Informed Consent, Assent and Permission Information - Faculty Senate

Forms

The Northwest IRB requires that research projects use the Informed Consent Template to obtain and/or document consent from adult subjects. To use the template, replace all red, bracketed text with information from your research project. Sections that are labeled as “[OPTIONAL]” should be deleted entirely if they are not relevant to your project. All text written in black font must be included in your submitted consent document, and your submitted document should be written in a single font color.

Research projects involving ingested substances should instead use the Informed Consent with Ingested Substances Template to obtain and/or document consent from adult subjects. The instructions for using this document are the same as those outlined for the general consent template above. For more information, see the Ingested Substances and Dietary Supplements page on the Northwest IRB website.

Research projects involving audio and/or visual recording of subjects must submit the Audio-Visual Consent Form Template in addition to informed consent for the broader project. Instructions for using this template are the same as those outlined above. If you prefer, you may incorporate information from this template into the broader consent document such that a single document obtains informed consent for the project as well as informed consent for audio/visual recording.

Research projects involving children must obtain assent from the child subjects as well as permission from the subjects’ parent(s) or guardian(s). Currently, the Northwest IRB does not provide templates for assent or permission statements. However, you may use the templates above to help structure your statements. You should also consult the Research with Vulnerable Populations section of the Northwest IRB website as well as the Detailed Information on Informed Consent information below; you may contact the Northwest IRB directly for more instruction.

Detailed Information on Informed Consent

Broadly speaking, informed consent means that subjects have been given all information necessary to make a decision about whether they would like to participate in the study. Informed consent (or, when conducting research with children as subjects, assent and permission) is a required component of all human subjects research.

The information below explains what is required in an informed consent statement, how (and whether) to obtain signed documentation of consent from subjects, differences between informed consent with adult subjects and assent and permission for child subjects, and special exceptions where informed consent can either be partially or fully waived. For more information on informed consent, assent, and permission, please see the OHRP guidelines at 45 CFR 46, particularly sections 46.116 and 46.117.

Informed Consent Statement

Informed consent information is provided to subjects through an Informed Consent Statement prepared by the investigator. OHRP guidelines provide specific details about what information should be included in this document at section 46.116 of 45 CFR 46, which can be read in its entirety here. A brief list of the required components of informed consent are listed below.

Unless otherwise noted in the Exceptions section below, all informed consent statements must include the following information.

A concise and focused explanation of what will occur during the study as well as any other key information that would be important for subjects (or their legally authorized representative) to know when deciding whether to participate in the project. This explanation must be placed at or near the beginning of the consent statement.
An explanation that the project is being conducted for research purposes.
An explanation of the purpose of your project in particular.
An estimation of how long a subject’s participation will take.
A list of any risks or discomforts that a subject might reasonably expect to occur, and a statement that the research may involve currently unforeseeable risks to subjects.
A list of any benefits the investigator anticipates, either for the subjects themselves or for others (e.g., the population being studied, society as a whole).
A list of any alternatives to the project that subjects could complete instead. Note that this does not refer to “alternative participation” in the context of students participating in research as part of a class. Rather, this list refers to other forms of treatment that subjects could receive (e.g., if the project was testing a new cancer medication, then alternate treatments for cancer should be listed).
An explanation of how subjects’ confidentiality will be maintained, or an explanation that identifiable information will not be obtained from subjects and thus their data cannot be tied to them in any way.
A statement of how data will be stored, who will be able to access the data, and for how long it will be stored (you are required to store data for at least three years, though you may choose a longer time period).
Contact information for subjects to ask questions about the research and subject rights. Specifically, you should provide contact information for the principal investigator and/or the faculty advisor as well as contact information for the Northwest IRB. Name and email address are adequate (for the IRB, the faculty chair’s name and the IRB email address are fine).
A statement that participation is voluntary, that subjects can refuse to participate without penalty or loss of benefits, and that subjects can stop participating during the study without penalty or loss of benefits.
One of the following must be included based on whether you wish to have the opportunity to use the data collected for this project with secondary research in the future:
- A statement that all identifying information will be removed from the data and that, once the data is anonymized, it may be used for future research or given to others without further informed consent being required.
- A statement that subjects’ data will not be used for any future research studies.

