September 2004

Human Subjects

Authorization Clarification: To "pre-check" or not to "pre-check" — that is the question According to RCA, the only areas in which the researcher should not “pre-check” a box within the Authorization, is in the following section: Specific Authorizations: I understand that this release also pertains to records concerning hospitalization or treatment that may include the categories listed below. I have the right to specifically request that records NOT be released from my health care providers to the Research Team. However, I understand that if I limit access to any of the records listed below, I may not be able to be in this research study. Check limitations, if any, below: Mental health records Psychotherapy notes HIV (AIDS) Sexually transmitted diseases Alcohol / substance abuse Other: ______________________ The purpose of including the above section in the Authorization order is to comply with Indiana State law. The subject should be informed that should they check any of these items, it may limit or eliminate their participation in the study. Additional information offered by RCA includes the following: HIPAA does not prohibit researchers from “pre-checking” the other check boxes in the Authorization, provided that the patient/subject is informed that these items have been “checked” and why they have been “pre-checked”. Although not required by HIPAA or the IRB, researchers may choose to “pre-check” these items in order to create a standard authorization for his/her study. If the items that are “pre-checked” are necessary for the subject to participate in the study, this will aid in consent process since the required items have already been filled in. It is important to note that keeping the patient informed is the key concern apart from the fact that the researcher may elect to “pre-check” or not to “pre-check” the boxes within the Authorization. OHRP Provides Review Guidance for IUPUI/Clarian IRB Procedures This finding has also been noted by the Association for the Accreditation of Human Research Protection Programs (AAHRPP) in reviews of organizations applying for accreditation for their human research protection program. In the event that IRBs, including the IUPUI/Clarian IRBs, may be inappropriately “provisionally approving” research that requires substantial changes and clarifications, OHRP made the following recommendations in response to this finding: When the convened IRB requests substantive clarifications or modifications regarding the protocol or informed consent documents that are directly relevant to the determinations required by the IRB under 45 CFR 46.111, IRB approval of the proposed research should be deferred, pending subsequent review by the convened IRB of responsive material. Only when the convened IRB stipulates specific revisions requiring simple concurrence by the investigator may the IRB Chair or another IRB member designated by the Chair subsequently approve the revised research protocol on behalf of the IRB under an expedited review procedure. Specifically for IUPUI/Clarian IRBs, this dictates that if the IRB requires substantial clarification or modifications (i.e., provisions) regarding the protocol or informed consent that are necessary to determine if the necessary requirements are satisfied in order to approve a study, the study must be tabled. Utilizing this procedure, the convened IRB would be providing a subsequent review of the investigator’s responses. Only when the IRB requests specific, directive revisions can the study be provisionally approved. Examples: If the IRB requests stipulations such as “clarify why this is the preferred method as opposed to other methods” or “will lab tests be done to monitor for safety,” the study must be tabled since the investigator cannot provide simple concurrence to these stipulations and the investigator’s responses are directly relevant to enabling the IRB to make the required determinations for approving such research. If, however, the IRB requests stipulations such as “state that X method is the standard method” or “include lab tests to monitor for safety at weeks 6 and 9,” the study may be provisionally approved assuming the investigator can simply concur with or directly respond to the IRB’s provisions. The result for IUPUI/Clarian is that the IRB must be more diligent at providing directive provisions to investigators, whenever possible, if a study is to be provisionally approved. However, if it is necessary for the IRB to request provisions such as “clarify…,” “provide more information…,” “explain which…,” etc., the IRB must table the study. As a result, the study would be re-reviewed at a subsequent convened IRB meeting. Unfortunately, this could delay approval time of the research. However, we must keep in mind that the IRB’s charge is to protect human subjects, and if the investigator does not provide sufficient and comprehensible information in the study documentation to enable the IRB to ensure that this has adequately been done, the study cannot be approved. Along with the IRB’s responsibility to provide explicit directives to investigators, the investigator must also ensure that s/he is providing complete and comprehensible information to the IRB pertaining to their research. As a result of this OHRP guidance, please note that for the next few months, the Research Compliance Administration will be including a note in all communication sent to investigators after an IRB meeting reminding them of this procedural change. Please send any questions or concerns regarding this issue to resrisk@iupui.edu.

What's New

Informatics Offers “Defining the Research Agenda” Conference Through formal lectures and informal conversations, this conference will provide a forum for shaping the future of informatics on topics pertaining to: Domain-centered Informatics Technology-centered Informatics Human-centered Informatics The deadline for online registration is September 8, 2004 at 5:00 PM. You can also register by phone, fax, or mail prior to the event, and on site during the event. Conference fees are based on your professional status and affiliation. To register or for more information, visit http://www.informatics.indiana.edu/ra/. Holiday Closing Information for Research and Graduate Education Additional holiday closing information is provided for the following Research and Sponsored Programs offices: Research Compliance Administration (IRB/IBC) If there is a life-threatening emergency which necessitates the use of an investigational agent, please call University Hospital Pharmacy at 274-0362. Sponsored Program Administration Proposals with a postmark or receipt date between December 23, 2004 and January 3, 2005 must be received by R&SP no later than noon on December 20, 2004. Proposals will not be processed during the holiday period. The staff of R&SP wishes everyone a happy, peaceful, and safe Holiday Season!

Submissions

Submit Your News to the R&SP Communicator Send us your news...... Deadline for R&SP Communicator news article submission: 5:00 PM on the 25th day of each month R&SP Communicator readers: IUPUI faculty, staff, and students interested in or involved with the conduct of research or other sponsored programs Submit news articles to: Shannon Walden Coordinator of Educational Programs for Responsible Conduct in Research UN 618 620 Union Drive, Room 618 Indianapolis, IN 46202-5167 Phone - (317) 274-8285 Fax - (317) 274-8744 E-mail: sfwalden@iupui.edu

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Research and Sponsored Programs UN 618 General - 317 274-8285 Research Compliance - 317 274-8289 Sponsored Program Development - 317 278-0249