91´ÎÔª

Chapter 7: Informed Consent

No investigator may involve a human being as a subject in research without obtaining the legally effective informed consent (providing enough information that a reasonable person would want to have) of the subject or the subject’s legally authorized representative. In general, the IRB considers individuals who are unable to consent for their own clinical care to be unable to consent for research participation.

Investigators must obtain consent prior to entering a subject into a study and/or conducting any procedures required by the protocol, unless consent is waived by the IRB.

Consent must always be sought using procedures that (a) provide the prospective subject or the subject’s legally authorized representative sufficient opportunity to consider whether or not to participate; and (b) minimize the possibility of coercion or undue influence.

In determining the appropriateness of the consent process, the IRB will consider:

• the timing and location where the consent process will take place;
• the individual who will be obtaining consent (e.g. the investigator, collaborator, or qualified designee) and his or her training;
• the age, language, literacy, and cognitive capacities of the prospective participant;
• pre-existing role relationships between the researcher and the prospective participant; and
• any factors that might be perceived as coercive or present undue influence to participate in the research.

The IRB will require an alternative process to obtain consent when it determines that a potential subject’s understanding of the research may be impaired due to the timing, location, or the individuals participating in the proposed consent process.

The information that is given to a subject or the legally authorized representative must be in a language understandable to the subject or the representative.

A person (i.e., a member of the project’s research team) knowledgeable about the consenting process and the research to be conducted must obtain the informed consent. If someone other than the investigator conducts the interview and obtains consent, the investigator needs to formally delegate this responsibility. The person to whom the responsibility is delegated must have received appropriate training to perform this activity.

No informed consent, whether oral or written, may include exculpatory language through which a subject or a 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, the institution or its agents from liability for negligence.

1. Basic Elements of Informed Consent

Informed consent must be sought from each potential subject or the subjects’ legally authorized representative, in accordance with, and to the extent required by 45 CFR 46.116. The informed consent process must begin with key information and this part of the informed consent must be organized and presented in a way that facilitates comprehension.

The basic elements of informed consent are:

1. a statement that the study involves research;
2. an explanation of the purposes of the research;
3. the expected duration of the subjects’ participation;
4. a description of the procedures to be followed, and identification of any procedures which are experimental;
5. a description of any reasonably foreseeable risks or discomforts to the subject;
6. a description of any benefits to the subject or to others which may reasonably be expected from the research;
7. when a protocol involves medical or other therapeutic treatments, it must include a disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;
8. a statement describing the extent, if any, to which confidentiality of records identifying the subject must be maintained;
9. for research involving more than minimal risk of physical, emotional, or psychological harm, information about the availability of professional services will be provided;
10. contact information for the person who can answer pertinent questions about the research;
11. contact information for the person to notify in the event of a research-related injury to the subject;
12. contact information for the UM IRB, so that subjects can report concerns or complaints about the research or obtain answers to questions about their rights as research participants; and
13. 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.

14. a place for participants to initial, when voice, video, digital, or image recording is involved.

15. a statement about the future use of the subject’s identifiable private information or biospecimens:

    1. Identifiers might be removed and the de-identified information or biospecimens used for future research without additional informed consent from the subject; or

    2. The subject’s information or biospecimens will not be used or distributed for future research studies even if identifiers are removed.

16. a statement about the potential for publication or presentation of the study results, and an explanation about how potential identifying information will be managed in those situations.

Additional elements of informed consent to be applied, as appropriate, are as follows:

• Anticipated circumstances under which the subjects’ participation may be terminated by the investigator without regard to the subjects’ consent. The IRB will carefully review the protocol to determine whether there might be situations where participants should be withdrawn from the research, or if it is reasonable to expect that participants may be withdrawn from the research, without their consent. For example, in a dietary study in which the participants have to follow a strict dietary regimen, there is a reasonable likelihood that some participants may not adhere to the regimen. Thus, such a situation might reasonably occur and the termination statement should be added to the consent form. 
• Additional costs to the participant that might result from participation in the research. Whenever the protocol information indicates a situation in which it is reasonable to expect that subjects will incur travel or non-travel expenses as a result of participating in the research, an additional cost statement should be included in the consent document. For example, if subjects are traveling from outside of the immediate area in which they live in order to participate in the research, they are likely to incur gas expenses for which they won’t be compensated.
• Consequences of a participant’s decision to withdraw from the research. A statement indicating any consequences that will be imposed if subjects end their participation in the research prematurely should be included on all consent documents. For example, any protocol involving UM students, staff, or faculty as subjects should indicate that their decision to withdraw from the study will have no effect on their current status or future relations with the 91´ÎÔª. Protocols that involve any form of remuneration (e.g., monetary, gift card, course credit) must include a statement on the consent form indicating whether the subject will still receive the full token, a reduced amount, or nothing if they withdraw from the study.

