VT Human Subjects Protection Tutorial
1. Welcome --- 2. Reason for Training --- 3. Importance of Compliance --- 4. History --- 5. Selection of Subjects --- 6. Recruitment --- 7. Consent --- 8. Paying Subjects --- 9. Confidentiality & Anonymity --- 10. Who Regulates Your Research? --- 11. VT IRB Submissions --- 12. Continued Compliance ---QUIZ
7 Consent Process & Document
Under the principle of respect for persons, subjects, to the degree that they are capable, must be given the opportunity to choose what shall or shall not happen to them.
There are three elements to the informed consent process:
- Information
- Comprehension
- Voluntariness
Information
Subjects must be given adequate information to properly make an informed decision regarding participation. At a minimum, federal regulations require the following information to be included in the consent process and consent document:
- Brief description of the research procedures, including length of procedures
- Statement that the study involves research
- Purpose of the research
- Risks and anticipated benefits
- Alternative procedures (if therapy – clinical/surgical treatment involved)
- Description of confidentiality/anonymity provided
- Explanation of compensation provided, if any
- Statement indicating that subject is free to withdraw at any time from the research project without penalty
- Statement that questions can be asked, and names and addresses/telephone numbers of PI and IRB Chair provided
The VT IRB has additional requirements that must be contained within a consent form. Visit our website at
http://www.irb.vt.edu/pages/consent.htm for a checklist that will help you ensure that all required elements are included.
Comprehension
Subjects must be able to adequately understand the project, his/her role, and the risks involved. As the risks become more serious, the obligation to ensure subject comprehension greatly increases.
Timing
To achieve understanding, potential subjects should not be presented information all at once or only at the last minute. People need time to think about whether or not they want to participate. They may wish to discuss the decision with family, close friends, or religious advisors. They should not feel rushed or coerced. They need time, especially if the information is disturbing or particularly complex, to digest the information and come to terms with it. Researchers should be prepared to give adequate time to the subjects for review – one day, a week, or more, depending upon the level of risk and complexity of the subject’s involvement in the research.
During lengthy studies, the researcher must also “maintain” consent. This may be accomplished by checking with the subject throughout the study to accomplish the following:
- To ensure that the subject still has a full understanding of the study
- To answer any questions that may have developed after the initial consent process
- To address issues of discomfort, confusion, or to have the subject decline continued participation
- To gather the opinion of the subject as of how the study is going or if he/she has any recommendations for the improvement of the study
- To discuss the remainder of the study procedures to remind the subject where he/she is at in the study process
Consent Process: Ensuring Comprehension
The informed consent process is different from the consent form. It involves meeting with a potential subject, finding out whether he or she is capable of giving consent, and discussing the purpose, risks, and benefits of participation. The consent form formalizes the agreement to participate and should be designed to document the process. Obtaining informed consent is not just giving a prospective subject a consent form and getting it signed. If consent by the subject involves their being truly informed, the subjects must genuinely understand the study; hence, researchers should strive to convey information to subjects, not merely disclose it to them. Subjects should be able to say what they are consenting to (i.e., be able to describe the project and their involvement in their own terminology).
Barriers to Comprehension
- Disorganized descriptive materials
- Rapid presentation with too little time for questions
- Subject’s intelligence, rationality, maturity, culture, and language
- Illiteracy
- “Incompetency” – infants, young children, mentally disabled or comatose patients
Voluntariness
Voluntary recruitment involves the free-will choice of individuals in conditions free of extreme urgency, with little time to ponder choices and undue influence / coercion. Recruitment not free of these conditions invalidates any consent that may be given.
Undue influence / coercion =
- To offer excessive, unwarranted, inappropriate, or improper rewards or overtures to obtain consent
- To manipulate a person’s choice through the controlling influence of a close relative or friend
- To threaten withdrawal of a service to which the person is otherwise entitled
Obtaining a Waiver of Informed Consent from the IRB
If necessary and adequately justified, researchers may request a waiver for the requirement to obtain informed consent from subjects. In other words, subjects are unaware that they are participating in the research. Obtaining this waiver is sometimes necessary in order to conduct research.
Obtaining a Waiver of Signed Consent from the IRB
Many socio-behavioral research projects qualify for a waiver of the requirement for the researcher to obtain signed consent documents from subjects. If this waiver is approved, researchers must ensure that subjects are fully consented to participate in the study. In other words, the research project and all of its elements are fully disclosed to subjects in order for subjects to make an informed decision about participating; however, the researchers do not need to obtain each subject’s signature on the consent form. If seeking a waiver of signed consent, the IRB highly recommends and may require that the investigator provide subjects with a written statement regarding the research. This is typically called an information sheet. The information sheet provides subjects with much of the same information required in a consent document; however, signatures are not obtained from subjects.
Both of the waivers discussed above may be requested for either some or all of the study’s procedures involving human subjects. If the waiver does not cover all study procedures involving human subjects, a consent form or the informed consent (depending on the type of waiver sought) may be required to cover the additional study procedures.
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