Part 11 - Standards, Compliance, and Education (January 2008)

INTRODUCTION

Excellence in research and compliance with ethical and legal standards go hand in hand.  To promote compliance, the HRPP elucidates the standards under which University research is to be conducted and educates researchers and those responsible for research oversight to recognize, comprehend and implement the standards.

GOVERNING LAWS, REGULATIONS AND OTHER STANDARDS

In addition to the ethical standards that guide all University research, many laws, regulations, formal and informal guidance, and other standards govern every aspect of research and related activities.  This section describes those standards and some of the methods the University uses to collect, analyze, and communicate them to individuals engaged in research or charged with research oversight.

Federal Research Laws and Regulations

Department of Health and Human Services

The U.S. Department of Health and Human Services (HHS) and its subsidiary agencies regulate all aspects of human research supported with federal funds or involving the use of investigational drugs, biologics and devices.  HHS also is responsible, through its Office for Civil Rights, for implementation and enforcement of privacy and security rules issued under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) to protect individually identifiable health information (See 45 CFR parts 160 and 164).  While the privacy and security rules do not directly regulate human subjects research, they do govern the circumstances under which “covered entities” (health care providers, health plans, and health care clearinghouses) who control information necessary for many research activities may use, disclose, or provide access to that information.  HIPAA is further discussed in section II.B below.

Office for Human Research Protections

The Public Health Service Act and its amendments empower the Department of Health and Human Services to issue regulations for the protection of human subjects.  These are compiled in the “Common Rule,” 45 CFR part 46, subpart A.  The Common Rule, which seventeen federal departments and independent agencies have adopted (see section II(A)(5) below), codifies and expands on the ethical principles described in the Belmont Report.  Its specific requirements are integrated throughout this Operations Manual and the standard operating procedures of the University’s IRBs and other review units. 

HHS has issued additional rules for federally funded research involving pregnant women, fetuses, and neonates (45 CFR part 46, subpart B), prisoners (45 CFR part 46, subpart C), and children (45 CFR part 46, subpart D).  The special protections applicable to federally supported research under these subparts have not been widely adopted by other agencies but generally are applicable to University research, as further described in section II(A)(5) below and Part 7 of this Operations Manual.

HHS provides guidance and information concerning its interpretation of the Common Rule and related regulations through regular publication of “Common Findings and Guidance,” determination letters directed to organizations performing research under federal wide or other assurances following investigations of research noncompliance, and other guidance documents.

Food and Drug Administration

The U.S. Food and Drug Administration enforces the Food, Drug and Cosmetic Act and associated regulations, including regulations covering human subjects protections generally (21 CFR part 50), institutional review boards (21 CFR part 56), investigational drugs and biologics (21 CFR part 312), and investigational devices (21 CFR part 812).  Additional information about research regulated by the FDA and special requirements for that research is provided in Parts 6 and 8 of this Operations Manual and at http://www.fda.gov.

National Institutes of Health, Office of Biotechnology Activities

The Office of Biotechnology Activities (OBA) oversees research involving recombinant DNA.  OBA develops and implements NIH policies and procedures for the safe conduct of recombinant DNA activities and human gene (See NIH guidelines for rDNA and Gene Transfer). Its duties include review and evaluation of the composition of institutional biosafety committees and development of registries of activities related to rDNA and human gene transfer research.  OBA-regulated research is subject to oversight by the University’s Institutional Biosafety Committee (IBC).

Office of Research Integrity

The Office of Research Integrity (ORI) is located in the Office of Public Health and Science (OPHS) within the Office of the Secretary of Health and Human Services.  ORI promotes integrity in biomedical and behavioral research supported by the Public Health Service (PHS).  ORI monitors institutional investigations of research misconduct and facilitates the responsible conduct of research through educational, preventive, and regulatory activities.  ORI’s response to misconduct depends on the circumstances, but may include government-wide debarment.  ORI publishes all findings of misconduct.  The University’s local policy on research misconduct is described in the Standard Practice Guide 303.03.  (See also the University’s policy on integrity in scholarship)

Other Federal Agencies

The Common Rule has been adopted by more than a dozen federal agencies involved with human research.  These are:

1. Agency for International Development/International Development Cooperation Agency (22 CFR part 225);
2. Central Intelligence Agency (by Executive Order 12333, 46 F.R. 59941);
3. Consumer Product Safety Commission (16 CFR part 1028);
4. Department of Agriculture (7 CFR part 1c);
5. Department of Commerce (15 CFR part 27);
6. Department of Defense (32 CFR part 219);
7. Department of Education (34 CFR part 97);
8. Department of Energy (10 CFR part 745);
9. Department of Health and Human Services (45 CFR part 46);
10. Department of Housing and Urban Development (24 CFR part 60);
11. Department of Justice (28 CFR part 46);
12. Department of Transportation (49 CFR part 11);
13. Department of Veterans Affairs (38 CFR part 16);
14. Environmental Protection Agency (40 CFR part 26);
15. National Aeronautics and Space Administration (14 CFR part 123);
16. National Science Foundation (45 CFR part 690); and
17. Social Security Administration (See P.L. 296 (103rd Congress).

The Office of Science and Technology Policy signed the federal policy for protection of human research participants but did not codify the Common Rule because it does not conduct or sponsor research.

The Common Rule is not, however, uniformly interpreted or enforced.  In addition, the subparts of 45 CFR part 46 imposing special protections for identified vulnerable populations (other than children) have not been widely adopted.  When a federal agency other than OHRP is responsible for oversight of a particular project or category of projects, the standards set by that agency’s interpretation of the Common Rule and adoption or failure to adopt the additional subparts of 45 CFR part 46 generally will inform the manner in which the corresponding University research is reviewed and conducted.

Absent an interpretation from a federal funding agency to the contrary, however, the requirements of all of the subparts of 45 CFR part 46 are applied to all University research, regardless of funding source.  For non-federally supported research, administrative requirements involving reports or applications to the relevant federal agencies are addressed through alternative mechanisms.  Part 7 of this Operations Manual provides additional information on University policy for research involving vulnerable subjects.

