Clinical Research and the Law


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Background

She is also author of a published handbook on needlestick injuries and the law, and is co-author of a book on the prevention and management of occupational exposure to HIV. She has served on various editorial boards. Free Access. Summary PDF Request permissions. Tools Get online access For authors. Email or Customer ID. Forgot password? Old Password. New Password. Password Changed Successfully Your password has been changed. Returning user. Request Username Can't sign in? Forgot your username? Enter your email address below and we will send you your username. The law also protects copyrightable and patentable information, until a reasonable opportunity has been provided to obtain a copyright or patent.

Additional laws and regulations provide more limited protection to certain research information, including MCL These regulations protect against unauthorized use and disclosure of individually identifiable information created or received by health plans, health care clearinghouses and most health care providers "covered entities". In general, a covered entity may allow protected health information under its control to be used or disclosed for research only with written authorization. This authorization is described in 45 CFR To be valid, the authorization must include at least the following information:.

This authorization must be written in plain language. This information may be incorporated into a research consent form or provided separately to prospective subjects, depending on the requirements of the IRB overseeing the research. In limited cases described in 45 CFR In addition to the federal privacy and confidentiality standards, Michigan law MCL Patients may refuse the release of their records outside a health facility except as required for transfer to another health facility or as required by law or third party payment contract.

Federal and Michigan law also provides additional confidentiality protections to certain types of records. All reports, records, and data pertaining to testing, care, treatment, reporting, and research, and information pertaining to partner notification under MCL Michigan law MCL Michigan law accords special protection to the privacy of mental health records.

Mental health information may be disclosed as necessary for outside research, evaluation, accreditation, or statistical compilation. In this case, the individual subject should not be identified in the disclosed data set unless the identification is essential to achieve the purpose for which the information is sought or if preventing the identification would clearly be impractical. Under no circumstances may the information be disclosed if the subject is likely to be harmed by the identification.

In general, information in the record of a recipient of mental health services must be kept confidential and only may be disclosed with specific authorization of the recipient, with the following exceptions:. The law also significantly restricts any redisclosure.

Even when information is disclosed, the identity of the person to whom it pertains should be protected whenever feasible. These regulations prohibit the disclosure and use of patient records unless certain circumstances exist. If a patient consents to a disclosure of his records, a program may disclose his records in accordance with that consent to any individual or organization named in the consent. The consent must include the following nine elements:. Further, per federal law 42 CFR 2. Per Michigan law, substance abuse diagnosis, prognosis, and treatment records are confidential and may be disclosed only with consent of the individual to whom the record pertains.

The individual may withdraw consent at any time unless prohibited by federal law.

Clinical Research and the Law

Research Involving Student Records. FERPA applies to all public elementary and secondary schools as well as post-secondary institutions that receive federal funding through the U. Department of Education. Under FERPA, for consent to be valid, it must be written, signed, and dated, and must specify the records to be disclosed, the purpose of the disclosure, and the person or class of persons to whom the disclosure may be made. The FERPA regulations permit electronic consents, as long as they are in a form that identifies and authenticates a particular person as the source of the electronic consent.

There are a number of situations in which FERPA allows disclosure of personally identifiable information from education records without prior written consent. Some information, such as social security number, is considered too sensitive and may not be named as directory information. If a parent or eligible student does not opt out, then the institution may disclose directory information without specific consent. An institution may also disclose the directory information of former students without notification or consent. As a postsecondary institution, at the U-M, only the student, and not the parents, has the right to opt out of disclosures of directory information.

The exception permitting disclosure of personally identifiable information from education records for certain research activities conducted on behalf of educational institutions is limited. First, the exception applies only to research to develop, validate, and administer predictive tests; to administer student aid programs; or to improve instruction. Second, researchers must use the data provided only for these stated research purpose s and must do so in a way that would not permit personal identification of parents or students by individuals other than the researcher and those on the study team with legitimate interests in those data.

Third, any personal information used in the study must be destroyed when it is no longer needed for the study. Finally, per 34 CFR If a researcher violates these requirements, the educational institution that had disclosed personally identifiable information to that researcher may not allow that researcher to access personally identifiable information from education records for at least five years. In summary, any researcher who seeks to use personally identifiable information from student education records must consider FERPA.

If the research project does not fall into one of the three permitted categories of study test development, student aid programs, improved instruction , and no other FERPA consent exception pertains, then the researcher needs to obtain individual consent from the parent or eligible student, as appropriate in order to view identified files.

