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The Nuremberg Code sets forth fundamental principles for conducting research involving human subjects. The code stresses the importance of voluntary consent to participate, labeling it “essential.” Informed consent is also a focus of The Belmont Report, especially as it relates to the ethical principles of respect for persons and beneficence.
All Union Institute & University-sponsored research involving human subjects must include an appropriate and effective informed consent process. An informed consent form is typically a component of that process. According to the Office of Human Research Protections of the U.S. Department of Health and Human Services:
Informed consent is a process, not just a form. Information must be presented to enable persons to voluntarily decide whether to participate as a research subject. Informed consent is a fundamental mechanism to ensure respect for persons through provision of thoughtful consent for a voluntary act.
In most studies, the informed consent process will include a form—a written explanation of the proposed study that is provided to and signed by each prospective subject as part of the discussion of his or her possible participation. The IRB developed a recommended outline for a comprehensive informed consent form. Although researchers may choose to use a different format, the informed consent process must include all elements required by the IRB.
In designing the informed consent process for a study, researchers should be guided by information on the IRB Web site, the comprehensive consent form, the consent form preparation instructions, and by the ethical standards of the researcher’s discipline or profession. If any conflicts exist, the IRB application should include citations of pertinent sections of the ethical standards to support any request for waiver of IRB requirements.
One decision researchers must make when designing a research project is how they will protect the identities of their subjects. They need to decide whether subjects will be anonymous, whether their identities will be kept confidential, or whether subjects will be identifiable.
Anonymity refers to the situation in which the dataset and/or research materials contain no personal identifiers through which anyone, including the investigator, could connect individual responses with a specific participant.
Anonymous means that the researcher cannot link the data to the participant. To ensure subject anonymity, the researcher will not know the names of participants or any personal characteristics that might reasonably lead the researcher or anyone else to discover their identities. Person-to-person interviews are not anonymous because the researcher knows the participant’s identity. Always, depending on the methodology, reasonable assurance of anonymity can be expected for some of the following data collection methods and instruments:
Researchers may not promise anonymity to potential subjects if they cannot reasonably expect to achieve it. They are expected to take appropriate steps to assure subject anonymity during the study. For example:
Even in the best-designed projects, anonymity can be breached. If a participant’s identity becomes known, the researcher must immediately advise the individual and then take appropriate action to protect him or her by maintaining confidentiality. The participant should be given the option to withdraw from the study. The researcher may also decide to withdraw the participant from the study. In either case, all data resulting from that individual’s participation must be destroyed and not used in the data analysis, writing of the findings, or final product. In extreme situations, such as when a subject has been harmed as a result of loss of anonymity and other participants also appear to be at risk, halting the study entirely and destroying all collected data may be necessary.
For some studies, such as historical and biographical studies, identification of subjects by name may be integral to the study and expected of studies in the field. In studies in which audio- and/or videotapes or other visual images of participants will be included in the findings, subjects are readily identifiable, even if their names are not used.
If subjects’ names will be used or they can be readily identified, the researcher must fully inform potential participants during the informed consent process. If a researcher will be using audio- or videotapes, or taking photographs, obtaining a signed release form is required. Potential participants must also be informed about planned uses of these materials and who will be likely to see them. For example, a videotape may be used in a professional presentation or as part of a public recruitment campaign to inform potential enrollees about an exercise program. For some other projects, if identifying a subject is unlikely to cause harm, revealing subjects’ identities may be acceptable, especially if the benefits of the study are likely to be enhanced. Researchers are, of course, required to advise potential participants if their identities will be revealed and include an analysis of any risks resulting from their participation.
Most social / behavioral studies involving human subjects operate under the Common Rule (45 CFR Part 46, Subpart A). The Health Insurance Portability and Accountability Act (HIPAA), Privacy Rule, issued August 14, 2002 (compliance date, April 14, 2003), establishes conditions under which protected health information (PHI) may be used or disclosed by covered entities for research purposes. HIPAA privacy regulations cover any situation involving personal medical information contained in insurance-related transactions. Medical information not involved in an insurance-related transaction is not covered. Insurance information not containing personal medical or health information about a person is also not covered. More information about the HIPAA Privacy Rule is accessible through links provided on the IRB website.
