions (or Modifications Required): The IRB has approved the study but requires you to make specific, minor changes. You must submit the revised documents for verification, but another full review is typically not needed. You may not begin your research until you receive final approval of the revised materials.
   • Deferred (or Major Revisions Required): The IRB cannot approve the research as submitted. This decision is made when significant questions or concerns are raised that require substantial clarification or revision to the protocol. You will need to revise your submission and resubmit it for review.
   • Disapproved: This outcome is rare and is reserved for studies with fundamental ethical or regulatory issues that cannot be resolved through modification. The IRB will provide a detailed rationale for the decision.

Protocol Templates

• New IRB Procedure TEMPLATE (docx)
• Revision of Procedure TEMPLATE (PDF)

Informed Consent Templates

• Informed Consent TEMPLATE (docx)

Submission Portal

• IRB Submission Portal

1. 1. Determine the Anticipated Review Level (exempt, expedited, full board)
   2. Review the Approval Criteria (PDF)
   3. Download & Prepare Materials
      • Exempt Review Application
      • Expedited Review Application
      • Full Board Review Application
   4. Confirm all protocol materials are combined into a single PDF
      • Application for Exemption (if applicable)
      • Completed IRB Protocol Application Form (docx) or Revision of Procedure Application Form (PDF)
      • All Consent/Assent documents (in appendix) (See consent form guide for directions) Note: For procedure revisions and continuing reviews, all consent documents (even if not revised) must be attached for re-approval.
      • A copy of all research materials (when possible). If it is not possible to submit a copy of some research material, then a full descriptive narrative must be submitted in the materials place (e.g. a Snellen Eye Chart does not need to be submitted if it is being used, but a description of the chart and its use in the research must be submitted).
      • All procedure revisions should include a version that tracks the changes on all documents that you want to revise (e.g. consents, recruitment material, application, etc.). Use the “track changes” function and/or highlights, strike throughs, and comments to clearly show where you made the changes within each document. Include a final clean version of all the files with accepted tracked changes as part of your modification submission.

5. Submit your application using the IRB Submission Portal

IRB approval is granted for a research protocol for one year as it is specifically written and submitted. Continuing review requires that any subsequent changes to an approved study receive IRB review and approval before the changes are implemented. This ensures that the rights and welfare of human participants remain protected throughout the lifecycle of the research.

Failure to secure approval prior to implementation constitutes a protocol deviation or non-compliance, which may jeopardize the research data and require reporting to federal oversight agencies.

A formal modification (also known as an amendment) must be submitted to the IRB for any proposed change to your study. The scope of changes requiring modification is broad and is not limited to procedures involving direct contact with participants.

Common examples of changes that require a modification include:

• Changes to Study Personnel: Changes to research staff such as adding or removing a Principal Investigator, Co-Investigator, or other key research personnel.
• Alterations in Methodology or Procedures: Modifying the study design, alterations to study activity duration or procedure, changes to the timing or frequency of study visits, alternations in participant compensation, or altering the data collection methods.
• Participant Population or Sample Size: Changing the inclusion/exclusion criteria, targeting a new population group, or increasing/decreasing the total number of approved subjects.
• Recruitment Materials & Methods: New or revised recruitment flyers, emails, or scripts, or recruiting from a new source.
• Informed Consent Document (ICF) or Process: Any change to the content of the consent form, or a change in how consent is obtained (e.g., moving to an electronic consent process).
• Survey Instruments or Interview Questions: Adding, removing, or substantively changing questions.
• Study Locations: Adding a new site for recruitment or data collection.
• Safety, Confidentiality, & Security: Changing the methods for storing, transmitting, or protecting research data, or updates or alternations to safety standards or participant protections

Modifications are typically categorized as either minor or major, which determines the path of IRB review.

