Section 5: Informed Consent of Research Participants

5.0 Informed Consent
5.1 Elements of Informed Consent / Assent Forms
5.2 Additional Consent Information for Different Types of Studies
5.3 Elements of a Consent / Authorization Using Personal Health Information (PHI)
5.4 Waiver of Authorization for the Use and Disclosure of Personal Health Information (PHI)
5.5 Documentation of Informed Consent
5.6 Waiver of Documentation of Informed Consent
5.7 Waiver of Informed Consent

5.0 Informed Consent

Except as described in Sections 5.6 and 5.7 below, investigators may not enroll human subjects in research unless they have obtained the legally effective, written, informed consent of the subject or the subject’s legally authorized representative, prior to enrollment of the subject in the research. Investigators are responsible for ensuring that the subjects, or their representatives, are given sufficient opportunity to consider whether or not to participate and must seek to avoid coercion or undue influence.  The IRB is responsible for evaluating the informed consent process.  The IRB may request to observe the informed consent process to ensure adequate consent when the research involves particularly vulnerable populations and as described in sections 7.0, 7.4, and 7.4.1.  The PI may not involve a human being as a participant in research unless the investigator has obtained the legally effective informed consent of the participant or the participant’s legally authorized representative.  Information given to potential subjects or their representatives must be in a language that is understandable to the subject or representative.  No process of obtaining consent may include exculpatory language through which subjects waive any of their legal rights or releases or appear to release the investigator, sponsor, or institution or its agents from liability for negligence.  The consent process must provide sufficient opportunity to consider whether to participate.  The PI should describe the consent process in “Topics to Address in your Research Proposal” (Appendix G).

Occasionally, the institutional setting in which the consent is sought will pose the possibility of coercion or undue influence. Conducting research at institutions that provide services to subjects may be perceived as implying that continued service is dependent upon participation in the research. Students in the educational setting may be concerned that refusal to participate will affect their grades. These institutional pressures should be addressed in the research design. The protocol must adequately preserve the right to refuse participation.

There are many other examples of possible sources of undue influence on subjects. It may not be possible to remove all sources of undue influence, but the principal investigator must examine each project to assure the elimination of coercion and minimization of other undue influences. The requirement to obtain informed consent should be seen as not only a legal obligation, but also as an ethical obligation. The research design must adequately address how informed consent will be obtained and what information will be given to prospective subjects. IRBs must look at the issues of coercion and undue influence in each proposal and insist on protocols where the circumstances of the consent process minimize the possibility of coercion and undue influence to participate.

For research studies involving non-English speaking participants the IRB will require the submission of the translated consent as an explicit condition for approval. 

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5.1 ELEMENTS OF INFORMED CONSENT/ASSENT¹⁴ FORMS

Current informed consent documents with required phraseology may be found on the IRB web page at http://www.utexas.edu/research/rsc/humansubjects/forms.html. The sample consent forms contains all the required consent elements. The following are the basic required elements (extracted from 45 CFR Part 46.116):

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 persons that 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; if the research is subject to FDA regulation, the statement also must note the possibility that the Food and Drug Administration will inspect the records.
6. For research involving more than minimal risk¹⁵, 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.

Whenever appropriate, one or more of the following elements of information shall also be provided to each subject:

1. If the risks of any research procedure are not well known, for example because of limited experience in humans: A statement that the particular treatment or procedure may involve risks to the participant, which are currently unforeseeable;
2. If the research includes women of child bearing potential or pregnant women, and the effects of any research procedures on embryos and fetuses is not well known: A statement that the particular treatment or procedure may involve risks to the embryo or fetus, if the participant is or may become pregnant, which are currently unforeseeable.
3. If there are anticipated circumstances under which the participant’s participation will be terminated by the investigator without regard to the participant’s consent: Anticipated circumstances under which participation may be terminated by the investigator without the participant’s consent.
4. If there are costs to the participant that may result from participation in the research: Additional costs associated with study participation.
5. If there are adverse consequences (e.g., physical, social, economic, legal, or psychological) of a participant’s decision to withdraw from the research: Consequences of a participant’s decision to withdraw from the research.
6. If there are adverse consequences (e.g., physical, social, economic, legal, or psychological) of a participant’s decision to withdraw from the research: Procedures for an orderly termination of participation
7. If significant new findings during the course of the research that may relate to the participant’s willingness to continue participation are possible: Statement that new findings developed during the course of the research that may relate to the participant’s willingness to continue in the research study will be provided to the participant.
8. If the approximate number of participants involved in the study might be relevant to a decision to take part in the research: Approximate number of participants involved in the study

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.  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.  The IRB provides a “Consent form 2” for use in minimal risk studies only.  The Consent form 2 is available online: http://www.utexas.edu/research/rsc/
humansubjects/forms/consent_form_2.doc.