• Procedures for orderly termination of participation by the participant. Consent forms should include an explanation of what will happen to the subjects’ data if he or she withdraws from the research (e.g., data will be excluded from the research and destroyed). Such statements are particularly important for protocols involving more than one data collection session or the collection of sensitive information.

• Risks related to pregnancy. Information regarding potential risks related to pregnancy is important when a research procedure may pose a risk to an embryo or fetus, but the applicability of the risks may not be apparent at the time of consent. For example, a female subject may not be pregnant at the time of consent but may become pregnant during the data collection or treatment phase of the research. Thus, such a statement would be important and required for MRI studies for which the MRI procedures may or may not pose a risk of harm to a developing embryo or fetus.

• New findings developed during the course of the research which might affect the subjects’ willingness to continue participation. Research protocols involving multiple data collection phases extending over time can generate preliminary findings that have risk implications for new or continuing subjects. Subjects must be informed of any significant findings that might affect their willingness to continue participation, and this is particularly important when the research conditions or procedures involve more than minimal risk of harm to the subjects.

• Number of participants involved in the study. When the number of subjects is relatively small (10 or less) and the information being collected from the participants is uniquely identifiable in nature, the need to protect confidentiality is particularly acute. Concern about protecting confidentiality is also magnified when data collection involves sensitive information. Under such circumstances, participants should be informed about the number of subjects expected to participate in the research, procedures taken to ensure confidentially, and any limitations on the researcher’s ability to protect confidentiality.

• Limitations on the researcher’s ability to protect confidentiality. When research data are collected under group conditions involving oral responses or behavioral observation (e.g., focus or intervention groups), the researcher cannot guarantee confidentiality. Research participants should be informed about the steps the researcher will take to protect confidentiality, but must also be informed of the limitations on the researcher’s ability to protect confidentiality.

• A statement that the subject's biospecimens (even if identifiers are removed) may be used for commercial profit and whether the subject will or will not share in this commercial profit.

• A statement regarding whether clinically relevant research results, including individual research results, will be disclosed to subjects, and if so, under what conditions.

• For research involving biospecimens, whether the research will (if known) or might include whole genome sequencing (i.e., sequencing of a human germline or somatic specimen with the intent to generate the genome or exome sequence of that specimen).

Consent Language and Reading Level

The individuals communicating information to the prospective participant, or to the legally authorized representative, during the consent process must provide the information in language understandable to the participant or representative. The language of the consent form should match the estimated reading level of the participants. Researchers may request a waiver or an alteration of the signed consent process for vulnerable populations who have cognitive impairments and/or low literacy levels, and provide additional assistance in reading the consent document and understanding the consent process. Options include using oral consent, providing short summary documents of the main consent documents that highlight the important points in a brief manner, etc.

Consent and Language Barriers

Researchers should prepare both English language and translated consent forms for proposals that include non-English-speaking subjects. An explanation of the translations and evidence of the comparability of the English and non-English consent forms is requested. The IRB may consult with language experts or require a "back-translation" into English. The translation should provide documentation to verify the accuracy of the translation and back-translation. 

If a non-English-speaking subject is enrolled unexpectedly, researchers may rely on an oral translation of the English language consent form, but should take extra care in the informed consent process to ensure that the subject has understood the project. A statement in the research records (and on the English language consent form) should indicate that the translation took place, identify the translator, and document the translator's belief that the subject understands the study and the consent process. If the subject is a patient, a note about the translation should be made in the patient's research records as well. Researchers should try to provide a written translation of the vital emergency contact information.

Sometimes a subject understands English but does not read or write English. Again, an impartial witness should document that the subject understands the research and the consent process and consented to participate. Whenever the protocol involves a significant number of participants for whom English is not the primary language, reasonable efforts must be made by the investigator to provide translation services and to offer translated consent documents whenever necessary.

