The Allen College Institutional Review Board (ACIRB) serves to protect the rights and welfare of human subjects. If you are working on a project or study for a course, a requirement for your educational program or a protocol related to your job that includes research involving human subjects, you will need to receive approval from the ACIRB.

• Instructors who assign a project or research study as part of a course will tell you if a submission to the ACIRB is required.
• For those completing a project or study for professional reasons, knowing when and if an ACIRB submission is required may not be clear. This table provides a comparison of characteristics of research, quality improvement and program evaluation activities. If the project involves some characteristics of research or quality improvement, submission to the ACIRB is expected. 
• If the project or activity is considered program evaluation, submission to the ACIRB may not be required unless it is being conducted by a student investigator. 

Case Reports

Some clinical activities that are not classified as research or an EBP/QI study may be considered a case report. Case reports, defined as descriptions of unusual or unique presentations of a disease or condition, are not considered reports of research and do not require review by the ACIRB if all the following conditions apply:

• Record review is performed by persons already involve in patient’s care (no new confidentiality risks are created by the activity);
• Information about the patient is presented in an anonymous fashion or with the explicit consent of the patient to the report; and
• No changes were made in the patient’s care or diagnostic testing for the sake of reportability.  

Students or investigators often work with organizations that are not affiliated with Allen College (e.g., school districts, businesses, health agencies, etc.) to conduct their research or complete a project. In this case, the ACIRB requires that students or investigators provide documentation of cooperation (DoC) in a letter (or email) from the organization to indicate the student or investigator has permission to conduct the research or project at that location, or that the site is providing the necessary assistance in implementing project or research activities (e.g., providing access to participants).

The DoC must be from:

Someone in authority at the organization, and, for example, not from a group counselor, teacher or floor charge nurse. Although students or investigators are encouraged to have contact with others in the organization whose cooperation will be needed to carry out the research or project (e.g., instructors, department supervisors, patient care personnel), only documentation from the top official should be submitted to the ACIRB. In some situations, it may make more sense to seek the permission of someone closer to the research or project rather a central administrator (e.g., supervisors or professors in large or international institutions).

In some situations, a cooperating organization may request IRB approval before providing DoC. If an organization requires IRB approval prior to agreeing to cooperate with a study, please contact the ACIRB for assistance.

The DoC should contain:

Any permission needed to access private records to collect information needed to conduct and evaluate the research or project, such as student, medical or employment records that are protected by FERPA, HIPAA or other confidentiality policies. Any access to private records must occur in accordance with the policies of the cooperating institution(s). In addition, students or investigators are cautioned to check with central administration at colleges and universities who may have their own rules about oversight of research or projects conducted at their institutions. They may require documentation of ACIRB review or require IRB review at that institution.

Regardless of format (letter mailed or emailed), DoC must include the following information: 

• Name of cooperating institution/organization
• Title of the project
• Brief explanation of the project
• Approximate timeframe of the project
• If appropriate, a statement regarding confidentiality and/or acknowledgment of any use of protected information
• IRB of record (some institutions may also require review by their own IRB or similar committee)
• Name of authorized representative
• Title of authorized representative
• Authorized representative’s phone number

Students or investigators who have questions about this process should contact the ACIRB for assistance. 

DoC that does not contain the required information or is not from a person in authority will not be accepted.

Students or investigators conducting research or EBP/QI (HSR or NHSR) projects at UnityPoint Health – Allen Hospital:

Must work with the Allen Hospital Privacy Office to obtain DoC. Specific requirements are described on the EBP/QI and Research Projects at UnityPoint Health – Allen Hospital webpage.

Methods to submit DoC:

DoC may be submitted as a formal signed hard copy letter either by mail or as an email attachment, or as an informal email from the organization. DoC that does not contain the required information or is not from a person in authority will not be accepted. 

Emailed:

• Must be sent to the investigator from the authorized representative’s email account, cc’ing ACIRB@AllenCollege.edu 
  
• Must have the text in the body of the email and not as document attached to the email (see information on hard copy letter formatting if an attachment is preferred)

Mailed:

Allen College
Attn: IRB
1825 Logan Ave.
Waterloo, IA 50703

Hard copy letter (mailed or emailed):

• Must be typed on the institution’s letterhead stationery.
• Must carry the handwritten signature of the authorized representative.

Template:

A template is available on the forms and templates webpage with additional information and instructions for investigators. Investigators should customize the template with information pertaining to their project and provide it to the authorized representative with instructions on how to send the information to the ACIRB. 

Additional Considerations:

• DoC approval needed: Research or project work may not commence at any given research site until DoC (if required) has been received and accepted by the ACIRB.
• Multiple study sites: If there are multiple study sites, DoC must be on file before the ACIRB application will be approved.
• Modifying study sites after DoC approval: If additional research sites are brought on board after ACIRB approval, a modification should be made to the original submission in addition to sending appropriate DoC, as instructed.
• If the study procedures involve recruitment on Facebook, other social media sites or email listservs: It is essential that the investigator review the site's policies on research and privacy before proceeding with the study. Among other things, it may be necessary to request permission of a group page or listserv administrator before posting information about the study.

For more information:

Refer to the Documentation of Cooperation Guidance document which is used by the ACIRB in determining when DoC is necessary.

Informed Consent and Providing Information to Participants

How does this apply to my study or project?

