Research Integrity and Assurance

Special Considerations

Special considerations

There are many special considerations that need to be addressed when planning a human subjects research study. The information below provides guidance for these situations.  For additional assistance with these topics, contact us.

Research on educational programs or in classrooms

This includes research on professional development programs, after school programs, extracurricular programs, college classrooms, K-12 classrooms or any other educational setting.

Research on Educational Programs or Practices typically overlap with other special considerations such as:

  • financial compensation and extra credit
  • FERPA and using educational records in research
  • HIPAA and using private health information or medical records in research
  • Research Involving Children or Minors.

Distinction between ‘standard educational practice’ and ‘research’

It is important to understand the difference between the standard educational practice and research portions of a program. An educational practice that is developed and implemented without any form of assessment would not be considered research. Collecting data on an implemented practice for research purposes is subject to IRB review and approval. A standard educational practice is any activity that is ongoing (as opposed to a one-time intervention) and implemented by the district/college/department/etc. When writing IRB protocols and consent materials, focus on the data that is being collected, not the educational practice. Ask yourself:

  1. What activities will be conducted for research purposes?
  2. What activities will be conducted for non-research purposes?
  3. What activities will be conducted for non-research purposes, but may also be collected/observed/assessed for research purposes?

Consent

Consent materials should clarify the difference between what the school/district/instructor/etc. has determined to be the best educational practice and the human subjects research (as the data being collected). Often it is the case that, even if they do not agree to have their data used in research, students will still be expected to participate in educational activities to fulfill the requirements of a class. In these situations, consent materials need to clarify this distinction and request permission to use the collected data for research.

Afterschool, extracurricular or other optional programs

The consent form should clearly state whether or not a student can participate in a program if consent to participate in the research is not obtained. It is recommended to allow participation in a program unless resources make this prohibitive (for example “we only have 10 robots and need the data”).

Permission to participate is different from consent for research. Avoid combining the two into a single document as it can be confusing. Both your application and consent documents should clearly outline how permission to participate will be obtained. In some situations, permission is implied by showing up: a public library reading program, for example. In other situations, permission may be more complicated: a program lasting 4 hours every Saturday at ASU that busses students in, for example. Please attach any permission forms and associated documents/materials where appropriate.

Benefits of participation

When you explain the benefits of participation, do not confuse the benefits of an educational practice—one that a child would receive regardless of research participation—with the benefits of research. In the example of the new method for teaching basic addition above, there are no benefits to the child for participating in the research. For example, do not say “your child’s teacher will receive free professional development” unless the teacher will not receive this free professional development if the parent of this single child does not consent.

Research with minors

Parental (or guardian) permission and child assent (where appropriate) should be obtained any time research involves minors. Your assent procedure should be appropriate for the cognitive level of the minors. Sometimes the children simply won’t be able to understand the research, so assent may be waived.

High school and College students:

Often researchers fail to account for the fact that some High school students are 18 or older and can (and should) consent themselves. Likewise, some college students are under 18 and cannot legally consent. See Research Involving Children or Minors for best practices.

Extra Credit Incentives:

OHRP has posted guidance related to the use of subject pools for recruitment of participants. Based on our interpretation of the guidance, the following options are applicable to research conducted at Arizona State University:

  1. Students who show up for scheduled appointments are awarded credit for experiments in which there is a credit option, whether or not they choose to participate in the study once details of the experiment are explained to them. There can be partial credit allocated.
  2. Students who do not show up for a scheduled appointment cannot be penalized. OHRP would consider that a penalty was imposed if the student was required to earn an additional research credit, thus increasing the credits required for that student.
  3. Students who fail to show up for a scheduled appointment could have a decrease in the number of credits that can be earned through participation in research for a particular course, provided such students can still earn the required number of credits by substituting an alternative non-research activity that involves a comparable amount of time and effort.

