Human Research

Any research study that involves human participants must be reviewed initially and periodically by the IRB, unless the study qualifies for exempt status under very specific conditions. The reason is to ensure that human participants are treated in an ethical manner that respects their rights and welfare. The need for this oversight developed over the course of the 20th century as numerous abuses of human rights were identified, including research conducted by the Nazis during WWII which resulted in the Nuremburg Code and later the Declaration of Helsinki, and the Tuskegee Syphilis study which led to the development of the Office of Human Research Protections within the Department of Health and Human Services and the publication of the Belmont Report. In the 1970s, the “Common Rule” (45 CFR 46) was published by the federal government as a set of human research protection policies that the federal agencies and anyone receiving funding from those federal agencies must follow. The Common Rule also sets forth the requirements for the IRB. These regulations must be followed by any institution that receives funding from the federal agencies, as well as any institution that has a federalwide assurance with the federal agencies. In addition, these practices have become the ethical standards by which most institutions and IRBs operate. ACU’s ORSP and IRB policies have been developed to be in compliance with the Common Rule regulations.

Step-by-step instructions on creating an IRB protocol can be reviewed in this document. 

In addition, this playlist of videos has been created to help walk you through the process.

All studies that were previously approved by expedited or full board review and that continue beyond the expiration date must undergo continuing review at regular intervals until inactivated (45 CFR #46.109(e); Investigator Responsibilities). Typically this period is once per year. However, studies with a high degree of risk may be reviewed more frequently at the IRB’s discretion. Your original approval letter from the IRB provides information about when your study expires and must be re-reviewed. Please submit a Renewal Request in Cayuse.

If your study expires before you obtain re-approval, you must halt all research activity on that protocol until approval is received or unless the IRB determines it is in the interest of participant safety to continue.

For any study that was previously approved by expedited or full board review, any and all proposed changes to the study, no matter how minor (including changes to personnel, methodology, or consent forms), must receive prior approval by the IRB before being implemented (45 CFR #46.103(b)(4); Investigator Responsibilities) (except when the change was made to eliminate an apparent immediate hazard to the participants, in which case an unanticipated problem report should be filed in addition to the amendment form). Please submit a Modification Request in Cayuse.

Changes that do not increase risk to participants, or seek to further minimize risk, can often be reviewed by an expedited procedure. Changes that significantly increase risk to subjects must go to full board review.

For studies previously determined to be non-research, non-human research, or exempt, amendments to the protocol do not have to be reviewed by the IRB unless the change increases risk or otherwise affects the study status. If the changes to the study may cause a classification change, such that it no longer qualifies for exemption, please submit the amendment for review via Cayuse.

If you have an unexpected event that is probably related to the research and potentially increases the risk profile of the study, there is a complaint from a participant that suggests there may be an increased risk to the study, or there is a breach of confidentiality, you must submit an Incident Report in Cayuse. Unanticipated problems that are serious UPIRSOs (Unanticipated Problems Involving Risk to Subjects or Others) should be reported within 7 days of learning of the event, unless the UPIRSO is potentially lethal, then it should be reported within 2 days. Other unanticipated problems should be reported within 14 days of learning of the event. UPIRSOs may require an amendment to the protocol to reduce risk, notification to current and/or past participants of the new risk, and/or, in some serious cases, inactivation of the protocol. Please include these materials with your report, as applicable.

All studies that were previously approved by expedited or full board review must be inactivated upon completion of the study (45 CFR #46.115(b); Investigator Responsibilities). Inactivation should be completed when enrollment is closed, data is no longer being collected, and analysis is complete or involves only de-identified data, in other words, when all human subjects activity has ceased. Note that if the study is federally funded or if you are the lead site on a multi-center trial with active sites, you must keep the protocol open and submit continuing reviews at least annually per your approval letter.

Any deviation from the approved protocol, no matter how small, must be reported to the IRB using the same timeline as unanticipated problems, with the exception that minor deviations that do not affect safety, increase risk, or violate rights and welfare of participants may be reported on the continuing review. If the reported deviation is a permanent change, it must be accompanied by an amendment request form.

