To document all correspondence between the study site and IRB includes notation of important dates (e.g. To document the investigator’s delegation of certain responsibilities to study personnel in order to conduct research

To keep track of all unanticipated problems occurring while research is active, and its reporting Normally used for clinical trials, but may be helpful for any large-scale research to help investigators manage their research Mental Health and Suicide Prevention During Times of Crisis Regulatory Documents/Investigator Toolkit TMP 470 Counseling Services Resource Information TMP 468 Adult Consent, Future Use of Biospecimen TMP 465 Deception Research, Debriefing Form Debriefing is often linked solely to social psychology or deception research with many researchers conflating informed consent with debriefing practices (. A useful and thorough consent template addressing an array of clinical trial procedures is provided by the National Cancer Institute at While this template was developed for cancer trials, the sample language addressing complex medical procedures is useful for many types of clinical trials. You use REP or Your study employs deception or you do not explain some. Because of the complexity of most clinical trials, it is important to focus on the process of informing individuals about the study in a way that is easy to understand. Below is an example debriefing statement that you may use as the basis for your. TMP 463 Assent, Genetic Study on Minors (7-13)įor Clinical Trials, start with the basic format provided in Model Consent Form (MCF) 442 above. TMP 455 Parental Consent, Curriculum Research on Minors TMP 454 Assent, Curriculum Research on Minors (14-17) TMP 445 Parental Consent to Interview Minors What should debriefing procedures / debriefing form be like Must happen in a way that all participants are aware of the full true purpose of the study and none left undebriefed. Research Involving Minors (under 18 years of age) Explain specific deception used in the study, and explain that the assurances of confidentiality, as described on the consent form, are TRUE. TMP 444 Anonymous Survey (Direct Interaction) Templates and Forms Model Informed Consents For Social and Behavioral Science (SBS) Research

Research debriefing form