Example: Assume that a student was scheduled for an appointment to participate in a study that would reward the student with 1 research credit toward the 5 credits required for the student (or 5 credits that translate into extra credit for a course). If the student does not show up for a scheduled research appointment and has not cancelled, a department could have a policy that allows the student to earn only 4 more credits through research participation but must provide the student with the opportunity to earn the 5th credit through an equally demanding and educational alternative (e.g. critique of a research article).

Site permissions:

Most research in non-ASU classrooms will require a letter of permission from the site/district/etc. This should be included in your initial submission or modification to add a site. If the site explicitly requires IRB approval before providing permission, revise your submission materials to explain this. 

Unless waived by the IRB, you must obtain child (or cognitively impaired adult) assent and parental/guardian permission for each participating minor. If you feel your research requires a waiver, please explain and justify the waiver in the protocol document.

What is assent?

Assent is defined as an “agreement by an individual not competent to give legally valid informed consent (e.g., a child or cognitively impaired person) to participate in research.”

Child Assent

The assent process, while not legally binding, should involve taking the time to explain to a child, at whatever age they can begin to understand, 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 research will be terminated and they will not be punished or scolded. Just as with informed consent, the emphasis on obtaining assent should be on the interactive process in which information and values are shared and joint decisions are made. The assent process should use language that is appropriate for the age level and mental capacity of subjects. This will vary depending on the target audience.

Signed parental or guardian permission must contain all the same elements of a typical consent form, but be written to reflect that you are requesting permission for their child’s involvement.

Hybrid parental permission/adult consent form

If your study involves participants who are both over 18 and under 18 (for example, seniors in high school), you can use a hybrid consent/permission form.

Adults unable to consent

As with parental consent for minors, the consent form should be directed to the caregiver or legally authorized representative, who should sign and date the form themselves. See the consent form templates and refer to the signature block for caregiver consent of an adult. You should also ensure voluntary participation from the adult who is unable to consent: typically, through an assent process. You should contact the ASU IRB to discuss the best ways to proceed.

Additional resources for this topic:

FERPA and using educational records

Any research using data from an educational record must comply with the Family Educational Rights and Privacy Act (FERPA). Education records include a range of information about a student that is maintained in schools in any recorded way, such as handwriting, print, computer media, video or audio tape, film, microfilm, and microfiche. Examples are:

  • homework assignments
  • a quiz or writing task completed in class
  • grades
  • guardian addresses
  • demographic information obtained from records
  • attendance information obtained from records
  • student ID numbers

Additional FERPA considerations

The IRB strongly discourages using data covered under FERPA if viable alternatives exist. Whenever possible (and whenever it will not detract from the integrity of a study), alternative approaches to data collection should always be considered. If data covered under FERPA is required, the protocol document needs to clearly describe:

  • all the data being accessed
  • why the data is needed
  • how the data will be analyzed
  • why alternative approaches might not work
  • when and how the data will be de-identified
  • when and how identifying information (master lists) will be kept and destroyed
  • what permissions have been or need to be secured to access the data

Signed consent for release

In many cases, signed consent must be obtained to use educational records for research purposes. If the records belong to a minor, the parent must give signed permission. Discuss specific FERPA requirements with the entity. 

Research subject compensation

Arizona State University (ASU) is responsible for maintaining various levels of confidentiality with respect to information obtained from or about individuals participating in research. At the same time, ASU must comply with the record keeping requirements of the State of Arizona, sponsoring agencies and the Internal Revenue Service. Consistent with FIN 421-05 (“Human Subject Payments”), payments to individuals participating in research studies must be recorded as a form of compensation. Payments may take the form of any type of remuneration including, but not limited to: checks, cash, stored value cards, gift certificates and non-cash items of value. 