Data and records related to human subjects research must be kept by the research team and the IRB for at least 3 years after the date of inactivation of the study (45 CFR #46.115(b); Investigator Responsibilities). These records are auditable and must be produced in a “reasonable amount of time.” Thus, ACU requires that a faculty member keep these records, in some form, on campus. This can be in electronic or paper form, as long as it is appropriately secure and available upon request.

Investigators also have a responsibility to follow the Common Rule. The Department of Health and Human Services outlines the investigator’s responsibilities. These include, but are not limited to, ensuring informed consent of all participants, reporting to the IRB as appropriate and required, and keeping records and data for 3 years following the inactivation of the study. The assurance page outlines all of the responsibilities expected of the investigator. Typically, the principal investigator signs off on these assurances. However, because we allow students to be PIs on a study, we require that an ACU faculty person commit to the responsibilities outlined on the form.

If you are conducting research that meets the 45 CFR 46 definition of “human subjects research,” you must complete the Social/ Behavioral/Education training (Basic) in CITI Program. Researchers are also required to complete All Researchers (RCR) training. This should take 3-4 hours to complete and can be done in blocks. Researchers must complete this training once every 4 years. All training modules are accessible via CITI Progam.

45 CFR 46 requires that certain elements be included in an informed consent process, whether done verbally or on paper. Briefly, those elements are 1) a statement that this is research and the purpose of the research; 2) descriptions of the procedures involved and the frequency and duration of participation; 3) descriptions of the risks and benefits anticipated; 4) any alternative treatment that may be available instead of the research treatment, if applicable; 5) any efforts that will be made to protect privacy and confidentiality; 6) if there will be any treatments or compensations made in the event of an injury; 7) who to contact for questions, issues regarding welfare and rights, and in the event of an injury; 8) a statement that participation is voluntary, and the participant may decline to participate or withdraw at any time without penalty or loss of benefits to which they are otherwise entitled. In some cases, additional statements may also need to be added when appropriate to the study including: 1) the possibility of unforeseen risks; 2) any situations whereby the investigator may withdraw the participant; 3) any costs that the participant may incur; 4) any natural consequences that may occur if the subject withdraws (e.g., withdrawal side effects of a study medication); 5) if any findings that occur during the study may affect the participant’s willingness to participate and how that will be communicated; 6) the number of participants to be enrolled.

Further detail about these requirements can be found at the DHHS link above.

The IRB can grant an alteration of consent procedure in certain cases. The research has to be minimal risk, can’t be practicably carried out without the alteration, and the alteration must not adversely affect the rights and welfare of the participants. In cases like deception, the researchers are often required to provide the participants additional information at the end of their participation. The Department of Health and Human Services website has a helpful decision chart to assist you in making the determination as to whether your study would qualify for such an alteration. Ultimately, it is up to the discretion of the IRB to determine if the conditions above have been met.

Documentation of informed consent is a general requirement for all studies, either requiring a signature on the full consent form or a short form confirming that the consent process was done orally. However, there are conditions under which the IRB can waive this requirement. The first condition is when breach of confidentiality is the primary risk of the research and the consent document is the only identifier. The second is when the research is minimal risk and involves no activities that would otherwise require consent documentation. The Department of Health and Human Services website has a helpful decision chart to assist you in making the determination as to whether your study would qualify for such a waiver. Ultimately, it is up to the discretion of the IRB to determine if the conditions above have been met.

The IRB can approve a waiver of the informed consent process in certain circumstances. The research has to be minimal risk, can’t be practicably carried out without the waiver, and the waiver must not adversely affect the rights and welfare of the participants. The Department of Health and Human Services website has a helpful decision chart to assist you in making the determination as to whether your study would qualify for such a waiver. Ultimately, it is up to the discretion of the IRB to determine if the conditions above have been met.

The IRB has the responsibility of weighing the risks of a research study against the benefits. The first criteria for IRB approval of a study states, “Risks to subjects are minimized: (i) By using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk. (46.111)” In addition, the Belmont Report states that there must be a positive balance of benefits to risks. If the risks to the study are quite minimal, and the study design is not sound, there is little concern. However, if there are greater than minimal risks, and the study design is not sound, then the benefits of the work may not be achievable, and thus, there may be a negative benefit to risk ratio. So while the IRB is not responsible, specifically, for reviewing the quality and soundness of the study design and methodology, it does have the responsibility of ensuring that the benefits stated can actually be achieved when determining the risk ratio.