IRB approval of the research project does not constitute institutional permission to access education records. Moreover, institutions including the U-M may require researchers to sign written agreements that go beyond the requirements of the study exception, described above, before accessing identifiable information from education records.

Again, though, many institutions, including the U-M, still require researchers to sign written agreements before accessing even de-identified information from education records, and IRB approval or exemption of the research project does not constitute institutional permission to access the requested records. Mandatory Disclosure Requirements. Various state laws require University personnel to report information that might otherwise be considered confidential. Only Michigan law is discussed below. Researchers are responsible for complying with the laws of other states, when applicable.

However, the institution must deny requests for student education records subject to the protections of FERPA. Michigan has adopted laws and regulations requiring disclosure by physicians, laboratories, and other health care professionals and facilities of certain information for public health activities.

Mandatory reporting requirements apply to the following health-related services or events:.

If these events occur during a research study conducted at a University health facility or by University health professionals, they generally must be reported as required by the Michigan Department of Community Health. Michigan has enacted laws designed to protect children and vulnerable adults from harm by requiring various professionals to report suspected abuse or neglect.

The following is a description of Michigan laws on mandatory abuse, neglect, and domestic violence reporting. Physicians and other licensed healthcare professionals, social workers, school administrators, counselors, teachers, law enforcement officers, clergy members, and child care providers with reasonable cause to suspect child abuse or neglect are required to report their suspicions to Child Protective Services.

The Michigan Department of Human Services maintains a list of professions required to report suspected child abuse or neglect. Failure to report may result in a misdemeanor conviction punishable by fines, civil penalties, civil liability for damages proximately caused by the failure to report, and up to three months in prison. Similar sanctions may be imposed for intentionally making false reports. In general, however, individuals who make reports in good faith are immune from liability for those reports. Individuals who are required to make reports under this law include those who are employed, licensed, registered, or certified to provide health care, educational, social welfare, mental health, or other human services; employees of agencies licensed to provide these services; law enforcement officers; and certain medical examiners.

There are penalties for failing to make a mandatory report. A court order, administrative agency record request, or subpoena may be issued to require an institution such as a hospital or university or an individual such as a researcher to give testimony or to provide documents related to a case or other controversy. These documents often require release of confidential research records or clinical information.

A University faculty, staff member, or trainee who receives a subpoena or court order related to University research should consult with an attorney in the Office of the Vice President and General Counsel at Protecting Against Disclosure: Certificates of Confidentiality. Certificates of Confidentiality are issued to institutions or universities where the research is conducted. They allow the investigator and others who have access to research records to refuse to disclose identifying information in any civil, criminal, administrative, legislative, or other proceeding, whether at the federal, state, or local level.

Information is considered sensitive if disclosing it could have adverse consequences for subjects or damage their financial standing, employability, insurability, or reputation. Usually, Certificates are issued for single, well-defined research projects following IRB approval.

They may, however, be issued for cooperative multi-site projects under limited circumstances. Certificates are issued with expiration dates, but may be extended if the research continues past those dates. The protection afforded by a Certificate is in any event permanent; all personally identifiable information maintained about subjects in the study while the Certificate is in effect is protected forever.

Certain disclosures are permitted even when a Certificate has been issued. These include:. The existence of a Certificate, the protection it provides, and any limitations on that protection should be described in the informed consent form. Federal and institutional requirements for research involving prisoners and other detained persons are described in Part 7 of this OM and in special Bureau of Prisons regulations described in Section 4. In addition, Michigan law Mich. Code R. An IRB should not approve research that would be prohibited under this regulation, even if a particular facility has failed to implement the required policies.

An IRB may approve University research involving pregnant women, human fetuses, neonates of uncertain viability, or nonviable neonates only if it meets the conditions described in Part 7 of this OM. Michigan law imposes additional requirements. Nontherapeutic research is prohibited if the researcher is aware that the embryo or fetus is subject to a planned abortion being performed for any purpose other than to protect the life of the mother.

This prohibition does not apply to any diagnostic, assessment, or treatment procedures performed on the fetus with the purpose of either determining the life or status of the fetus or improving the health of either the fetus or the mother. However, Michigan law permits research on a dead embryo, fetus, or neonate only if the mother grants express written consent. This research is to be performed in accordance with the same standards applicable to research conducted pursuant to the Uniform Anatomical Gift Law. In addition to the limitations on embryonic research described above, Michigan law MCL Michigan law does not, however, prohibit other scientific research or cell-based therapies.