General requirements for informed consent are described in 45 CFR 46.116. Informed consent is “shorthand for informed, voluntary and capacitated consent” (Bankert et al., 2022, p. 247). The Belmont Report identifies three basic ethical principles that guide human subjects research: respect for persons, beneficence and justice. Informed consent is one of three requirements for human subjects research described by the Belmont Report that guides IRBs (assessment of risks and benefits and fair subject selection are the other two requirements). Often when we think of informed consent, a form that participants must sign comes to mind. However, thinking about informed consent more creatively may assist researchers in making choices that align better with their studies. This guidance document will cover:

• the concept of informed consent,
• what is included in the informed consent process,
• when informed consent is needed,
• documenting informed consent and
• waivers or alterations of consent or documentation of consent.  

Concept of Informed Consent

Thinking about informed consent beyond a paper form that must be signed may help us better understand what we are trying to achieve with informed consent. It may be helpful to consider informed consent as a process to share information and determine how potential participants comprehend what a research study involves. Receiving information allows potential participants to decide if they understand the potential risks and benefits and voluntarily opt in. In some cases, informed consent creates a record, especially if a participant’s decision is captured on a form. Forms that capture the decision can be written or electronic. Usually, one of the easiest ways to record a potential participant’s decision to participate is by capturing a signature.

What is included in informed consent?

Informed consent should “[f]ully explain the study, inform participants of their rights, answer your participant’s questions and take care to document consent” (Poth, 2021, p. 40). The process of informed consent should communicate the following rights to potential participants:

• Voluntary participation – Participants are not obligated to participate or answer questions they do not want to answer.
• Withdraw without penalty – Participants can withdraw at any time and need to know how to do this.
• Access findings – If participants will have access to the findings, they need instructions on how to do this.
• Clarify their understanding – If participants have further questions, they need to know whom to contact for more information.

(List adapted from Poth, 2021)

Unless a waiver or alteration is approved (see section below), informed consent must include the basic elements outlined in 45 CFR 46.116(b). The elements need not be presented in the order outlined by the Code of Federal Regulations (CFR), but each must be addressed. 

When is informed consent needed?

Research studies classified in the full review or expedited categories [nonexempt research] must include a process to capture informed consent. Other review categories (exempt or evidence-based practice/quality improvement studies) do not require consent documentation, but the ACIRB requires that participants receive information about the study. 

Waiver or Alteration of Consent

The ACIRB can alter or waive the general requirements for consent when the following apply:

• The research involves no more than minimal risk to the subjects;
• The research could not practicably be carried out without the requested waiver or alteration;
• If the research involves using identifiable private information or identifiable biospecimens, the research could not practicably be carried out without using such information or biospecimens in an identifiable format;
• The waiver or alteration will not adversely affect the rights and welfare of the subjects; and
• Whenever appropriate, the subjects or legally authorized representatives will be provided with additional pertinent information after participation.

[45 CFR 46.116(f)]

This chart may be helpful in deciding if waiving or altering informed consent is appropriate.

Documentation of Informed Consent

As previously discussed, all potential research subjects must be informed about the research and provide voluntary consent to participate. Documentation of informed consent is outlined in 45 CFR 46.117. The CFR states, “…informed consent shall be documented by the use of a written informed consent form approved by the IRB and signed (including in an electronic format) by the subject or the subject’s legally authorized representative. A written copy shall be given to the person signing the informed consent form” [§46.117(a)].

Even though the CFR says a written or electronic form must be signed and provided to the participant, if we continue to consider informed consent as a process, there are creative options to meet this requirement. The following approaches may be considered to document consent (Poth, 2021, p. 46-47):

• Participants can sign their name in writing or type their name on a consent form.
• Participants can state their name verbally. This can be especially helpful when writing is a challenge for participants, or they are not culturally accustomed to signing their names. A verbal statement of consent can be audio or video recorded. 
• If data is being collected anonymously or written or verbal communication is a challenge for potential participants, they can be asked to complete an overt action that is appropriately recorded as implied consent. A common example of this is asking a potential participant to click a link to start a survey.
• If the research has no other record of participant’s identities and where the main risk for potential harm would be their identity, then you may document informed consent by having a second eyewitness. This would require a waiver of documentation (see next section).
• If the research involves participants who are considered vulnerable, then a designate may provide consent verbally or in writing on their behalf. 

Waiver or Alteration of Documentation of Consent

The ACIRB can waive the requirement for the investigator to obtain a signed informed consent form for some or all subjects if any of the following apply:

• That the only record linking the subject and the research would be the informed consent form and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject (or legally authorized representative) will be asked whether the subject wants documentation linking the subject with the research, and the subject's wishes will govern;
• That the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context; or
• If the subjects or legally authorized representatives are members of a distinct cultural group or community in which signing forms is not the norm, that the research presents no more than minimal risk of harm to subjects and provided there is an appropriate alternative mechanism for documenting that informed consent was obtained.

[45 CFR 46.117(c)]

In cases in which the documentation requirement is waived, the ACIRB may require the researcher to provide participants or the legally authorized representatives with a written statement regarding the research.

This chart may be helpful in deciding of a waiver of documentation is appropriate.

How can I get help?

• Talk with your advisor or instructor
• Email the ACIRB
• Check out the Forms & Templates page on the ACIRB 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).