The second reason for asking about methodology is that the reviewers need to understand the full scope of human participant interaction. This is necessary to assess the risks that are involved in the study and whether the research team has implemented adequate solutions to minimize that risk.

The IRB has certain key things that it must consider when making a determination. Specifically, in order to approve a study, the IRB has to make 7 determinations related to risk assessment, subject selection, informed consent, safety monitoring, and privacy and confidentiality. In addition, there are very specific requirements related to the informed consent process and document, as well as special provisions for certain populations (such as pregnant women and neonates, prisoners, and children). Studies that may be eligible for the special categories of exemption or expedited review also must meet very specific requirements. In addition to the regulations in 45 CFR 46, the IRB also has to consider other laws and regulations, for instance HIPAA and FERPA laws related to medical and educational records, respectively. If the IRB reviewer feels that there is insufficient information related to one or more of these items to make a determination on the study, the reviewer may request clarification or additional information related to those items.

Full board review is considered the default type of review. The other classifications and review types (e.g., exempt and expedited) represent special cases with specific parameters that must be met. Having your study called to full board does not automatically mean that there are major issues with your protocol. It may only mean that the study did not meet the specific criteria for another classification. Protocols in which investigators requested another level of review (e.g., exempt or expedited) may still be routed for full board review if the ORSP Office and/or IRB determines the study does not meet the criteria for that classification.

A protocol that was submitted on an expedited request form might get called to full board for two reasons: 1) The ORSP Office or IRB reviewer determined that the study did not, in fact, meet the criteria for expedited review, or 2) the reviewer did not feel that he/she could approve the study, even after revision. 45 CFR 46 does not permit disapproval of a study under expedited review, but instead requires that it go to full board for consideration. If you have any questions as to why your study was routed to full board review, you may contact the ORSP.

The IRB Policy states: “Full board meetings are generally scheduled for the first Monday of each month during the academic year. If the protocol is received at least 30 days before the meeting, it will be assigned to that meeting, space allowing. Protocols received less than 30 days prior to the meeting cannot be guaranteed an assignment at the next meeting and may be assigned to the following month. Protocols received less than 2 weeks prior to the meeting will automatically be assigned to the following month to allow for appropriate preparation by the IRB. The PI and Point of Contact named in the protocol will receive notice of full board review and the date assigned for review.”

In general, the ORSP Office strives to get your protocol assigned to the earliest meeting possible given the necessary timelines for adequate preparation and review.

If you have any questions about meeting assignments, you may contact the ORSP.

The IRB has several ways it can vote on a protocol: approved, approved with minor revisions, or not approved/major revisions required. If the study was approved with minor revisions, then generally the committee has a set of small revisions requested that do not require a reconvening of the full board once those changes are made. The ORSP Office or the primary reviewer will review the revisions once submitted, and if they are in line with what the committee has requested, the approval letter will be provided to the PI.

The IRB reviewers strive to have their questions answered prior to convening the full board. However, if a question arises during the meeting, and the research team is not available to answer the question, the study may have to be tabled until a later meeting after the additional information has been gathered.

Another reason a study could get tabled is if the IRB meeting fails to establish or maintain quorum. The IRB is required to have greater than 50% of the members present (e.g., 4 out of 6 or 4 out of 7 members present), and one of those in attendance must be someone with a “non-science” background. If the IRB is not able to establish or maintain this requirement during a meeting, then all deliberations and voting must cease until quorum can be established. The IRB committee strives to schedule meetings at a time when quorum can be met and maintained, but if quorum is lost, we may have to reschedule study discussions to a later meeting.

