Human Subjects/IRB

There may be times when it is more appropriate for consent to be presented and obtained orally rather than in written form, particularly if participants have limited proficiency with the English language.  In such instances, an investigator may use a short form written consent document, stating that the elements of informed consent have been presented orally to the subject or the subject's legally authorized representative.

The oral and short form written consent process is designed to provide a mechanism for individuals with limited English language proficiency to participate in human subject research where their lack of proficiency would otherwise be a barrier to their participation.

Participants who have limited English proficiency may be enrolled in research provided that researchers have the resources to communicate effectively during the recruitment process, while obtaining consent, and for the duration of the study.  Oral consent in combination with short form written consent may be used to obtain a subject’s consent.

The use of oral and short form written consent is not intended for use when research is focused on an entire or large population that lacks proficiency with the English language; in these cases, the normal consent process should be used with consent documents translated into the subject population’s native language.

Investigator Responsibilities

Investigators must obtain IRB approval for use of the short form written consent process.  For new studies, this request should be made when completing the application in Kuali.

The investigator must provide the following to the IRB for review:

  • A written summary of the information that will be presented orally to participants or their legally authorized representatives.
  • The short form document that will be signed by the participant and the person obtaining consent.
  • Identification of the individual obtaining consent.
  • Confirmation that there will be a witness to the oral presentation of consent (this cannot be the same individual who is obtaining consent).  When the person obtaining consent is assisted by a translator, the translator may serve as the witness.
  • Confirmation that the witness is fluent in the same language as the potential participant.

The short form written consent document and written summary of oral presentation must be translated into the participants’ native language.

When this method is used, there must be a witness to the oral presentation. Only the short form itself is to be signed by the participant or legally authorized representative.  The witness must sign both the short form and a copy of the summary, and the person actually obtaining consent must sign a copy of the summary.  The investigator must provide the participant with both a copy of the summary and a copy of the signed short form.

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What is MTurk?

MTurk is a website run by Amazon that works as a readily available marketplace to match “workers” with available work from various “requesters.”  Amazon describes MTurk as, “a marketplace for work that requires human intelligence.  The Mechanical Turk service gives businesses access to a diverse, on-demand, scalable workforce and gives workers a selection of thousands of tasks to complete whenever it’s convenient.”

How are academic researchers using MTurk?

MTurk allows researchers to have access to a large population of willing participants for research studies.  Researchers can generate a HIT (Human Intelligence Task) that gives MTurk users a Title and description of the online task.  It also states the amount of compensation users will receive and the amount of time it takes to complete.  Because MTurk is being used primarily as a recruitment site, researchers have been routing users to links for their online survey’s that are housed at different online survey software sites (i.e. – Qualtrics, Survey Monkey, Google Forms, Survey Gizmo, etc.).  MTurk houses a more diverse, heterogeneous, population that is more attractive to researchers than the typical college campus population.  It also allows for pseudo-anonymity between researchers and participants by having a third party (Amazon) overseeing payments (compensation) to participants.

Amazon Mechanical Turk is a site primarily for matching people with work and submitting payments to workers.  It is not designed with an eye towards human subjects research.  It lacks the sophistication and security measures of dedicated survey software tools and collection of data by Amazon is subject to Amazon’s Privacy Policy and Terms of Service.

What do academic researchers need to consider when submitting an MTurk study to the IRB?

Recruitment: The title of the study and the description of the HIT are acting as a form of recruitment.  Researchers should be sure to include the title and HIT description as part of the Kuali application. In the description, researchers should be sure to include the following information:

  • Researchers should be clear about compensation and bonuses.  Also, it would be useful for participants to know how long it will take for the researchers to approve their HIT (i.e. – how long it takes for turkers to receive payment).
  • Clearly and accurately state the time required to complete the task.
  • Participants should be told if there is a screener in order to qualify.  It would be important for researchers to make clear if participants are being paid for the time it takes to complete the screener or not.  One option would be to list qualifications for participation in the description.  Another option would be to make a hit for the Screener (which would pay a nominal amount) and then if a turker is eligible for the main study, they get a bonus amount or are invited to a follow-up HIT which includes the main study.
  • If any extraneous software is required to complete the task, this should be stated in the description (e.g. this task requires javascript or inquisit).
  • Researchers should be clear about the type of task participants are being asked to do.  For instance, if the task involves writing, or watching videos, this should be stated in the description.  Also be aware that certain types of tasks, such as writing tasks, elicit higher compensation.
  • The researchers name and/or school affiliation should be listed either as the Requester or in the description of the HIT.
  • If applicable: The link to the online survey should be included.

Consent: The first page of the online survey should be the consent document. The online consent will have all of the elements of a regular consent, but it will not require a signature.  Participants will either click an “I Agree” or an “I do not Agree” box.  The “I Agree” box will take them into the survey.  The “I do not agree” box will thank them for their time and take them away from the survey.  For a sample of an online consent form, please see our one page, online survey consent template.

Debrief: If the researchers are using deception or incomplete disclosure (i.e. – are not stating exactly what the study is about so as not to bias participants responses), then it is important to include a debriefing form at the end of the survey.  This debriefing form could be embedded into the last page of the survey and would require participants to answer a final question allowing researchers to use their data (or not use their data) now that they know the true purpose of the study.  For more information on debriefing forms, please see our debriefing process. Please note: For particularly sensitive topics, the IRB may want to ensure that participants receive a debriefing form, even if they do not complete the full study (i.e. – they click out before the end of the survey).  This might mean contacting participants (through MTurk) and providing them a debriefing form.  If this is something that will happen for your study, it would be important to include a statement in the HIT description and in the informed consent that the researchers will be providing participants with additional information after the study and that they may contact participants through MTurk.  This might mean collecting participants MTurk worker IDs.  Researchers should be sure to state that the collection of MTurk worker IDs will only be for debriefing purposes and after debriefing, MTurk worker IDs will be deleted and will at no time ever be linked to their survey data.

Confidentiality: While it may have been the goal that MTurk workers were anonymous to academic researchers, the reality is that anonymity cannot be guaranteed in any online environment were data is being collected.  Recent research shows that MTurk worker IDs can easily be linked to individuals Amazon profiles including individuals wish lists and previous product reviews.  This means that researchers must be careful in deciding what information to collect from participants.  The default should be that participants MTurk worker IDs not be collected.  If it is necessary to collect worker IDs, then the researchers should ensure that worker IDs are kept confidential and secure, are not linked back to survey data, and are deleted after use.

Additional things to consider with regard to confidentiality of participants identity and data are the Amazon MTurk (AMT) Terms of Service (TOS) and online survey software (qualtrics, survey monkey, google forms, survey gizmo, zoho survey, etc.) TOS especially as it relates to the collection of participants online behavior and history (through the use of cookies or other tracking systems) and the selling of participants data to third parties.  It would also be important for researchers to be aware of any policies or procedures in place by AMT and/or online survey software companies when a breach of data occurs.  It might be helpful to think about the researchers own protocol for when a breach of data security occurs.  Working with IT to solidify this process may be necessary.  This information could then be relayed to participants through the consent.

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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 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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