Document retention obligations may vary depending on the nature of the research and the academic unit with which the PI is affiliated. Generally, the most restrictive requirement applicable to a particular research record should be applied. Record retention requirements that may be applicable to research records include the following:.

These records must be retained for at least three 3 years. All records must be accessible for inspection and copying by authorized representatives of the University, relevant sponsors, and government authorities with jurisdiction such as OHRP, FDA, and NIH at reasonable times and in a reasonable manner.

Articles 15 MCL These laws limit who may practice in the various health professions, define the scope of practice of various types of licensees e. They also often describe specific standards of practice for designated procedures or therapies. Similarly, institutional credentialing and privileging policies and determinations restrict who may practice at individual institutions and the specific procedures or treatments they are authorized to perform. Generally, investigators and research staff may not perform functions for clinical trials that they are not otherwise eligible to perform for non-research purposes.

Specific state licensing laws should be consulted if there is any question as to the appropriateness of an individual's functions in the context of a research study. For research conducted at Michigan performance sites, the following laws and regulations apply:. Failure to comply with these legal requirements may result in administrative sanctions and civil penalties and, when applicable, withholding or even possible repayment of NIH funding. Researchers involved in clinical trials must consider who the responsible party is for the purposes of registration and results reporting.

In other cases, it is generally the initiator of the trial who controls the protocol. S Law. This website will not include information that can identify you.

Updated trials

At most, the website will include a summary of the results. You can search this website at any time. In addition, certain pediatric post-marketing trials, required by FDA, must be registered, as well as Phase I trials of drugs, biologics or devices being tested to treat a serious or life-threatening disease or condition. Life-threatening conditions are defined to include diseases or conditions where the likelihood of death is high unless the course of the disease is interrupted; and diseases or conditions with potentially fatal outcomes, where the endpoint of clinical trial analysis is survival.

Supplemental information e. Results reporting in www. In addition, journals increasingly refuse to publish results of trials that were not adequately registered in a comparable registry prior to enrollment of the first participant. The International Committee of Medical Journal Editors ICMJE , for instance, generally requires registration of research projects that prospectively assign human subjects to intervention and comparison groups to study the cause-and-effect relationship between a medical intervention e.

Clinical trial ethics

Additional information about clinical trials registration requirements is available at ClinicalTrials. Skip to main content. These include but are not limed to: Submission of research proposal to the Human Research Protection Office of the DoD component for administrative review after U-M IRB review has been completed; Special education requirements for Navy-funded funded human subjects research; Appointment of research monitor for all research involving more than minimal risk to research participants; Special protections for U.

Researchers are responsible for reviewing these documents in order to understand the regulatory requirements and University policies related to: Research proposal and design; Subject selection and incentives; Investigator requirements and responsibilities; Confidentiality, privacy, and access to records; and Disclosure and consent. International Research The U-M facilitates the conduct of international transnational human subjects research by its faculty, students, and staff. General Requirements for Informed Consent Federal research laws and institutional policy require that written informed consent be secured from prospective subjects before they participate in studies, unless informed consent requirements have been waived by the IRB or the research is determined to be exempt.

Who May Give Consent Competent adults those able to understand the nature and consequences of their actions must consent on their own behalf to participate in research. Federal Law 45 CFR Parents or legal guardians generally must consent on behalf of children younger than eighteen, with the following exceptions: Emancipated minors generally those who are validly married or are on active duty in the United States armed forces MCL Michigan Laws Requiring Special Consent Like many states, Michigan has adopted laws and regulations imposing specific consent requirements for certain types of clinical activities, any of which may be the subject of clinical research.

For a legal guardian to provide consent, the guardian must have the power to execute consent for ECT procedures. The child or child's advocate may object to the procedure, orally or in writing to a probate court.

Clinical trials: "The law is not in favour of patients"

In this case, the procedure may not be initiated before a court hearing. Recipient with durable power of attorney DPOA or advance directive Patient advocate or designated representative The patient advocate or designated representative must have power to execute an ECT consent under the DPOA or advance directive.

The pre-test information must include, at a minimum: An explanation of the test including, but not limited to, the purpose of the test, the potential uses and limitations of the test, and the meaning of test results; An explanation of the rights of the patient including, but not limited to: i the right to withdraw consent at any time before test administration; ii the right to confidentiality of the test results; iii the right to consent to and participate in the test on an anonymous basis; and iv the person or class of persons to whom the test results may be disclosed under Michigan law.

