Human Subjects Research at the University of Michigan Module 3 Ethics and Law

Introduction This module contains information about ethical principals and the law including: Belmont Report Common Rule: 45 CFR 46 Conflict of Interest Federal, State, and Local Laws HIPAA FERPA

Belmont Report The Belmont Report is a statement of the basic ethical principles and guidelines that should be used to resolve the ethical problems that surround the conduct of research with human subjects. It identifies three basic ethical principles that underlie all human subject research. These principles are commonly called the Belmont Principles. Respect for persons Beneficence Justice Belmont Report

Respect for Persons This principle requires researchers to treat individuals as autonomous human beings, capable of making their own decision/choices, and not to use people as a means to an end. The principle also provides extra protection to those with limited autonomy. Elements of autonomy include: Mental capacity (the ability to understand and process information) Voluntariness (freedom from the control or influence of others)

Rules derived from Respect for Persons Rules derived from the principle of respect for persons include: The requirement to obtain and document informed consent. The requirement to respect the privacy interests of research subjects. The requirement to consider additional protections when conducting research on individuals with limited autonomy

Beneficence This principle requires researchers to minimize the risks of harm and maximize the potential benefits of their work. This principle demands that researchers and IRBs conduct a careful assessment of the risks of harm and the potential benefits of the research and ensure that the potential benefits justify the risks of harm. This may include, in some cases, alternative ways of obtaining the benefits sought in the research.

Rules derived from the Principal of Beneficence The requirement to use procedures that present the least risk to subjects consistent with answering the scientific question. The requirement to gather data from procedures or activities that are already being performed for non- research reasons. The requirement that risks to subjects be reasonable in relation to both the potential benefits to the subjects and the importance of the knowledge expected to results. The requirement to maintain promises of confidentiality. For research that involves more than minimal risk of harm, the requirement to monitor the data to ensure the safety of subjects.

RISK There are 4 levels of risk to subjects: No more than minimal risk Minor increase over minimal risk Moderate risk High risk

No more than minimal risk No more than minimal risk: the probability of harm or discomfort anticipated in the research is not greater than those ordinarily encountered in daily life or during the performance of routine physical or psychological examination or test. This includes the potential for economic, physical, psychological, or social harm. In children, minimal risk is further defined as: the level of risk that a normal, average, healthy child may be exposed to in the course of that child’s everyday life or those risks encountered by normal, average, healthy children living in safe environments in daily life.

Minor Increase over Minimal Risk Minor Increase over minimal risk: This category of risk refers to activities that would be more harmful than what would be encountered in daily life but not cause temporary financial, emotional, social, or physical harm. For Children, research that represents a minor increase over minimal risk is allowable if: the intervention or procedure presents experiences to the child subjects that are reasonably commensurate with those inherent in their actual, or expected medical, dental, psychological, social, or educational situations; the intervention or procedure is likely to yield generalizable knowledge about the subject's disorder or condition which is of vital importance for the understanding or amelioration of the disorder or condition; adequate provisions are made for soliciting the assent of the children and the permission of their parents or guardians, as set forth in HHS regulations at 45 CFR 46.408.

Moderate Risk 3. Moderate risk are those risks that could cause temporary psychological, legal, financial or physical discomfort. Examples include: Feeling sad, tearful, mild changes in sleep, mild alteration of relationship dynamics. Temporary or moderate harm to social reputation Temporary or moderate financial cost or loss Temporary, moderate discomfort or pain

High Risk 4. High risk are those research activities that cause pronounced distress during the research activity or negative outcomes that impair or persist for more than a few days. Examples Include: Depressive symptoms Major alteration of relationship dynamics Severe or long-term harm to social reputation (release of information leads to loss of insurance, social stigma, or criminal charges.) Permanent physical disability Severe pain or death

Justice The principle of justice requires us to treat people fairly and to design research so that its burdens and benefits are shared equitably. Those who benefit from the research should share in the burden of being subjects in the research. Those who serve as subjects in the research should share in the potential benefits from the research. Individuals or groups should not be selected for research participation solely because they are available, cannot say "no" or do not know that they can say "no". In order to avoid exploitation the selection of subjects should solely based on scientific justification.