Other Legal Standards That Impact Human Research

Many other federal laws, regulations and administrative agency actions, as well as investigator-initiated commitments to research sponsors and others, affect the conduct of human research.  For example, while the Common Rule requires that researchers protect the privacy of study participants, privacy regulations issued under HIPAA further restrict the use and disclosure of individually identifiable health information by health care providers, health plans and health care clearinghouses that create and maintain much of the data necessary for many research activities.  Federal and state fraud and abuse laws regulate billing for research-related services and payments to researchers and research staff; they also prohibit misrepresentation to induce participation in studies or in the conduct of studies.  The Internal Revenue Service enforces rules requiring institutions such as the University of Michigan to maintain documentation of and in some cases report payments made to subjects in return for their participation in research.  Civil rights, employment and non-discrimination laws impact research project administration.  National security laws regulate who may be involved in certain sensitive research and whether and under what circumstances investigational test articles may be exported to other countries.  The list goes on.

Countless state laws and regulations also impact research.  Studies conducted at University or other in-state facilities are subject to Michigan state laws and regulations.  Studies performed in whole or in part in other states or internationally may be subject to different requirements.  Contracts signed with sponsors and funders of research and with research performance sites typically impose further restrictions. The Principal Investigator is responsible to assure that the study complies with all of these requirements.

Section III below discusses how federal and state laws together affect selected issues common to all University research or to broad categories of research conducted in state. For research conducted out-of-state, researchers are expected to comply with local requirements.  Typically, U-M IRBs rely on local IRB or ethics board oversight to assure project compliance with local laws and regulations.  Where the design of the research does not anticipate local review, investigators may contact the Office of the General Counsel or Health System Legal Office to determine whether the protocol is likely to implicate state laws that are inconsistent with Michigan’s.

International Research

 [RESERVED]

Access to Legal Counsel

All University faculty, staff and trainees conducting human research, as well as members and staff of IRBs and other review units, have access to legal advice concerning application of the laws and regulations that affect human research through the Office of the Vice President and General Counsel and in particular through Health System attorneys who specialize in human research. 

OTHER RELATED LAWS, REGULATIONS, AND STANDARDS

It is impossible to summarize all of the laws and regulations that affect in one way or another the conduct of human research.  This section describes some of the legal standards that apply to research routinely performed by University faculty, staff and trainees.  It is not intended to serve as a comprehensive resource  and addresses only federal and Michigan requirements.  Research proceeding in other states or abroad may be subject to different requirements.  For example, the definition of “child” under the Common Rule is a person who has not “attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted.” 45 C.F.R. § 46.402(a); see also 21 C.F.R. § 50.3(o).  Most, but not all states set the “age of majority” at 18; several, though, set the age higher.   State laws on virtually every other aspect of human research vary to some degree, including: requirements for informed consent; confidentiality, privacy and security standards; public health reporting mandates; limitations on participation of vulnerable populations in research; professional licensing requirements; and use of lotteries or other incentives.

Informed Consent and Legally Authorized Representatives

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. However, exempt research may require some version of informed consent to comply with the ethical principles of the Belmont Report and other ethical guidelines.  OHRP guidance reiterates that “deferred consent” and “ratification” are not appropriate consent mechanisms absent a waiver appropriately granted by an IRB

The general requirements for informed consent are discussed in Part 6 of this Operations Manual.  Failure to obtain informed consent for research involving certain clinical procedures may, depending on the circumstances, violate federal and state laws and institutional policies and have, in some instances, been prosecuted as assault and battery.

Who May Give Consent

Competent adults (those able to understand the nature and consequences of their actions) must consent in their own right to participate in research.  Children and adults with diminished capacity, however, are considered vulnerable and susceptible to coercion and undue influence.  In general, neither group may provide legally effective informed consent.

Additional guidance on who may provide consent on behalf of children and incompetent adults for participation in human research may be found at the following web sites:

http://www.hhs.gov/ohrp/policy/index.html#informed
http://www.fda.gov/oc/ohrt/irbs/informedconsent.html
http://www.fda.gov/oc/ohrt/irbs/faqs.html#Informed%20Consent%20Process
45 CFR §§ 46.116-46.117 (Common Rule requirements)
21 CFR part 50, subpart B (FDA regulations)

Children as Subjects

Investigators must be aware of the special requirements for permission by parents or guardians and for assent by children.  The IRB shall determine that adequate provisions are made for soliciting the assent of children when, in the judgment of the IRB, the children are capable of providing assent.  The IRB must take into consideration the ages, maturity, and psychological state of the children involved.  See 45 CFR § 46.408.  In addition, the IRBs must “determine, in accordance with and to the extent that consent is required by 45 CFR § 46.116 of Subpart A, that adequate provisions are made for soliciting the permission of each child’s parents or guardian (45 CFR § 46.408).

Under Subpart D of the Common Rule, “children” are defined as people “who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law (usually state law) of the jurisdiction in which the research will be conducted.”  See 45 CFR § 46.402(a).  The legal age to consent to the treatments or the procedures involved in the research can depend on the legal status of the individual (e.g. emancipated or married) and can depend on the specific procedures involved (general medical care, substance abuse counseling, completion of a survey or interview, or consumption of alcohol).

“Legally authorized representatives: are individuals or judicial or other bodies authorized under applicable law (usually state law) who may consent on behalf of a prospective participant to his or her participation in the procedures involved in the research.

“Guardians” are individuals who are authorized under applicable law (usually state law) to consent on behalf of a child to general medical care.

As noted above in section B, where the design of the research does not anticipate local review, investigators may contact the Office of the General Counsel or Health System Legal Office to determine whether the protocol is likely to implicate state laws that are inconsistent with Michigan’s.

In Michigan, the “age of majority” – and legal age to sign contracts or consent to undergo most medical procedures – is eighteen (See M.C.L. § 722.51 (“The Age of Majority Act of 1971”)), with the following exceptions:

1. Emancipated minors (generally those who are validly married or are on active duty in the United States armed forces);
2. Children seeking prenatal and pregnancy-related care;
3. Children age 14 and above seeking limited outpatient mental health services;
4. Children receiving substance abuse treatment; and
5. Children seeking treatment for sexually transmitted diseases and HIV/AIDS.