Exculpatory Language

The information communicated to the prospective participant, or the participant’s representative, during the consent process may not include exculpatory language through which the participant or the legally authorized representative was made to waive or appear to waive any of the participant’s legal rights.

The information being communicated to the participant or the legally authorized representative during the consent process may not include exculpatory language through which the participant or the legally authorized representative release the investigator, the sponsor, UM or its agents from liability for negligence. Research studies involving human subjects that involve more than minimal risk of physical harm (for example, studies that require the participant to engage in moderate or higher levels of physical exercise) may contain the following liability statement. However, even this statement makes clear that any legal obligation would be honored if required by law:

The 91´ÎÔª does not provide medical or hospitalization insurance coverage for participants in this research study nor will the 91´ÎÔª provide compensation for any injury sustained as a result of participation in this research study, except as required by law.

2. Broad Consent

Broad consent is the seeking of prospective consent from subjects to unspecified future research for the storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens. It is an alternative to the standard informed consent process described in 45 CFR 46.116(d). The UM IRB currently does not allow the use of this alternative consent method. Investigators are advised to obtain standard consent or apply to the IRB for a waiver of informed consent.

3. Waivers or Alterations of Informed Consent

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 for informed consent provided the IRB finds and documents that:

• the research involves no more than minimal risk to the subjects;
• the waiver or alteration will not adversely affect the rights and welfare of the subjects;
• the research could not practicably be carried out without the waiver or alteration for access to identifiable information and/or biospecimens;
• whenever appropriate, the subjects’ must be provided with additional pertinent information after participation;

or

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

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

4. Parental Permission and Child Assent

Please see Chapter 4 for policies concerning parental consent and child assent.

5. Surrogate Consent

Unless waived by the IRB, informed consent must be obtained directly from the individual subject. Under appropriate conditions, investigators also may obtain informed consent from a legally authorized representative of a subject (surrogate consent). The provision allowing surrogate consent is designed to protect human subjects from exploitation and harm and, at the same time, make it possible to conduct essential research on problems that are unique to persons who have an impaired decision-making capacity or who are not otherwise competent to provide consent.

The IRB will require investigators to provide evidence of a completed competency assessment whenever there is a possibility of either impaired mental status or decision-making capacity in prospective subjects. The IRB will assess whether the proposed plan to evaluate capacity to consent is adequate.

If feasible, the investigator must explain the proposed research to the prospective research subject even when the surrogate gives consent. Under no circumstances may a subject be forced or coerced to participate in a research study. The IRB will evaluate (a) whether the assent of the subjects is required, and (b) whether plan for obtaining assent is adequate.

Legally authorized representative means an individual or judicial or other body authorized under applicable law or institutional policy to consent on behalf of a prospective subject to the subjects’ participation in the procedure(s) involved in the research [45 CFR 46.102(i)].

Legal Counsel of the University has determined that, in Montana, the following meet the definition legally authorized representative and, thus, can give surrogate consent:

• a court appointed guardian of the person.
• a health care agent appointed by the person in a Durable Power of Attorney for Health Care (DPAHC) that specifies that the individual also has the power to make decisions of entry into research.

Investigators should consult with UM Legal Counsel when conducting research outside of Montana to determine the requirements for a legally authorized representative in the jurisdiction in which the research will occur.

Conditions for Requesting Surrogate Consent

Such consent may be requested and accepted only when the prospective research participant is not competent or has an impaired decision-making capacity, as determined and documented in the person’s medical record in a signed and dated progress note. The determination must be made in accordance with the following requirements:

1. A medical practitioner may determine after appropriate medical evaluation that the prospective research subject lacks decision-making capacity and is unlikely to regain it within a reasonable period of time.
2. Consultation with a psychiatrist or licensed psychologist must be obtained when the determination that the prospective research subject lacks decision-making capacity is based on a diagnosis of mental illness.

6. Documentation of Informed Consent

Informed consent must be appropriately documented in accordance with, and to the extent required by policy and federal regulations, as follows:

1. Informed consent is documented using a written consent form approved by the IRB and signed and dated by the subject or the subject’s legally authorized representative at the time of consent. Electronic signatures are allowed.

