Under Title VIII, Sec. 801 of Public Law 110-85 (also known as the FDA Amendments Act or FDAAA), section 402(i) of the Public Health Service Act mandates registration and results reporting of certain applicable clinical trials, as defined by law, in the ClinicalTrials.gov registry. This legislation includes a requirement that if an Applicable Clinical Trial is funded in whole or in part by a grant from any agency
responsible party, as defined by law, has made all required submissions for the Applicable Clinical Trial to ClinicalTrials.gov. Public Law 110-85 also includes registration data elements that must be submitted initially, requires that certain Applicable Clinical Trials also report certain basic results (including adverse event information), and establishes penalties for noncompliance with the law. The signature of the AOR on the application assures compliance with Public Law 110-85, as applicable.
Registration is accomplished at the ClinicalTrials.gov Protocol Registration System Information Web site (http://prsinfo.clinicaltrials.gov/). A unique identifier called an NCT number will be generated during the registration process.
In summary, FDAAA requires:
• the registration of applicable clinical trials in ClinicalTrials.gov no later than 21 days after the first subject is enrolled,
• the reporting of summary results information (including adverse events) no later than 1 year after the completion date for registered applicable clinical trials involving drugs that are approved under section 505 of the Food, Drug and Cosmetic Act (FDCA) or licensed under section 351 of the PHS Act, biologics, or of devices that are cleared under section 510k of FDCA, and
• if an applicable clinical trial is funded in whole or in part by an NIH grant or cooperative
agreement, grant and progress report forms shall include a certification that the Responsible Party has made all required submissions to ClinicalTrials.gov.
Applicants and grantees should carefully read instructions in the application guides to determine applicable requirements under FDAAA. While FDAAA only requires registration and results reporting for certain trials, the NIH strongly encourages registration of all clinical trials whether required by law or not.
For additional information, see
4.1.4 Confidentiality
http://grants.nih.gov/ClinicalTrials_fdaaa/index.htm.
4.1.4.1 Certificates of Confidentiality
Section 301(d) of the PHS Act provides that the Secretary may authorize people engaged in biomedical, behavioral, clinical, or other research activities to protect the privacy of research subjects by withholding the names and other identifying characteristics of those subjects from individuals not engaged in the research. Individuals that have such authorization may not be compelled to disclose subjects’ names or other identifying characteristics in any Federal, State, or local civil, criminal, administrative, legislative or other proceeding. CoCs may be granted for studies collecting information that, if disclosed, could have adverse consequences for subjects or damage their financial standing, employability, insurability, or reputation. By protecting researchers from being compelled to disclose information that would identify research subjects, CoCs contribute to achieving research objectives and promote participation in studies by helping to ensure confidentiality and privacy to participants. Information on CoCs is available on the NIH Web site at the CoC Kiosk at http://grants.nih.gov/grants/policy/coc/index.htm. Requests for CoCs should be submitted to the GMO, and, subject to awarding IC review and approval, a certificate may be issued pursuant to section 301(d).
Research subject protections under CoCs differ from those provided under the HIPAA Privacy Rule 42 CFR parts 160 and 164 (HIPAA) and under Section 543 of the PHS Act (see Confidentiality of Alcohol
and Drug Abuse Patient Records
4.1.4.2 Confidentiality of Alcohol and Drug Abuse Patient Records
below) by protecting identifiable health information from forced disclosure (e.g., by court order). Therefore, researchers may obtain CoCs to withhold (protect) information that otherwise may be subject to the Privacy Rule or Section 543 of the PHS Act.
Section 543 of the PHS Act, as implemented in 42 CFR part 2, requires that records of substance abuse patients be kept confidential except under specific circumstances and purposes. These protections differ from those available to patients under HIPAA and are intended to ensure that a patient in a drug or alcohol abuse program is not made more vulnerable than a similar patient who does not seek treatment. The covered records are any information, written or not, of a patient who has applied for or been given diagnosis or treatment for alcohol or drug abuse at a federally assisted program and includes any individual who, after arrest on a criminal charge, is identified as an alcohol or drug abuser in order to determine that individual’s eligibility to participate in a program. This includes records of the identity, diagnosis, or treatment of any patient which are maintained in connection with the performance of any program or activity relating to substance abuse education, training, treatment, rehabilitation, or research, which is conducted under an NIH grant. Except as authorized under a court order, no patient record may be used to initiate or substantiate any criminal charges against a patient or to conduct any investigation of a patient. The regulations also describe procedures to allow for nonvoluntary disclosure of certain
information by persons engaged in research on mental health, including research on the use and effect of alcohol and other psychoactive drugs.
4.1.4.3 Confidentiality of Patient Records: Health Insurance Portability and
Accountability Act
HHS issued the final version of the “Standards for Privacy of Individually Identifiable Health
Information”—the Privacy Rule—on August 14, 2002. The Privacy Rule is a Federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information. It is administered and enforced by OCR, HHS. Those entities required to comply with the Privacy Rule (classified under the rule as “covered entities”) had until April 14, 2003 to do so (with the exception of small health plans which have an extra year to comply).
Decisions about applicability and implementation of the Privacy Rule reside with the researcher and the grantee organization. The OCR Web site (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including the complete text of the regulation and a set of decision tools for determining whether a particular entity is subject to the rule. An educational booklet, Protecting Heath Information in Research: Understanding the HIPAA Privacy Rule, is available through OCR’s Web site and also at
http://privacyruleandresearch.nih.gov/. That Web site also includes other educational materials including information specific to grants.