Covered entities are health plan providers, health care providers, medical billing services, community health information systems, health care providers who transmit PHI electronically, etc. PHI includes individually identifiable health information, in any form, received or created as a consequence of providing healthcare services or health plan benefits (including demographic information). PHI may be included in health care provider notes, test results, genetic information, medical conditions, diagnoses, treatments, and medication lists.
Individually identifiable health information identifies or reasonably can be used to identify an individual and relates to:
The HIPAA Act of 1996 mandates resulted in significant changes in laws and regulations governing the provision of health benefits, the delivery and payment of healthcare services, and the security and confidentiality of individually identifiable, protected health information in written, electronic, or oral formats.
Researchers planning to use and access health care information from a covered entity are required to do the following to obtain authorization:
Researchers are ethically obligated to avoid doing harm. Without appropriate protections, a study could possibly harm someone not otherwise affiliated with the study. For example, unless the study will involve biographical or historical research, the researcher should adopt a “no-names” policy in reporting on the research. If a subject mentions a nonparticipant by name, the report should not include that name. Avoiding unintended harm to nonparticipants is also important for the researcher’s own protection.
If a study participant provides information about another person—such as a spouse, relative, friend, co-worker, or social acquaintance—the individual is known as a third party. A third party is not considered to be a human subject of a study unless and until the researcher obtains information about the third party that is both private and individually identifiable. When this situation occurs, the Common Rule then applies and requires that the researcher either obtain the informed consent of the individual or destroy the data identifying the third party. If certain criteria are met, the subject’s informed consent may be waived. For example, the Common Rule states that information collected must be individually identifiable such as name, address, other contact information, social security number, and identifiable photographic images.
Relationships identified only by association—spouse, father, mother, sister, friend, social contact, etc.—are not usually considered readily identifiable information. Readily identifiable is the primary criterion. Possibly or potentially identifiable information through which someone could ascertain the identity of a third party (e.g., the father of the subject) by piecing together bits and pieces of information requires time and effort unless the third party’s full name or other identifying information is also collected. Information that requires such effort is generally not considered readily ascertainable.
A well-designed informed consent process will include all the following basic elements. If any of these elements are not applicable to the study, the researcher should explain why in IRB application.
The informed consent process should include:
Documenting the informed consent process for every participant is critically important for the protection of subjects and researchers. For most studies, this documentation will mean a consent form to be signed by each person agreeing to participate and by the researcher or the researcher’s representative.
Two general types of informed consent forms may be used—comprehensive and abbreviated. The type selected will depend on the study and the participants. Regardless of the type of form, the informed consent process must include all required elements. Before designing the informed consent form, read all informed consent topics, OHRP Tips on Informed Consent, and Your Rights as a Participant in Research. Review Form IRB002 Comprehensive Informed Consent Form template.
Informed Consent for Protected Populations and Special Circumstances
Some studies may call for more than one signed informed consent form. In studies involving children or adults who have cognitive impairments, for example, researchers will need to obtain the assent of the subject and the consent of the subject’s parent(s), guardian(s), of legal representative(s). (See “Informed Consent with Children” and “Protected Populations” for information about studies involving children and other protected populations.)
Informed Consent in Pilot Studies (Tests)
Researchers planning a pilot study or test prior to engaging in a full study will need to obtain separate IRB approval for the pilot test. An informed consent process for a pilot test must clearly identify it as a pilot study. Risks and benefits for pilot tests are likely to be different from those related to an actual study and must be disclosed in the informed consent process. Once the pilot test is completed, the researcher will need to submit a second application for the full study; the proposal should include findings from the pilot test.
Informed Consent with Focus Groups
Focus groups are sometimes used to obtain feedback on services and to test new ideas. A focus group is essentially a group interview from which the researcher will collect information, and thus requires IRB review and an informed consent process. The application to the IRB for conducting a focus group will need to include the questions to be asked as well as an informed consent process and form. Focus groups may be conducted effectively online as well as face-to-face. For more information about conducting an online focus group, see “Research Using the Internet.”
A comprehensive written informed consent form will include all the following elements:
A comprehensive written informed consent form may also include any or all the following elements:
An abbreviated written informed consent form is a simple written statement that all the elements of a comprehensive informed consent form (as outlined in “Comprehensive Written Informed Consent Form.”) have been provided to potential subjects in nonwritten form. The purpose of an abbreviated written informed consent form is to document the granting of consent in projects where the researcher has made an oral presentation of informed consent elements to the subject. An abbreviated consent form may be used with participants whose native language is not English. Abbreviated written informed consent forms are appropriate only for studies involving minimal risk where all the following requirements will apply:
An abbreviated informed consent form must include, at a minimum, all the following elements:
Note: Researchers / investigators are strongly encouraged to supplement a comprehensive or an abbreviated informed consent form with the IRB’s publication, “Your Rights as a Participant in Research.” It may be downloaded and copied as needed for use as a handout for potential subjects.