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5.2 ADDITIONAL CONSENT INFORMATION FOR DIFFERENT TYPES OF STUDIES

1. Studies involving blood samples:  The consent form should contain a statement such as, “Blood samples will be obtained by venipuncture. This method involves inserting a needle into a vein in the arm and withdrawing a sample of blood. It is routinely used to obtain blood for physical examinations. Venipuncture is accompanied by minor discomfort at the site of the needle entry and may result in slight bruising and a feeling of faintness. In this study a trained technician will obtain a 30 ml (about 2 tablespoonfuls) sample of your blood that will be analyzed for…”
2. Studies involving blood, tissue or body fluid for possible genetic research: If the research involves the use of a subject’s blood, tissue or body fluid for current or future genetic research, the researcher should modify the consent form to explain subjects’ rights, including:
   1. the fact that the specimens will be maintained without identifiers,
   2. the risk level to the subject if they agree to participate,
   3. where the specimens will be stored,
   4. who owns the specimens, and
   5. how the specimens will be used in the future.
3. Studies that involve physical risk:  The University does not have a plan to provide facilities or insurance to cover research-related injuries. UT student participants will be afforded access to the designated services available to all students through The University of Texas Student Health Center. Other research participants are not covered. If the study involves physical risk, assess the risk and add a statement such as, “The University has no plan to provide treatment for research related injury and no plan to provide payment in the event of a medical problem.”  If emergency treatment for research-related injuries is arranged by (for example) having a medical doctor available for emergency treatment, that should be stated, but a disclaimer for extended care should be put into the consent form, such as “You will be charged for continuing medical care and hospitalization for research-related injuries.  The University has no plan to provide financial compensation.”  If all of the participants are UT-Austin students, it is appropriate to state, “If injuries occur as a result of study activity, eligible University students may be treated at the usual level of care with the usual cost for services at the Student Health Center, but the University has no policy to provide payment in the event of a medical problem.”  If the research protocol includes both student and non-students the consent form should indicate how research related injuries are handled for each population or the researcher may use two separate consent forms: one for students, one for non-students.
4. Studies that involve a risk to a fetus:  The female participant must be informed of the risk and the methods to be used (such as a pregnancy test) to minimize the risk.
5. Studies that involve drugs:  The participants must be given a statement of known side effects, warned about possible drug interactions (including interactions with alcohol), and warned about activities that may be dangerous (such as driving with a drug that has a sedative effect).
6. Studies that involve psychological risk: The principles that apply to studies that involve psychological risk or mental stress are similar to those that involve physical risk. Participants should be informed of the risk and told that the University has no plan to provide treatment. They should be given the names and telephone numbers of agencies that may alleviate their mental concerns, such as a crisis hot line. If the principal investigator or the faculty sponsor of a student investigator is qualified to treat mental health problems, that person may be listed as a resource.
7. Studies that involve sensitive topics: Participants should be told that some of the questions are of a personal or sensitive nature and should be given examples of the topics or questions. They should also be told that they can skip a question if they do not wish to answer it. If questionnaires or interviews may generate reports of child physical or sexual abuse, the participant must be informed that the researcher is legally required to report this information to Child Protective Services.  If the questionnaire or interview may generate reports that the participant plans to harm him or herself or others, the participant must be told that the investigator is ethically required to report that information the local police department. This information about the legal obligations to report abuse and threats of harm to oneself or others may be omitted if the responses are anonymous.  In the event that the Privacy rule is more restrictive than the procedures described in the consent requirements, the more restrictive rule must be followed.
8. Studies that involve 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 of the research. 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. Deception requires that a PI get formal approval of a waiver of informed consent, due to the initial consent being used.
9. Studies that involve audio or video recordings: Participants must be told:
   1. that the interviews or sessions will be audio or videotaped;
   2. that the cassettes will be coded so that no personally identifying information is visible on them;
   3. that the recordings will be kept in a secure place (e.g., a locked file cabinet in the investigator’s office);
   4. that recordings will be heard or viewed only for research purposes by the investigator and his or her associates; and
   5. that recordings will be erased after they are transcribed or coded.

