Standard Operating Procedures - Chapter 3

GUIDING PRINCIPLES AND REGULATORY REQUIREMENTS FOR HUMAN SUBJECT PROTECTION

The conduct of research with human participants is highly regulated and guided by ethical considerations. First and foremost, researchers must be cognizant of the fact that research with human participants is a privilege, not a right stemming from academic freedom. Researchers are obligated to conduct research with human participants in a way that minimizes any risks or harm to participants. The IRB review and approval process is in place to ensure that all research with human participants adheres to this mandate.

Guiding principles, accepted as essential requirements for the ethical conduct of human participant research, are embodied in the Belmont Report:Ethical Principles and Guidelines for the Protection of Human Participants of Research (1979) by The National Commission for the Protection of Human Participants of Biomedical and Behavioral Research (for more information, go to http://ohrp.osophs.dhhs.gov/humanparticipants/guidance/belmont.htm).

Three basic principles regarding ethical research are outlined:

1. Respect for persons addresses the personal dignity and autonomy of individuals, and addresses additional protection for special populations with less autonomy, such as minors, pregnant women, fetuses, terminally ill patients, people with impaired mental capacities, medically incompetent persons, and prisoners. This principle reflects the need for proper informed consent, which must include all the essential elements and the additional elements (if applicable) as outlined in the federal regulations.

2. Beneficence, “do no harm,” implies an obligation to protect human participants from harm by assessing the risks and benefits of the research. Anticipated benefits must be greater than anticipated risks to comply with this principle.

3. Justice requires that research participants be fairly selected through a process that involves consideration of the purpose and expected outcome of the research. Selection should include consideration of the participant as an individual and as a member of society with regard to race, sex and ethnic group. The population of research participants should be similar to the population expected to benefit from the outcome of the research.

Compliance provides protections for human participants as mandated by applicable laws, regulations and standards of local, state and federal government agencies concerning the protection of human participants.

The University’s policy for the protection of human participants “ Assurance of Compliance with OHRP Regulations for Protection of Human Research Subjects” specifies that the ethical principles, regulations, and institutional requirements be met for all research, not just federally funded research.

Department of Health and Human Services Regulations (DHHS 45 CFR 46)

UMASS holds a federal-wide assurance (FWA 00003909) Office of Human Research Protection. Under this assurance, UMASS complies with 45 CFR 46. UMASS chooses to limit this assurance to federally funded research; however, the regulations under 45 CFR 46, including all of Subparts B, C, and D, provide the practical basis for the review and approval of all research at UMASS regardless of funding. UMASS policy requires all research that involves human subjects, that is conducted by UMASS staff on its premises or under its sponsorship, whether or not supported by external funding, to be reviewed and approved.

Other Federal Funding Agencies

Any other Federal Agency regulations if funding research at UMASS.
The most frequent are:

Department of Education 34 CFR Part 97
Department of Defense 32 CFR 219
NSF 45 CFR 690
Department of Energy 10 CFR part 745
Department of Justice 28 CFR 46
Food and Drug Administration 21 CFR 50

Commonwealth of Massachusetts

UMASS complies with Massachusetts state regulations. The two regulations specific to research are:

Investigational Drugs
This regulation requires investigators to obtain a license from the State of Massachusetts in order to administer an investigational drug or Schedule II drug during the conduct of a research protocol. For academic institutions, the state permits department chairs to hold a license for any investigators working in the department. The license is renewed annually and the cost of the license is covered by the institution.

Massachusetts Fetal Research Statute, Section 12J of MGL, Chapter 112 (FHS)
The Fetal Research statute prohibits research on fetuses; however, two exceptions to this prohibition apply. These two exceptions are for protocols that meet the definition of 1) therapeutic exception; or 2) "no substantial jeopardy" exception. The definition of fetus extends to a neonate from birth to 28 days of life.

Other Massachusetts Laws that Impact Clinical Research

Although the following laws do not pertain specifically to research, they may impact research and are to be taken into consideration as necessary.

Laws that address a minor's right to consent (e.g., 112 MGL 12E, drug dependent minors; and 112 MGL 12F, emergency and other treatment of minors and emancipated minors)
Laws that protect or affect confidentiality (e.g., 111 MGL 70E, the Patient Bill of Rights); laws that protect various forms of records (e.g., 111 MGH 119, venereal disease; 111 MGL 70F, HIV testing and results; 111E MGL 18, drug abuse treatment; and 111B MGL 11, alcohol abuse treatment); and laws that privilege various clinical relationships (e.g., 112 MGL 135, social worker-patient privilege; 233 MGL 20B, psychotherapist-patient privilege; 112 MGL 129A, psychologist-patient privilege; and 233 MGL 20K, domestic violence counselors),
Consent requirements for autopsy tissue (105 CMR130)
Laws that provide for mandatory reporting (e.g., 119 MGL 51A, child abuse and neglect reporting; and 111 MGL 6, infectious disease reporting)
genetic testing (111 MGL 70G)