The latter four exceptions are intended to permit children to seek the designated services confidentially.  If research involves only the above services either alone or accompanied by additional surveys, interviews, medical records reviews, or similar minimal risk activities, a minor generally may consent in his or her own right if receiving the services confidentially.  However, if the minor is not otherwise receiving the services confidentially, or if the research involves experimental procedures, unapproved drugs or devices, or any intervention that might add to the risk to which the minor may consent independently, consent of a parent with legal custody (or, in the case of certain research involving more than minimal risk, both parents) or legal guardian is required.   A summary of who may consent to a child’s participation in research in Michigan is posted at http://www.med.umich.edu/irgmed/guidance/IC-who_can_consent.pdf

Other states’ laws vary.  Some set the age of majority higher than 18.  The Juvenile Law Center has complied a list of states’ age of majority requirements, which is available on the web at http://www.jlc.org/index.php/agerequirements/majority.  May recognize, by statute or “common law” (court decisions), that minors may be “emancipated” earlier.  And, like Michigan, many permit minors to consent to medical care for certain conditions without the involvement of their parents, even if they are not legally emancipated for all purposes.  Where parental consent is not required, a minor may not be enrolled in research on the basis of his or her parents’ permission.

In those cases where children may not consent in their own right but can understand the research and any research related procedures, they should be given an opportunity to assent or be provided with information about the research.  Details on assent requirements, and the circumstances where an IRB may waive assent to determine that assent is not a necessary condition for proceeding with the research are found at 45 CFR § 46.408 and, for research subject to FDA oversight, at 21 CFR § 50.55.   Children who reach age 18 while participating in a study must be re-consented if continuing interventions or interactions (including collection or analysis of identifiable private information) are planned, unless an IRB grants a waiver of consent.

Note:  Research protocols designed for conditions or for a subject population for which parental or guardian permission is not a reasonable requirement to protect subjects (e.g., neglected or abused children), and that are not subject to FDA oversight, may be eligible for waiver of parental or guardian permission.  45 CFR § 46.408(c).  See Parts 6 and 7 for details, or visit the OHRP website.

Incompetent and Incapacitated People

A person is considered “incompetent” if the person lacks sufficient capacity to make or communicate responsible decisions because of an infirmity, old age, mental illness, mental deficiency or retardation, drug addiction, trauma or coma.  Minors (individuals under 18 years of age) are generally considered incompetent solely by virtue of age. A person may be considered incompetent even though a formal adjudication has not taken place.  Once determined incompetent, a person may not consent to participation in research but depending on the circumstances, may be enrolled in a study when a proxy or surrogate grants consent.  If a person regains competency and the ability to provide legally effective informed consent after his or her participation in a study has begun, he or she may need to be reconsented.

A summary of authorized proxies or surrogates for incapacitated individuals is provided on a grid .  If it is unclear who should act for a prospective subject, it may be necessary to petition a court to appoint a temporary guardian.  A person faced with questions or concerns regarding who is responsible to make decisions for an incompetent person may contact the Health System Legal Office at (734) 764-2178. 

Michigan Laws Requiring Special Consent

Michigan, like many states, has over time adopted numerous laws and regulations imposing specific consent requirements for certain types of clinical activities, any of which may be the subject of clinical research.  These requirements generally apply equally to the clinical and research context, although many are addressed before research begins.  When devising an informed consent process and developing the form for documenting consent, an investigator who seeks through a clinical trial to treat patients with one of the conditions discussed below may consider incorporating the required language or forms into the research informed consent process.  In such a case, a copy of the research informed consent should be incorporated into the patient/subject’s medical record to assure regulatory compliance.

Breast Cancer Treatment (See M.C.L. § 333.17013 )

A physician treating breast cancer must inform a patient diagnosed with breast cancer, orally and in writing, about alternative methods of treatment, including surgical, radiological, or chemotherapeutic treatments, or any other generally accepted medical treatment.  The physician also must inform the patient about the advantages, disadvantages, and risks of each method of treatment, and about the procedures involved in each.  Providing the patient with a standard written summary produced by the Michigan Department of Community Health entitled Breast Cancer: What You Should Know Before Treatment can satisfy this rule.  A form signed by the patient indicating the patient has received a copy of the brochure (or an equivalent written summary) must be included in the patient’s medical record.

Electroconvulsive Therapy (ECT) (See M.C.L. § 330.1717 )

ECT (or any procedure intended to produce convulsions or coma) may be administered to a recipient of mental health services only if consent is obtained as described below:

Recipient	Who May Consent	Conditions
Adult ≥ 18	Recipient	If the recipient has a guardian, follow the guardian rules below
Child < 18 years old	Parent or legal guardian (if no parent has legal and physical custody)	If a parent, the parent must have physical and legal custody If a guardian, the guardian must have power to execute an ECT consent Two child/adolescent psychiatrists, neither of whom may be the treating psychiatrist, must have examined the child and documented their concurrence with the decision in the medical record before the procedure Child must be informed of their right to object to the procedure at least 72 hours (excluding Sundays and holidays) prior to the procedure Child or child’s advocate may object orally or in writing to a probate court; if they do, the procedure may not be initiated before a court hearing
Recipient with guardian	Legal guardian	Guardian must have power to execute an ECT consent Two psychiatrists must examine the recipient and document their concurrence with the decision in the medical record before the procedure
Recipient with DPOA or advance directive	Patient advocate or designated representative	Patient advocate or designated representative must have power to execute an ECT consent under the durable power of attorney (DPOA) or advance directive
Recipient with no eligible person to give consent	Probate court	Diligent effort must be made to locate a person eligible to give consent Probate may approve the procedure only after a hearing

Genetic Testing (See M.C.L. §§ 333.17020 and 333.17520 .)

The following rules do not apply to procedures performed as a component of biomedical research subject to FDA and OHRP oversight.  However, they do establish best practice in Michigan and, therefore, should be followed when judged appropriate in the context of an individual research project.