   If the researcher wishes to keep the recordings because of the requirements of his/her professional organization with respect to data or because the researcher may wish to review them for additional analyses at a later time, the statement about erasing them should be omitted and replaced with a statement that recordings will be retained for possible future analysis.  If the researcher wishes to present the recordings at a convention or to use them for other educational purposes, he/she should get special permission to do so by adding, after the signature lines on the consent form, the following statement, “We may wish to present some of the tapes from this study at scientific conventions or as demonstrations in classrooms. Please sign below if you are willing to allow us to do so with the tape of your performance.”  Additionally, a second signature line should be added with the preface, “I hereby give permission for the video (audio) tape made for this research study to be also used for educational purposes.”  This procedure makes it possible for a participant to agree to being taped for research purposes and to maintain the confidentiality of the information on that tape.

10. Studies that involve monetary or other compensation: The amount and type of the stipends or other compensations and the requirements to earn them must be clearly specified. This part of the consent form should be written as if it were a contract. If the study extends over a period of time, it is acceptable to reward a participant with a bonus if he or she completes all the interim components of the study. However, the participant must be paid for each component, and the bonus should not be greater than 50% of the total compensation.
11. Cover Letters:  Cover letters, rather than consent forms, may be used for some categories of exempt minimal-risk research with adults such as survey or questionnaire research on non-sensitive topics.  Cover letters are most frequently used for survey or questionnaire studies.  The cover letter should state the purpose of the survey, the expected number of respondents, a description of the topic of the survey and the content of the questions on the survey, a statement about confidentiality or anonymity, and a statement about how the participant may obtain additional information about the study.  The cover letter should also state that a decision not to participate will not affect, “ … Your current or future relationships with (names of relevant entities, such as University of Texas at Austin, standing in this class, grade in this class, status on this team, etc.).”  The participant should be allowed to keep the cover letter.  He or she need not sign it, because responding to the survey indicates a willingness to participate in the study.  In the event that a cover letter is used, it must confirm to the authorization procedures required by HIPAA.

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5.3 ELEMENTS OF A CONSENT / AUTHORIZATION USING PERSONAL HEALTH INFORMATION (PHI)

A. The authorization section of the form must set out the specific information stipulated in the Privacy rule:

1. A description of the information to be used or disclosed that identifies the information in a specific and meaningful fashion.
2. The name or other specific identification of the person(s), or class of persons, authorized to make the requested use or disclosure.
3. The name or other specific identification of the person(s), or class of persons, to whom the covered entity may make the requested use or disclosure.
4. A description of each purpose of the requested use or disclosure. The statement, “at the request of the individual” is a sufficient description of the purpose when an individual initiates the authorization and does not, or elects not to, provide a statement of the purpose.
5. An expiration date or an expiration event that relates to the individual or the purpose of the use or disclosure. A statement of the individual’s right to revoke the authorization in writing and the exceptions to the right to revoke, together with a description of how the individual may revoke the authorization. The statement, “end of the research study,” “none,” or similar language is sufficient if the authorization is for a use or disclosure of protected health information for research, including for the creation and maintenance of a research database or research repository.
6. Signature of the individual and date. If the authorization is signed by a personal representative of the individual, a description of such representative’s authority to act for the individual must also be provided.

B. Required statements. In addition to the core elements, the authorization must contain statements adequate to place the individual on notice of all of the following:

1. The individual’s right to revoke the authorization in writing, and either:
2. The exceptions to the right to revoke and a description of how the individual may revoke the authorization; or
3. To the extent that the information in (A) of this section is included in the notice required by § 164.520, a reference to the covered entity’s notice.
4. The ability or inability to condition treatment, payment, enrollment or eligibility for benefits on the authorization, by stating either:
5. The covered entity may not condition treatment, payment, enrollment or eligibility for benefits on whether the individual signs the authorization when the prohibition on conditioning of authorizations applies; or
6. The consequences to the individual of a refusal to sign the authorization, the covered entity can condition treatment, enrollment in the health plan, or eligibility for benefits on failure to obtain such authorization.
7. The potential for information disclosed pursuant to the authorization to be subject to redisclosure by the recipient and no longer be protected by this subpart.

C. Plain language requirement.  As with the Consent element of the form, the authorization must be written in plain language.

D. Copy to the individual.  If a covered entity seeks an authorization from an individual for a use or disclosure of protected health information, the covered entity must provide the individual with a copy of the signed authorization.