Rules Derived from the Principal of Justice The requirement to select subjects equitably. The requirement to avoid exploitation of vulnerable populations or populations of convenience.

Vulnerable Populations Vulnerable populations are groups of individuals who may be subject to coercion. This includes: prisoners, children, pregnant women (whose choice impacts their unborn child), mentally disabled persons. There are additional protections put in place for these populations.

What is the Common Rule? The term Common Rule refers to 45 CFR 46. CFR is the Code of Federal Regulations (administrative law that governs research with human subjects and codifies the ethical principles of the Belmont Report.) It defines what constitutes “research” as well as defines “human subject.” 45 CFR 46

What is a Human Subject? A living individual about whom an investigator conducting research obtains: data through intervention or interaction with the individual or identifiable personal or private information

What is regulated research? Systematic investigation including research development testing and evaluation designed to develop or contribute to generalizable knowledge. 45 CFR 46.102(d) Generally, if you intend to publish the results of your study "outside the walls" of the University, or your study is not a single "case study," journalism, or oral history, then your study is regulated research and under IRB jurisdiction.

Informed Consent Informed Consent is: The voluntary choice of an individual to participate in research based on a complete and accurate understanding of the study. It is not a single event or document but rather an ongoing process that takes place between the investigator (or designees) and the research participant. Requires full disclosure of the nature of the research and the participant’s role in that research, understanding of that role by the potential participant and the participant’s voluntary choice to join the study.

Consent Document Consent is documented by use of a Consent Form approved by the IRB unless a waiver of Informed Consent or waiver of documentation of informed consent is approved by the IRB.

Elements of Consent A statement that the study involves research, the purpose of the research, expected duration of participation, and a description of procedures. A description of reasonably foreseeable risks or harms. A description of any benefits to the subjects or others. Disclosure of appropriate alternative treatments/procedures. (not required for research that does not involve clinical trials.) Description of protection of confidentiality of records If more than minimal risk, a description of compensation & injury procedures if injury occurs. Contact information for PI and IRB (this is standard on our Consent form templates) A statement that participation is voluntary, subject my withdraw at any time with no penalty or loss of benefit.

Consent Waivers Waiver of consent: Waiver of documentation of consent:

Waiver of Informed Consent An IRB may waive or alter the requirements for informed consent only if it finds and documents that: The research involves no more than minimal risk to the subjects; The waiver or alteration will not adversely affect the rights and welfare of the subjects; The research could not practicably (i.e., feasibly) be carried out without the waiver or alteration; and Whenever appropriate, the subjects will be provided with additional pertinent information after participation.

Waiver of Documentation of Informed Consent Documentation may be waived under two circumstances: 1. The principal risks are those associated with a breach of confidentiality concerning the subject's participation in the research, and the consent document is the only record linking the subject with the research. 2. Study participation presents minimal risk of harm to the subject and the research involves no procedures requiring consent outside the context of participation in a research study.

Conflict of Interest Conflict of interest arises when a faculty or staff member, in relationship to an outside organization is in a position to influence the university’s business, research or other decisions in ways that could lead directly or indirectly to financial gain for the faculty or staff member or a member of his / her family or give improper advantage to others to the detriment of the University. Financial conflicts are not inherently wrong and should always be disclosed in the research context. The University and individual academic units have established mechanisms to identify and manage potential conflicts including annual disclosure requirements and questions in the eResearch IRB and Proposal Management systems. COI’s that involve Sponsored Projects are reviewed by OVPR.

Other Federal, State, and Local Laws HIPPA Health Insurance Portability and Accountability Act: Establishes a Federal floor of privacy protections for most individually identifiable health information by establishing conditions for its use and disclosure by certain health care providers, health plans, and health care clearinghouses. FERPA Family Educational Rights and Privacy Act: The regulations provide that educational agencies and institutions that receive funding under a program administered by the U. S. Department of Education must provide students with access to their education records, an opportunity to seek to have the records amended, and some control over the disclosure of information from the records. With several exceptions, schools must have a student's consent prior to the disclosure of education records.

Module 3 Conclusion If you have any questions or concerns please contact: Deb Schneider IRB Administrator (313) 593-5468 dbn-research@umd.umich.edu