A physician or other provider may perform a pre-symptomatic or predictive genetic test only after obtaining specific informed consent from the patient or patient’s legally authorized representative.  The informed consent must explain at least:

1. The nature and purpose of the pre-symptomatic or predictive genetic test;
2. The effectiveness and limitations of the pre-symptomatic or predictive genetic test;
3. The implications of taking the pre-symptomatic or predictive genetic test, including, but not limited to, the medical risks and benefits;
4. The future uses of the sample taken from the test subject in order to conduct the pre-symptomatic or predictive genetic test and the information obtained from the pre-symptomatic or predictive genetic test;
5. The meaning of the pre-symptomatic or predictive genetic test results and the procedure for providing notice of the results to the patient; and
6. Who will have access to the sample taken from the patient in order to conduct the pre-symptomatic or predictive genetic test and the information obtained from the pre-symptomatic or predictive genetic test, and the patient’s right to confidential treatment of the sample and the information.

The Michigan Department of Community Health has developed a patient information brochure and model informed consent document recommended for use with genetics testing.  A copy of the informed consent form should be provided to the person who signed it.  If the MDCH model form is used, the person receiving the test is legally barred from later claiming that she was not provided with informed consent (or adequate consent).

HIV/AIDS Testing (See M.C.L. § 333.5133 .)

Generally, a physician (or person working on his behalf) may order a test to diagnose HIV infection only with the prior written informed consent of the patient.  The consent must include at least:

1. 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;
2. 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; and (iii) the right to consent to and participate in the test on an anonymous basis; and
3. The person or class of persons to whom the test results may be disclosed under Michigan law.

Each patient must be given a pamphlet developed by the Michigan Department of Community Health entitled Important Health Information.  A form signed by the patient indicating he or she has received the pamphlet must be included in the person’s medical record.

State law also requires pre- and post-test counseling by the ordering physician.  When test results are positive, federal rules may require patient notification.  See OHRP’s AIDS Research Guidance for additional information.

If the test is performed solely for research purposes and the test is performed in a way that the identity of the subject is not revealed to the researcher and the results are not revealed to the subject, the consent requirements described above may not apply.  In addition, these requirements may not apply if the subject is incompetent and his or her legally authorized representative is not readily available to receive the MDCH pamphlet or provide proxy consent.

Pregnancy Termination (See M.C.L. § 333.17015 .)

A physician may perform an abortion only after obtaining advance, uncoerced, written consent from the patient.  At least 24 hours before the procedure, the physician (or a qualified assistant) must examine the patient, confirm the pregnancy and determine the probable gestational age of the fetus.  The physician must 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.  The patient also must receive written information on the gestational age of the fetus (including pictures, illustrations or descriptions), risks of termination procedures or continuing pregnancy and more.  The information must be approved by MDCH or, if the procedure is not recognized by MDCH, prepared by the physician. The patient must sign a written acknowledgement prepared by MDCH that she has received the information. The state-approved materials with this information are located on the MDCH web site.  

Surgery for Mental Health Patients (See M.C.L. § 330.1716 .)

A recipient of mental health services may undergo surgery only if consent is obtained from one of the following: (i) the recipient if 18 years of age or older and without a guardian for medical care; (ii) the recipient’s guardian (A guardian or durable power of attorney must be specifically empowered to consent to the recipient’s participation in research) if the guardian is authorized to consent to surgery on behalf of the recipient; (iii) the parent of the recipient if the parent has legal and physical custody and the recipient is 18 years of age or younger; or (iv) the recipient’s durable power of attorney for healthcare.**  If the situation involves a threat to the recipient’s life, consent is not needed.  If surgery is advisable, and there is no one eligible to consent, a probate court may consent to the surgery after receiving a petition and conducting a hearing.

Terminal Illness (See M.C.L. §§ 333.5651-333.5661 .)

The “Michigan Dignified Death Act” is an informed consent law that ensures patients with advanced illness the ability to make informed decisions to receive, continue, discontinue, or refuse medical treatment.  An advanced illness is defined under the law as a “medical or surgical condition with significant functional impairment that is not reversible by curative therapies and that is anticipated to progress toward death despite attempts at curative therapies or modulation, the time course of which may or may not be determinable through reasonable medical prognostication.”

Under the law, a physician who has diagnosed a patient with an advanced illness and is recommending medical treatment (including treatment received during the course of a clinical trial) must orally inform the patient, patient’s surrogate or patient advocate about the recommended treatment and alternatives, as well as the advantages, disadvantages, and risks associated with the recommended medical treatment and alternative medical treatment.  In addition, the physician must inform the patient, patient’s surrogate or patient advocate both orally and in writing that the patient has the right to make an informed decision regarding receiving, continuing, discontinuing, and refusing medical treatment, as well as the right to choose palliative care treatment and appropriate pain and symptom management. A physician will be considered to be in full compliance if he or she gives the patient, patient surrogate or patient advocate a copy of a standardized written summary produced by the Michigan Department of Community Health that contains the above information. A copy of the form is available at http://www.michigan.gov/documents/DignifiedDeathAct_69787_7.pdf; see also http://www.michigan.gov/documents/End_of_Life_Resource_Guide_51281_7.pdf.

Confidentiality of and Access to Research Records and Other Information

Confidentiality of Research Records Generally

The “Confidential Research and Investment Information Act,” M.C.L. §§ 390.1551 et seq., exempts from disclosure under the Michigan Freedom of Information Act (FOIA – see section III.B.3 below) intellectual property created by individuals employed or contracted by the University for research, education and related activities until a reasonable opportunity has been provided to publish.  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 research information, including M.C.L. § 333.2611 (MDCH-supported health services research).

Research Involving Use or Disclosure of Patient Health Information

The U.S. Department of Health and Human Services, Office for Civil Rights (OCR) has issued privacy and security regulations under the Health Insurance Portability and Accountability Act of 1996 (HIPAA).  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”).  Components of the University of Michigan that are covered entities (or their designated “business associates”) and therefore directly or indirectly regulated by HIPAA include:

• The Health System (including the Medical School, Hospitals and Health Centers, M-CARE and its subsidiaries, and Michigan Health Corporation);
• Institute for Human Adjustment;
• School of Dentistry;
• School of Public Health;
• Components of the School of Nursing; and
• University Health Service.