Requirements of FIN 421-05: Human Subject Payments

ASU has adopted FIN 421-05 to ensure that payments to individuals participating in research are reported in accordance with state and federal income reporting requirements while providing an appropriate level of confidentiality to participants. Payments to individuals participating as human subjects in authorized ASU research or to individuals as research incentives for participation in studies are typically modest in amount ($100 or less). Such payments may be in the form of a check, cash, cash equivalent or noncash incentive such as clothing. For large studies, or when confidentiality is part of the human subjects protocol approved for the research, subject pay can be disbursed from a checking account established with an expense advance. Any single payment or series of payments to a single individual (whether from one or more investigators, on one or more projects) equal to or greater than $600 during a calendar year is subject to income tax reporting requirements and must be reported to the Tax Unit of ASU Financial Services, which will issue an IRS Form 1099-MISC if a U.S. citizen or resident alien.

Procedure

For research studies not subject to confidentiality constraints, subject pay must be disbursed through the Accounts Payable process for tax reporting purposes.

When payments to a single individual are expected to equal or exceed $600 in a calendar year, the department must obtain a completed ASU Substitute W-9. The department must collect all of the following from the individual:

  • human subject participant’s name
  • social security or taxpayer identification number
  • whether the individual is a U.S. citizen, permanent resident or a nonresident alien
  • the title of the research project
  • the date(s) of participation
  • compensation received by the participant
  • the amount and details of any expense reimbursement with dated recipient signature
  • dated signature of an ASU project person with responsibility for records retention

Cash equivalents of $600 or more that are distributed to a single individual in a calendar year are subject to the tax reporting rules described above. The fund custodian is responsible for reporting such distributions to the Tax Unit of ASU Financial Services. The report must include receipt documentation equivalent to that described above and a completed ASU Substitute W-9.

For research studies subject to confidentiality requirements, only the minimal reportable payment information must be reported (name, SSN and amount of payment). All confidential documentation must be retained at the project level. Additional accommodation necessary to meet the confidentiality requirements should be discussed with the IRB and, when appropriate, the Tax Unit of ASU Financial Services.

It is not clear if a Certificate of Confidentiality would be upheld in the face of an IRS audit of ASU’s accounting systems. In circumstances where a subject’s confidentiality must be assured, the IRB recommends that the investigator develop a compensation plan that would not exceed the reporting threshold or would not require collecting or recording information that would put the subject at risk.

ASU employees as research participants

If ASU employees are paid for acting as a research subject dependent of their role at ASU, such payments generally must be handled through the regular payroll process for tax withholding and reporting purposes. However, when ASU employees participate as subjects in a research project that is unrelated to their employment, subject pay is permitted. For documentation purposes, the ASU ID can be used for ASU employees or students.

IRS reporting

Research subject payments made to a single individual by ASU that equal or exceed $600 from all sources during any calendar year will result in a Form 1099-MISC (Miscellaneous Income) being issued to the individual with a copy sent to the Internal Revenue Service.

Recruiting non-resident aliens (NRA) and tax reporting

Federal regulations require that appropriate tax must be withheld at the time of any payments. Payments to NRAs are subject to the tax withholding and reporting rules described in FIN 425: Payments to Nonresident Aliens.

FICA (Social Security and Medicare) tax is charged to NRAs that are subject to FICA tax. The university portion of FICA is not charged to the research grant. At year-end, a 1042-S tax form is mailed to the individual to be used in preparation of his/her tax return.

Under the Internal Revenue Code (IRC), payments to individuals who are NRAs are subject to 30% withholding unless exempt under some provision of law or a tax treaty. In addition, year-end tax reporting requirements apply to NRAs regardless of any applicable exemption or tax treaty. There is no minimum threshold in the IRC that acts as an exception to the tax withholding/reporting requirements (unlike the $600 threshold for 1099-MISC reporting for human subject payments to US citizens or Resident Aliens addressed above). All payments to NRAs, regardless of the amount, are subject to tax withholding and IRS reporting requirements.

Investigator and department responsibilities

The principal investigator (PI) for a research project must confirm with each participant that he or she is not receiving any other compensation from ASU such as human subjects pay from other research projects or compensation for services (employee or independent contractor) during the calendar year. The PI must document this information. If the participant is receiving such payments or if the PI is unable to confirm and document such information, then any single payment or series of payments totaling $100 (as opposed to $600) or more is subject to the reporting requirements to the Tax Unit of ASU Financial Services. Such reporting to the Tax Unit of Financial Services must include the required documentation from above as well as a completed ASU Substitute W-9.

