The Informed Consent Process

The Informed Consent Process :

The Informed Consent Process

Informed Consent:

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. An investigator shall seek such consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to 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 shall be in language understandable to the subject or the representative. 45 CFR 46.116 Informed Consent

Slide 3:

IRB 1998;20:1-7.

Objectives:

Objectives Informed Consent Process Informed Consent Interview Informed Consent Document Informed Consent and Vulnerable Populations

Research  Medical Practice :

Research  Medical Practice

Patients vs. Subjects:

Patients vs. Subjects When a person volunteers to participate in a research trial, his or her status changes from patient to subject Subjects may not be receiving “standard of care”. The risks may be higher Documentation for subjects is MORE EXTENSIVE than regular clinical documentation The subject is the ultimate decision maker and must have complete information to assure his participation remains voluntary

The Informed Consent Process:

The Informed Consent Process Informed consent is information exchange including subject recruitment materials, verbal instructions, written materials, questions and answer sessions and signature documenting consent with date. Subjects are given opportunity to choose involvement based on information, comprehension and voluntariness.

The Informed Consent Process:

The Informed Consent Process Is the key to respecting autonomy Provides a reasonable assurance that the subject has not been deceived or coerced Cannot be obtained from those who are vulnerable, dependent or cognitively impaired

Steps in Informed Consent Process:

Steps in Informed Consent Process Starts with an interview Is an exchange of essential information about the research Allows an opportunity for subject to ask questions and have them answered Is evidenced by the signing of informed consent document Is documented in record Requires giving a copy of the Informed Consent form to the subject Continues at each interaction by providing the subject new information as it develops

Informed Consent Interview:

Informed Consent Interview

Interview:

Interview Choose a quiet, private, non-intimidating place to talk to the prospective subject An investigator shall seek such consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence. The information that is given to the subject shall be in language understandable to the subject or representative 45 CFR 46.116

Interview:

Interview Explain the research in simple terms Describe what is going to happen Be clear this is a voluntary activity Truthfully state any possible benefits (payment is not considered benefit) Truthfully state known possible risks Lay out alternatives to participation Describe how personal information will be kept confidential OHRP Tips for Informed Consent

Interview:

Interview Talk about research related injury – and if there would be any compensation Will the subject undergo any additional direct or indirect costs? Make sure and explain that no legal rights will be waived Emphasize that the subject may quit the study at any time with NO affect on their medical care

Interview:

Interview Explain that participation can be terminated by the investigator without subject’s permission Give the IRB number to the subject should they have questions about their rights as a research subjects Some studies require 24 hour contact numbers for the investigator Discuss the possible risks to pregnant women and fetus

Interview:

Interview Tell the subject that if new information, positive or negative is discovered regarding the research that they will be informed. During the interview be aware of the things you might be saying that would affect voluntariness or be coercive “free drug” “free treatment” “I think this is best for you” “do this for me”

Interview:

Interview Who can conduct the Interview to obtain Informed Consent? The PI A subinvestigator A study staff person, listed with the IRB, whom the investigator has documented is fully conversant with the study and is able to answer subjects questions.

The Informed Consent Document:

The Informed Consent Document Use the current, IRB approved version

Informed Consent Document:

Informed Consent Document The ICD should Contain all required elements Describe the study in language the person can understand Be signed and dated by Subject or Legally Authorized Representative (LAR) Witness Investigator Person obtaining the consent , if not an investigator

Informed Consent Document:

Informed Consent Document The person signing as the witness cannot be the same as the person obtaining consent or the investigator The subject MUST be given a copy of the complete consent form.

Documentation of Informed Consent:

Documentation of Informed Consent The subject record should contain a note that documents the Process Today I discussed the ABC Drug Company hypertension study with Mrs. Jones. I explained the study and went over the consent form with her and her husband. They had time to ask questions and have them answered. Mrs. Jones voluntarily agreed to participate. She signed the informed consent form and her husband signed as a witness. She was given a copy of the signed form. Mary Price, RN participated in the interview.

When Is the Informed Consent Process Finished?:

When Is the Informed Consent Process Finished? When the study is closed and final reports are issued! At each interaction, the investigator must reassure Voluntary participation continues New information is given to the subject

Vulnerable Populations:

Vulnerable Populations

Vulnerable Populations and Informed Consent:

Vulnerable Populations and Informed Consent Persons who may not be able to make free and informed decisions about their participation in research or medical care are considered vulnerable Vulnerable populations may be easily coerced or have limited freedom to choose Persons identified as vulnerable have additional safeguards in the research informed consent process

Informed Consent & Vulnerable Populations:

Informed Consent & Vulnerable Populations Vulnerable Populations protected in regulation are: Children and wards of the state Prisoners Pregnant Women and fetuses Cognitively Impaired

Informed Consent & Vulnerable Populations:

Informed Consent & Vulnerable Populations Other accepted vulnerable populations are: Non-English speaking persons Illiterate persons Financially impaired Terminally Ill

Prisoners:

Prisoners

Informed Consent & Prisoners:

