RCATT at NDSU

The U.S. Code of Federal Regulations governing research on human subjects (45 CFR 46.116) states that, ".no investigator may involve a human being as a subject in research covered by this policy unless the investigator has obtained the legally effective informed consent of the subject or the subject's legally authorized representative. An investigator shall seek such consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence. The information that is given to the subject or the representative shall be in language understandable to the subject or the representative. No informed consent, whether oral or written, may include any exculpatory language through which the subject or the representative is made to waive or appear any to waive any of the subject's legal rights, or releases or appears to release the investigator, the sponsor, the institution or its agents from liability for negligence."

For those studies subject to FDA regulations (clinical investigations involving an FDA-regulated product), there are similar requirements, as defined in 21 CFR 50.20. However, FDA allows a waiver of IRB review and informed consent for emergency use of a test article (21 CFR 50.23) in specific situations. FDA regulations also allow for exceptions from informed consent requirements in emergency research (21 CFR 50.24).

Apart from these federal requirements, the principal reason for informing participants about an experiment is that they have a moral and ethical right to know certain things about the project before they give their consent. The use of human participants is a privilege-a favor-granted to the experimenter, rather than a right. An experiment is something that is done to a participant as compared to medical practice, where something is done for a patient.

Obtaining informed consent from a prospective participant is a two-step process: 1) giving the prospective participant sufficient information about the project to enable him/her to make an "informed" decision about whether to participate; and 2) if he/she decides to participate, obtaining his/her consent in a manner that documents the information that was given and that documents that the participant's consent was obtained.

The information about a project that a prospective participant has a right to know is called "The Elements of Informed Consent." In compliance with federal regulations, the NDSU IRB requires that the following basic information be communicated by means of a written consent form to prospective participants. In addition to the federal minimum requirements explained below, NDSU requires that certain additional information be included in consent forms.

Top

1. Elements of Informed Consent

Unless the requirement for informed consent is waived, the Code of Federal Regulations requires the following information be provided to each participant when seeking informed consent:

45CFR46.116 (a) Basic elements of informed consent. Except as provided in paragraph (c) or (d) of this section, in seeking informed consent the following information shall be provided to each subject:
(1) a statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental;

(2) a description of any reasonably foreseeable risks or discomforts to the subject;

(3) a description of any benefits to the subject or to others which may reasonably be expected from the research;

(4) a disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;

(5) a statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained;

(6) for research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained;

(7) an explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject; and

(8) a statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.

FDA regulations at 21 CFR 50.25 specify the same requirements, with an additional requirement to inform the subjects that their records may be inspected by the Food and Drug Administration.

Top

2. Additional Elements of informed Condent

When appropriate, one or more of the following elements of information must also be presented to each participant:

45CFR46.116(b) (21 CFR 50.25(b). Additional elements of informed consent. When appropriate, one or more of the following elements of information shall also be provided to each subject:
(1) a statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) which are currently unforeseeable;

(2) anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent;

(3) any additional costs to the subject that may result from participation in the research;

(4) the consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject;

(5) A statement that significant new findings developed during the course of the research which may relate to the subject's willingness to continue participation will be provided to the subject; and

(6) the approximate number of subjects involved in the study.

Top

3. Waiver of the Requirement for Informed Consent

There may be situations in some research projects in which it is not feasible to communicate some or all of the elements of informed consent (ie, the use of deception to determine subjects' 'natural' responses). In such cases, a request for waiver of some or all of the elements of informed consent may be submitted to the IRB. Section 46.116 of the Code of Federal Regulations 45 CFR 46, describes circumstances in which the IRB may approve a waiver:

(c) An IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent set forth above, or waive the requirement to obtain informed consent provided the IRB finds and documents that:

the research or demonstration project is to be conducted by or subject to the approval of state or local government officials and is designed to study, evaluate, or otherwise examine: (i) public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs; and

the research could not practicably be carried out without the waiver or alteration.

(d) The IRB may also approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent set forth above, or it may waive the requirements to obtain informed consent provided the IRB determines that:

the research involves no more than minimal risk to the subjects;

the waiver or alteration will not adversely affect the rights and welfare of the subjects;

the research could not practicably be carried out without the waiver or alteration; and

whenever appropriate, the subjects will be provided with additional pertinent information after participation.

(e) The informed consent requirements in this policy are not intended to preempt any applicable federal, state, or local laws which require additional information to be disclosed in order for informed consent to be legally effective.