Children
It is permissible to use child participants in your study when certain conditions are met. First, the research team should justify the need to use children (e.g., the question of interest pertains to child life or conditions that affect children). Second, the study should be either 1) minimal risk, 2) greater than minimal risk but of direct benefit to the child participants, or 3) only a minor increase over minimal risk, of no benefit to the child participant, but potentially yielding important information about the child’s condition. Consent should be sought from one or both of the parents, in accordance with the regulations, unless a waiver is sought and granted by the IRB. In addition, the assent of the child should also be sought when the child is cognitively and developmentally able (this is typically around 7 years of age in a developmentally typical child). Signs of dissent should be respected and usually lead to exclusion of the child participant. If children who are wards are used, additional protections are required if the study is greater than minimal risk and has no direct benefit to the child. In this instance, the child may only participate if the study relates to their status as a ward or is conducted in a location where most of the other children are not wards (such as a school or hospital). In addition, an advocate must be appointed who will act in the child’s best interest.

Prisoners
The use of prisoners as participants is only allowable in very limited circumstances. Prisoners have had many of their rights and freedoms stripped through incarceration, and as such, are very vulnerable to coercion. Prisoners can only be used as participants when the research relates to life as a prisoner, conditions that affect prisoners at high rates, or improvements in the health and well-being of prisoners. Additionally, the research cannot be of any greater risk than a non-prisoner would accept. The parole board cannot consider the prisoners’ participation in the study when making decisions, and the participants must be explicitly informed of this during the consent process. Finally, the IRB must have a prisoner representative on the board. Further detail can be found on the DHHS site.

Pregnant women and fetuses
Pregnant women may participate in research when the assessment of risk can be made, such as by the existence of preclinical and clinical studies, and the risk is either none to minimal or if greater than minimal, there is direct benefit to the woman or fetus. In some cases, the father of the fetus may be required to also consent to the woman’s participation in the research. In addition, the research team is not permitted to be involved in any decisions related to the viability or termination of the pregnancy. Further detail can be found on the DHHS site.

Neonates
Healthy, viable neonates may be used as participants in research and are treated the same as other children. Non-viable neonates and neonates of uncertain viability may be used under limited circumstances. There should be sufficient information to make an assessment of risk, such as by the existence of preclinical and clinical studies, and there should be no other means for achieving the purpose of the research. For non-viable neonates, there should be no added risk to the baby’s health by participating in the study, and the research cannot artificially prolong or prematurely terminate the baby’s life. In general, both parents must consent for the child. In the case of neonates of unknown viability, the research should have the potential of increasing the probability of survival for the baby or be of no added risk to the baby’s health. Consent should be obtained from at least one parent. Further detail can be found on the DHHS site.

Decisionally impaired
While the federal regulations do not address the use of decisionally impaired individuals as a vulnerable population, it is important that we consider that these individuals may have reduced autonomy and, therefore, require additional safeguards to ensure their safety and welfare. The researcher should identify how the individual’s capacity to consent will be assessed. When possible, the individual should be permitted to self consent. However, if there is sufficiently reduced decision-making ability, then a surrogate may consent on the participant’s behalf, preferring first a legally authorized representative of the participant. In the case of surrogate consent, the participant should be permitted to give assent when possible, and signs of dissent should be respected and usually lead to exclusion of the participant. In general, the research team should justify the need to include decisionally impaired individuals as participants.

Students
While the federal regulations do not address the use of students as a vulnerable population, we must consider that, in the case of faculty research, students may feel pressured or compelled to participate in order to please the professor. Because of this, students are considered vulnerable to coercion. It is advised that faculty consider ways that they may reduce this risk, such as having an alternate individual handle the student interactions, blinding the faculty person to enrollment until the end of the semester, or recruiting broadly outside of the faculty person’s own classroom. It is also advised that participants be clearly informed of these protections to stress the voluntariness of their participation. Consent forms should all include the basic language, “Your participation is entirely voluntary. You may decline to participate or withdraw from the study at any time and for any reason without any penalty or loss of benefits to which you are otherwise entitled.”

It has been common in the past to offer extra credit or to require research participation as part of a course grade. Today, these practices are generally advised against, again in order to avoid potential for coercion. However, if any extra credit is to be offered for participation in a study, there must be a non-research alternative offered, and that alternative must not be any more burdensome to the student and his/her time than the research participation. If research participation is required for course credit (as is often still the case in many research methods and intro to psychology courses), there must be a wide array of research studies available for the students’ choosing AND there must be a non-research alternative that is no more burdensome than the research participation. You can avoid these challenges by simply not offering credit for participation.