Informed Consent & Prisoners Prisoners, due to the lack of control of their circumstances are considered vulnerable DO NOT enroll prisoners unless you check with the IRB first. There MUST be a prisoner representative on the IRB if a prisoner is enrolled If a person becomes a prisoner during a trial, notify the IRB immediately

Informed Consent & Prisoners:

Informed Consent & Prisoners Informed consent for a prisoner would state that participation will not be considered in parole consideration Must state that risks for prisoner in this study same as for a non-prisoner If a prisoner is treated in a research study and the IRB is not aware or does not have a prisoner advocate on the committee, federal regulatory bodies must be notified

Pregnant Women and Fetuses:

Pregnant Women and Fetuses

Informed Consent & Pregnant Women:

Informed Consent & Pregnant Women Researchers should obtain informed consent from both the pregnant woman and the father Consent of the father is not necessary if: The purpose of the study is to meet the health needs of the mother. The identity or whereabouts of the father can not be reasonably ascertained. The father is not reasonably available. The pregnancy is the result of rape. NOTE: Research targeting pregnant women as subjects does not qualify for an exempt status.

Informed Consent in Fetal Research:

Informed Consent in Fetal Research In utero fetal research Same signature as those for pregnant women Study personnel may play no part in determination of fetal viability

Informed Consent in Fetal Research:

Informed Consent in Fetal Research Ex Utero Research Study personnel may play no part in determination of fetal viability Many regulatory restrictions based upon viability of fetus. Mother and father must be legally competent and have given their informed consent. (Consent of Father may not be required) If anticipating this type of research, contact IRB or ORC during planning phases.

Cognitively Impaired:

Cognitively Impaired

Informed Consent & Cognitively Impaired:

Informed Consent & Cognitively Impaired Persons with diagnosed cognitive impairment such as mental retardation, dementia, and coma, can participate in research. This type of research must specifically address how an individual’s capacity to give informed consent will be determined. The signature of a legally authorized representative will be required Research with Cognitively Impaired subjects cannot be considered exempt by the IRB

Informed Consent & Cognitively Impaired:

Informed Consent & Cognitively Impaired For persons whose cognitive status is suspect, but there is no definitive diagnosis Use the Cognitive Impairment Algorithm in the Investigator’s Handbook to determine ability to give free informed consent Document the use of the algorithm

Cognitively Impaired:

Cognitively Impaired Document carefully the enrollment of persons whose cognitive status is not outwardly obvious e.g. stroke patients, psychiatric patients or persons with speech or language disorders If a person is enrolled in a study during a period of cognitive impairment and regains his ability to give consent – he must be re-consented

Non-English Speaking and illiterates :

Non-English Speaking and illiterates

Informed Consent & Non-English Speaking Persons:

Informed Consent & Non-English Speaking Persons Persons must be consented in a language that is understandable to them Non-English speaking subjects may not be excluded on the basis of language If the principal investigator anticipates that consent interviews will be routinely conducted in a language other than English, the IRB requires a translated consent document be submitted with the original protocol for approval. It is the investigator’s responsibility to ensure that the translation is accurate.

Informed Consent & Non-English Speaking Persons:

Informed Consent & Non-English Speaking Persons A copy of the consent document must be given to each subject. While a translator may be helpful in facilitating conversation with a non-English speaking subject, verbal translation of the consent document must not be substituted for a written translation. If a Non-English speaking subject is unexpectedly encountered, and a written translation of the consent document is not available. Investigators should carefully consider the ethical/legal ramifications of enrolling subjects when a language barrier exists

Informed Consent & Illiterate Persons:

Informed Consent & Illiterate Persons An investigator may enroll individuals, who can speak and understand English, but cannot read or write. The potential subject must be able to place a written mark on the consent form. . The subject must also be able to: Comprehend the concepts of the study and understand the risks and benefits of the study as it is explained verbally, and. Be able to indicate approval or disapproval for study enrollment.

Informed Consent & Illiterate Persons:

Informed Consent & Illiterate Persons Additional items to document what method was used to communicate the information about the study Who was present during the Informed Consent Interview The specific ways that the subject communicated agreement to study participation

Special Issues:

Special Issues

Informed Consent Issues:

Informed Consent Issues Groups where coercion is a serious concern Terminally ill are desperate for any type of cure. These are probably the persons MOST vulnerable to coercion. Beware the therapeutic misconception Poor – the poor can be coerced by “free care” and re-imbursements can substantially affect the voluntariness of the decision to participate.

Informed Consent Issues:

Informed Consent Issues Beware the Therapeutic Misconception “What goes awry is that the ill subject does not grasp that what she has volunteered for really is research; It can be enormously hard to shake the erroneous belief that the intervention is designed to make the volunteer better, rather than contribute to anything as faceless as the medical welfare of future patients” James Lindemann Nelson

Summary:

Summary The Informed Consent Process begins with an interview and continues through the study Participation in research must begin as a voluntary activity and remain voluntary Persons who are vulnerable may not be able to freely consent, and require special protections in the informed consent process.

Summary:

Summary The Investigator is primarily responsible for the ethics and practice of informing persons about their participation in research

Summary:

Summary The Investigator should communicate the importance of the Informed Consent Process to the research staff and expect them to maintain high ethical standards.