Human Subjects/IRB

Process for Reviewing External Recruitment Requests

Researchers not affiliated with UMass Amherst who wish to recruit students, faculty, or staff as research participants are required to submit a recruitment request to the UMass Amherst Human Research Protection Office (HRPO) before beginning their research project. All requests will be screened by the UMass Amherst IRB; we also require research projects to have obtained prior approval through the non-UMass Amherst researcher’s home Institutional Review Board.

Submission Requirements

If you are an external researcher, and are interested in recruiting UMass Amherst students, faculty, or staff as research subjects, please send an email to humansubjects@ora.umass.edu that includes the following information:

  • An overview of your project, including a rationale and specific procedures for recruiting UMass Amherst students, faculty, or staff as participants
  • A copy of the completed research protocol application, including any data security plans, that was approved by your home institution’s IRB, along with the IRB’s approval letter
  • All relevant study materials (e.g. recruitment materials for UMass Amherst participants, interview questions, surveys)

Staff from the HRPO will contact you and may request more information if necessary. Approval to recruit on our campus is finalized once you receive an official letter from the HRPO that confirms approval to begin recruiting at UMass Amherst.

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Determining whether a project requires review by the IRB is sometimes difficult and for this reason it is always best to consult with the Human Research Protection Office (HRPO) for guidance.  The following flowchart is designed to assist in making this determination.

The HRPO makes the determination whether or not a project meets the definition of human subject research.  Federal regulations require that proposed research involving human subjects be reviewed and approved by the Institutional Review Board prior to project initiation. If you are unsure if your project meets the definition of research or if you require documentation that your project does not require IRB review, complete and submit the Determination of Human Subject Research form.

The determination of whether or not a project or activity is defined as human subject research rests on the answers to the following three questions:

  1.  Is it research? Federal regulation defines research as a systematic investigation, including research development, testing, and evaluation, that is designed to develop or contribute to generalizable knowledge.  Research is usually described in a protocol, a formal document that describes the research question or hypothesis and how it is to be tested (methodology) to establish facts and reach conclusions.
  2.  Is the intent to produce generalizable knowledge? The intent to develop or contribute to generalizable knowledge makes an activity research.  Generalizable knowledge is knowledge that is expressed in theories, principles, or statements of relationships that can be generally applied to our experiences.  Activities designed to contribute to generalizable knowledge are those designed to draw general conclusions, inform policy, or generalize findings beyond a single individual or an internal program.  The information is collected to share with others in a discipline and is created to make a broad statement (conclusion) about a group of people, procedures, programs, etc.

    *If the activity is not a systematic investigation designed to contribute to generalizable knowledge, the activity does not meet the regulatory definition of research.

    Generalizable knowledge includes one or more of the following concepts: (1) The information contributes to a theoretical framework or an established body of knowledge; (2) The primary beneficiaries of the study are other researchers, scholars, and practitioners in the field of study; (3) Publication, presentation or other distribution of the results is intended to inform the field of study; and, (4) The results are intended to be replicated in other settings

  3.  Does it involve human subjects? Although a seemingly straight-forward question, whether or not an activity involves human subjects can be somewhat confusing, especially when using coded private information or specimens.  Human subjects are defined as “living individuals about whom an investigator conducting research obtains:
  • Data through intervention or interaction with the individual, or
  • Identifiable private information

Intervention includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes. Interaction includes communication or interpersonal contact between investigator and subject. Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.

For purposes of this document, coded means that:

  • Identifying information (such as name or social security number) that would enable the investigator to readily ascertain the identity of the individual to whom the private information or specimens pertain has been replaced with a number, letter, symbol, or combination thereof (i.e., the code); and
  • A key to decipher the code exists, enabling linkage of the identifying information to the private information or specimens.

Determinations of what does or does not involve human subject research must be made by the IRB or individuals designated by the IRB Chair who have sufficient training and expertise in making such determinations.

In analyzing a particular activity under this question, it is important to focus on what is being obtained by the investigators. If the investigators are not obtaining either data through intervention or interaction with living individuals, or identifiable private information, then the research activity does not involve human subjects.

What about Research Involving Coded Private Information or Biological Specimens?