Procedures to follow when payments are made to human subject participants:

  1. obtain IRB approval and recruit and select participants in accordance with IRB protocol approval.
  2. contact the Tax Unit in Financial Services with any questions related to compensating research subjects.
  3. provide a letter to each participant explaining that any combination of payments, gift cards and/or other items that meet or exceed $600 in value in a calendar year are reported by ASU to the IRS.
  4. determine, for each individual, whether there are any other income payments from ASU, such as human subject pay from other research projects or compensation for services (employee or independent contractor), during the calendar year and document this information for your records.
  5. the university will not file a Form 1099-MISC with the IRS if following are all true:
    1. The payment or series of payments to the individual in the calendar year is less than $600.
    2. The individual is a U.S. citizen or permanent resident alien for tax purposes.
    3. The individual is not receiving other compensation or payment from ASU. If the individual is receiving a payment or series of payments equal to or greater than $600.00 or is receiving other compensation from ASU, the PI must collect and submit the required documentation and a completed Substitute W-9.
  6. if the participant is a non-resident alien for tax purposes, the payment is likely taxable at a rate of 30% (withholding to occur at the time of payment) and requires submission of a completed IRS Form W-8BEN with payment request. ASU reports to the IRS and the NRA via the Form 1042-S.
  7. when tax withholding is required, secure a completed copy of either a Substitute W-9 for non-employees (for U.S. citizens, permanent resident aliens and residents for tax purposes) or an IRS Form W-8BEN for non-resident aliens. Completed forms must include the Social Security number or Tax Identification Number.

Noncash compensation

For noncash items under $600 in cumulative value, the purchase and distribution of such items must be documented as to public purpose. However, individuals do not need to be identified. If the total value of noncash items is $600 or more to a single individual, then the above documentation requirements apply, including identification of the individual.

If cash equivalent sources of compensation are to be used (e.g., gift cards, stored value cards, gift certificates), the PIs must use the payment voucher (PV) process along with a justification for the use of cash equivalents, a description of the controls in place to manage them, and plans for disposition of cash equivalents not used for research purposes.

Confidentiality

When a PI learns that an individual participating as a research subject will have reportable tax implications, the PI must obtain the individual’s basic information including name, mailing address and Social Security number. The PI should inform the individual that collecting this information allows ASU to meet government reporting obligations and that ASU has in place precautions to keep this information secure. The individual may choose to waive compensation if he/she does not wish to provide identifying information. The Institutional Review Board requires that notification of this waiver option be included in the Informed Consent Form.

HIPAA and using medical records

The Health Insurance Portability and Accountability Act (HIPAA) is a federal law that provides privacy standards to protect patients’ medical records and other health information provided to health plans, doctors, hospitals and other health care providers. The HIPAA Privacy Rule protects personally identifiable health information, known as Protected Health Information (PHI).

Any research that wishes to access identifiable health information from any HIPAA Covered Entity must comply with HIPAA.  ASU’s covered entities are:

  • ASU Health Services
  • ASU Counseling Services
  • Speech and Hearing
  • College of Nursing and Healthcare Innovations Health Clinics
  • Center for Health Information and Research
  • University Technology Office

If you have questions related to HIPAA, please contact us.

Examples that require HIPAA compliance:

  • examining the medical records of patients at a hospital
  • asking a physician what medications a research participant is taking

Examples of research typically not requiring HIPAA compliance:

  • Getting aggregate data via a report from a provider site (total number of X within Y). While the information is accessed from a covered entity, it is not individually identifiable.
  • Asking a participant on a survey what medications they are currently taking. While the information is individually identifiable, it is not gathered from a covered entity.
  • Asking a primary care provider to tally up the total number of referrals he has done the month before and after a professional development session.

