Updated July 1, 2021 Show
Federal Regulations for Consent Related to Cessation of ParticipationThe voluntary nature of participation in research requires the investigators to inform each participant she/he/they may discontinue participation in an ongoing research study, without penalty or loss of benefits to which she/he/they may be otherwise entitled (per general requirements for informed consent at 45CFR46.116 item (b)(8)). A participant can leave a research study at any time. When withdrawing from the study, the participant should let the research team know that he/she/they wishes to withdraw. A participant may provide the research team with the reason(s) for leaving the study, but is not required to provide their reason. Per 45CFR46.116 items (c) (2) and (4), when applicable researchers must inform each participant of:
Other information and nonbinding recommendations may be found in the OHRP guidance for withdrawal of participants. The IRB application requires University and affiliate researchers to describe plans both for investigator and participant-initiated withdrawal. The consent form templates and instructions address the requirements for informed consent and discontinuation of participation, including requirements to inform participants of anticipated conditions under which termination of participation may occur. Reasons for Discontinuation of ParticipationDepending on the type of study, the participant may be given a variety of instructions for ending his/her/their participation in the study. For instance, a participant may be given instructions on how to safely stop using study medications. Instructions may also be given on who to contact if there are any questions or concerns that arise after completing the study. The research team may need to have the participant return so that he/she/they can be monitored for any future adverse effects from the study treatments, procedures, or interventions. For evaluation and reporting purposes, researchers may ask participants for their reasons for early withdrawal. Information about the reasons a participant chooses to end her/his/their participation in the study allows the PI and the IRB to identify potential problems related to the conduct of the research. For example, high withdrawal rates secondary to serious adverse events require:
An investigator may terminate an individual’s participation in a research study to:
Whenever an investigator terminates an individual’s participation in research, the investigator must explain to the participant the reasons for the termination and, as appropriate, other treatment options available to the participant. The continuing review/progress report form requires PIs to note the number of and summarize the reasons for early withdrawals. Depending on the screening and enrollment processes, screen failures may or may not comprise a reason for participant withdrawal. For example, screen failures may NOT be noted as withdrawals when informed consent for the primary study is obtained after the eligibility screening and only from individuals determined to be eligible for the study. Regardless of the reasons for the withdrawal, the PI and the IRB must consider the following:
Safe Discontinuation of ParticipationWhen investigators anticipate unfavorable consequences for participants who withdraw from a research study, both anticipated consequences of and planned safeguards for early withdrawal must be disclosed in the IRB application and consent documents. Retention and Use of Data Collected Prior to Participant WithdrawalUniversity and affiliate investigators may retain and use data collected prior to participant withdrawal, including Protected Personally Identifiable Information (PPII) (see IRB Policy Manual Definitions), as long as the uses are consistent with the study purpose and procedures as described in the IRB application and consent documents. If the study involves collection of health information, at the time of withdrawal, the research participant should let the research team know if he/she/they will allow the continued collection and use of his/her/their health;information by the researchers. At its discretion, the IRB may require the PI to include processes for participants to ask that their PPII be removed from the data-set if retention of personal identifiers may pose risks to participants after their withdrawal from the study (e.g., research data involves illegal or stigmatizing behaviors). This policy does not preclude PIs from voluntarily including procedures for participants to ask that their data be destroyed or excluded from analysis, as long as these processes are described in the IRB application and the research is not regulated by FDA. NOTE: Participant data cannot be removed from an FDA-regulated study. The data collected about the participant up to the point of withdrawal must remain in the study database. Discontinuation of Research Activities Following Participant WithdrawalThe investigator must discontinue the following research activities for any participant who withdraws from an ongoing study:
Continuation of Research Activities Following Participant WithdrawalA participant may withdraw from:
University and affiliate investigators may ask a participant who is withdrawing whether she/he/they wishes to allow follow-up and further data collection subsequent to their withdrawal from the interventional portion of the study. Follow-up activities may be implemented post-withdrawal under the following two conditions:
A participant's agreement to continue with non-interventional components after withdrawal from the primary intervention allows the investigator to complete follow-up activities involving the collection of private information:
The PI is responsible for explaining to the participant which non-interventional components will continue. Participant Withdrawal from Clinical TrialsClinical trials are designed to evaluate the safety and effectiveness of specific interventions in the management of diseases or disorders. Continued participation in the secondary components of a research study may be particularly important in such trials. If a participant wants to withdraw from a clinical trial, the PI may clarify if the participant wishes to withdraw from the study entirely, or only from the interventional components. During this clarification, the PI may let the participant know the importance of collecting follow-up safety data about the participant. Collection of Clinical Outcome or Public Information Post-WithdrawalWhen a researcher is also a participant's physician or treating clinician, early withdrawal may trigger the need for follow-up for clinical purposes (i.e., post-withdrawal assessments and documentation of the course of the illness/condition). In such situations, there must be a separation of:
Following a participant's withdrawal from a research study, the researcher-clinician may wish to use information from the clinical follow-up procedures to be used for research. Assuming such a situation was not described in the original application and consent document, the PI must obtain the participant-patients consent for the use of clinical information for the research. The PI must obtain IRB approval for an amendment to the protocol and an addendum to the consent document. The consent addendum would specify the information the researcher-clinical would obtain from the participant's clinical records to use for the research. If a participant withdraws from the research intervention for a study and does not consent to continued follow-up of associated clinical outcome information, the investigator cannot access the participant's medical or other confidential records requiring the participant's consent, for purposes related to the study. Under these conditions, the clinician/researcher may:
Which of the following should be included in a consent form?A statement that the study involves research, an explanation of the purposes of the research, the expected duration of a subject's participation, a description of the procedures to be followed, and if applicable identification of any experimental procedures.
Which of the following is the alpha level accepted by most in psychological research as indicating significance?Researchers who analyze data within the framework of null hypothesis significance testing must choose a critical “alpha” level, α, to use as a cutoff for deciding whether a given set of data demonstrates the presence of a particular effect. In most fields, α = 0.05 has traditionally been used as the standard cutoff.
How many branches to statistics frequently used by psychologists?The two main branches of statistics are descriptive statistics and inferential statistics.
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