In general, a covered entity may allow protected health information under its control to be used or disclosed for research only with written authorization.  The authorization, to be valid, 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.g., “your primary care physician” or “your health care providers”) who can make the use or disclosure.
• The names or other identification of the specific people or categories of people who may receive the information (e.g., “the University of Michigan,” “the researchers,” “the Institutional Review Board and other University officials,” “study sponsors,” “government oversight agencies”).
• A description of each purpose of the authorized disclosure (e.g., “to conduct the study,” “to analyze any adverse reactions to the study intervention,” “for study oversight,”).
• An expiration date (e.g., January 1, 2006) or expiration event (e.g., “one year from signing” or “at the end of the study” or “none”).
• Signature of the individual (or the person’s legally authorized representative) and date.
• A statement of the individual’s right to revoke his or her authorization in writing and any exceptions to that right (e.g., “except to the extent the authorization already has been relied on to make a disclosure,” “to preserve the integrity of the other information collected during the study,” “as part of a research dataset,” “to individuals and organizations responsible for research oversight,” “as required by federal or state law”).
• Whether treatment or payment will be conditioned on granting the authorization (often, participation in the research project is conditioned on granting the authorization).
• The potential for the information used or disclosed for the research to be redisclosed and no longer protected by the Health Insurance Portability and Accountability Act of 1996.

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, an IRB or Privacy Board may waive these authorization requirements.

In addition to the federal privacy standards, Michigan law generally provides that patients are entitled to privacy and prohibits hospitals and other health facilities from providing copies of patient medical records to third parties without prior authorization.  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.  Michigan also has enacted laws providing additional confidentiality protections to certain types of records.  These are discussed below:

HIV/AIDS and Other Serious Communicable Diseases

A “communicable disease” means an illness due to a specific infectious agent or its toxic products that results from transmission of that infectious agent or its products from a reservoir to a susceptible host, directly as from an infected individual or animal, or indirectly through the agency of an intermediate plant or animal host, vector, or the inanimate environment.  A “serious communicable disease or infection” means a communicable disease or infection that is designated as serious by the Michigan Department of Community Health.  Serious communicable disease or infection includes, but is not limited to, HIV infection, acquired immunodeficiency syndrome, venereal disease, and tuberculosis.  (See web site for communicable disease reporting in Michigan).

Any report, record or data related to HIV/AIDS or other serious communicable disease testing, care, treatment, reporting, or research is confidential and may be disclosed only as follows: 

• In response to a court order but only if (1) the court determines that other ways of obtaining the information are not available or would not be effective; and (2) the public interest in and need for the disclosure outweigh the potential for injury to the patient.  The court order must limit disclosure to those parts of the patient’s record that are determined to be essential to fulfill the objective of the order; must limit disclosure to those individuals whose need for the information is the basis of the order; and must include other measures necessary to limit disclosure for the protection of the patient.
• To the Michigan Department of Community Health, a local health department, or another health care provider (1) to protect the health of an individual; (2) to prevent further transmission of HIV; or (3) to diagnose and care for the patient.
• By a physician or local health officer to a known contact of the infected patient, if the physician or local health officer determines that disclosure is necessary to prevent a reasonably foreseeable risk of transmission.  (In this case, disclosure to the contact is mandatory, but the mandate may be fulfilled by referring the patient to a local health department for assistance with partner notification.)
• With written authorization of the patient, if the patient specifically refers to HIV or AIDS.  If the patient is a child or incapacitated, only the parent or legal guardian may execute written authorization.
• As otherwise required or permitted by Michigan law (largely inapplicable to University research).

To the extent released, the information should not identify the individual patient unless reasonably necessary to prevent a foreseeable risk of transmission.  Violation of these requirements is punishable as a misdemeanor with imprisonment of up to one year or a fine up to $5,000 (or both); it also may result in civil liability, including costs and attorneys’ fees.

Mental Health Treatment

Michigan law accords special protection to the privacy of mental health records (See M.C.L. § 330.1748.).  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 (if the recipient is a child, the authorization may be granted by the recipient’s parent with legal custody; if the recipient is an incompetent adult, authorization may be granted by the recipient’s legal guardian; if the recipient is deceased, the authorization may be granted by the personal representative or executor of the estate).  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. 

Substance Abuse Treatment

Substance abuse diagnosis, prognosis and treatment records are protected from routine disclosure, together with the identity of individuals receiving these services (See M.C.L. §§ 333.6111-333.6113 and 42 CFR part 2.).  These records may be disclosed only with specific authorization of the patient or for other designated purposes, including research.  Under federal law, specific required elements of an authorization to disclose substance abuse records include: (i) specific name or general designation of the program or person permitted to make the disclosure; (ii) the name or title of the individual or name of the organization to which the disclosure is to be made; (iii) the name of the patient; (iv) the purpose of the disclosure; (v) how much and what kind of information is to be disclosed; (vi) patient signature (or signature of legally authorized representative); (vii) date of signature; (viii) 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 (ix) the date, event, or condition upon which authorization will expire if not earlier revoked (authorization may not last longer than reasonably necessary to serve the purpose for which it is given).

Research Involving Student Records

The Family Educational Rights and Privacy Act (FERPA) (See 20 U.S.C. § 1232g; 34 CFR Part 99) governs the disclosure of student records and access to student records by parents and eligible students.  FERPA applies to all public elementary and secondary schools as well as post-secondary institutions that receive federal funding through the Department of Education.  The University of Michigan is subject to FERPA.

FERPA distinguishes between two classes of information: 

• Directory information is information in an educational record “that would not generally be considered harmful or an invasion of privacy if disclosed.”  Institutions covered by HIPAA define what data they consider to be directory information.  At the University of Michigan, directory information includes the student’s name, address, telephone number, major, enrollment status, and activities.  Each University campus has established a student rights and records policy that can be found on its registrar’s web site.
• Other information contained in education records.

“Education records” are defined under FERPA as records that directly relate to a student and are maintained by an educational agency or institution, or a third party on their behalf.  “Education records” generally do not include: records maintained by law enforcement units, such as the University’s Department of Public Safety; employment records related to students in their capacity as employees and where the employment is not a result of the person’s status as a student; medical records made by a physician, psychiatrist, psychologist or other health professional for treatment of the student and disclosed only to individuals providing the treatment; and records that only contain information about the individual after he/she is no longer a student at the institution.