A list of any circumstances under which a subject’s participation might be ended by the investigator without the subject’s consent. This may be related to the safety of the subject or the integrity of the project.
Any costs that subjects will accrue by participating in the project.
Any consequences the subject will face by withdrawing early from the project.
A statement that if, during the project, the investigator learns something that might influence a subject’s willingness to participate in the study, the investigator will share this information with the subject.
An approximation of how many subjects will participate in the study.
If conducting a clinical study, a statement of whether any clinical results will be shared with subjects and under what conditions those results will be shared.
If collecting biospecimens, a statement that subject’s biospecimens might be used for profit, and a statement about whether subjects will share in any profits from their biospecimens.
If collecting biospecimens, and if those biospecimens may be used for genome sequencing, a statement of such must also be included in the informed consent statement.
If your project received full review from the IRB, an explanation of any compensation or treatment that subjects can expect in case of injury and, if provided, what that compensation or treatment will consist of.
If an aspect of your project is not addressed in the list above, but a reasonable person would want to know about it prior to consenting to participate in your project, this information should also be included in the consent statement.

Informed Consent Documentation

It is also the duty of the investigator to ensure that subjects’ consent is documented in some manner. OHRP outlines a few methods by which documentation of consent can be obtained; these methods are outlined below.

Typically, informed consent should be obtained through a signed informed consent statement. This is usually done by including a place for subjects to print their name, sign, and date at the bottom of the informed consent statement. A statement of agreement may be included above the signature line in which subjects acknowledge reading the consent statement and agree to participate in the project.

There is an alternative to the typical signed consent statement in which the researcher reads aloud a short form of the written consent statement. This oral presentation must be witnessed by a third party and the subject must sign a version of both the short and long form of the consent statement. This alternative is not recommended, but if you would like more information, see section 46.117(b)(2) of the OHRP guidelines at this link.

In some cases, signed consent is not required and can be waived. A signed consent waiver is only appropriate under the circumstances outlined below.

If 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. In other words, if your study poses no threat of harm to participants, responses are otherwise anonymous, and the possible breach of confidentiality tied to signed consent forms would be the only harm associated with your study, you are not required to obtain signed consent.
If the research is exempt or expedited and involves no procedures for which written consent is normally required outside of the research context. Note that this means signed parent/guardian consent will be required for almost any research with children as subjects.
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.

If signed consent is waived, the investigator is still required to obtain the informed consent of participants. There are several ways to obtain unsigned consent, including a verbal agreement, clicking “I agree to participate” on an online survey, or following a link at the bottom of a consent form which clearly states that clicking the link implies agreement to participate.

Note that waiving the requirement for signed consent is not the same as waiving the requirement to obtain consent at all; for special circumstances where consent may be waived, see the Waiving or Altering Consent section below.

Differences between Informed Consent and Assent/Permission

While consent must be obtained no matter the subjects’ age, OHRP uses different terminology to acknowledge differences in how consent is obtained for adult subjects compared to how it is obtained with child subjects. For the purposes of this document, assent refers to a child’s agreement to participate in research and permission refers to a parent or guardian’s agreement to their child’s participation in research. Note that assent must involve an affirmative agreement to participate, not simply a lack of disagreement.

Assent is required for all child subjects who are capable of making an informed decision. When determining whether children involved in a project are capable of assenting, the IRB considers the expected subjects’ age, maturity, and psychological state. You should assume that the IRB will consider your subjects capable of assenting and craft your study materials under this assumption. If you believe your subjects will not be capable of assenting, contact the Northwest IRB through email (IRBNWMS@qqzhangui.com) prior to submitting your materials.

