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The Informed Consent Process — Selecting, Recruiting, and Consenting Subjects

IRB Policies and Procedures

The IRB uses the IRB Decision Quadrant and Informed Consent Checklist (.pdf 161kb) to review human subject protocols to ensure compliance with the following federal regulations and guidelines. See the IRB Review and Approval section for detailed information.

During the development of their human subject protocols, investigators must take into consideration the entire informed consent process, which includes the equitable selection of subjects, the use of appropriate recruitment materials and finally, the documentation of legally effective informed consent. To facilitate a fully informed decision, investigators must provide their potential subjects with clearly written, accurate information that describes the possible risks and benefits of their participation in the study. The informed consent process is described below. See Documentation of Informed Consent for additional information

Selecting Subjects

Distributive justice, the third principle of The Belmont Report requires the fair selection of subjects and the equitable distribution of the risks and benefits of research. Systematic selection of subjects because of easy availability, compromised position, or social, racial, sexual, economic or cultural biases results in an uneven distribution of the benefits and the burdens of research. The IRB will closely examine research that appears to recruit subjects based solely on their easy availability, compromised position, or susceptibility to manipulation. For example, students, patients, or laboratory employees are compromised to the extent that their grades, access to health care, or jobs may be dependent on the investigators recruiting them for research. Protocols are expected to clearly articulate how recruitment will avoid the possibility of actual or perceived coercion when subjects who are in a dependent relationship to the investigator are selected for participation in a study. Refer to Special Classes of Research Subjects in Items for Consideration for additional guidance.

Note: Battelle Corporate Policy 1.1.1.6 forbids the use of Battelle staff or their families as subjects of research without prior approval by the IRB and the Institutional Official (IO), and then only under minimal risk conditions.

Vulnerable Subjects

Currently, PNNL does not conduct research involving the vulnerable subjects who are afforded special protections under 45 CFR 46, Subparts B, C, and D. Pregnant women, human fetuses and neonates, prisoners, and children who are asked to participate as subjects of research require additional consideration and protections.

Supporting information for the use of these subjects may be found in Items for Consideration, "Special Classes of Subjects - Vulnerable Subjects." Research involving vulnerable subjects at PNNL would not be allowed unless and until specific policies and procedures could be established for the review and conduct of those activities.

To make sure that certain populations, such as prisoners or patients in mental institutions, are not recruited solely because of their easy availability, the National Commission for the Protection of Human Subjects has recommended a hierarchy of preference in the selection of subjects for research: adults before children; competent individuals before incompetent individuals; and non-institutionalized persons before institutionalized persons. To adequately assess the risks and benefits of participation, the IRB requires information regarding the number of subjects to be recruited and tested and will closely examine the procedures for identifying and recruiting subjects as well as the characteristics of the subject population, such as age, gender, and population diversity.

The mandate for the equitable distribution of risks and benefits of participation in research to include women and minorities was addressed by the National Institutes of Health (NIH), in the "Outreach Notebook for the NIH Guidelines on Inclusion of Women and Minorities as Subjects in Clinical Research" (.pdf), published in 1994. The guidelines indicate that minorities and women should be involved in study populations, "so that the research findings can be of benefit to all persons at risk of the disease, disorder, or condition under study." The IRB asks for a clear and compelling justification if women and/or minorities are not appropriately represented or are excluded from research. Conversely, the EPA issued a Final Rule effective April, 2006 which bans any research involving the intentional exposure of pregnant women and children to pesticides and strengthens restrictions associated with other similar research involving pesticides, pregnant women and children.

To confirm that the burdens of research are evenly distributed, the IRB must consider more than the physical risks associated the research, such as the impact participation may pose on the daily life of the potential subject. It will, for example, consider reimbursement of subjects for inconvenience posed by the research, such as the time required to participate, travel and parking costs and restrictions on diet or other activities, for example. Investigators should include provisions in the protocol for addressing these concerns, especially for research that poses little or no direct benefit for the subjects.