(f) Nothing in this policy is intended to limit the authority of a physician to provide emergency medical care, to the extent the physician is permitted to do so under applicable federal, state, or local law.

Note that these conditions do not apply to clinical investigations involving FDA-regulated products, since FDA regulations do not allow for a waiver or alteration of the elements of informed consent under these conditions.

Top

Part B: Documentation of Informed Consent

1.Signature Requirement

Step 2, Documentation of Informed Consent, applies to all research projects that require review by the full board, or are eligible for review by the expedited method, and for exempt projects for which the signed consent of participants will be obtained.

When the required elements of informed consent have been communicated to the prospective participant and he or she has decided to participate, that decision must be documented by means of the participant's signature on the consent form. The Code of Federal Regulations, 45 CFR 46, section 46.117, describes the following procedures for obtaining informed consent:

(a) Except as provided in paragraph (c) of this section, informed consent shall be documented by the use of a written consent form approved by the IRB and signed by the subject or the subject's legally authorized representative. A copy shall be given to the person signing the form.

(b) Except as provided in paragraph (c) of this section, the consent form may be either of the following:

A written consent document that embodies the elements of informed consent required by 46.116. This form may be read to the subject or the subject's legally authorized representative, but in any event, the investigator must give either the subject or the representative adequate opportunity to read it and ask questions before it is signed; or

A short form written consent document stating that the elements of informed consent required by 46.116 have been presented orally to the subject or the subject's legally authorized representative. When this method is used, there must be a witness to the oral presentation. Also, the IRB shall approve a written summary of what is to be said to the subject or representative. Only the short form itself is to be signed by the subject or the representative. However, the witness shall sign both the short form and a copy of the summary, and the person actually obtaining consent shall sign a copy of the summary. A copy of the summary must be given to the subject or representative, in addition to a copy of the short form.

FDA regulations describe the same procedures, with the additional requirement that the form be dated as well as signed (21 CFR 50.27).

Top

2. Waiver of Signed Consent

Section 46.117 of the Code of Federal Regulations, 45 CFR 46, describes circumstances in which the IRB may approve a waiver of the requirement to obtain signed consent:

(c) The IRB may waive the requirement for the investigator to obtain a signed consent form for some or all subjects if it finds either:

That the only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. In this case, each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject's wishes will govern; or

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.

In cases in which the requirement for signed consent is waived, the IRB requires the investigator to provide participants with a written statement regarding the research. FDA regulations make no provisions for a waiver of the signature requirement because the FDA does not apply to studies of this nature.

If a waiver of the signature requirement cannot be granted, or is not practical, an investigator may consider obtaining a 'Certificate of Confidentiality'from the National Institutes of Health to protect sensitive study data. This is available even if the project does not receive federal funding. The certificate is intended to prevent involuntary disclosure of sensitive data by the investigator, but they may still be required to report certain findings (ie, child abuse) to the proper authorities. If a Certificate of Confidentiality is to be obtained, this should be disclosed to participants in the informed consent form.

Top

3. Storage of Consent Forms

Signed copies of informed consent forms must be maintained by the principal investigator and be stored in a secure manner. Unless otherwise specified by federal and/or state regulations, retention of the signed consent forms is for a period of at least three years beyond the termination of the study. If the investigator resigns or graduates from North Dakota State University before the end of the designated period, the informed consent forms must be maintained by the department of record unless otherwise specified.

Top

Part C: Consent/Assent Procedures for Minors

Research involving children is governed by the U.S. Code of Federal Regulations 45 CFR 46, Subpart D (and 21 CFR 50, Subpart D for investigations involving FDA-regulated products). NDSU complies with these federal regulations, and may have, in some cases, supplemented them with additional requirements.

Under 45CFR46.402, children are defined as "persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted." In North Dakota, anyone under the age of 18 is considered a minor. Pregnancy does not confer majority status. A minor may, however, with IRB approval, legally consent on his/her own behalf (as a mature minor) if the research involves a treatment for which minor consent is permissible under applicable law (e.g., use of contraceptives, treatment for venereal disease, or a drug abuse).

Minors are considered a vulnerable research population because their intellectual and emotional capacities are limited. Where appropriate, studies should be conducted first on animals and adult humans, then on older children prior to involving younger children.