Whether or not an activity is classified as “not involving human subjects” or qualifies for exemption under 45 CFR 46.101(b)(4) is determined by the following:

  • the source of the data (primary or secondary data)
  • ability or inability of the investigator to link data or specimens to specific individuals either directly or indirectly through coding systems

Research involving only coded private information or specimens is not considered human subject research if both of the following conditions are met:

  1. The private information or specimens were not collected specifically for the currently proposed research project through an interaction or intervention with living individuals (i.e. it is pre-existing data); and
  2. The investigator(s) cannot readily ascertain the identity of the individual(s) to whom the coded private information or specimens pertain because, for example:
    1. The investigators and the holder of the key enter into an agreement prohibiting the release of the key to the investigators under any circumstances, until the individuals are deceased (note that the HHS regulations do not require the IRB to review and approve this agreement);
    2. There are IRB-approved written policies and operating procedures for a repository or data management center that prohibit the release of the key to the investigators under any circumstances, until the individuals are deceased; or
    3. There are other legal requirements prohibiting the release of the key to the investigators, until the individuals are deceased.

The exemption under 45 CFR 46.101(b)(4) applies to research involving private information and specimens when:

  1.  Data is already existing at the time the research is proposed and is available publicy, or
  2. The information is recorded by the investigator(s) in such a manner that subjects cannot be identified, directly or through identifiers linked to subjects.

This exemption would not apply if the investigators, having obtained identifiable private information or specimens from existing records or specimens, record the data or information in a coded manner, since the code would enable subjects to be identified through identifiers linked to the subjects.

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Human Body Fluids Precautions Policy

 

Sen. Doc. No. 90-028

University of Massachusetts
Amherst, Massachusetts

POLICY: HUMAN BODY FLUIDS PRECAUTIONS

Statement of Policy

The Amherst campus of the University of Massachusetts shall establish, adopt, and enforce a comprehensive set of standards, guidelines, and procedures that will minimize the risk to students, faculty, and staff of occupational exposure to human body fluids and other materials that may contain agents of human infection. In areas and activities similar to non-campus settings (e.g. laboratories, health care facilities, etc.), the policy shall apply regulations, standards and practices that have been developed by relevant governmental or professional agencies (e.g., U.S. Public Health Service, Centers for Disease Control, Occupational Safety and Health Administration, Massachusetts Department. of Public Health, National Collegiate Athletic Association, etc.) insofar as they are not in conflict with laws governing the University of Massachusetts or the ethical standards of the academic community. In other areas or activities in which risks are identified or suspected and for which legal or professional standards have not been developed and/or published, the Amherst campus shall adopt standards, guidelines, and practices that are appropriate for the level of risk identified. Included will be educational activities to explain risks and to allay unwarranted fears arising from misconceptions of risk.

Inherent in this policy is the responsibility of the Amherst campus to identify risks, to differentiate them according to severity, and to maintain adherence to reasonable or established standards, guidelines, and practices. Administrative oversight for the risk identification and reduction program is the responsibility of Environmental Health and Safety, in collaboration with all segments of the University community. Actual implementation of the policy and adherence to the policy is the responsibility of the department or unit involved.

Background

Human blood, body fluids, and other body tissues are widely recognized as vehicles for the transmission of human disease. Although many of these diseases are readily identified and can be prevented and/or treated successfully by well-accepted measures (e.g. syphilis and tuberculosis), others are not.

At least three infectious agents transmitted through human blood products and/or body fluids (BBF) continue to present a serious health problem: hepatitis B virus (HBV), hepatitis C virus (HCV) and human immuno-deficiency virus (HIV). Because of difficulties in identifying, preventing, and treating the diseases they cause, special precautions for minimizing the risk of exposure to them are warranted. The means of transmission are common to all.

HBV, the more common of the three infectious agents, causes a serious form of hepatitis, which can lead to a permanent loss of liver function or even death. When suspected, it can be detected readily in blood or body fluids. Persons exposed can be protected temporarily by the use of hepatitis B immune globulin. An available vaccine provides long-term protection for those whose work or travel entails a high risk of exposure. Its cost is high but readily justifiable in view of the serious consequences of clinical disease.

