In addition to concerning itself with risk, the IRB must consider the subject's consent to participate in the research project. An underlying ethical principle of the Federal regulations is that human subjects enter into research voluntarily and with adequate information. (See The Belmont Report on Ethical Principles and Guidelines for the Protection of Human Subjects of Research, 1979) Thus, consent must be informed and voluntarily given. A subject's consent is "informed" if he/she has a reasonable comprehension of that to which he/she is consenting. The investigator must use language appropriate to the subject's ability to comprehend. Generally, the consent form should be written at the 8th grade reading level. Nondisclosure of information to subjects must not be used simply to assure their participation in the research. It is desirable, but not mandatory, that the investigator, rather than an assistant, obtain the consent.

To ensure that subjects' consent is voluntary, the IRB considers whether any undue pressures will be brought to bear on potential subjects. Such pressure may be subtle as, for example, when a teacher asks his or her own students to become subjects of his or her research. Excessive compensation or no payment for withdrawals is viewed by the IRB as pressure. See the Compensation Policy.

In order to obtain informed consent the investigator must provide a statement that includes the information listed on the Informed Consent Statement Checklist. A sample informed consent statement is included in the application forms to assist investigators in the preparation of the consent form. The sample reflects both requirements of the Federal regulations and customary language adopted by OHRPP. Use of the sample will facilitate the review process. Each subject must be given a copy of the signed consent form.

The consent statement (or information sheet) that is approved by the IRB will be stamped with two dates, the approval date and the expiration date. When the form has expired it must be submitted for reapproval by the IRB. Exempt level documents will be stamped for the time period of the study. Expedited and full committee documents will be stamped for the time period of the approval (no longer than one year). The stamped version must be used to make the copies for the subjects.

Who is to give consent? Any legally competent adult can give consent; but said adult cannot give valid consent if he/she is under the influence of alcohol or drugs, or if the consent is obtained under duress. This latter point is important in academic circumstances since students are often asked to volunteer as subjects. If possible, investigators should not use their current students. If current students must be used, it must be made clear to the subjects that the decision to participate will have no effect upon their grades.

Investigators should be aware that the IRB will not approve a study involving a researcher's current students even if no adequate alternative design is available, unless the IRB is satisfied that voluntary consent can be obtained. Guidelines with respect to the inclusion of the investigator's own students in research (including model consent forms are available at Students as Subjects

The consent process for studies conducted in foreign countries, or with illiterate populations, may be altered so that consent may be given orally and documented on tape. Such tapes must be treated in the same manner as paper consent forms.

WAIVER OF CONSENT

Any other alteration (waiver) to the consent process will normally be reviewed by the full committee. Justification for such a waiver must be documented according to the regulations below. If these criteria cannot be met, a waiver will not be approved.

Under CFR 46.116(d) "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 in this section, or waive the requirements to obtain informed consent provided the IRB finds and documents that:

1) The research involves no more than minimal risk to the subjects;
2) The waiver or alteration will not adversely affect the rights and welfare of the subjects;
3) The research could not practicably be carried out without the waiver or alteration; and
4) Whenever appropriate, the subjects will be provided with additional pertinent information after participation."

Further, under CFR 46.408(c), "in addition to the provisions for waiver contained in 46.116 of Subpart A, if the IRB determines that the study is designed for conditions or for a subject population for which parental or guardian permission is not a reasonable requirement to protect the subjects (for example, neglected or abused children), it may waive the consent requirements in Subpart A of this part and paragraph (b) of this section, provided an appropriate mechanism for protecting the children who will participate as subjects in the research is substituted, and provided further that the waiver is not inconsistent with federal, state, or local law. The choice of an appropriate mechanism would depend upon the nature and purpose of the activities described in the protocol, the risk and anticipated benefit to the research subjects, and their age, maturity, status, and condition."

Minors

Minors require special consideration. Persons aged 18 and older may consent to participating in research and parental permission is not required. For subjects aged 17 and under, however, the consent of at least one parent or guardian is required. If a child is age 7 or older, the aims and general nature of the project must be described in language the child can comprehend, and the child's assent must be obtained. Children under age 7 need not be asked to assent; parental or guardian consent is sufficient. If biomedical research on infants is planned, the drugs or procedures must first have been tried on animals, adults, and older children. In certain cases where there is no risk and where it would be unreasonable to require parental permission, the IRB may waive the requirement. Research on minors which involves more than minimal risk will be approved only if it is (i) of direct benefit to the subject or (ii) yields useful knowledge about a subject's problem or disorder. In the latter case, both parents must give consent. If a child is a ward of the state, the IRB must require that there be an advocate appointed to function as a guardian in the child's behalf.