Research projects involving greater than minimal risk according to 45 CFR 46.406 (no prospect of direct benefit, but likely to yield generalizable knowledge about a subject’s disorder or condition) and 46.407 (not otherwise approvable but presents an opportunity to understand, prevent, or alleviate a serious health or welfare of children problem) are prohibited. Research involving no more than minimal risk to children may be approved only if the IRB finds that adequate provisions are made for soliciting the assent of the children and the permission of their parents, guardians, or legal representative as set forth in 45 CFR 46.408 (taking into account age, maturity, and psychological state when determining a child’s capability for providing assent).
In general, permission should be obtained from both parents before a child is enrolled in research. In some cases, however, permission from one parent is acceptable. Consent from one parent is permitted if a parent is deceased, unknown, incompetent, not reasonably available, or if one parent has legal responsibility for the care and custody of the child. In the absence of a parent or parents able to give consent, consent may be given by a child’s legal guardian or legal representative.
Children are a vulnerable population because they are vulnerable to coercion or undue influence. Consequently, the informed consent process for studies involving children requires special care on the part of the researcher. (See “Protected Populations” for information on children as a protected population.) In the State of Ohio, all persons of the age of eighteen (18) or more, who are under no disability, are capable of contracting and are of full age for all purposes. Researchers are required to secure the assent of each child under the age of 18, as well as the consent of the parent(s), guardian(s), or legal representative, provided that the child has sufficient reasoning ability to express the child’s wishes; i.e., the child is capable of even limited understanding of what he or she is being asked to do. Researchers in other locations need to be aware of the age of majority of children to assure that assent is obtained in accordance with the application state, country, or local laws.
The IRB does not stipulate the minimum age for which a child must be asked for assent—in some cases, the age and the informed consent process will need to be determined individually. A child who cannot read may still be capable of assent if the study is presented verbally or visually.
In accordance with OHRP guidelines, the IRB does not stipulate whether the child’s assent should be sought before or after seeking consent of a parent or guardian. In general, however, parental, guardian, or legal representative permission should be obtained before seeking permission from the child, particularly in studies involving more than minimal risk. This decision will often be dictated by the study design. For example, for a study involving minimal risk that will occur in a school setting, seeking assent from the children first may be best. If they agree, they are sent home with a request for parent, guardian, or legal representative permission. If the children’s assent is obtained first, however, researchers need to make clear that the children cannot participate unless their parents, guardians, or legal representatives also agree—in all cases.
Making separate presentations to the child and the parent, guardian, or legal representative is advisable whenever possible. Combined presentations could result in the child feeling obliged to participate because the parent has agreed. Researchers need to make clear to the parent / guardian / representative that, ultimately, the decision to participate is the child’s and that they should not pressure their child into assenting.
When developing an appropriate written assent form for children, take care to use age-appropriate language. In some cases, consulting with an expert in language comprehension abilities (such as a teacher) for the age group under study may be appropriate. Studies that involve children in a broad age range (e.g., age 5 to 12) may require multiple consent forms to avoid “talking down” to the older children. (See sample child assent forms on the IRB Web site.)
Studies that will involve adult participants who have diminished capacity to understand the implications of the study, and thus make an informed consent, will need an informed consent process very much like that used for minor children. Special rules apply to prisoners as subjects, who are, by definition, in circumstances where ability to freely consent can be considered questionable. See “Protected Populations” for information about studies involving these protected populations.
Studies that will involve subjects with special communication requirements such as individuals who speak a language other than English, who are illiterate, or who have no spoken language will need an adapted informed consent process and informed consent form (See “Abbreviated Written Informed Consent Form.”). Individuals with visual impairments also require special accommodation in the consent process. If potential subjects will be selected from the general population, consider setting eligibility requirements for study participants that would eliminate the need for adapting informed consent to meet an individual’s special communication needs.