Recruiting Subjects

Recruiting subjects, which is the first step in the process of informed consent, may be accomplished verbally or with the use of post cards, flyers, postings on the internet, newspaper advertisements or brochures. More detailed information sheets may be provided during this time or during presentation of the consent. Recruitment materials should be written clearly and they should not contain any misleading or exculpatory information regarding the benefits that might be realized by subjects from their participation in the study, or claims to the superiority, safety, or effectiveness of drugs or devices used in the research. At a minimum, the following information should be provided in recruitment materials:

  1. Investigator name, affiliation, address, and phone number.
  2. Purpose and sponsor of the research.
  3. Inclusion and exclusion criteria.
  4. Accurate description of risks and benefits.
  5. Estimate of time required for participation.
  6. Plans for compensation, if any.

Advertisements

In its review of direct advertising for subjects, the IRB will consider:

The IRB will also review the amount of payment and proposed method and timing of disbursement to assure that neither are coercive nor present undue influence. Please note that the following practices are prohibited in general and more specifically, may not be used in advertisements or consent forms.

Respect for potential subjects begins with recruitment procedures that ensure their participation is fully informed and voluntary. Potential subjects should not feel coerced into participating in research, nor should they fear the loss of some benefit to which they are otherwise entitled if they choose not to participate. A person in authority, such as a teacher, a physician or a work supervisor should take special precautions to make sure that a potential subject's decision to participate in research is not based on subtle pressures such as grades or a fear of loss of benefits or employability.

Investigators proposing to recruit their students, patients, employees or co-workers as research subjects must justify the inclusion of these "dependent" persons and the IRB should closely scrutinize the precautions in place to prevent the appearance of coercion in the recruitment of those subjects.

Because personal privacy and confidentiality may be compromised simply by being identified as a potential subject in studies involving sensitive personal problems such as AIDS or sexual preference, for instance, investigators should not ask institutions or their employees to identify those persons or ask for their records or personal information. They might instead, ask the institution, physician or case worker to inform potential subjects about the research or simply ask to leave flyers or contact letters where potential subjects with a condition specific to the study would have access to them, leaving them free to contact the investigator without any appearance of coercion or concern for breach of privacy.

Consenting Subjects [45 CFR 46.116]

"Unless waived or altered, no investigator may involve a human being as a subject in research unless the investigator has obtained the legally effective informed consent of the subject or the subject's legally authorized representative. Investigators must seek consent only under circumstances that provide the prospective subject or the representative sufficient opportunity 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 must be in language understandable to the subject or the representative and must not include any exculpatory language through which the subject or the representative is made to waive or appear to waive any of the subject's legal rights, or releases or appears to release the investigator, the sponsor, or the institution or its agents from liability for negligence."

Informed consent is an ongoing process that starts with the initial presentation of a research activity to a prospective subject or their representative and continues until the subject ends their participation or the study closes. Selection and recruitment of subjects has been described above. The next step involves presentation of the consent form to subjects or their legal representative. Actual enrollment of subjects can take place at this time or can be delayed to allow adequate time for subjects to consider their participation. By the time the consent is presented to subjects, they should, if properly recruited and enrolled, have a basic idea of the purpose of the research and the role they will play in it.

When dealing directly with subjects, the PNNL Principal Investigator or co-investigator are expected to administer consent. Other important decisions that must be documented as part of the consent process include the location and timing of consent, both of which can impact a subject's general state of mind and, therefore, their ability to fully comprehend the information provided.

Regardless of the type of consent, or the time or place it is administered, potential subjects must be given sufficient time to review the information, ask questions, and reflect on the nature of their participation before making a decision to volunteer as a research subject. This might include an overnight review and consultation with their family members or others they trust to help with their decision.

