Research

Human Research Protection Program Policy and Procedure Manual - Section 5

5 Obtaining Informed Consent from Research Participants

5.1 Purpose

5.2 Definitions

5.3 Basic Requirements

5.4 Informed Consent Process

5.5 Basic Elements of Informed Consent

5.6 Documentation of Informed Consent

5.7 Consent Monitoring

5.8 Waiver of Informed Consent

5.9 Waiver of Documentation of Informed Consent

 

5 Obtaining Informed Consent from Research Participants
5.1 Purpose

The following procedures describe the requirements for obtaining consent from participants in research conducted under the auspices of Brown University.

 

5.2 Definitions 

Legally Authorized Representative. A legally authorized representative is an individual or body authorized under applicable law to provide permission on behalf of a prospective participant for the participant's participation in the procedure(s) involved in the research. For the purposes of this policy, a legally authorized representative includes not only a person appointed as a health care agent under a Durable Power of Attorney for Health Care (DPAHC), a court appointed guardian of the person, but also next-of-kin in the following order of priority unless otherwise specified by applicable state law: spouse, adult child (18 years of age or older), parent, adult sibling (18 years of age or older), grandparent, or adult grandchild (18 years of age or older).

 

Legal guardian. A person appointed by a court of appropriate jurisdiction.

 

5.3 Basic Requirements

No investigator may involve a human being as a participant in research without obtaining the legally effective informed consent of the participant or the participant’s legally authorized representative unless a waiver of consent has been approved by the IRB.  Except as provided in Section 5.9 of these procedures, informed consent must be documented by the use of a written consent form approved by the IRB (See Section 5.6).

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

 

If someone other than the investigator conducts the interview and obtains consent from a patient, the investigator needs to formally delegate this responsibility, and the person so delegated must have received appropriate training to perform this activity. The person so delegated must be knowledgeable about the research to be conducted and the consenting process, and must be able to answer questions about the study.

 

These informed consent requirements are not intended to preempt any applicable federal, state, or local laws that require additional information to be disclosed for informed consent to be legally effective.

 

5.4 Informed Consent Process

Informed consent must be obtained under the following circumstances:

  1. Informed consent may only be obtained from participants who have the legal and mental capacity to give consent.  For participants without that capacity, consent must be obtained from a legal guardian or a legally authorized representative.
  2. The informed consent process shall be sought under circumstances that provide the participant (or legally authorized representative) with sufficient opportunity to consider whether or not to participate.
  3. The informed consent process shall be sought under circumstances that minimize the possibility of coercion or undue influence.
  4. The informed consent information must be presented in language that is understandable to the participant (or legally authorized representative).  To the extent possible, the language should be understandable by a person who is educated to 8th grade level and layman’s terms shall be used in the description of the research.
  5. For participants whose native language is not English, informed consent must be obtained in a language that is understandable to the participant (or the participant’s legally authorized representative).  The IRB requires that informed consent conferences include a reliable translator when the prospective participant does not understand the language of the person who is obtaining consent.
  6. The informed consent process may not include any exculpatory language through which the participant is made to waive, or appear to waive, any of the participant’s legal rights or through which the investigator, the sponsor, the University, or University employees or agents are released from liability for negligence, or appear to be so released.
  7. The PI is responsible for insuring that each prospective participant is adequately informed about all aspects of the research and understands the information provided.
    • A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the participant's participation, a description of the procedures to be followed, and identification of any procedures which are experimental; a description of any reasonably foreseeable risks or discomforts to the participant;
    • A description of any benefits to the participant or to others which may reasonably be expected from the research;
    • A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the participant;
    • A statement describing the extent, if any, to which confidentiality of records identifying the participant must be maintained;
    • For research involving more than minimal risk, an explanation as to the availability of medical treatment in the case of research-related injury, including who will pay for the treatment and whether other financial compensation is available;
    • An explanation of whom to contact on the research team for answers to pertinent questions about the research or to voice concerns or complaints about the research, and whom to contact in the event of a research-related injury to the participant;
    • Contact information for the IRB to obtain answers to questions about the research; to voice concerns or complaints about the research; to obtain answers to questions about their rights as a research participant; in the event the research staff could not be reached; and in the event the participant wishes to talk to someone other than the research staff.
    • A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the participant is otherwise entitled, and the participant may discontinue participation at any time without penalty or loss of benefits to which the participant is otherwise entitled;
    • For FDA-regulated studies, the possibility that the Food and Drug Administration may inspect the records needs to be included in the statement regarding participant confidentiality.

 

5.5 Basic Elements of Informed Consent

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

  1. A statement that the particular procedure or treatment may involve risks to the participant, which are currently unforeseeable. (For example: Include when the research involves investigational test articles or other procedures in which the risks to participants is not well known.)
  2. A statement that if the participant is or becomes pregnant, the particular procedure or treatment may involve risks to the embryo or fetus, which are currently unforeseeable. (For example: Include when the research involves pregnant women or women of childbearing potential and the risk to fetuses of the drugs, devices, or other procedures involved in the research is not well known.)
  3. Anticipated circumstances under which the participant’s participation may be terminated by the investigator without regard to the participant’s consent. (For example: Include when there are anticipated circumstances under which the investigator may terminate participation of a participant.)
  4. Any additional costs to the participant that may result from participation in the research. (For example: Include when it is anticipated that participants may have additional costs.)
  5. The consequences of a participant’s decision to withdraw from the research. (For example: Include when withdrawal from the research is associated with adverse consequences.
  6. Procedures for orderly termination of participation by the participant. (For example: Include when the protocol describes such procedures.)
  7. A statement that significant new findings developed during the course of the research which may relate to the participant’s willingness to continue participation will be provided to the participant. (For example: Include when the research is long term and interim information is likely to be developed during the conduct of the research.)
  8. The approximate number of participants involved in the study. (For example: Include when the research involves more than minimal risk.)