If an interpreter is required, she or he may also serve as a witness, as long as the interpreter has no other affiliation with the study. All circumstances described below require adaptation of the informed consent process before meeting with potential subjects. A description of the process must be included in the application to the IRB:
Researchers in positions of authority or perceived authority with potential subjects should take extra precautions in the informed consent process so that potential subjects do not feel coerced into participation. Authority relationships include, but are not limited to, teacher / student, therapist / patient, and/or priest / parishioner. Authority relationships are also inherent to all protected populations with the exception of pregnant women. Additional precautions in the informed consent process and for protected populations are needed.
Researchers who are likely to be perceived as being in a position of authority should always present potential subjects with equivalent alternatives (equivalent for-credit activities, alternative but equivalent treatment options, etc.) so that they know they will not suffer any negative consequences if they choose not to participate. The researcher should also be extremely careful when interacting with subjects, both during the informed consent process and during the study, so that subjects will not feel pressured or coerced. (See “Students Used as Research Participants.”)
An informed consent process that does not call for subjects to sign an informed consent form may occasionally be acceptable to the IRB. The researcher should determine ahead of time whether to request to waive subjects’ signatures. All subjects must be treated the same—either get signatures from all subjects or do not get signatures from any subjects. Unless the IRB has approved an informed consent process through which the researcher will not get subjects’ signatures, any person who agrees to participate but refuses to sign the consent form may not be included in the study. The IRB will not accept possible difficulty in securing subject consent as a valid reason for waiving the requirement for signed informed consent forms.
The IRB will typically waive the signature requirement for studies involving surveys (written, online, or conducted by telephone), where the subject’s responses to the survey questions constitute implicit consent. An informed consent process is still required: an introductory note, a cover letter, or an oral presentation that contains all the elements of informed consent is required.
The IRB may also waive the requirement for subjects’ signatures if the researcher makes a convincing case that (1) the only record linking the subject and the research would be the consent document and that the principal risk would be potential harm resulting from a breach of confidentiality. Each subject should be asked whether she/he wants documentation linking the subject with the research, and the subject’s wishes will govern; or that (2) 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.
If the informed consent documentation requirement is waived, the researcher must provide potential subjects with an informed consent form; it would simply not include a line for the subject to sign.
Studies without an informed consent process are rarely acceptable to the IRB. Difficulty in obtaining subjects is not an acceptable reason for eliminating the informed consent process. Studies for which the IRB may agree to waive an informed consent process include:
A clandestine research study is one in which subjects do not know that they are participating in a research study, as in the Humphrey’s Tearoom Trade project. In a deceptive project, such as Milgrim’s Shock Psychology study, subjects know they are participating in a research project, but they are not told its true purpose.
Because clandestine and deceptive research preclude true informed consent, studies of this type will rarely be acceptable to Union Institute & University’s IRB. A researcher who is designing such a project will need to make an extremely strong case for the reason for the design and provide strong assurances of subject safety, guided by the following statement from The Belmont Report:
A special problem of consent arises where informing subjects of some pertinent aspect of the research is likely to impair the validity of the research. In many cases, it is sufficient to indicate to subjects that they are being invited to participate in research of which some features will not be revealed until the research is concluded. In all cases of research involving incomplete disclosure, such research is justified only if it is clear that (1) incomplete disclosure is truly necessary to accomplish the goals of the research, (2) there are no undisclosed risks to subjects that are more than minimal, and (3) there is an adequate plan for debriefing subjects, when appropriate, and for dissemination of research results to them. Information about risks should never be withheld for the purpose of eliciting the cooperation of subjects, and truthful answers should always be given to direct questions about the research. Care should be taken to distinguish cases in which disclosure would destroy or invalidate the research from cases in which disclosure would simply inconvenience the investigator.
Researchers should be prepared to provide subjects with information about the findings of the study after it has ended, including any previously undisclosed information about the study. Note that this usage, which occurs within the behavioral sciences, departs from the standard meaning of debriefing, which is obtaining rather than imparting information.
A debriefing may also be provided after study participants have completed an online questionnaire, interview, or survey. This type of debriefing may serve as a vehicle for thanking the participants for participating in the study.
Office of Human Research Protections, “Informed Consent Frequently Asked Questions.”
Institutional Review Boards and HIPAA Privacy Rule – NIH Fact Sheet (revised 7/08/04).
Source: “Protection of Third Party Information in Research”
Oral presentations—reading the informed consent form to potential participants—are the most common. Use of a PowerPoint presentation is another option.