Federal regulations require that whenever there is more than minimal risk, consent is to be documented by a signed and dated consent and a copy is to be provided to the subject or their legal representative. Oral or short form consent and the alteration or waiver of consent or documentation of consent may apply under certain circumstances but, in general, the standard approach and procedures for consent are required. Information regarding the waiver or alteration of consent and documentation of consent are provided in subsequent paragraphs.

Feedback

Investigators are responsible for confirming that subjects or their representative have read the consent and can demonstrate a basic understanding of the study and the requirements and responsibilities of their participation. To assess a subject's comprehension, particularly where there is concern as to the level of understanding, investigators may wish to ask the subject to summarize the study, including the potential risks and benefits, and describe the procedures they will be asked to take part in. Subjects should also be able to describe the procedures for withdrawal from the study and, if applicable, any alternatives to participation that might apply to them.

Feedback is the third step in the process of consent and the one that ideally continues for the life of a study because truly informed consent does not end with a signature on a form; it is an ongoing process that involves the constant re-evaluation of current information and procedures as appropriate to the study and the subject's willingness to continue their participation. Investigators are responsible for keeping subjects apprised of all issues related to their participation in a study, even in some instances after their participation is concluded.

Writing Consent Forms

The following guidelines encourage the development of a document that presents all necessary information to subjects or their representative in a clear and easily readable format.

General Requirements for Informed Consent [45 CFR 46.116]

Federal regulations stipulate eight basic required elements of consent, and note six additional elements that may be added when appropriate. Broader descriptions for each are provided below.

  1. A statement that the study involves research and which describes the purpose of the research; the expected duration of participation; description of procedures to be followed, and identification of any procedures which are experimental;
  2. A description of any reasonably foreseeable risks or discomforts;
  3. A description of any benefits to subjects or to others which may reasonably be expected from the research;
  4. Disclosure of alternative procedures or courses of treatment, if any;
  5. A statement describing how and to what extent confidentiality of records will be maintained;
  6. For research involving more than minimal risk, an explanation as to whether any compensation and/or medical treatments are available if injury occurs and, if so, what they consist of, who will pay, and where further information may be obtained;
  7. Contacts for technical questions, subjects' rights, and research-related injuries;
  8. Statements regarding the voluntariness of participation and ability to withdraw consent at any time without penalty or loss of benefits.

Additional Elements of Consent

Additional elements of consent may include:

The IRB may require disclosure or inclusion of one or all of the following in the consent form if it determines the information is appropriate to the circumstances of the protocol and is required to protect the rights and welfare of subjects.

Purpose and Background

This section should clearly state that the subject is being invited to participate in a research study, describe the purpose and scientific aim of the study and tell why they, in particular, are being invited to participate (e.g., "because you have periodontal pockets around your teeth," "because you are a healthy person"). If an investigational device is being used in the study, it should be mentioned in this section and the device should be named and described.

Procedures

Each procedure the subject will be asked to participate in should be clearly described in the order in which it will occur. If the study involves screening procedures they should be mentioned first and identified as tests that will determine eligibility to participate in the study. In studies that involve patient/subjects, this section should describe what will be done to the individual and explain how it might differ from standard treatment or what would happen to the individual if they did not participate in the study. Any experimental procedures should be described in this section.

If a standard medical procedure is being done as part of the study, it should not be referred to as "standard" or "routine," because this could easily imply that the procedure would be done anyway for clinical reasons. Rather, what should be conveyed is that this procedure is an extra laboratory test that is commonly done for clinical purposes, but is being done here for research purposes.

Amounts of blood or tissue to be taken for study purposes should be specified using lay equivalents (e.g., teaspoons, ounces) rather than metric terms. The number of times a procedure will be done, the time involved for each procedure, and the total amount of time for participation in the study should be specified. The location(s) where the procedures will be done and by whom should also be stated.