As stated in the U.S. Code of Federal Regulations, only some research projects involving children are eligible for exemption:

Subpart D - Additional Protections for Children Involved as Subjects in Research. 45CFR46.401(b): Exemptions at 46.101(b)(1) and (b)(3) through (b)(6) are applicable to this subpart. The exemption at 46.101(b)(2) regarding educational tests is also applicable to this subpart. However, the exemption at 46.1101(b)(2) for research involving survey or interview procedures or observations of public behavior does not apply to research covered by this subpart, except for research involving observation of public behavior when the investigators do not participate in the activities being observed.

Research projects involving survey or interview procedures with children must be reviewed by expedited, or full board procedures. Research projects conducted in schools are eligible for exemption only when they will be carried out in established commonly accepted educational settings and normal education practices will be used.

The U.S. Code of Federal Regulations requires parent/guardian permission and child assent for participation in research:

45CFR46.408(a). In addition to the determinations required under other applicable sections of this subpart, the IRB shall determine that adequate provisions are made for soliciting the assent of the children, when in the judgement of the IRB the children are capable of providing assent. In determining whether children are capable of assenting, the IRB shall take into account the ages, maturity, and psychological state of the children involved. This judgement may be made for all children to be involved in research under a particular protocol, or for each child, as the IRB deems appropriate. If the IRB determines that the capability of some or all of the children is so limited that they cannot reasonably be consulted or that the intervention or procedures involved in the research holds out a prospect of direct benefit that is important to the health or well-being of the children and is available only in the context of the research, the assent of the children is not a necessary condition for proceeding with the research. Even where the IRB determines that the subjects are capable of assenting, the IRB may still waive the assent requirement under circumstances in which consent may be waived in accord with Sec. 46. 116.

The same provisions for child assent are described in FDA regulations at 21 CFR 50.55(a-d).

Legally, minors cannot give consent on their own behalf. The permission of their parent(s) or a legal guardian is, therefore, required before they can participate in any non-exempt (and some exempt) research projects. Also, the assent, or agreement, of the child to participate must be adequately obtained. Under special circumstances (e.g., research involving neglected/abused children), the IRB may approve a waiver of parental permission, provided the required findings can be made, as described earlier in this section (Waiver of the Requirement for Informed Consent).

If the research involves only minimal risk activities (e.g., venipuncture, skin biopsy, EEG, EKG, urine collection, moderate exercise, standard psychological testing), permission of only one parent or legal guardian may be obtained. If, however, the research involves greater than minimal risk activities, and no prospect of direct benefits, permission of both parents must be obtained unless one parent is deceased, unknown, incompetent, or not reasonably available, or when only one parent has the legal responsibility for the care and custody of the child. See additional requirements for research involving children in Section I, Part B: The IRB Review Process Review of Prospective Participant Population.

For research subjects under the age of seven, only parental permission is required. For research participants ages seven through 17, an investigator must obtain assent of the minor in addition to parental permission, unless the subject displays intellectual/emotional development below that of the average seven year old child. A child assent form should be used for subjects age seven through 12 and a youth assent form should be used for participants age 13 through 17 . Formats for parental permission forms, child assent, and youth assent forms are provided at the end of this section.

In most circumstances, a minor's deliberate objection should be regarded as a veto of his or her involvement in a research project. Parents or guardians may, however, with IRB approval, override a young child's objections to interventions that hold the prospect of direct benefit to the participant that is important to their health or well-being and is available only in the context of the research.

Top

Part D: Format for Informed Consent Forms

Unless the IRB approves a waiver request, the signed consent of participants is required at NDSU for all research projects involving human participants, unless the project qualifies for exemption. In addition, it may be advisable to obtain signed consent from participants in some exempt projects. In order to increase readability and facilitate IRB review, the following format is required for consent forms for all projects in which the signed consent of participants will be obtained.

The informed consent must be written in the second-person, addressing participants directly (ie, 'You are invited to participate in a research study...'), and using simple language that is readily understood by the least educated, least sophisticated of the participants to be utilized.It is recommended that the language consist of short, concise sentences. Terms that are commonly used by members of a profession are a part of the profession's language, and may not be understood by the ordinary "lay"participant. If there is any doubt that a term may be understood, other words should be used or a definition of the term included, (e.g.," ...4cc (about a teaspoon)").If some of the anticipated participant population does not understand English, appropriate translation should be provided. Investigators should take appropriate measures to ensure that prospective participants have a complete understanding of their role in the research study, the risks that may be involved, and their rights as subjects, before accepting their consent.