In addition to assent, you must make adequate provisions to obtain the permission of each subjects’ parent(s) or guardian. Although permission from all parents or guardians is preferred, permission from one parent is sufficient as long as the project is approved as Exempt or Expedited, or if the project is greater than minimal risk to subjects but also directly benefits the subjects in the study.

If your project received a Full Review, is greater than minimal risk, and does not directly benefit the subjects, permission must be obtained from all parents or guardians unless one parent/guardian is deceased, unknown, incompetent, or not reasonably available, or when there is only one parent/guardian with legal responsibility or the care and custody of the child.

In very special circumstances, permission from parents/guardians can be waived. Specifically, if the project is on a topic where permission would be unreasonable, such as research on neglected or abused children, permission can be waived as long as an appropriate mechanism for protecting the children who will participate as subjects in the research is instituted. If you believe this permission waiver applies to your project, contact the Northwest IRB prior to submitting your application.

Permission should be documented in the same manner as signed documentation of informed consent for adult subjects. Unlike research with adult subjects, signed documentation cannot be waived for permission with child subjects under any circumstance.

Wards of the state have special IRB regulations beyond those that apply to all child subjects. If you will use wards as subjects, see section 46.409 of the OHRP regulations.

Additional Considerations

OHRP guidelines require that a written copy of the informed consent statement is provided to subjects, even when documentation of consent is not required. In other words, you should plan to have copies of the informed consent statement available for subjects to take with them. This can take the form of physical copies; you may also provide a digital link that subjects can access. If your project takes place electronically, you should provide a link or attachment that subjects can download at their convenience.

OHRP guidelines also require you to be mindful of the language and reading level of your subjects. Informed consent can only be obtained if participants can read and understand what the statement says. If you are conducting research with subjects that may speak another language, then multiple versions of the consent statement should be submitted with your application, each written in different languages.

More commonly, you may need to consider whether subjects understand the words used within your statement. This is particularly important in assent statements used with child subjects. If your statement is written in technical jargon and uses wording appropriate for an adult, then a child may not actually understand their rights or what you are asking them to do. Thus, assent statements should be written at a reading level that is appropriate given the age and maturity.

Waiving or Altering Consent

Informed consent is considered critical to the ethical treatment of human subjects. Therefore, in almost all cases, subjects should provide informed consent to participate prior to completing any aspect of the project. However, OHRP recognizes that there are circumstances under which informed consent would be impossible without sacrificing the integrity of a project. For instance, research involving deception could not occur if subjects had to be informed of the deception beforehand.

For the purposes of this section, waiving and altering consent are treated the same because the regulations for when consent can be waived or altered are identical as outlined in section 46.116(f)(3). For more information on the difference between waiving and altering consent, see the aforementioned section in the official regulations at this link.

Informed consent may not be waived or altered for a project unless all of the following are true and can be proven true through documentation:

The research is of no more than minimal risk to subjects.
The research could not be practicably carried out without a waiver or alteration of consent.
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.
When appropriate, the subject or their legal representative will be provided with the withheld information (including the true nature of the study) after participation is completed.

If you feel your project necessitates a waiving or alteration of informed consent, it is recommended that you contact the Northwest IRB to discuss the project prior to submitting your application.

Broad Consent

The term broad consent refers to an informed consent that is necessary if the investigator wishes to have identifiable private information or biospecimens available for future secondary research projects. This is different from point 11 in the Informed Consent Statement requirements above because the earlier statement was in regards to anonymous data, or data which had been stripped of any identifying private information. If the investigator deems it necessary for this private information to remain in the dataset, then broad consent must be obtained.

The steps for broad consent are beyond the scope of this document. If you believe your project requires broad consent to be obtained, see section 46.116(d) for more information on what elements should be included and how to properly obtain broad consent from subjects. You can also contact the Northwest IRB through email (IRBNWMS@qqzhangui.com) with questions or assistance with broad consent.