• Minor Modifications: These are changes that, when evaluated, do not materially increase the risks to research participants or fundamentally alter the study’s design. Examples include correcting typographical errors, adding a non-sensitive survey question, or adding research staff who are not investigators. Minor modifications are generally eligible for expedited review.
• Major Modifications: These are changes that could increase the risk to participants or substantially change the approved protocol. Examples include adding procedures that are more invasive, recruiting from a vulnerable population not previously approved, or making significant changes to the study’s risk/benefit assessment. Major modifications may require review by the Full Board at a convened meeting. Additional examples of major modifications include:
  • Substantially extending the duration of a participant’s exposure to the study activity, test material, or intervention.
  • Introducing a new study device not included in the originally approved study.
  • Adding measures to the Informed Consent Form to disclose serious, unexpected adverse events or other significant, newly identified risks.
  • Adding a qualified investigator who has a disclosable conflict of interest.
  • Implementing site-specific requirements that substantively impact the procedures of the originally approved study.
  • Adding procedures that are more invasive or carry a higher potential for physical or psychological harm.
  • Recruiting from a vulnerable population not previously approved (e.g., children, prisoners).
  • Any change that, in the opinion of the IRB reviewer, does not meet the criteria for a minor modification.

To your revision of procedure form, please attach:

• All consent documents (even if not revised) as these must be re-approved
• A “track changes” version of all revised materials
• A clean version of all revised materials

Revision of Procedure Application Form (PDF)

In accordance with federal regulations (45 CFR 46.109), the Institutional Review Board (IRB) is responsible for the continuing review of ongoing research appropriate to the degree of risk and not less than once per year for studies requiring it. The purpose of continuing review is to ensure the criteria for IRB approval, particularly the risk/benefit assessment, continue to be met throughout the life of the study. Renewals must be made no less than once per year and must be renewed prior to the end of the previous approval. Studies may be renewed for up to two years beyond this initial date of approval. 

The requirement for continuing review is determined by the study’s initial level of review and the governing regulations.

• Full Board Research: Any study that required review by the convened Full Board must undergo continuing review at least annually.
• Expedited Research: The 2018 Revised Common Rule eliminated the requirement for annual continuing review for most studies that qualify for an Expedited level of review, unless justified by the IRB. The project is subject to annual renewals if it is regulated by the Food & Drug Administration (FDA) or another sponsor that requires continuing review, the project involves additional regulatory oversight, the study procedures or risks indicate greater oversight is necessary, or other justifiable research specific considerations apply. If continuing review is required, this will be noted on the official IRB approval notice. 

The Principal Investigator (PI) is directly responsible for submitting the continuing review application and receiving re-approval from the IRB prior to the expiration of the current approval period. The continuing review submission must document the study’s progress, including current enrollment data, a summary of any adverse events or unanticipated problems, any new information that may alter the risk/benefit analysis, and a copy of the current informed consent document.

Continuing Review Form

Upon the completion of all research activities, including all follow-up with participants and the analysis of identifiable data, the PI must submit a Study Closure Report to the IRB. This action formally documents the completion of the study and terminates IRB oversight.

Protocol Closure Form

The Institutional Review Board (IRB) operates within a comprehensive legal framework designed to protect human research participants. This framework is primarily based on federal regulations, commonly known as the “Common Rule,” which are codified in the Code of Federal Regulations (CFR) and published in the Federal Register. The following sections outline key regulations and policies that govern human subjects research.

Data Protection Regulations

• Family Educational Rights and Privacy Act (FERPA) – U.S. Department of Education policy that safeguards the privacy of student education records and establishes guidelines for accessing these records.
• General Data Protection Regulation (GDPR) – European Union regulation that sets standards for handling personal data of EU residents and non-EU citizens located within
• Health Insurance Portability and Accountability Act (HIPAA) – U.S. federal law that protects the privacy and security of Protected Health Information (PHI).