Minimizing access to PHI

The IRB strongly discourages using PHI as part of a research project whenever possible (and whenever it will not detract from the integrity of a study). Alternative approaches to data collection should always be considered. For example, you should consider running aggregate EHR reports or have patients self-report conditions rather than reviewing individual medical records. If PHI is needed, the IRB protocol needs to clearly describe all the PHI being accessed (specific data points), why the PHI is needed, and why alternatives might not work. In addition, documentation of permission to release PHI must be provided by the covered entity (a hospital administrator, etc.).

Signed consent

In general, any project obtaining Identifiable health information from a covered entity (PHI) will need to obtain signed consent from the individual the PHI belongs to.

Additional ASU HIPAA resources

Collaborating with other institutions and affiliation agreements

When work involves researchers from multiple institutions under the purview of different IRBs, you may proceed one of two ways:

  • Have each IRB review the submission independently. Your initial submission should only include ASU researchers and describe the scope of the project as ASU will be involved. Other researchers can then be added via a modification as their IRBs review and approve their role in the project.
  • Have one IRB serve as the IRB of record. This means that one IRB gives up oversight of the research activity to another IRB via an affiliation agreement. These agreements are designed to reduce duplication and increase efficiency by designating a single IRB review when more than one site is involved in a research project. The research team will need to contact each IRB to confirm that they are willing to defer review to a single IRB of record before submitting. Institutional officials at each IRB will then sign an affiliation agreement that you will need to submit according to their policies and procedures.

Affiliation agreements

In general, ASU is willing to sign affiliation agreements with most other qualified institutions. The ASU IRB will enter into affiliation agreements with other institutions based on recommendation and approval from the ASU Institutional Official. The institutions may cover single protocols or enter into general agreements for reciprocity between institutions. Once an affiliation agreement is finalized, the agreement is filed electronically. If you believe your research project requires a new affiliation agreement, contact us.

ASU has standing “blanket" affiliation agreements with Northern Arizona University, University of Arizona and Western Institutional Review Board. This means that you do not need to sign a new agreement for each new project involving one of these institutions.

Required training

The IRB of record will be responsible for determining what training is required. Other institutions will often accept ASU’s IRB CITI training if you have already completed it.

Forms and required materials for a local context review

When another IRB is designated as the IRB of record, then the ASU IRB will rely on the review, approval and continuing oversight by the responsible IRB. After the external IRB has agreed to serve as the IRB of record, ASU will conduct a local context review which must include:

  • a copy of the approved protocol, consent forms, instruments, and any other materials submitted.
  • a completed copy of the Template: Local Context Review
  • a copy of the approval letter from the external IRB
  • ASU Federal-Wide Assurance # 
ASU FWA 00009102
  • ASU FWA IRB Registration #
IRB00000128

Submitting the materials to the ASU IRB

Use our step by step tutorial to submit the above materials for a local context review.  Note that on questions # 6, "Will an external IRB act as the IRB of record for this study?", select "yes".

Just-in-time reviews and 118 letters

Occasionally, a sponsor will require IRB approval or pending approval before a grant will be accepted. This can result in a ‘chicken or the egg’ issue where funding might be needed to develop a protocol, but, in order to obtain funding, IRB needs to approve the protocol. In these situations, a 118 letter can be issued. A 118 letter (named from 45CFR46.118) is for just-in-time situations where the funding agency needs documentation from the IRB, but the IRB doesn’t have anything to review.  It is notification that the IRB is aware of the study and that approval will be obtained once materials have been developed. The 118 letter doesn’t let you conduct any research with human subjects (actual approval is still required), but does let you develop the materials to conduct that research. For more information, contact us.

