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Modifications to protocols Any proposed change to an already approved human subject research protocol, measures, or informed consent document during the period of IRB approval must be submitted in writing to the IRB immediately for review and approval. An investigator cannot initiate the procedures/changes stated in the amendment until IRB approval has been obtained. An amendment to the protocol does not change the approval date. Investigators will be notified of approval of requests for minor changes in approximately one (1) week following submission. Click on the below to download: Determining whether a modification request should receive expedited or full convened committee review can be difficult. Most modifications will be handled through expedited review regardless of whether the original application was reviewed by the full board or expedited. However, modifications that substantially change the study design or that change the risk to subjects may require review by the full IRB. The IRB chair will make the decision about the type of review. The following definitions* may be helpful to investigators to determine the level of approval to pursue; investigators are encouraged to contact the Human and Animal Protections Research Office (HARPO@umbc.edu) with any questions prior to submitting the request. Minor Changes Definition: Minor changes have no substantive effect upon an approved protocol or reduce the protocol risk already approved by the IRB Examples of minor changes are: 1) Changes in contact names, addresses, telephone numbers, advisor, ending date, adding a researcher, etc. 2) Scientific and/or therapeutic changes that leave the research population at the same or lower risk than risk(s) already approved 3) Changes in the consent form that reflect changes in scientific/therapeutic changes noted above 4) Adding additional subjects of the same type of population indicated in the original protocol 5) Changing the title of the protocol Major Changes Definition: Major changes are changes that may increase the research population's risk or are of questionable risk. Examples of Major Changes are: 1) Adding a subject population different from those already approved 2) Adding questions to a questionnaire 3) Changing consent procedures which involves the reconsenting of subjects 4) Changing the location of the research from that which has already been approved for projects other than no risk survey/interview research. 5) Adding an element that may breech the confidentiality of the subject 6) Adding a deceptive element to the research or changing the debriefing procedures for already approved deception 7) Changing the way subjects are compensated for participation in research - such as increasing the amount, changing from a lottery to cash, etc. *(definitions adapted from Kent State University - Human Subjects Review Board)
Note about changes to informed consent Federal regulations (46.116 General requirements for informed consent) do not require reconsenting of subjects who have completed their active participation in the study, or of subjects who are still actively participating, when the proposed change will not affect their participation. However, when changes do occur in the conditions or the procedures of a study which alter how consent was previously obtained, the investigator should once again seek informed consent from the subjects. Those subjects who are presently enrolled and actively participating in the study should be informed of the change and reconsented if it might relate to the subjects' willingness to continue their participation in the study. If reconsenting in necessary, investigators must submit a Request for Modification to a Protocol form as well as an Addendum to Informed Consent form. Click on the below to download: Addendum to Informed Consent Form
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Last updated 04/28/2008 |
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