Department of Defense (DoD) Regulations

• 32 CFR 219: Protection of Human Subjects
• 10 USC 980: Limitations on the Use of Humans as Experimental Subjects
• DoD Instruction 3216.02: Protection of Human Subjects and Adherence to Ethical Standards in DoD-Supported Research (PDF)

Food and Drug Administration (FDA) Regulations

• 21 CFR Part 50: Protection of Human Subjects
• 21 CFR Part 56: Institutional Review Boards
• 21 CFR Part 312: Investigational New Drugs
• 21 CFR Part 812: Investigational Device Exemption
• 21 CFR Part 11: Electronic Records, Electronic Signatures

U.S. Department of Health and Human Services (HHS) Regulations

• 45 CFR Part 46: Policy for the Protection of Human Research Subjects
• 45 CFR Parts 160 & 164 (subparts A & E): Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule
• Federalwide Assurance (FWA) for the Protection of Human Subjects – Outlines institutional commitments to comply with 45 CFR Part 46

The ethical conduct of research is critically dependent upon the investigator’s ability to protect participant data and confidentiality. A primary focus of IRB review is to ensure that a robust data management and security plan is in place to mitigate the risks of harm resulting from an unintentional disclosure of sensitive information. The plan must cover the entire data lifecycle, from collection and storage to final disposition.

It is essential to use precise terminology when describing your data security plan in the protocol.

• Anonymous Data: Identifiers are never collected. There is no way for anyone, including the research team, to link the data back to an individual participant. True anonymity is rare in research.
• Confidential Data: The research team can link data to specific individuals, but is obligated to protect that link from disclosure. This is typically achieved by replacing identifiers with a code and securing the code key separately from the data.
• De-identified Data: All direct and indirect identifiers have been removed from the dataset. A code key may still exist, but it is not readily available to the data user.

Your protocol must also describe the specific procedures for securing research data.

• Storage and Access: Identifiable data must be stored on encrypted devices, secure university servers, or in locked, physically secure locations (for hard copies). Access should be limited to essential research personnel. A crucial best practice is to store the master list linking codes to participant identities separately from the primary research data.
• Transmission: Identifiable data should never be transmitted over unsecured networks or via standard email. Utilize secure file transfer protocols or university-approved, encrypted services.

Data Disposition: The protocol should specify a timeline for when identifiable data will be destroyed. This often involves destroying the master code key after data analysis is complete, rendering the dataset fully de-identified for long-term archiving.

Depending on the source and nature of your data, specific federal and international regulations may apply. The Principal Investigator is responsible for ensuring compliance with all applicable laws. (Please see the Governmental Regulations section for more.)

• Family Educational Rights and Privacy Act (FERPA): U.S. Department of Education policy that safeguards the privacy of student education records and establishes guidelines for accessing these records. Research involving student records requires specific consent or must meet narrow exceptions.
• General Data Protection Regulation (GDPR): European Union regulation that sets standards for handling personal data of EU residents and non-EU citizens located within the EU. If you are collecting data from individuals in the EU, you must comply with GDPR’s stringent requirements for consent and data processing.

Health Insurance Portability and Accountability Act (HIPAA): U.S. federal law that protects the privacy and security of Protected Health Information (PHI). If your research involves accessing, using, or creating PHI from a healthcare provider or other covered entity, HIPAA regulations apply and specific authorizations are required.

The consent process must afford the prospective subject adequate opportunity to consider all aspects of the research and to ask questions. It is the investigator’s responsibility to ensure the subject’s comprehension of the disclosed information. The language used, both in conversation and in written materials, must be understandable to the subject or their legally authorized representative.

Federal regulations (45 CFR § 46.116) delineate the essential information that must be conveyed to each subject. The IRB will not approve a study unless the consent process and its documentation include these required elements:

1. A statement that the activity involves research, an explanation of the purposes of the research, the expected duration of participation, and a detailed description of the procedures.
2. A description of any reasonably foreseeable risks or discomforts.
3. A description of any benefits to the subject or to others that may reasonably be expected from the research.
4. A disclosure of appropriate alternative procedures or courses of treatment, if any might be advantageous to the subject.
5. A statement describing the extent, if any, to which the confidentiality of records identifying the subject will be maintained.
6. For research involving more than minimal risk, an explanation regarding the availability of compensation and/or medical treatment in the event of injury.
7. Contact information for inquiries regarding the research, subjects’ rights, and research-related injuries.
8. A statement that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and that the subject may discontinue participation at any time without penalty or loss of benefits.

