Research Participants Who Cannot Write

Q – If, for any reason, an English-speaking research participant is physically unable to sign a consent form (i.e., bandaged hands, loss of limbs, contact isolation, etc.), how should this individual’s consent to participate be documented?
A - The IRB will accept consent obtained in the following way as valid consent: The participant should be presented with a copy of the IRB-approved written consent document, the text should be read aloud by the person obtaining consent and the participant should be encouraged to ask questions and allowed to have questions answered, as is usual during a normal consent process. The participant would give consent verbally. The person obtaining consent and one other person (not associated with the study) would then sign and date the document. A complete and explicit description of why the participant was not able to sign the document should be included in the chart to provide a clear record of the event and the surrounding circumstances.

Research Participants Who Cannot Read

Q-If, for any reason, an English-speaking research participant is not able to read a consent form (i.e., illiteracy, vision-impairment), how should this individual’s consent to participate be documented?
A-In cases where the research participant is not able to read, the informed consent dialogue becomes extremely important. An impartial witness should be present during the entire informed consent conversation. The text of the informed consent document and any other written information should be read aloud by the person obtaining consent. The participant should be encouraged to ask questions and allowed to have questions answered, as is usual during a normal consent process. If the research subject wishes to enroll in the study the subject may consent orally and if able, may sign and date the consent form. After the subject has consented, the witness signs and dates the consent form to attest that the subject received the information, the risks/benefits/alternatives were discussed, and informed consent was freely given. A complete and explicit description of why the participant was not able to sign the document should be included in the chart to provide a clear record of the event and the surrounding circumstances. For additional information, see Guidance for Industry – Documenting Informed Consent, Section 4.8.9 @ http://www.fda.gov/cder/guidance/959fnl.pdf

Subject Recruitment

Q – When does the IRB believe recruitment begins?
A – Recruitment involves seeking individuals to enroll or participate in a research project through advertisement. An advertisement is a public announcement usually by a printed notice or voice or data broadcast that describes a research study including contact information. The IRB considers advertising or soliciting for study participants to be the start of recruitment and in turn, the informed consent process and subject selection process. When advertising is to be used, the IRB must review the information contained in the advertisement, and the mode of its communication, to determine that the procedure for recruiting participants is not coercive and does not state or imply a certainty of favorable outcome or other benefits beyond what is outlined in the consent document and study protocol.

Protocol Deviation

Q – What is the difference between a Protocol Deviation and an Amendment?
A – An amendment is a change or changes that are premeditated, intentional, and occur prior to implementation. Therefore, prior to any change in the protocol the submission of an amendment is required. It should be noted that the Committee approves a study in its totality. Once altered, the study is no longer that which the Committee approved. Therefore, the Principal Investigator cannot change a study prospectively without an approved amendment. To do so, would alter a study from one approved by the IRB to a study that has not been approved.

Alternatively, a protocol deviation does not occur as a deliberate, purposeful change to an approved protocol. It is an unplanned, unintended change to the protocol, which is a written plan. Sometimes an unplanned change will happen due to patient error, incidental oversight by the study staff, or to protect patient safety or welfare. It is for these occasions that the category of protocol deviation was designed. If this occurs it should be reported on a Protocol Deviation Form (#1123).

IRB Contact Information

Q – Where is the IRB located?
A – On the 5th Floor of the Oxford House

Q – What is the phone number for the IRB?
A – You can reach the IRB at (615) 322-2918 or (866) 224-8273 toll free.

Participant Enrollment

Q – When does an individual become enrolled in a study?
A – The IRB considers a person enrolled after he/she has agreed to participate in a study and has signed a consent form.

IRB Committee/Members

Q – When do the IRB Committees meet?
A – The Vanderbilt IRB has four committees that meet weekly. Three of the committees review biomedical/health science research. One of the committees reviews social/behavioral science research.

Grants

Q – Why does the IRB need to review my grant?
A – In the past, numerous instances have been identified in which human subject research described in a grant application differed significantly from how it was described in an IRB application/protocol. The grant included important elements (e.g., targeting of vulnerable subjects, additional arms, different doses, etc.) that were ultimately implemented without IRB review and approval. Department of Health and Human Services (HHS) regulations at 45 CFR 46.103(f) require that each grant application or proposal for HHS-supported human subject research be reviewed and approved by the IRB.

Consent Process/Document

Q – When should a participant be re-consented?
A – The IRB will consider, on a case-by-case basis, whether and when periodic re-consenting of individuals is required to assure that a participant’s continued involvement is voluntary. The IRB may require that the investigator re-consent subjects after taking into account the study’s anticipated length and the condition of the individuals to be included (e.g., participants with progressive neurological disorders, participants who may become incarcerated, an altered risk/benefit ratio, etc.). Additionaly, the IRB will consider whether and when to require a reassessment of decision-making capacity.

Communication with Participants

Q – For participants who were previously enrolled and are no longer part of long-term follow-up, how should new safety information about a drug be communicated to them?
A – With each safety update or amendment, the local Principal Investigator is responsible for assessing the potential impact on all current and previously enrolled participants. This assessment should be submitted to the IRB to be reviewed on a case-by-case basis. In some cases, re-consent may be necessary.