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5.4 WAIVER OF AUTHORIZATION FOR USE AND DISCLOSURE OF PERSONAL HEALTH INFORMATION (PHI)

To use or disclose PHI without authorization by the research participant, The University of Texas at Austin must obtain one of the following:

1. Documentation that an amendment or waiver of the research participants’ authorizations, for use/disclosure of PHI has been approved by the IRB. This provision of the rule might be used for example, to conduct records research, when researchers are unable to use de-identified information; or
2. Where researchers represent:
   1. That the research is only for purposes of preparing a research protocol or similar uses preparatory to research. 
   2. That he or she will not remove any PHI from the covered entity and
   3. That PHI is necessary for the research purpose; or
3. To disclose PHI of decedents, where the researcher represents that the use or disclosure of PHI is:
   1. Solely for research on the PHI of decedents,
   2. Necessary for the research, and
   3. Documentation of the death of the individuals about whom PHI is sought and provided.

In addition, the researcher is required to provide:

1. Documentation indicating that an amendment to, or waiver, in whole or in part, of the individual authorization required by 45 CFR 164.508 for use or disclosure of protected health information, has been approved by the Institutional Review Board (IRB).         
2. Documentation of approval of an amendment or waiver must include the following information:
   1. A statement identifying the IRB and the date on which the amendment or waiver of authorization was approved;
   2. A brief description of the protected health information for which use or access has been determined to be necessary by the IRB;
   3. A statement that the amendment or waiver of authorization has been reviewed and approved under either normal or expedited review procedures following the requirements of the Common Rule, including the normal review procedures.
   4. A statement that the amendment or waiver of authorization has been reviewed and approved, under either normal or expedited review procedures, by the IRB which reviews proposed research at convened meetings;
   5. A statement that the IRB has determined that the authorization may be altered or waived, in whole or in part, indicating:
      1. The use or disclosure of protected health information involves no more than minimal risk to the privacy of individuals, based on, at least, the presence of the following elements:
         1. an adequate plan to protect the identifiers from improper use and disclosure;
         2. an adequate plan to destroy the identifiers at the earliest opportunity consistent with conduct of the research, unless there is a health or research justification for retaining the identifiers, or such retention is otherwise required by law; and
         3. adequate written assurances that the protected health information will not be re-used or disclosed to any other person or entity, except as required by law, for authorized oversight of the research project, or for other research for which the use or disclosure of protected health information would be permitted by the Privacy rule
      2. The research could not practicably be conducted without access to, and use of, the protected health information
3. Documentation of the amendment or waiver of authorization must be signed by the chair or other member, as designated by the chair of the IRB, as applicable.
4. Prior to a review preparatory to research, the IRB will obtain from the researcher representations that:
   1. Use or disclosure is sought solely to review protected health information as necessary to prepare a research protocol or for similar purposes preparatory to research;
   2. No protected health information is to be removed from the covered entity by the researcher in the course of the review; and
   3. The protected health information for which use or access is sought is necessary for the research purposes.
5. Prior to research using information relating to decedent(s), the IRB will obtain from the researcher:
   1. Representations that the use or disclosure sought is solely for research on the protected health information of decedents;
   2. Documentation, at the request of the IRB, of the death of such individuals; and
   3. Representation that the protected health information, for which use or disclosure is sought, is necessary for the research purposes.
6. Personnel receiving a request from an individual or entity for use or disclosure of protected health information will determine whether the requesting individual is a person with whom the IRB has a knowing relationship.
7. Personnel will follow appropriate policies and procedures for verifying the identity and authority of individuals requesting protected health information.
8. Once it is determined that use or disclosure is appropriate, personnel with appropriate access clearance will access the protected health information using proper access and authorization procedures.
9. The requested protected health information will be delivered to the requesting individual in a secure and confidential manner, such that the information cannot be accessed by employees or other persons who do not have appropriate access clearance to that information.
10. Personnel will appropriately document the request and delivery of the protected health information.
11. In the event that the identity and legal authority of an individual or entity requesting protected health information cannot be verified, Staff will refrain from disclosing the requested information and report the case to the Jeffrey Graves, Privacy Officer, in a timely manner.
12. Knowledge of a violation or potential violation of this policy must be reported directly to the Jeffrey Graves, University of Texas at Austin Compliance Officer, or to the employee compliance hotline.

