1. Sal Iva, a PhD candidate, wants to study electrolytes in the saliva of patients with cystic fibrosis. Dr Rosenstein, Director of the CF clinic, offers to collect 1 cc of saliva from 10 patients at their next clinic visit. Sal does not want or need any identifying information. Is Sal exempt from IRB oversight? Cite the Common Rule for justification.
Ans: Yes, Sal is exempt from IRB oversight. In this case, Sal is only obtaining the saliva sample from the patients, not the identifying information. According to the Common Rule [46.101 (b), paragraph 2], Basic HHS Policy for Protection of Human Research Subjects is not applicable for any research involving any educational tests where the information is recorded in such a way that the subjects cannot be identified by …show more content…
Connie Fadenshull, a medical student working with Dr Rosenstein wants to do a medical records study of patients with CF who died at Hopkins between 1950 and 2000. She plans to record identifiable information in her spreadsheet.
a. Does she need IRB approval? Cite the Common Rule.
Ans: Yes, Connie needs IRB approval for this because she is obtaining the identifiable information of the subjects and it is not exempt from the IRB oversight. She might not need to the IRB approval for this medical records study if she did not plan to record the identifiable information [Common Rule 46.101 (b) paragraph 4]1.
b. Does Melton believe consent should be required for Connie’s study?
Ans: Though Melton believes in patient’s privacy and the confidentiality of identifiable information, he does not think that consent is necessary for this circumstances. The subjects Connie wants to deal with are already expired. Practically it is not feasible to find out the relatives of every patient and ask for their consent. Medical records study is virtually impossible and vulnerable for selection bias if we need informed consent for every patient, especially the patients with adverse outcome and the expired
Ans: Yes, Sal is exempt from IRB oversight. In this case, Sal is only obtaining the saliva sample from the patients, not the identifying information. According to the Common Rule [46.101 (b), paragraph 2], Basic HHS Policy for Protection of Human Research Subjects is not applicable for any research involving any educational tests where the information is recorded in such a way that the subjects cannot be identified by …show more content…
Connie Fadenshull, a medical student working with Dr Rosenstein wants to do a medical records study of patients with CF who died at Hopkins between 1950 and 2000. She plans to record identifiable information in her spreadsheet.
a. Does she need IRB approval? Cite the Common Rule.
Ans: Yes, Connie needs IRB approval for this because she is obtaining the identifiable information of the subjects and it is not exempt from the IRB oversight. She might not need to the IRB approval for this medical records study if she did not plan to record the identifiable information [Common Rule 46.101 (b) paragraph 4]1.
b. Does Melton believe consent should be required for Connie’s study?
Ans: Though Melton believes in patient’s privacy and the confidentiality of identifiable information, he does not think that consent is necessary for this circumstances. The subjects Connie wants to deal with are already expired. Practically it is not feasible to find out the relatives of every patient and ask for their consent. Medical records study is virtually impossible and vulnerable for selection bias if we need informed consent for every patient, especially the patients with adverse outcome and the expired