Unless otherwise requested, the exempt category search does not require a signature line. All other search categories must include one line for the topic to be signed and one line for the date. To send your comments by mail to the waybill, the following address must be used. Be sure to include file number FDA-2006-D-0031 on each page of your written comments. Start with the appropriate IRB consent form template and follow these guidelines when customizing each section of the form: In research involving children, consent considerations – both process and documentation – become more complex than in adult subjects. See the IRB`s Guide to Children and Minors in Research for information on the documentation required for child consent and parental consent, and use the sample consent and consent forms for examples of age-appropriate forms. With the exception of the provisions of § 50.23, no researcher may include a human being as a subject in the research covered by these rules, unless the investigator has obtained the legal consent of the subject or his legal representative. An investigator may obtain such consent only in circumstances which give the potential subject or his or her representative a sufficient opportunity to consider whether or not to participate and minimise the possibility of coercion or undue influence. The information provided to the participant or representative shall be in a language understandable by the participant or representative. No oral or written informed consent shall contain exculpatory language whereby the subject or his/her representative is induced to waive or waive any of the subject`s rights, or releases or appears to release the investigator, sponsor, institution or its representatives from liability for negligence. The IRB may impose additional requirements that are not explicitly listed in the regulations to ensure that adequate information is provided in accordance with institutional policy and local laws. The IRB has the authority to require disclosure to subjects in addition to the information specifically set out in 21 CFR 50.25 if, in the opinion of the IRB, the information would reasonably enhance the protection of the rights and welfare of subjects (21 CFR 56.109(b)).

For example, local circumstances may require the inclusion of additional information relevant to the informed consent process for potential individuals in that particular community. Informed consent should be written in plain language at a level appropriate to the relevant population, generally at the Grade 8 reading level. A best practice is for a colleague or friend to read the consent document with the IRB application to understand it before filing it. Always: The FDA recognizes that subjects are often interested in the aggregated results of the clinical trial in which they have been enrolled. Aggregated research results should be returned to subjects in a clear and understandable manner. Title VIII of the FDAAA requires the „responsible party“ (usually the sponsor or principal investigator) of certain clinical trials involving drugs, devices, and biologics (referred to in the FDAAA as „applicable clinical trials“) to register the studies and submit the summary results to the clinical trials database maintained by the www.ClinicalTrials.gov government within a specified time frame. 65 The summary results of those clinical trials are published in the database. 66 As explained above in Section III.D (Informed Consent Element for „Applicable Clinical Trials“) of these Guidelines, the FDA issued a final Rule 67 amending the informed consent requirements (21 CFR 50.25) so that informed consent documents for applicable clinical drug studies, Biologics and products contain the specific statement contained in the Regulation: that information on clinical trials for these clinical trials will be available at www.ClinicalTrials.gov. This website does not contain any information that identifies individual participants. When reviewing clinical trials, IRBs must ensure that the consent process minimizes the possibility of coercion and undue influence (21 CFR 50.20 and 56.111(a)(4)).

If a clinical trial involves subjects who may be subject to coercion or undue influence, IRBs must determine that additional safeguards have been included in the clinical trial to protect their rights and well-being.