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5.5 DOCUMENTATION OF INFORMED CONSENT

Federal regulations governing the use of human subjects in research activities require written documentation of informed consent unless the research meets the criteria for Waiver of Documentation of Consent.  The participant, witness, and investigator should sign and date the IRB approved consent form.  UT Austin’s IRB does not permit use of the “short form of consent documentation” as outlined in the OHRP memorandum of understanding by Melody H. Lin in 1995¹⁶.  The IRB does permit the use of an abbreviated document that highlights major points with the assumption that the PI / Investigator provides a thorough explanation to participants.

Confusion sometimes arises as to who can obtain consent and who can be designated to sign the consent form. The following are the acceptable methods for documentation of informed consent of human research subjects at The University of Texas at Austin:

1. The IRB must be made aware of the person(s) who will be conducting the consent interviews. These faculty/staff members should be listed in the IRB application and research proposal, and unless indicated otherwise, are the only personnel allowed to obtain consent.
2. Each subject (or their legally authorized representative) must be provided adequate time to read and review the consent form, in addition to being advised of the procedures, risks, potential benefit, alternatives to participation, etc. This is frequently accomplished using the consent form as an outline for the interview process.
3. After completing the consent interview and assuring that the subject (or their representative) has no further questions and agrees to participate in the research activity, the interviewer should instruct the subject (or their representative) to sign and date the consent form in the appropriate spaces.
4. The person conducting the consent interview must then sign and date the consent form in the appropriate spaces (PI or designee). It is assumed that in most cases, all persons signing the consent form will do so at the conclusion of the consent interview.
5. Each subject (or their representative) must be given a copy of the signed consent form. The original consent form should be filed in such a manner as to ensure immediate retrieval when required by auditing entities, e.g., FDA, IRB, or sponsor monitors.
6. The regulations are clear that written documentation of informed consent is required, unless waived. Therefore, obtaining consent from an authorized third party via the telephone is not acceptable unless the IRB waives the requirement to document the informed consent process.
7. The regulations also include provisions for approval of a waiver or amendment of part or all of the consent process. The IRB will consider written requests for waiver or amendment of the process when accompanied by sufficient justification.
8. Obtaining informed consent from subjects must be accomplished prior to performing the research activity and using only an IRB approved and stamped consent form. Written requests for amendments to an existing consent form must be approved prior to implementation, at which time the IRB office will provide a formal approval letter of the amendment to the consent form.
9. Investigators may use the “Consent form 2” for minimal risk studies (“Consent Form 2 – Only for Minimal Risk Studies” [Word Document]).

Upon receipt of an IRB approved consent form, all old versions should be discarded to prevent inadvertent use of an outdated consent form. Copies of the most recently approved consent form may be made and should be used until replaced by an amended consent form. The consent form must be reviewed at least annually as part of the continuing review process.  The IRB does not grant exceptions to the requirement to obtain informed consent for planned emergency research.

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5.6 WAIVER OF DOCUMENTATION OF INFORMED CONSENT

The IRB can waiver the requirement that the consent process include a signed consent form.  Investigators desiring to not have a signed consent form must still provide participants with a consent document disclosing all the required elements necessary for informed consent.  In such cases, the IRB encourages investigators to use the consent templates and remove the signature section.  Investigators are free to format the consent document as necessary.  According to 45 CFR 46.117 and / or 21 CFR 56.109(c)(1) an IRB may waive the requirement for the investigator to obtain a signed consent form for some or all subjects if it finds:

1. The research presents no more than minimal risk; and
2. The research involves procedures that do not require written consent when performed outside of a research setting 45 CFR 46.117; 21 CFR 56.109(c)(1)

Or,

1. The principle risks are those associated with a breach of confidentiality concerning the subject's participation in the research; and
2. The consent document is the only record linking the subject with the research (45 CFR 46.117); and
3. Each participant will be asked whether the participant wants documentation linking the participant with the research, and the participant’s wishes will govern.
4. The study is not FDA regulated

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5.7 WAIVER OF INFORMED CONSENT

The IRB may waive the requirements for obtaining informed consent or approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent listed in 5.1, provided that all of the following five conditions are met:

1. The research involves no more than minimal risk to the subjects;
2. The waiver or amendment will not adversely effect the rights and welfare of the subjects;
3. The research could not practicably be carried out without the waiver or amendment;
4. Whenever appropriate, the subjects will be provided with additional pertinent information after participation; and
5. The study is not FDA regulated.

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