Orally describe, in language understandable to the patient, the probable gestational age of the fetus, what to do in case of complications from the procedure, and how to obtain pregnancy prevention information from the Michigan Department of Community Health MDCH. Provide information approved by the MDCH regarding the abortion procedures available, the risks and possible complications of such procedures, and services available through public agencies to assist the patient i.

If the procedure has not been recognized by MDCH, but is otherwise allowed under Michigan law, and the department has not provided a written standardized summary for that procedure, the physician will develop and provide a written summary that describes the procedure, any known risks or complications of the procedure, and risks associated with live birth.

Provide the patient with a written description of the fetus including pictures, illustrations, or descriptions , provided by the MDCH, based on the nearest probable gestational age of the fetus. Provide the patient with a physical copy of the prenatal care and parenting information pamphlet developed by the MDCH. Provide the patient with a physical copy of the prescreening summary on prevention of coercion to abort.

However, before obtaining the patient's signature on the acknowledgment and consent form, a physician must do all of the following in the presence of the patient: Provide the patient with the physician's name, confirm with the patient that the coercion to abort screening required under section MCL Confidentiality of and Access to Research Records and Other Information Confidentiality of patient records and research records is governed by both federal and state law. To be valid, the authorization must include at least the following information: A description of the information to be used or disclosed that identifies the information in a specific and meaningful way; The names or other identification of the specific people or categories of people e.

To the Michigan Department of Community Health, a local health department, or other health care provider 1 to protect the health of an individual; 2 to prevent further transmission of HIV; 3 to diagnose and care for a patient. By a physician or local health officer to a known contact of the individual who is HIV infected or has been diagnosed as having acquired immunodeficiency syndrome AIDS , if the physician or local health officer determines that disclosure is necessary to prevent a reasonably foreseeable risk of further transmission of HIV.

The referral shall include available contact information for known contacts of this individual. To the extent released, the information should not identify the individual to whom the information pertains unless reasonably necessary to prevent a foreseeable risk of transmission. As otherwise required or permitted by Michigan law. If the recipient is deceased, the authorization may be granted by the personal representative or executor of the estate.

The consent must include the following nine elements: The specific name or general designation of the program or person permitted to make the disclosure; The name or title of the individual, or name of the organization, to whom the disclosure is to be made; The name of the patient; The purpose of the disclosure; How much and what kind of information is to be disclosed; The patient signature or signature of legally authorized representative ; The date of signature; A statement that authorization may be revoked at any time except to the extent it already has been relied on to make a disclosure; and The date, event, or condition upon which authorization will expire if not revoked the authorization may not last longer than reasonably necessary to serve the purpose for which it is given.

Michigan Law Per Michigan law, substance abuse diagnosis, prognosis, and treatment records are confidential and may be disclosed only with consent of the individual to whom the record pertains. Mandatory Disclosure Requirements Various state laws require University personnel to report information that might otherwise be considered confidential. Mandatory reporting requirements apply to the following health-related services or events: Abortions , within 7 days after the procedure MCL Code R Deaths , within 48 hours of pronouncement report to be made by personal physician or attending physician MCL These include: Voluntary disclosure of information by study subjects themselves or any disclosure that the study subject has consented to in writing, such as to insurers, employers, or other third parties; Voluntary disclosure by the researcher of information on such things as child abuse, reportable communicable diseases, possible threat to self or others, or other voluntary disclosures provided that such disclosures are spelled out in the informed consent form; Voluntary compliance by the researcher with reporting requirements of state laws, such as knowledge of communicable disease, provided such intention to report is specified in the informed consent form; or Release of information by researchers to HHS as required for program evaluation or audits of research records or to the FDA as required under the federal Food, Drug, and Cosmetic Act 21 U.

Research Involving Prisoners and Other Detained Persons Federal and institutional requirements for research involving prisoners and other detained persons are described in Part 7 of this OM and in special Bureau of Prisons regulations described in Section 4. Research Involving Pregnant Women, Fetuses, and Neonates An IRB may approve University research involving pregnant women, human fetuses, neonates of uncertain viability, or nonviable neonates only if it meets the conditions described in Part 7 of this OM.

Document Control and Record Retention and Destruction 1. Generally Document retention obligations may vary depending on the nature of the research and the academic unit with which the PI is affiliated.

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