An educational institution may disclose directory information if it has given public notice to parents and eligible students (i.e., students who are 18 or older or are attending postsecondary education institutions) regarding the types of information included in the institution’s definition of “directory information” and the right to opt out of disclosure of any or all types of directory information.  Parents’ rights automatically transfer to the student once the student becomes an “eligible” student.  If a parent or eligible student declines to opt out, then the institution may disclose directory information without the student’s specific consent.  At the University of Michigan, only the student and not the parents has the right to access a student’s file; opt out of a directory listing; or authorize disclosure of student record information.  An institution may also disclose the directory information of former students without notification.

Before an educational institution discloses personally identifiable non-directory information from a student record, the parent or eligible student must provide a signed and dated authorization for the disclosure.  The authorization must specify the records to be disclosed; state the purpose of the disclosure; and identify the person to whom the disclosure is to be made.  The authorization may be in electronic form.  Written authorization is necessary only if the information contains personally identifiable information such as, but not limited to, the student’s name or a parent’s name; an address; a social security or student number; or a list of personal characteristics that would enable identification of a student.

There are a number of situations where FERPA allows disclosure of individually identifiable information without prior written authorization.  These include disclosure to other school officials with legitimate educational interests; to officials at other schools where the student seeks to enroll; to various state or federal officials; for the purpose of determining or implementing financial aid; and to organizations conducting studies for, or on behalf of, educational agencies or institutions, and more.  This last exception is the most important for research considerations.

The exception for research activities conducted on behalf of educational institutions is limited.  The exception for research activities applies to research to develop, validate and administer predictive tests, to administer student aid programs, or to improve instruction.  Research organizations must use the data provided only for these stated research purpose(s). Academic records may be disclosed only if a study is conducted and reported in such a way as to prevent personal identification of parents or students by individuals not associated with the researcher.  Any personal information used in the study must be destroyed when it is no longer needed for the study. A research organization that violates these requirements will be banned from accessing individually identifiable educational records for at least five years.  In addition, a research organization that receives educational record information from an educational agency without the parent’s or eligible student’s prior consent is prohibited from re-disclosing that information.

FERPA only protects education records.  These are records that are directly related to a student and are maintained by an educational agency.   This does it include records of the law enforcement unit of the educational agency, employment records other than records of individuals employed as a result of their status as students, or records containing information about an individual after he or she is no longer a student at that institution. Finally, records of an eligible student made or maintained by a physician, psychiatrist, psychologist or other health professional in connection with treatment of the student are not educational records.

The definition of an education record requires that the record is related to a student.  FERPA defines a student as “any individual who is or has been in attendance at an educational agency or institution and regarding whom the agency or institution maintains education records.”  Thus, an application for admission alone is not an educational record.  On the other hand, the application of an accepted student who attends the educational institution appears to be an educational record.  The application remains protected by FERPA even after the student graduates.  FERPA requires that the institution keep a record of each request for access to and each disclosure of identified information.  The institution must allow the parent or eligible student to inspect this record upon request.

The second part of the definition of an educational record requires that it be “maintained” by an educational agency.  If the record is not yet being maintained it is not covered by FERPA.  A student grading another student’s paper and then calling out the grade and name is not covered because at that point the scores are not being maintained within the meaning of FERPA.  Instead, maintain implies that the records are “kept in a filing cabinet in a records room…or on a permanent secure database.”  Students who handle assignments for a few moments do not maintain the papers as a registrar who keeps records in a permanent file.  Without this type of maintenance, information is not covered by FERPA.

Any researcher who seeks to use existing educational records must consider FERPA.  Even researchers who are members of the educational institution cannot automatically access student records that contain identifiable information unless they are conducting specific types of studies for or on behalf of educational institutions.  If the study does not fall into one of the three categories (test development, student aid programs, improved instruction) then consent is needed in order to view identified files.  If the records are de-identified by removal of all designated identifiable information, then FERPA no longer applies.  As long as the information sought by the researcher is part of the educational record and the educational institution maintains the record, researchers must follow FERPA and obtain consent.

Mandatory Disclosure Requirements

Michigan Freedom of Information Act

The Michigan Freedom of Information Act (See M.C.L. §§ 15.231-15.246.) requires “public bodies” including the University of Michigan to allow people to inspect, copy, or receive copies of “public records.”  A public record is defined as “a writing prepared, owned, used, in the possession of, or retained by a public body in the performance of an official function, from the time it is created.”  Most records created by University faculty, staff and trainees in the performance of their University functions, or retained on University property or in University electronic resources, are public records subject to disclosure under FOIA. 

Public Health Reporting: Disease Surveillance

Michigan and other states have 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:

1. Abortions, within 7 days after the procedure; and complications from abortions, within 7 days of diagnosis of the complication
2. Birth defects (defined to include congenital or structural malformations and biochemical or genetic diseases present at birth), as well as information relevant to incidents of birth defects, within 30 days of diagnosis, regardless of when detected
3. Cancer diagnosis, within 180 days of diagnosis or initial treatment
4. Communicable diseases, within 24 hours, 3 working days, or 1 week, depending on the diagnosis (See Critical Health Problems Reporting Act, MCL §§ 325.71-325.79; Mi. Admin. Code R. 325.171-325.199; see also MI physician and health care provider reporting, laboratory reporting, and national disease reporting.) Disease reporting is mandatory only at the state level.
5. Deaths, within 48 hours of pronouncement (report to be made by personal physician or attending physician, (See M.C.L. § 333.2843)
6. Fetal death, defined as death of a fetus which has completed at least 20 weeks of gestation or weighs at least 400 grams, and has been separated from the mother, within 5 days of delivery (if death occurred at the facility or if it was attended to shortly afterward at the facility, for example if death occurred en route to the facility). (See M.C.L. § 333.2834 and § 333.2803)

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, unless the facility or non-research clinical staff makes other reporting arrangements.

Standards for Reporting Abuse, Neglect and Domestic Violence

Michigan, like most states, has enacted laws designed to protect children and vulnerable adults from harm by requiring various professionals they are likely to encounter in daily activities to report suspected abuse or neglect.