HCV, once called non-A non-B hepatitis also causes a serious form of hepatitis which can lead to a permanent loss of liver function and death. There is no vaccine to protect against this type of hepatitis but this disease can be partially treated in some cases with interferon.

HIV may cause Acquired Immuno-Deficiency Syndrome (AIDS). In addition, once introduced, it may exist in humans for many years before causing symptoms; during this long latent period, it can be transmitted through blood products and other body fluids. Unprotected sexual contact is widely recognized as the most common mode of transmission but transmission is well recognized via transfusion, shared use of intravenous needles, and pregnancy. Documented cases have been traced to work related inadvertent contact, such as needle sticks with infected blood.

HIV appears to be very fragile, hence, unable to survive for substantial periods outside the body of humans. Efforts to develop a useful vaccine have not been successful; researchers generally hold out scant hope for success in the near future. Although there is no cure for HIV disease, it is important to recognize the disease at an early stage so that treatment for the disease can be initiated. A particularly disturbing feature of the HIV infection is the long latent period between introduction of the virus into a person's body and clinical symptoms, which may average five to seven years. There appears to be no bar to transmission during the latent period. This characteristic poses an especially serious threat to human health since there is neither an effective cure nor an agent for prevention, such as a vaccine. Disease control must rest solely, therefore, with behavioral strategies at both the individual and collective levels. Individual protective behaviors can result from programs to provide information and alter attitudes; the adoption of collective measures is an institutional and social responsibility.

Definitions

Infectious body fluids shall include blood, semen, vaginal secretions, cerebrospinal fluid, synovial fluid, pleural fluid, pericardial fluid, peritoneal fluid, amniotic fluid, saliva in dental procedures, any body fluid that is visibly contaminated with blood, and all body fluids in situations where it is difficult or impossible to differentiate between body fluids.

Other potentially infectious materials shall include infectious body fluids, any unfixed human tissue or organ, HIV, HCV, or HBV containing cell or tissue cultures, organ cultures, culture medium, or blood, organs, or other tissues from experimental animals infected with HIV,HCV, or HBV.

Occupational Exposure means reasonably anticipated skin, eye, mucous membrane, or parenteral contact with blood or other potentially infectious materials during the performance of an employee's duties or assignments of a student in a class.

"HIV infection" shall include all stages in the progression of infection, including HIV seropositivity and AIDS.

Levels of Exposure:

The campus policy is intended to apply to occupational exposure to human blood, or other materials which may be potentially infected with human immuno-deficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV) or any other bloodborne pathogen (other potentially infectious material).

Each on- or off-campus activity in which students, faculty, or staff may participate in shall be classified as Category I (exposure) or Category II (non-exposure). This is consistent with occupational exposure as established by the U.S. Department of Labor, Occupational Safety and Health Administration standards(OSHA Occupational Exposure to Bloodborne Pathogens, 29 CFR 1910, December 6, 1991).

  • Category I (Exposure): Procedures and activities that involve (known or predictable) contact with human blood, body fluids, or tissues - including spills or splashes. Risks are identifiable, since they are inherent in regular job-related tasks. Examples: laboratories, dental offices, and other health care settings.
  • Category II (Non-exposure): Procedures and activities that do not involve regular or occasional contact with human blood, body fluids, or tissue and in which there is an extremely low risk of transmission of HBV,HCV or HIV. Examples: sharing wind instruments (saliva does not transmit HIV), hand shaking, use of public or shared toilets or phones. (Note: This is not to suggest or imply that other infectious diseases, such as upper respiratory infections are not transmitted via direct or indirect contact. These diseases are either self-limited or treatable by available therapeutic agents. Customary hygienic precautions, based primarily on individually adopted procedures, are adequate measures of protection.)

Control Measures

  • Category I: Appropriate protective measures shall be identified, adopted and required for every person whose work or activity is classified as Category I. These shall be outlined in a written Exposure Control Plan which will specify which job classifications and specific tasks are defined as potential occupational exposures. The Amherst campus shall be responsible for providing appropriate protective supplies and equipment (e.g. gloves for routine use by anyone drawing human blood samples.) The Amherst campus shall provide immunization to protect against HBV infection and appropriate medical treatment following contact with human blood and other potentially infectious materials for all students and employees whose work involves this level of risk.
  • Category II: Educational programs shall be introduced to explain lack of risk to persons active in these settings. In addition, appropriate medical treatment following contacts with human blood and other potentially infectious materials shall be provided if an accidental exposure occurs.