Risks and Discomforts

The risks and/or possible discomforts of all study procedures should be listed and explained in this section. It is best to describe the risks of each procedure in a separate point and arrange them according to severity and the likelihood of occurrence. Where appropriate, the precautions that will be taken to avoid certain side effects or outcomes from occurring should be indicated and what will be done should they occur. Types of risk that should be considered include not only physical and emotional, but also social and legal issues such as employability, insurability, confidentiality and privacy.

To the extent possible, consent forms should characterize the likelihood of risks using words like "likely," "frequent," "occasional," and "rare." When using these words it is more descriptive to define them by percentages. For example, "likely" risks could be expected to affect more than 50% of subjects; "frequent" risks could affect 10–50% of subjects; "occasional" events could affect 1–10% of subjects; and "rare" events would affect less than 1% of subjects. Because of the difficulty of quantifying risks, and because consent forms should emphasize the most important risks as well as the most frequent risks, the exact wording and organization of the discussion of risks must be adjusted for each individual study.

Privacy and Confidentiality

Joan Sieber, California State University, describes privacy and confidentiality as follows. You might want to keep these definitions in mind when reviewing or conducting research that involves data collection and the use of human biological materials.

Privacy in research typically refers to whether the subject considers it the researcher’s business to delve into the subject’s life concerning whatever matter is the topic of the research. Privacy is about persons and their sense of being in control of the access of others to themselves.

Confidentiality is an extension of the concept of privacy; it refers to (a) identifiable data and (b) agreement about the handling of the data in keeping with the subject’s interest in controlling the access of others to information about themselves.

Private Information "includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may be readily ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects."

Confidentiality

Confidentiality "pertains to the treatment of information that an individual has disclosed in a relationship of trust and with the expectation that it will not be divulged to others in ways that are inconsistent with the understanding of the original disclosure without permission of the subject."

Investigators are required to maintain and protect the privacy and confidentiality of all personally identifiable information of subjects participating in research, except as required by law or released with the written permission of the subject. Subjects have the right to be protected against invasion of their privacy, to expect that their personal dignity will be maintained, and that the confidentiality of private information will be preserved. The more sensitive the research material, the greater the care required in obtaining, handling, and storing it.

Information through which subjects may be identified include their names, student identification numbers, hospital ID numbers, Social Security numbers, driver's license numbers, home addresses, photographs, videotapes, and the like. Individuals also may be identified by description, for example, as the personnel manager in a particular company or the sixth grade teacher in a certain school. If information or data to be collected may be traced back to individual subjects, safeguards should be provided to fully protect confidentiality.

Because loss of privacy presents a risk to subjects, a discussion of confidentiality issues should be included in the Risks section of the consent. The consent form may then proceed to describe how the confidentiality of private information will be protected and disclosed only with the subject's permission or as required by law.

Limits to Confidentiality: For all statements regarding confidentiality of research records, keep in mind that there is no legal privilege between investigator and subject like the one between physician and patient or counselor and client. Thus, a guarantee of complete confidentiality, or "strictest confidentiality," should not be given or implied. One should always state instead that confidentiality will be protected "as far as is possible" or "as far as is possible under the law." When the results of the research are to be published or presented at conferences, it is the investigator's responsibility to make sure that no personal information will be included that would reveal a subject's identity.

Guidelines for Protecting Confidentiality

Audio/Video-Tapes and Photographs

Investigators are required to protect a subject's identity when using photographs, videos, or audio-tape recordings that have been collected for research purposes. The consent form should indicate when tapes/photographs will be destroyed and should also describe how they will be used in future publications, conferences, demonstrations, etc. If a subject is identifiable from the photographs, videos, or audio-tape recordings, they should be given the right to review and edit or delete them as they wish.

Certificates of Confidentiality

Data collection about sensitive issues that, if revealed, might prove harmful to a subject, their family or immediate social group (such as illegal behavior, alcohol or drug use, or sexual practices or preferences) requires the protection of confidentiality beyond preventing accidental disclosures. Under federal law, researchers can obtain an advance grant of confidentiality, known as a Certificate of Confidentiality that will provide protection against compulsory disclosure, such as a subpoena, for research data of this type.

