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Forms and Instructions Forms Submission Guidelines Amendments Continuing Review Adverse or Unanticipated Events Ceded Review Study Closure Deadlines and Timelines Committee Meeting Dates Consent Requirements Information About Consent Required Consent Elements Conditions for a Waiver of Consent Study Management Tools Responsibilities of the Investigator Active-Study Record Management Post-Study Record Retention Policy and Procedures IRB Policy and Procedures HMS and Harvard University HIPAA at HMS Required Training CITI Human Subjects Training HETHR and Other Trainings Training Requirements Information for Students Student Information Student FAQ Student IRB Submission Information Special Requirements for Students Frequently Asked Questions FAQ What the IRB Reviews Who Needs to Submit an Application Why the IRB Conducts a Review Reference Federal and State Guidelines Countway Library Records Review Harvard University Links Definitions Presentation Library Faculty Information Research with Student Participants Information for Multi-Site Studies Information for International Studies Non-Full Time Faculty Information Information for IRB Members Reviewer Sheets Educational Materials Electronic Training Book Information for Participants Information about Research Your Rights as a Research Participant Sus Derechos como Participante de un Estudio de Investigación Who to Contact with Complaints or Comments Quality Assurance P-StAMP Program Information P-StAMP Policies and Procedures Contact Information	Informed Consent Requirements As many Investigators are aware, informed consent is a process, not a form. As such, the CHS pays particular attention to the information potential participant’s receive from the time of recruitment through enrollment. The CHS will sometimes require re-consent of participants if a study is to be carried-out over long periods of time, with participants who may need to be reminded of study activities (such as the elderly, or those with cognitive disabilities), a study that is inclusive of numerous procedures, or a study that has been modified so that the modifications could effect participants, or their decision to continue to participate in the study. Once recruitment is complete for a participant, the actuality of consent begins. Consent form content must: Be provided in a format understandable to the participant. Reading levels should generally be at an 8 th grade level or under; Be provided in the primary language of the individual; Define medical terminology and jargon; and Be written in a context that is easy to follow (i.e. subject headings, short and concise sentences). In compliance with 45 CFR § 46.116, participants (or their legally authorized representative) should be presented with study information in ample time to consider whether or not to participate in the study, and reduce the likelihood of coercion or undue influence (or feeling such pressure). No informed consent (oral or written) should include exculpatory language whereby the participant or their representative is made to waive or appear to waive any of the participant’s legal rights, or releases or appears to release the Investigator, the sponsor, the Institution or its agents from liability for negligence. Informed Consent Form The Investigator is responsible for using a current, validated consent form with participants. A copy of the informed consent form must be given to the participant (or legal representative) to read and sign, the original should be placed in the participant’s record (hospital/clinic or other, as appropriate), and a copy must be maintained in the Investigator’s study file. Investigators’ study files are subject to CHS review, as well as federal audits (i.e. FDA, NIH, or OHRP). To assist with creating the consent document, please reference the Sample Informed Consent Form for Adults. Please note, Consent Forms must contain the required elements of informed consent. Updated: 26-May-2011
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