Fee structure for industry sponsored research or WIRB review

The ASU IRB charges a fee for protocols funded by private industry sponsors as well as protocols submitted to the Western Institutional Review Board (WIRB). There is no charge for research funded from other sources or for unfunded research. The fee is not based on whether the project is initiated, but rather on the fact that the project received review by the ASU IRB. The fee is paid up front at the time of protocol submission and covers the initial and subsequent review of amendments and adverse event reports during the 12-month period of approval. Investigators and/or units are responsible for paying this fee at the time of protocol submission. Payment is required before final IRB approval can be granted.

*Internal fees cover the administrative costs associated with the local contextual review and the ongoing maintenance of the file. These fees are in addition to the WIRB fees: http://www.wirb.com or other affiliated IRB charges.
Review Type Initial Fee Annual Review Fee
Convened (Full Board) $2,500 $1,000
Expedited $1,000 $  100
Exempt $1,000 N/A
Amendments $       0 N/A
Adverse Events $       0 N/A
Final Report $       0 N/A
Internal Fee Payable to ORIA for WIRB or other Affiliated IRB Review* $1,000 $  100

 

Example A:

John Smith submits a protocol for research that will be funded by Intel Inc. for review by the ASU IRB.  The study involves no more than minimal risk and will be reviewed under expedited criteria.  The ASU fee due at the time of initial protocol review is $1000. If the research will continue after the initial expiration date, the fee for continuing review is $100. No ASU fee is assessed for review of amendments or reporting of adverse events.

Example B:

Jane Doe submits a protocol through the ASU IRB for review under the negotiated affiliation agreement with the Western IRB (WIRB). The WIRB fee will be assessed in addition to the ASU internal fee of $1000 and both must be submitted to ORIA prior to initial protocol review. No ASU fee is assessed for review of amendments or reporting of adverse events.

If the research will continue beyond the initial expiration date, the WIRB and ASU fees for continuing review will be assessed at the time of protocol submission.

How to pay
Submit a check or internal purchase order to the Office of Research Integrity and Assurance (ORIA) at the time the project is submitted to the IRB. ORIA is vendor EC51046 in the ASU financial system. The IRB submission is done through ERA.  

Research on tribal lands or with tribal populations

ASU acknowledges and affirms its special relationship with American Indian tribal governments. This relationship is built on recognizing and complying with the intent and spirit of laws and policies relating to American Indians and the laws and policies enacted by tribal governments.  Thus, before undertaking any activity or project that has the potential to affect a tribal government, its community or tribal members, ASU faculty, staff and students must first determine whether tribal government input, participation or approval is required. Work must be done in accordance with the ABOR Tribal Consultation policy.

What needs to be reviewed?

  • human subjects research
  • classroom projects
  • sponsored programs
  • service agreements
  • any project occurring on or near tribal land
  • any project utilizing samples from American Indians or tribal land

Cultural review process

The review process may vary depending on the nature of the study and tribal requirements. Points to consider:

  • some tribes have an IRB
  • tribal approval may take other forms such as:
     
    • tribal counsel
    • tribal leader approval
    • educational counsel
    • research counsel

Ideally, if any part of your activity/proposal/research will occur on tribal lands, or involve an agency or department of an Indian tribe, identify early potential partners within the tribe/department that may collaborate with you. Often, letters of support or a tribal partnership can help you through the requisite tribal approval process. 

The Office of Special Advisor on American Indian Affairs is responsible for enhancing and building relationships between ASU and Indian tribal governments. Each tribal engagement has the potential to enhance ASU’s reputation in the tribal government community. Therefore, if you are unsure how to engage a tribal partner, you are encouraged to work with the Special Advisor. In addition, the Special Advisor:

  • can direct you to helpful resources or tribal personnel to facilitate the success of your proposal
  • can coordinate the process and requirements for working with a tribal government, when necessary.
  • provides online examples of various projects relating to Indians and Indian tribal governments; once your proposal is approved, you are encouraged to list your project at: https://americanindianaffairs.asu.edu/
  • is physically located in Discovery Hall Room 216 or available by phone at (480) 965‐5793

Every IRB study that is submitted that might involve Indian partners undergoes a local cultural review.

Additional resources:

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