Releasing Information

Investigators should describe in the IRB application any conditions under which confidential information might be disclosed and create an informed consent document that accurately reflects those conditions, including any voluntary disclosure by the researcher. The IRB is required to determine whether the risks to subjects are minimized, informed consent is appropriate, and privacy and confidentiality protections are adequate.

If investigators intend to release information, the consent should describe the person(s) or agency to whom information will be furnished, the nature of the information, the purpose of the disclosure and whether the subject's name will be used. When the research records may be subject to inspection by DOE, a funding agency, or an industrial sponsor, the following information must be included:

Authorized representatives of the Department of Energy (DOE) (or a funding agency such as the National Institutes of Health) and the manufacturer of a drug (or device) being tested (insert name of company) may need to review records of individual subjects. As a result, they may see your name, but they are bound by rules of confidentiality not to reveal your identity to others.

Anticipated Benefits

Any potential direct benefits to the subject should be described first, followed by potential general benefits (e.g., to the group of subjects to which the individual belongs, to medical knowledge, etc.). The IRB recommends that a description of possible direct benefits be qualified with the phrase, ". . . but this cannot be guaranteed." If there is no direct benefit to the subject anticipated from the study, this should be stated at the beginning of the section. Payment for participation is not considered a benefit of participation in research.

Alternative Procedures or Courses of Treatment

This section is generally included only when patients volunteer as subjects in a study designed to addresses their particular disease or medical condition. It can be a short statement that presents possible choices available to individuals who choose not to participate in a study.

Compensation for Injury

For research involving more than minimal risk, an explanation as to whether any compensation or medical treatment is available if injury occurs and, if so, what it consists of, or where further information may be obtained must be included in the consent. Injury compensation statements for greater than minimal risk studies will be reviewed by the Board on a case-by-case basis.

Contacts/Questions

Contact names and numbers must be provided for technical or project-related questions, research subjects' rights (IRB), and research related injuries. PNNL requires that the principal investigator or co-investigator be available for research related inquiries.

Statement of Voluntary Participation

Subjects must be told that their participation is voluntary and that their refusal to participate will involve no penalty or loss of benefits to which they are otherwise entitled, also that they may discontinue participation at any time without penalty or loss of benefits to which they are otherwise entitled by simply notifying the PI. Subjects should also be informed of any procedures for withdrawing, or consequences that might result; for instance, data that may have already been aggregated with other data and may be un-retrievable.

Signatures

Signature of the subject: Unless a waiver of signed consent (i.e., use of an Information Sheet rather than a Consent Form) is approved by the IRB, lines for the subject's printed name, signature, and date should be provided.

Signature of person obtaining consent: In signing on this line, the individual obtaining consent is attesting that the requirements for informed consent have been satisfied.

Third-party signatures: If the study involves subjects who cannot give consent for themselves, and the IRB accepts the justification for their inclusion in the study, a separate, appropriately worded and labeled signature section must be added. For studies involving children, this signature line will be for the parent(s) or legal guardian(s).

New information

Federal regulations require the inclusion of a separate statement indicating that if new information that may affect a subject's willingness to continue participation (e.g., changes to the risk/benefit ratio or new alternatives to participation) develops during the course of the study, the subject will be promptly informed and may then decide whether to continue participation in the study. The IRB will advise the investigator whether or not subjects should be asked to sign a revised consent form containing the new information.

Costs/Financial Considerations for Subjects

Participation in research can lead to additional costs for study subjects. Procedures billed to insurance companies may require a significant co-payment on behalf of the subjects: insurance companies may refuse to pay for "investigational" therapies, and subjects may have to pay for transportation or lost wages during their participation in a study. Investigators should attempt to minimize any economic costs to subjects. Any anticipated costs should be described to subjects during the consent process. If there are no costs to the subject, this should be clearly stated as well.