Research Home Compliance Home Animal Use Biological Safety Feedback Forms Human Subjects Research Policies Responsible Conduct Staff		Standard Operating Procedures - Chapter 3 GUIDING PRINCIPLES AND REGULATORY REQUIREMENTS FOR HUMAN SUBJECT PROTECTION The conduct of research with human participants is highly regulated and guided by ethical considerations. First and foremost, researchers must be cognizant of the fact that research with human participants is a privilege, not a right stemming from academic freedom. Researchers are obligated to conduct research with human participants in a way that minimizes any risks or harm to participants. The IRB review and approval process is in place to ensure that all research with human participants adheres to this mandate. Guiding principles, accepted as essential requirements for the ethical conduct of human participant research, are embodied in the Belmont Report:Ethical Principles and Guidelines for the Protection of Human Participants of Research (1979) by The National Commission for the Protection of Human Participants of Biomedical and Behavioral Research (for more information, go to http://ohrp.osophs.dhhs.gov/humanparticipants/guidance/belmont.htm). Three basic principles regarding ethical research are outlined: 1. Respect for persons addresses the personal dignity and autonomy of individuals, and addresses additional protection for special populations with less autonomy, such as minors, pregnant women, fetuses, terminally ill patients, people with impaired mental capacities, medically incompetent persons, and prisoners. This principle reflects the need for proper informed consent, which must include all the essential elements and the additional elements (if applicable) as outlined in the federal regulations. 2. Beneficence, “do no harm,” implies an obligation to protect human participants from harm by assessing the risks and benefits of the research. Anticipated benefits must be greater than anticipated risks to comply with this principle. 3. Justice requires that research participants be fairly selected through a process that involves consideration of the purpose and expected outcome of the research. Selection should include consideration of the participant as an individual and as a member of society with regard to race, sex and ethnic group. The population of research participants should be similar to the population expected to benefit from the outcome of the research. Compliance provides protections for human participants as mandated by applicable laws, regulations and standards of local, state and federal government agencies concerning the protection of human participants. The University’s policy for the protection of human participants “ Assurance of Compliance with OHRP Regulations for Protection of Human Research Subjects” specifies that the ethical principles, regulations, and institutional requirements be met for all research, not just federally funded research. Department of Health and Human Services Regulations (DHHS 45 CFR 46) UMASS holds a federal-wide assurance (FWA 00003909) Office of Human Research Protection. Under this assurance, UMASS complies with 45 CFR 46. UMASS chooses to limit this assurance to federally funded research; however, the regulations under 45 CFR 46, including all of Subparts B, C, and D, provide the practical basis for the review and approval of all research at UMASS regardless of funding. UMASS policy requires all research that involves human subjects, that is conducted by UMASS staff on its premises or under its sponsorship, whether or not supported by external funding, to be reviewed and approved. Other Federal Funding Agencies Any other Federal Agency regulations if funding research at UMASS. The most frequent are: Department of Education 34 CFR Part 97 Department of Defense 32 CFR 219 NSF 45 CFR 690 Department of Energy 10 CFR part 745 Department of Justice 28 CFR 46 Food and Drug Administration 21 CFR 50 Commonwealth of Massachusetts UMASS complies with Massachusetts state regulations. The two regulations specific to research are: Investigational Drugs This regulation requires investigators to obtain a license from the State of Massachusetts in order to administer an investigational drug or Schedule II drug during the conduct of a research protocol. For academic institutions, the state permits department chairs to hold a license for any investigators working in the department. The license is renewed annually and the cost of the license is covered by the institution. Massachusetts Fetal Research Statute, Section 12J of MGL, Chapter 112 (FHS) The Fetal Research statute prohibits research on fetuses; however, two exceptions to this prohibition apply. These two exceptions are for protocols that meet the definition of 1) therapeutic exception; or 2) "no substantial jeopardy" exception. The definition of fetus extends to a neonate from birth to 28 days of life. Other Massachusetts Laws that Impact Clinical Research Although the following laws do not pertain specifically to research, they may impact research and are to be taken into consideration as necessary. Laws that address a minor's right to consent (e.g., 112 MGL 12E, drug dependent minors; and 112 MGL 12F, emergency and other treatment of minors and emancipated minors) Laws that protect or affect confidentiality (e.g., 111 MGL 70E, the Patient Bill of Rights); laws that protect various forms of records (e.g., 111 MGH 119, venereal disease; 111 MGL 70F, HIV testing and results; 111E MGL 18, drug abuse treatment; and 111B MGL 11, alcohol abuse treatment); and laws that privilege various clinical relationships (e.g., 112 MGL 135, social worker-patient privilege; 233 MGL 20B, psychotherapist-patient privilege; 112 MGL 129A, psychologist-patient privilege; and 233 MGL 20K, domestic violence counselors), Consent requirements for autopsy tissue (105 CMR130) Laws that provide for mandatory reporting (e.g., 119 MGL 51A, child abuse and neglect reporting; and 111 MGL 6, infectious disease reporting) genetic testing (111 MGL 70G)


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