Following is a description of Michigan laws on mandatory abuse, neglect and domestic violence reporting.  When a researcher can reasonably anticipate that mandatory reporting requirements will be triggered during the course of a project (for example, because members of these vulnerable populations are likely to be recruited to participate in the study or the researcher plans to explicitly question subjects about any history of abuse, neglect or domestic violence), the informed consent discussion and document should include a description of the mandatory reports that may need to be made.  If the researcher determines (and the IRB agrees) subjects will be better protected by non-disclosure, then the researcher should procure a certificate of confidentiality to avoid any mandatory reporting requirements. NIH may issue certificates of confidentiality even for non-NIH funded studies.  See section III(B)(5) below for additional information on certificates of confidentiality.  Although a certificate of confidentiality purports to override any mandatory reporting requirements imposed by law (e.g., disclosures demanded by statute) or legal process (e.g., court order or subpoena), the effectiveness of a certificate in this context has not been thoroughly tested.

Child Abuse and Neglect

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 Family Independence Agency, or FIA). The FIA maintains a list of individuals required to report suspected child abuse or neglect.  Failure to report may result in a misdemeanor conviction punishable by up to three months in prison, fines, civil penalties, and civil liability for damages proximately caused by the failure to report.  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. Note that withholding consent for medical treatment for a child based on a parent’s religious beliefs does not necessarily constitute abuse or neglect.

Vulnerable Adults (See M.C.L. § 400.11 .)

In Michigan, the Social Welfare Act imposes similar reporting requirements and provides similar immunities for reporting (and penalties for failing to make a mandatory report of) suspected abuse or neglect of “vulnerable adults.”  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.  The term “vulnerable adults” refers to individuals who are unable to protect themselves because of mental or physical impairment or because of advanced age.  Some commentators have interpreted the law to extend to domestic violence victims who due to coercion or other pressures are unable to escape their abusers.  This analysis has not, however, been universally adopted.

The “Gun and Knife Law” (See M.C.L. § 750.411 .)

Although many people refer to this statute as the “gun and knife law,” the term is a misnomer.  The law requires hospitals, pharmacies, and their managers to report immediately to law enforcement authorities any person brought to these facilities with a “wound or other injury inflicted by means of a knife, gun, pistol, or other deadly weapon, or by other means of violence.”  It likewise requires physicians treating patients with these types of injuries to report.  The Washtenaw County, Michigan prosecutor has interpreted this law to refer to suspected domestic violence victims, for example, an injury suffered by an otherwise healthy 35-year-old woman who “fell” down the stairs.  However, his analysis is controversial and has not been universally adopted.

Court Orders and Subpoenas

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 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 a University attorney at (734) 764-0304.

Protecting Against Disclosure: Certificates of Confidentiality

Certificates of Confidentiality are issued by the National Institutes of Health (NIH) to protect the privacy of research subjects by allowing investigators and institutions to avoid compulsory release of information that could be used to identify subjects with a research project (i.e., any information that could lead directly or indirectly to identification of a research subject). 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. A project may receive protection under a certificate of confidentiality even if the project is not sponsored or funded by NIH.

Certificates may be used for biomedical, behavioral, clinical or other types of research that is sensitive.  Research is considered sensitive if disclosing the information could have adverse consequences for subjects or damage their financial standing, employability, insurability, or reputation.  Examples of studies that may be considered sensitive include those collecting genetic information, information on subjects’ psychological well being, information on sexually transmitted diseases or on subjects’ sexual attitudes, preferences or practices, data on substance abuse or other illegal conduct, and studies where subjects may be involved in litigation related to exposures under study (i.e., breast implants, environmental or occupational exposures).

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:

• 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 (see Attachment D, which sets forth PHS policy on reporting of communicable diseases); or
• Release of information by researchers to DHHS 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.S.C. 301 et seq.); and
• Disclosures required by the Department of Health and Human Services for audit or program evaluation activities and disclosures required by the Food and Drug Administration under the Food, Drug and Cosmetic Act.

The existence of a Certificate, the protection it provides, and any limitations on that protection should be described in the informed consent form.  The Vice President for Research (Institutional Official) or his designee must sign all certificate of confidentiality applications before submission to NIH.

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 Operations Manual. In addition, Michigan law (See Mi. Admin. Code R. 791.733 ) requires correctional facilities to implement policies to prohibit the use of inmates for “medical, pharmaceutical, or cosmetic experiments.”  This prohibition does not apply to individual treatment of an inmate based on the need for a specific medical procedure that is not generally available outside of the research.  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.

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 Operations Manual.  Michigan law imposes additional requirements.  In Michigan, a live human embryo, fetus or neonate may participate in non-therapeutic research if the research does not “substantially jeopardize” its life or health, based on the judgment of the researcher and the available knowledge at the time of the research.  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 (See M.C.L. § 333.2685.).  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.

A dead fetus is not considered a “human subject” for purposes of the HRPP.  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.  See M.C.L. § 333.2688.

Stem Cell Research

In addition to the limitations on embryonic research described in subsection D above, Michigan law prohibits “human cloning.”  It does not, however, prohibit other scientific research or cell-based therapies. “Human cloning” means the use of human somatic cell nuclear transfer technology to produce a human embryo. “Human embryo” means a human egg cell with a full genetic composition capable of differentiating and maturing into a complete human being. “Human somatic cell” means a cell of a developing or fully developed human being that is not and will not become a sperm or egg cell. “Human somatic cell transfer” means transferring the nucleus of a human somatic cell into an egg cell from which the nucleus has been removed or rendered inert.  The University has developed a Policy on Research Involving Human Embryonic Stem Cells, which describes the conditions, limitations and restrictions imposed on stem cell research not otherwise prohibited by state law.

Michigan also requires registration of clinical laboratories performing rDNA research, exempting from this requirement certain licensed clinical laboratories as well as the following activities: (i) collection of specimens, (ii) initial inoculation of specimens into transport media or culture media, and (iii) shipment to registered laboratories where no additional rDNA research is performed.  Where registration is required, a University department, rather than the laboratory itself, may register.  Special requirements apply to the sale or gift of rDNA materials.

See M.C.L. § 333.2686, 333.16274 and 750.430a, which explicitly prohibit “human cloning,” defined as “the use of human somatic cell nuclear transfer technology to produce a human embryo”; see also the NIH Requirements Affecting the Rights and Welfare of Individuals as Research Subjects, Patients, or Recipients of Services: Human Embryo Research, Cloning, and Transplantation.