 

5.6 Documentation of Informed Consent

Except as provided in Section 5.9 of this document, informed consent must be documented by the use of a written consent form approved by the IRB.

  1. Informed consent is documented by the use of a written consent form approved by the IRB and signed and dated by the participant or the participant's legally authorized representative at the time of consent.
  2. A copy of the signed and dated consent form shall be given to the person signing the form.
  3. The consent form may be either of the following:
    • A written consent document that embodies the basic and required additional elements of informed consent. The consent form may be read to the participant or the participant's legally authorized representative, but the participant or representative must be given adequate opportunity to read it before it is signed; or
    • A short form written consent document stating that the elements of informed consent have been presented orally to the participant or the participant's legally authorized representative.

When this method is used:

  • there must be a witness to the oral presentation; and
  • the IRB must approve a written summary of what is to be signed by the participant or representative; and
  • the witness must sign both the short form and a copy of the summary; and
  • the person actually obtaining consent must sign a copy of the summary; and
  • a copy of the summary must be given to the participant or representative, in addition to a copy of the short form.

 

5.7 Consent Monitoring

In reviewing the adequacy of informed consent procedures for proposed research, the IRB may on occasion determine that special monitoring of the consent process by an impartial observer (consent monitor) is required in order to reduce the possibility of coercion and undue influence, ensure that the approved consent process is being followed, or ensure that participants are truly giving informed consent.

 

Such monitoring may be particularly warranted for:

  • High risk studies
  • Studies that involve particularly complicated procedures or interventions
  • Studies involving highly vulnerable populations (e.g., children)
  • Studies involving study staff with minimal experience in administering consent to potential study participants, or 
  • Other situations when the IRB has concerns that consent process is not being conducted appropriately.

 

Monitoring may also be appropriate as a corrective action where the IRB has identified problems associated with a particular investigator or a research project.

 

If the IRB determines that consent monitoring is required, the IRB Chair and the RPO Director will develop a monitoring plan and submit it to the IRB for approval. The consent monitoring may be conducted by IRB staff, IRB members or another party, either affiliated or not with the institution. The PI will be notified of the IRB’s determination and the reasons for the determination. Arrangements will be made with the PI for the monitoring of the consent process for a specified number of participants.  When observing the consent process, the monitor will determine:

  • Whether the informed consent process was appropriately completed and documented,
  • Whether the participant had sufficient time to consider study participation, 
  • Whether the consent process involved coercion or undue influence, 
  • Whether the information was accurate and conveyed in understandable language, and
  • Whether the participant appeared to understand the information and gave their voluntary consent.

 

Following the monitoring, a report of the findings will be submitted to the IRB, which will determine the appropriate action to be taken.

 

5.8 Waiver of Informed Consent

An IRB may approve a consent procedure that does not include, or that alters, some or all of the elements of informed consent set forth above, or waive the requirements to obtain informed consent, provided the IRB finds and documents that:

  • The research involves no more than minimal tangible or intangible risk to the participants;
  • The waiver or alteration will not adversely affect the rights and welfare of the participants;
  • The research could not practicably be carried out without the waiver or alteration; and
  • Whenever appropriate, the participants must be provided with additional pertinent information after participation.

 

In addition, an IRB may approve a consent procedure that does not include, or that alters, some or all of the elements of informed consent; or waives the requirements to obtain informed consent, provided the IRB finds and documents that:

  • 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:
    1. public benefit or service programs
    2. procedures for obtaining benefits or services under those programs
    3. possible changes in or alternatives to those programs or procedures; or
    4. possible changes in methods or levels of payment for benefits or services under those programs.
  • The research could not practicably be carried out without the waiver or alteration.

FDA regulations do not provide for waivers of informed consent except in emergency situations (See Section 10.6.2).

 

5.9 Waiver of Documentation of Informed Consent

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

 

  1. Only record linking the participant and the research would be the consent document and the principle risk would be potential harm resulting from a breach of confidentiality, and the research is not FDA-regulated, or only record linking the participant and the research would be the consent document and the principle risk would be potential harm resulting from a breach of confidentiality, or
    Note 1: Participants must be asked whether they want documentation linking them with the research, and their wishes must govern. (Example: domestic violence research where the primary risk is discovery by the abuser that the participant is talking to researchers.)
    Note 2: In order to waive written documentation of consent where the only record linking the participant and the research would be the consent document, the IRB has to determine that the research was not FDA-regulated.
  2. The research presents no more than minimal risk of harm to participants and involves no procedures for which written consent is normally required outside of the research context. 

 

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 participant, and the IRB will consider whether to require the investigator to provide participants with a written statement regarding the research.

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