A final consideration for students involved in faculty research is privacy and confidentiality. Research teams on campus often include a mix of faculty and student researchers. If a study involves sensitive and private information, student participants may find that this information is falling into the hands of their peers and professors. The research team should consider extra steps they may take to protect the privacy of these students and any effect this sensitive information may have on the student-instructor or peer relationships.

For participation selection
Medical records include protected health information (PHI) that is covered by the Health Insurance Portability and Accountability Act (HIPAA). In general, accessing medical records for research purposes requires a consent to access and disclose PHI, even if you are only going to look at the information for participant selection. However, sometimes we cannot know from whom to seek permission without accessing the records. In such cases, a waiver of consent requirement can be approved if the PHI disclosure represents no more than minimal risk and the research could not be conducted without the waiver. In all cases, researchers should take care to only look at and collect the minimum PHI necessary to achieve the goals of the research and any personal identifiers should be destroyed as soon as possible.

To collect data
Medical records include protected health information (PHI) that is covered by the Health Insurance Portability and Accountability Act (HIPAA). In general, accessing medical records for research purposes requires a consent to access and disclose PHI. Researchers should prepare a HIPAA/PHI consent to disclose form in addition to or as part of the research consent document. In limited cases, a waiver of such consent can be granted if the PHI disclosure represents no more than minimal risk and the research could not be conducted without the waiver. The researcher will need to justify this need and explain why obtaining consent to access and disclose PHI is not practicable. In all cases, researchers should take care to only look at and collect the minimum PHI necessary to achieve the goals of the research and any personal identifiers should be destroyed as soon as possible.

For participant selection and/or to collect data
Educational records include private information that is protected by the Family Educational Rights and Privacy Act. In general, accessing educational records for research purposes requires consent, even if the educational information is something the researcher typically has access to (such as a teacher/professor having access to their students’ grades). FERPA requires a signed consent in all but very limited situations, even if you just need to view the information for participant selection. A signed disclosure authorization is required unless one of the following conditions are met: 1) You will only be viewing/collecting directory information; 2) The study is for, or on behalf of, the institution to either develop, validate, or administer predictive tests; administer student aid programs; or improve instruction; 3) The study involves only de-identified records, including the removal of all direct and indirect identifiers. Studies on behalf of the institution require a written agreement between the institution and the researcher which includes the stipulations outlined in 34 CFR §99.31(a)(6)(iii). In all other cases, researchers should prepare a FERPA consent to disclose form in addition to or as part of the research consent document.

You are allowed to provide compensation to research participants, but the compensation must abide by ACU policy and IRB regulations.

Compensation, financial or otherwise, must not be great enough to be considered undue influence (convincing someone to do something they would otherwise not be willing to do). As part of the review process, reviewer(s) will determine if compensation qualifies as reasonable or undue influence. Compensation will not be approved if concerns about undue influence exist.

Financial compensation using ACU funds (including external grants) may only be given in the form of checks distributed by Accounts Payable. In order to receive compensation, each research participant must fill out a W9 form. (If participants do not wish to fill out a W9 form but still wish to participate in the research, they may participate but may not be paid.) The Principle Investigator is responsible for giving all W9 forms to Accounts Payable before compensation is given. You are required keep financial records in the case of an audit.

Gift cards may not be purchased using ACU funds. Likewise, requests for reimbursements for cash payouts are not allowable. A very limited set of exceptions can be made only when such payouts are necessary for the valid conduct of the research (i.e., not just for compensation or incentives for participation). Please see the ORSP handbook and/or contact ORSP for guidance on what is required for this exception.

If you wish to provide compensation to research participants, make sure your consent form explicitly states under what conditions participants will receive compensation, including filling out a W9 and/or other required documentation. You should also include a statement regarding the limits of confidentiality as financial records may be accessed by Finance, Accounts Payable, ORSP, the IRS, and/or external funding agencies as necessary and appropriate.