Data and Specimen Repositories

[RESERVED]

Document Control and Record Retention and Destruction

Generally

Document retention obligations may vary depending on the nature of the research and the academic unit with which the PI is affiliated.  For any clinical research or other research involving the collection or use of protected health information, the general rule of thumb is that documents must be retained at least 6 years after the last intervention or interaction with subjects.  For FDA-regulated research, records must be retained the longer of: (i) 6 years after the last intervention; or (ii) 2 years after approval of the drug or device or, if there is no approval, then 2 years after termination of the study with FDA.  All federal grant-related administrative/financial records must be maintained at least 3 years following the end of the grant (or in the case of a repeating 5-year grant, 3 years following the end of the relevant segment).  Private sponsors may require longer periods and this can be determined only by reviewing the sponsorship agreements on a case-by-case basis.  For other research, records should be retained for at least 3 years.  These are minimum standards.  Because health care fraud and abuse laws allow the government to reach back at least 10 years, a 10-year retention period is recommended where feasible for research that may be regulated by these laws, but is not mandated.  See Part 6 of this Operations Manual.

Investigator and Sponsor-Investigator Responsibilities

[RESERVED]

IRB Responsibilities

Each IRB is responsible to prepare and maintain records adequate to document its activities, including:

• Copies of all research proposals reviewed, scientific evaluations, if any, accompanying the proposals, approved sample consent documents, progress reports submitted by investigators, and reports of injuries to subjects;
• Minutes of IRB meetings sufficiently detailed to show attendance at meetings; actions taken by the IRB; the vote on these actions including the number of members voting for, against, and abstaining; the basis for requiring changes in or disapproving research; and a written summary of the discussion of controverted issues and their resolution;
• Records of continuing review activities;
• Statements of significant new findings provided to subjects;
• Copies of all correspondence between the IRB and investigators;
• A list of IRB members; and
• SOPs.

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.

State Professional Licensing Laws and Institutional Credentialing Policies

State professional licensing laws limit who may practice in the various health professions, define the scope of practice of various types of licensees (e.g., doctors, nurses, dentists, psychologists, social workers, etc.) and whether and to what extent licensed professionals may delegate their functions to unlicensed individuals (See M.C.L. § 333.16215.). 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, these laws and regulations may be found as follows:

• health professional licensing laws;
• health professional licensing regulations;
• health facility licensing laws; and
• health facility licensing regulations.

In addition, for research conducted at University of Michigan Hospitals and Health Centers, IRBs or others monitoring the activities may consult the UMHHC web site to verify an individual practitioner’s scope of privileges at the UMHHC.

Registration of Clinical Trials

FDA regulations and an increasing number of peer reviewed publications mandate public registration of certain clinical trials.  Failure to register may result in administrative sanctions and civil penalties, in addition to refusal by journals to publish. 

Federal law requires IND holders to submit information to http://www.clinicaltrials.gov (an NIH/National Library of Medicine databank) about IND trials designed to test the effectiveness of drugs for serious or life-threatening conditions.  Determining whether a condition is serious is, according to FDA, a matter of judgment, but generally is based on such factors as survival, day-to-day functioning, and the likelihood that the disease, if left untreated, will progress from a less severe condition to a more serious one.  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.  Under federal law, information about new trials generally must be submitted within 21 days after enrollment begins; supplemental information (e.g., significant amendments, clinical holds) must be submitted at 30-day intervals, although FDA recommends more immediate updates when trials are unexpectedly suspended or closed.

Many peer reviewed medical journals also require clinical trials registration.  The International Committee of Medical Journal Editors 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.g., drug, surgical procedure, device, behavioral treatment, process-of-care change) and a health outcome.  Phase 1 drug trials are generally exempt from this requirement, while Phase 3 trials are almost always affected by it.

Additional information about clinical trials registration is available at ClinicalTrials.gov, on the Food and Drug Administration web site, at the International Committee of Medical Journal Editors, and on the University’s IRBMED web site

Lotteries

[RESERVED]

Screening Logs

[RESERVED]

Electronic Records and Electronic Signatures

[RESERVED]

Research Involving Human Specimens

[RESERVED}

EDUCATION AND TRAINING FOR THE RESEARCH COMMUNITY

Educational Initiatives for the Research Community

[RESERVED]

[CITE TO http://www.fhi.org/en/RH/Training/trainmat/ethicscurr/index.htm FOR BELMONT REPORT IN OTHER LANGUAGES AND http://www.fhi.org/training/sp/RETC/belmont.htm FOR SPANISH VERSION]

Tracking and Communicating New Developments

University officials responsible for regulatory compliance are made aware of new legal and policy developments through a variety of sources.  These include: membership in trade associations such as the American Association of Universities, the American Association of Medical Colleges, the Council on Government Relations, and the University Healthcare Consortium; participation in and assumption of leadership roles with professional organizations such as the Applied Research Ethics National Association, the Association of Clinical Research Professionals, the National Council of University Research Administrators, the Society of Research Administrators, and the Society of Clinical Research Associates; subscription to industry newsletters; participation in relevant electronic listserves; access to electronic regulatory, legislative and analysis resources; and attendance at regional and national educational conferences such as PRIM&R.  Government Relations representatives keep regulatory compliance staff apprised of relevant pending legislation and regulatory activities, and the Office of the Vice President and General Counsel assists in providing analysis of these developments.

In addition, virtually all of the individuals with a defined leadership role in the HRPP are linked to multiple nodes in the system.  For example, the Deputy Institutional Official has roles on the Conflict of Interest Review Committees, the Radiation Policy Committee, and the Institutional Biosafety Committee.  IRB chairs serve on the Human Research Coordinating Council and the IRB Council.  IRB staff representatives serve on these and other committees, and provide direction to the eResearch initiative.  This integrative approach facilitates communication of new legal and policy developments throughout the HRPP structure.

Regulatory compliance officials and research review unit staff in turn notify the research community of relevant developments through policy revisions, changes to application forms and guidelines, newsletters, educational sessions, web postings, and other communications, as necessary to promote ongoing compliance.