If a protocol involves more than minimal risk, the IRB will require that the investigator provide appropriate information about any compensation and/or medical treatment that would be available if an injury or illness were to occur.

If any real or potential financial conflicts of interest have been identified regarding the research activity, that information, as it affects the subject's decision to participate, should be included in this section.

Reimbursement or Payment for Participation

The nature, amount and method of payment or other remuneration should not constitute undue inducement to participate. Investigators should consider reimbursement for the inconvenience posed to subjects or other costs to subjects resulting from participation in the research, such as: parking fees, travel, lost time from work, baby-sitters, etc. Subjects should also be told if they will not be paid for participation.

Since subjects reserve the right to withdraw their participation from the research without prejudice, payment to subjects should be prorated. The IRB will review both the amount of the payment and the proposed method of disbursement to confirm that neither includes problems of coercion or undue influence.

Subjects should be told exactly how and when payment will be made. Payments in excess of $600 per calendar year are considered taxable income. In those instances where payment exceeds that amount, subjects will be required to provide their Social Security number so the income can be reported and the use of the Social Security number for this purpose must be explained in the consent. Payment or reimbursement should not be confused with or considered a benefit of participation.

Waiver or Alteration of Consent [45 CFR 46.116(c)(d)]

To assist in its determination for waiver or alteration of consent, the IRB uses OHRP Chart 10, "Can Informed Consent Be Waived or Consent Elements Be Altered Under 45 CFR 46.116(c) or (d)?" The 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 in the project records and meeting minutes that:

  1. The research or demonstration project is 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 other 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
  2. The research could not practicably be carried out without the waiver or alteration.

The IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent, or waive the requirement to obtain informed consent provided the IRB finds and documents in the project records and meeting minutes that [45 CFR 46.116(d)]:

  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; and
  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 following their participation.

Consent cannot be waived simply for convenience or because difficult situations or conditions are encountered in the enrollment of subjects. Investigators requesting a waiver or alteration of consent must provide written justification for doing so. When consent or documentation of consent is waived, the IRB may require the investigator to provide subjects with an information sheet that includes most or all of the elements of consent but does not require the subject's signature.

Documentation of Informed Consent [45 CFR 46.117]

Except as otherwise waived or altered, informed consent will 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 will be given to the person signing the form.

The consent form may be either of the following:

The Long Form Consent

The IRB has developed a standard consent form (SBMS Form HS-3) that incorporates all of the required and additional elements of consent into a document that can be adapted as appropriate to individual studies. Guidance for writing the consent is embedded in the consent form.

The Short Form Consent

The short form consent is most often used when subjects are unable to consent for themselves or for non-English speaking subjects. Because PNNL staff seldom work with vulnerable or non-English speaking subjects, detailed policies and procedures for using the short form consent will be developed and implemented if those subjects are ever involved in research conducted by PNNL. In general, a "short form" is a written consent document stating that the elements of consent have been presented orally to the subject or the subject’s legally authorized representative. For participants who do not speak English, the witness must be conversant in both English and the language of the participant. When using the short form consent, the following are required:

Waiver of Documentation of Informed Consent [45 CFR 46.117(c)]

To assist in its determination for waiver of documentation of consent, the IRB uses OHRP Chart 11, "Can Documentation of Informed Consent Be Waived Under 45 CFR 46.117(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:

The IRB will document waiver of documentation of consent to project files and in the meeting minutes.

When Consent is Obtained by a Collaborating Institution

When subject involvement takes place at another institution, a copy of the collaborating investigator's protocol, IRB approval and current consent form must be provided in support of the PNNL Application for IRB review. This holds true where multiple sites are involved. If the PNNL IRB finds that the Federal requirements for consent are not met, it will document its findings to the PNNL PI who is responsible for communicating with the other institution. If necessary, the work being performed at PNNL will not be approved until the consent is deemed sufficient and approvable.

For information regarding monitoring or observation of the consent process, refer to the IRB Review and Approval section.