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Students

The State of Indiana has placed certain restrictions on research conducted in the public schools. The restrictions apply to personal analyses, evaluations, programs, or surveys that:

are not directly related to academic instruction; and
that reveal or attempt to affect the student's attitudes, habits, traits, opinions, beliefs, or feelings concerning:

--political affiliations;
--religious beliefs or practices;
--mental or psychological conditions that may embarrass the student or the student's family;
--sexual behavior or attitudes;
--illegal, antisocial, self-incriminating, or demeaning behavior;
--critical appraisals of other individuals with whom the student has a close family relationship;
--legally recognized privileged or confidential relationships, including a relationship with a lawyer, minister, or physician; or
--income (except as required by law to determine eligibility for participation in a program or for receiving financial assistance under a program).

Prior to conducting research which could be classified under one or more of the above categories, the researcher must obtain:

the student's consent (if the student is an adult or an emancipated minor), or
the parent or guardian's written consent (if the student is an unemancipated minor), which form must accurately reflect the contents and nature of the personal analysis, evaluation, or survey.

State law also requires that the school corporation make available for inspection by parents or guardians any materials used in connection with research described above. Investigators should include in their application to OHRPP a letter from the school corporation indicating that permission has been given to do the research in the school.

Mentally Disabled

Persons with mental disabilities also require special consideration. They may or may not be able to give consent depending upon the severity of their disabilities. If a person is capable of understanding the nature of the project, consent should be obtained from both the subject and a parent or guardian. In instances where the person is not competent to consent, parental or guardian consent alone is sufficient.

Secondary Data Sources

Secondary research is often a problem. Ordinarily, when a person uses data collected by someone else for another purpose, the consent of the subjects must be sought again. For example, if researcher A has interviewed a number of persons for project A, the interview cannot be released later to researcher B for project B. The subject who consented for his or her data to be used in project A might disapprove heartily of project B and thus might refuse to cooperate. The wording of the original consent form is critical. If a subject consented to allow his or her blood sample to be available to persons studying blood diseases, his or her sample could be shared with many researchers without additional consent. The original researchers who received consent can re-work the data without new consent provided it is for a related purpose and the original consent form informed subjects of this possibility.

If the data from the original research is truly anonymous or the data is pooled in a form ensuring anonymity, then consent for secondary use is not required.

Deception

Deception should be employed only when there are no viable alternative procedures. Where deception is a necessary part of an experiment, the IRB will generally require that a preliminary consent be obtained, in which the investigator informs the subject that the experiment cannot be described fully in advance. After the experiment, the subject should be informed of the deception and its purpose. We recognize that there are rare instances in which no consent can be obtained or debriefing done: e.g., if the researcher pretended to lie unconscious on a sidewalk and noted how many and what sorts of persons stopped, attempted assistance, or simply hurried past; or where debriefing would cause more harm to the subject than the deception itself.

Web Based Studies

The IRB understands that because of the two different methods (electronic versus paper), the processes of providing information to potential subjects and obtaining documentation of consent will not be the same. Nevertheless, the Committee wants to encourage subjects to read the consent documentation first, before being able to actually participate in the study.

When a study requires a Study Information Sheet, the following must be used in addition to the requirements for the Sheet itself:

1. Describe the process: “Here is an information sheet that describes the study. Please read it and if you want to participate, click the button at the bottom.”
2. Then the subject works through (scrolls down) the entire Study Information Sheet, and at the bottom finds a button that they can click on to indicate that they are now ready to begin the study.
3. After clicking the button the subject will be taken via a link to the study task.

When a study requires documentation of consent, Informed Consent Statement, the following must be used in addition to the above:

1. The “agreement” button must contain a message, or there must be a separate statement right above the button, that indicates that clicking the button means the subject has read the statement, printed a copy for their files, and agrees to participate in the study and accepts that personal information will be electronically supplied to the researcher to document their participation (such as name, e-mail name, and date).
2. There must be a mechanism by which information is returned to the researcher that identifies the person who is participating. This documentation must be kept by the researcher for at least the standard three years beyond the end of the study.

The following apply to both information sheets and consent statements:

1. Subjects must be able to easily print a readable copy for their own records.
2. The document must carry the “approved” and “expires” dates as stamped on the paper copy that will be returned to the researcher. The researcher should replicate the text of the stamps on the electronic version of the information sheet or consent statement.
3. OHRPP staff must be able to access the document on-line before approval will be given.

There is one sample for web-based survey with follow-up interviews. web consent

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