If parents or other legal representatives will be requested to permit or provide consent for a minor or legally incompetent individual to participate in research, the permission or consent form must be written in a style that reflects the fact that it is the minor or other subject who is the participant and the parent/legal guardian is agreeing to allow the said participant to participate in the study.

The use of departmental letterhead, or a prominent display of NDSU departmental affiliation is required; collaborative projects may incorporate headings of both institutions. Pages should be numbered in the footer (ie. Pg 1 of 5), and contain the version date of the form. The format for an informed consent document, with the required subheadings, is as follows:

Top

1. Format for projects to be reviewed by the full board or expedited methods
Click here to print the format

2. Parental/Guardian Permission Form
Click here to print the format

3. Child Assent Form
Click here to print the format

4. Youth Assent Form
Click here to print the format

Top

5. Informed Consent for Exempt Projects

Potential research participants have a moral and ethical right to know what is to be done to them (or required of them), and the voluntary nature of their participation before they give their consent. NDSU IRB policy requires that the “elements of informed consent” be communicated in some manner to prospective participants of exempt projects. Because some of the elements required for non-exempt projects generally do not apply to exempt projects (e.g., potential risks and discomforts, statement of injury or special costs), an abbreviated version of the elements is usually appropriate.

The method of communicating the elements of informed consent will vary, depending upon a project’s design. In mail surveys, they can be communicated in a cover letter. In settings in which questionnaires will be distributed to potential subjects such as in a classroom or meeting, the elements could be communicated by means of an information sheet, attached to the front of the questionnaire that the subject can tear off and keep for his/her reference after completing and returning the questionnaire. In phone surveys, or when the investigator is doing research “in the field” and selecting participants at random as they approach, it may be difficult or impractical to present the elements of informed consent in writing. In these circumstances, informed consent may be presented orally; the IRB must review and approve a copy of the oral script.

Obtaining the signed consent of participants involved in exempt research projects is generally not required, although the NDSU IRB reserves the right to require signed consent of participants for certain exempt projects. Nevertheless, it may be desirable to obtain a signature should a problem or question arise about a participant’s involvement in the research. When signed consent will be obtained from participants, follow the required format, with subheadings, as described for expedited and full board projects.

Regardless of the method chosen, all of the elements listed below (as applicable) are to be included:

Elements of informed consent:

1. Introduction and purpose of study: identify yourself, including your NDSU department affiliation, and indicate the nature of the research study and why it is being conducted.

2. Invitation to participate/voluntary choice: invite their participation in a research study; clearly indicating the voluntary nature of the request, and that they can quit at any time with no penalty

3. Explanation of procedures: explain what they will be asked to do, what information is being requested from them, what data will be obtained about them, etc., indicating approximately how much time will be required for their participation

4. Confidentiality: explain the extent to which their information will be held confidential. Indicate whether or not their names or other identifiable information will be recorded, and whether or not results will be reported in a manner that potentially allows them to be identified, and associated with their responses.

5. Potential benefits and risks: explain any potential benefits to the participant and/or to society in general. Also explain any potential risks (usually not applicable, as projects involving any kind of risk to participants are not eligible for exemption).

6. Alternatives to participation (if applicable)

7.Compensation (if applicable; e.g., payment, extra course credit)

8. Contact information for questions or concerns: provide researcher(s)' names and contact information (NDSU phone #, or email address); include faculty advisor's name/contact information, if applicable. Also include the IRB Office contact (ndsu.irb@ndsu.edu, or 701-231-8908) for information about rights of research participants, or to report a problem.

Oral script: attach a written summary of the information to be presented
Printed or electronic documents: attach a copy of the document to be presented to potential participants. Use of simple, non-technical terms likely to be understandable to all proposed participants is suggested; address participants directly with second-person language (ie, 'you are invited to participate in a research study'). Printed documents should be on NDSU department letterhead, or with the NDSU affiliation and address prominent in the header. Participants will keep this for their information.

The following template contains suggested language suitable for a printed cover letter/information sheet for a paper/pencil survey. It includes all the necessary elements mentioned above, and could be modified accordingly for other types of projects:

Template for NDSU Research Study

Top

If the layout of this web page appears plain, and you see few or no graphics, you are probably looking at it with a browser or device that does not fully support CSS.

While this site looks more appealing through CSS-compliant browsers, it content is the same for any web browser

Press Room |

Contact Us |

RCATT Home

Institutional Review Board (IRB)

Guildelines :: Section II