Implementation

Administrative oversight for the risk identification and reduction program rests with the Environmental Health and Safety (EH&S). The primary goal of the program is to provide a systematic approach aimed at the primary recognition, evaluation and control of (Category I, II.) exposures to human blood, body fluids, and other potentially infectious materials. Successful implementation of this policy requires close collaboration between all segments of the University community. EH&S is responsible for providing central coordination of the program, but adherence with established Safe Operating Practices (SOP's) is a shared campus-wide responsibility. The EH&S Biological Safety Program will be responsible for providing the following services:

  1. Identification and categorization of activities (I or II) that may fall within the scope of this policy and developing exposure control plans. University Health Services, Occupational Health Program and individual departments shall assist in this effort;
  2. Development of SOP's in consultation with the individual departments and appropriate committees, such as the Graduate School Biological Safety Committee and the University Health Services Infection Control Committee;
  3. Monitoring of work places and activities on a periodic basis to assure that the departments are cognizant of the SOP's and proper precautions are being followed;
  4. Investigation of known or suspected exposures to determine the circumstances and to prevent recurrence;
  5. Development of appropriate educational programs in cooperation with the Occupational Health Program and the Employee Assistance Program;
  6. Ongoing review of the overall program to insure that the intent of the policy is being achieved. Periodic reports shall be made to the appropriate Faculty Senate committees including the Biological Safety Committee of the Graduate School, the University Health Council of the Faculty Senate, the University Committee on AIDS or other appropriate body.

Actual implementation of the policy and adherence to the policy is the responsibility of each department or unit where human blood, body fluids, or other infectious materials may pose a risk to the safety of students, faculty, or staff. It is the responsibility of the principal investigator, researcher, or administrative unit head to be aware of appropriate federal, state, or university regulations involving the safe handling of human body fluids, to implement policies and procedures that adequately protect the environment and those working in the environment, and to request assistance whenever potential or actual violations of prudent practices occur. Inadequate attention to human body fluid precautions may lead to appropriate sanctions or disciplinary actions within approved health and safety practices of the University.

University Health Services will be responsible for providing the HBV immunizations and the medical treatment of employees and students following occupational contacts with human blood and other potentially infectious materials.

MOTION 16-90: APPROVED on December 7, 1989: That the Faculty Senate recommend to the administration the adoption of the Policy on Human Body Fluids Precautions developed and approved by the University Health Council as set forth in Sen. Doc. No. 90-028.

University Health Services
Environmental Health and Safety

 

GUIDELINES FOR MANAGEMENT OF
OCCUPATIONAL EXPOSURE TO HUMAN BLOOD OR BODY FLUIDS

Transmission of hepatitis B virus (HBV), human immunodeficiency virus (AIDS virus, HIV), and other pathogenic microorganisms to health care and research workers through human blood, body fluids, and other body tissues has been documented. Although all efforts should be made to prevent exposure, employees who are performing known or predictable procedures and activities with human body fluids (see campus policy Human Body Fluids Precautions), may be exposed to infectious agents. As part of the occupational health program, University Health Services (UHS) will provide medical care if an accident occurs and an employee becomes exposed to human blood or body fluids during his/her job.

If an employee has a parenteral (E.g. needlestick, cut, bite) or mucous membrane (splash to the eye or mouth) exposure to human blood or other body fluids, or has a skin exposure involving large amounts of human blood or prolonged contact with blood especially when the exposed skin is chapped, abraded, or afflicted with dermatitis (eczema):

1. This incident should be reported to the supervisor.

2. The employee should report to UHS, Urgent Care immediately to have the exposure evaluated. If necessary, post exposure treatment should be initiated within 2 hours of exposure.

3. The supervisor should report accidents to the Division of Environmental Health and Safety.

4. If you have any questions, please call the Biological and Chemical Safety Officer at Environmental Health and Safety (545-2682) or the Occupational Health Physician at UHS (577-5000).

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