2. A copy shall be given to the person signing the form. The consent form may be either of the following:

   1. a written consent document that embodies the elements of informed consent may be read to the subject or the subjects’ legally authorized representative, but the subject or representative must be given adequate opportunity to read it before it is signed, or
   2. a short form written consent document (when the elements of informed consent have been presented orally to the subject or the subjects’ legally authorized representative). When this method is used, be met:
      1. there must be a witness to the oral presentation; 
      2. the IRB must approve a written summary of what is to be signed by the subject or representative;
      3. the witness must sign both the short form and a copy of the summary;
      4. the person actually obtaining consent must sign a copy of the summary; and
      5. a copy of the summary must be given to the subject or representative, in addition to a copy of the short form.

7. Waiver of Documentation of Consent

The IRB may waive the requirement for the investigator to obtain a signed consent form for some or all subjects’ if it finds that:

1. the only record linking the subject and the research would be the consent document, and the principal risk would be potential harm resulting from a breach of confidentiality, and the research is not FDA-regulated; or
2. the only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality [NOTE: Subjects must be asked whether they want documentation linking them with the research, and their wishes must govern. For example, domestic violence research where the primary risk is discovery by the abuser that the subject is talking to researchers]; or
3. 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. Procedures such as non-sensitive surveys, questionnaires, and interviews generally do not require written consent when conducted by non-researchers; or
4. the subjects or legally authorized representatives are members of a distinct cultural group or community in which signing forms is not the norm, the research presents no more than minimal risk of harm to subjects, and there is an appropriate alternative mechanism for documenting that informed consent was obtained.

In cases in which the documentation requirement is waived, the IRB requires the investigator to provide, in the application materials, a written summary of the information to be communicated to the subject, and the IRB will consider whether to require the investigator to provide subjects with a written statement regarding the research.

8. Review and Approval of the Informed Consent Process

The IRB is responsible for the review and approval of the informed consent form prepared by the investigator. The informed consent form must contain all of the required elements and meet all other requirements as described in this section. If the informed consent has been initially prepared by an external entity other than a UM Principal Investigator, the IRB needs to ensure that the consent meets all the requirements of this policy.

IRB approval of the consent must be documented through the use of a certification stamp on each page that indicates the expiration date. If the consent form is amended during the protocol approval period, the date on the modified form will be the original expiration date.

In the case of federally-funded clinical trials, the investigator must post the consent form document for the trials on a publicly available federal website after the clinical trial is closed to recruitment, and no later than 60 days after the last study visit by any subject, as required by the protocol. Posting only a single consent form from a single site is required to satisfy the requirement for a multi-site study.

The investigator will obtain the legally effective informed consent of the subject or the subject’s legally authorized representative. IRB staff and IRB board members may use reviewer checklists that include an element designed to prompt consideration of this issue. Particular emphasis is placed on this issue to ensure that the assent of any individual under age 18 is accompanied by some form of consent from the child’s parent(s) or guardian(s). This is also a focus of concern for any situation where the subject (even if an adult age 18 or over) experiences a cognitive impairment that makes it essential that a guardian serve as a witness to a signature or that a proxy for that individual provides consent. Further guidance on this issue is offered in 45 CFR 46 Subpart D.

The circumstances of the consent process must provide the prospective participant or the legally authorized representative sufficient opportunity to consider whether to participate. The consent process should be carefully detailed on the IRB application. The information provided should detail how each potential participant will have an opportunity to ask questions prior to any signature of consent or other form of agreement when a waiver/alteration of signed consent is sought.

Risk of Coercion and/or Undue Influence

The circumstances of the consent process must minimize the possibility of coercion or undue influence. In particular, the IRB must determine that there is no coercion or undue influence in relation to the following situations:

• Remuneration: The IRB must determine that there is no monetary compensation/gift certificate/prize, or other award or remuneration that is out of proportion to the amount of time and effort that participants would expend during their involvement in the research. This must be carefully assessed to determine whether remuneration might make participation in the study difficult to reject. This would be of particular concern when remuneration is being offered to individuals from vulnerable populations who have minimal financial resources.
• Dual Relationships: The researcher(s) should disclose any dual relationship, or potential dual relationship, that might be involved in the research process. Dual relationships of concern exist when the investigator or the individual administering the research is in a position of power or influence over the research subjects for a reason not connected with the research. For example, when the investigators are course instructors or supervisors of 91´ÎÔª students who are being recruited to participate in the research, students may feel coerced to participate in the research in order to please the professor and/or avoid retribution related to grading. The same issue would arise when a 91´ÎÔª researcher is recruiting participation from UM faculty, staff, or students who are also being supervised by the researcher. Similar relationships could exist in contexts outside the university.