Informed Consent TEMPLATE (docx)

Informed consent shall be documented by the use of a written consent form approved by the IRB and signed by the subject or their legally authorized representative. However, the IRB holds the authority to approve modifications to this requirement under specific regulatory provisions.

• Waiver of Documentation (45 CFR § 46.117(c)): The IRB may waive the requirement for a signed consent form under two conditions: (1) when the only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality; or (2) when the research presents no more than minimal risk and involves no procedures for which written consent is normally required outside of the research context.

Waiver or Alteration of the Elements of Consent (45 CFR § 46.116(f)): The IRB may approve a consent procedure that does not include, or which alters, some or all of the elements of informed consent, provided the research could not practicably be carried out without the waiver, involves no more than minimal risk, and the waiver will not adversely affect the rights and welfare of the subjects.

Heightened protections are required when enrolling individuals with diminished autonomy. For research involving children, investigators must obtain the permission of at least one parent or legal guardian and, where appropriate, the affirmative assent of the child. For adults with impaired decision-making capacity, consent must be obtained from a legally authorized representative.

A number of Adams State University professors have designed courses where the students must conduct research of various kinds. Most of these activities do not require an IRB application provided that they meet the criteria for “exempt” status (see exempt status application form and exempt research explanation form). The primary factor that makes these activities exempt is that they are not considered research that adds to the “general knowledge” of a field because they will not be published in a journal or presented at a conference. For any of the following class activities the professor of record must file an application for exempt status for the assignment. The IRB must have these applications on record in order for the research to be conducted.

If at a later date a student decides to present the information at a conference or to try to publish the research in a journal then an application for IRB clearance can be completed along with a “change of status” memo informing the IRB as to why the application is being made after the research was conducted.

The following class-based activities are considered to be research:

• Observations of anyone under the age of 18 (e.g. classroom or child observations). Note: Observations also require the permission of the educational institute where the observation will take place and/or the parent of the child being observed. The professor of record is responsible for documenting this permission.
• Survey, interview, focus group, or experimental research that is of minimal risk and will involve students, staff, or faculty of Adams State University. Minimal risk means that the probability and magnitude of harm or discomfort 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. Note: all projects that all under this category will require the student researcher to obtain either verbal or written consent from all participants
• Research using public records that are gathered from courses outside of the classroom setting.

Note: Observations of people over the age of 18 who are not a special population and who are in a public setting do not require IRB oversight provided these observations will not be used in a publication or presentation.

Faculty are asked to evaluate student projects closely to make sure they meet the criteria for exemption. If faculty have any questions about a projects ability to meet the criteria for exemption then they should either submit the project for IRB evaluation or ask the student to redesign the project.

Certain populations are considered vulnerable in the context of research because they may have a diminished capacity to protect their own interests. This susceptibility can arise from an inability to provide fully informed consent, or from circumstances that make them subject to coercion or undue influence. Federal regulations codify specific protections for certain groups, including pregnant women, human fetuses, and neonates (45 CFR 46, Subpart B), prisoners (Subpart C), and children (Subpart D).

The IRB’s responsibility extends beyond these federally designated categories. The board must also consider whether additional safeguards are necessary for other populations whose circumstances may render them vulnerable, such as adults with impaired decision-making capacity, economically or educationally disadvantaged persons, or individuals in subordinate positions like students or employees. The inclusion of any vulnerable population must be specifically justified in the research protocol, and the IRB must ensure that the proposed safeguards are sufficient to mitigate the unique risks associated with that population’s vulnerability.