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Human Subjects Division (HSD)

Questions and Answers

  • Confidential or Anonymous?

    Anonymity and confidentiality are not the same.

    Data

    When data are anonymous, they are not linked to the identity of individual subjects in any way that would make it possible to connect the information to the individual from whom it came. Anonymous data do NOT have direct identifiers like names, addresses, clinic or hospital number, Social Security Number, or insurance agency numbers.

    Data that are linked to subjects via a CODE are NOT anonymous.

    When data are confidential, there is a link between data and the individuals who provide it, but the link is obscured by coding or other procedures so that even someone who has access to the raw data cannot identify a subject without also having access to the link between the subject code and the subject\'s identity.

    Participation

    When participation is anonymous, it is impossible to know whether or not an individual participated in a study.

    When participation is confidential, the study participation of a specific individual is recorded, but cannot be known by anyone except the researcher and authorized research staff who have legitimate access to participation records.

  • Does all research go through the same review process?

    No. There are three types of research, each of which receives a different level of review.

    1. Exempt Research

      The University of Washington applies the federal regulations and guidance about exemption to all UW human subjects research, regardless of funding or funding source. The staff of the Human Subjects Division (HSD) are the only individuals authorized to determine that research activity is exempt from federal regulations. In addition to the federal criteria, HSD requires that exempt research involve no more than minimal risk and that interactions with subjects must include some type of consent process that provides the subjects with basic information about the research.

      Researchers do not have the authority to determine that their own research qualifies for exempt status. The research may not begin until the researcher has received notification from HSD that the research qualifies for exemption. Exempt status is granted for a five-year period.

    2. Minimal Risk Research

      Research falling into minimal risk categories is reviewed by a subcommittee of the IRB (use form UW 13-11). You may also hear the term "expedited review" used in conjunction with the review of minimal risk research; describing the ability of the research to be reviewed by a subcommittee - not that the review process is necessarily faster.

    3. More than Minimal Risk Research

      Research falling into categories considered to be of more than minimal risk requires review by the full Committee (use form UW 13-11).

  • Does my research require review?

    If you are a faculty or staff member, or a student at the University of Washington, and your research involves the use of human subjects (either directly or through records or other data such as specimens or autopsy materials), your research requires human subjects review and approval before beginning the research.

  • Does research involve special risks?

    Before the study begins, the researchers attempt to reduce any risk of physical or psychological discomfort or harm to you and others who take part in the study. Yet, for research to be absolutely "risk-free," every possible outcome would have to be known-and if it were, the research would not be necessary. The amount or level of risk will vary from one study to another. It is important to ask the researcher and/or research staff about the specific risks in an individual study and to think carefully about what the risk described would potentially mean for you.

  • How do I get involved in a research study?

    There are many ways to find out about research studies. If you have a specific interest, such as a certain disease, condition, or topic, the internet is a tremendous resource. Many college and university departments will also list studies that are going on and how to participate on their departmental web sites.

    As you proceed towards involvement, ask lots of questions about the study and what participation might mean for you.

  • How does one apply for an FWA?

    The OHRP website provides the information, and the application form, needed to apply for a Federalwide Assurance (FWA) including step-by-step instructions for domestic (U.S.) and international (non-U.S.) institutions. The FWA form is to be completed and signed by the collaborating institution. The FWA form does not need a signature by anyone at the University of Washington. Step-by-step instructions provided by the OHRP web site should be followed by the institution completing this form. The FWA form, Section 5, "Designation of Institution Review Boards IRBs," requests that the institution designate IRB(s) for review of research under their Assurance. The institution may list the University of Washington IRB(s), and other IRBs, if and as appropriate.

  • How long does the IRB review process take?

    Multiple factors affect the time required for IRB review. They include:

    • type of application
    • level of review (e.g., exempt, minimal risk, full committee)
    • complexity of the study
    • involvement of other compliance offices or institutions
    • quality and completeness of the application when first submitted

    We encourage researchers to plan for sufficient time for review based on the research and their particular situation. Here are some general recommendations based on HSD's current workload:

    • Allocate adequate preparation time before submission, in most cases a minimum of two weeks to one month.
    • For full IRB review, plan for at least 12 to 16 weeks for the review and approval process.
    • For Minimal Risk review, plan for at least 6 to 8 weeks.
    • For Exempt review, plan for at least 2 to 3 weeks.
  • How long is approval valid?

    Approval is generally valid for one year from the date of Committee approval.

  • If I am a student, do I have to participate if it is a class or program requirement?

    Yes, and no...

    Please see OHRP guidance on this issue

  • May the investigator pre-sign the consent form?

    Except in very specific circumstances, approved on a case-by-case basis by reviewing Committee or subcommittee, consent forms should not be pre-signed.

  • What are some good questions to ask before deciding to participate?

    What are some good questions to ask before deciding to participate?

    • Where will the research take place? How do I get there?
    • How long will it last? How much of my time will it take?
    • What exactly will happen to me in the research?
    • What are the potential risks? How likely are they to occur?
    • Is participating in the study likely to benefit me? Will the study benefit others?
    • Are there other options – such as alternative procedures or treatments besides the ones being studied? How do the alternatives compare with this study?
    • How will my privacy be protected? Can anyone find out that I am participating in this study?
    • Will I have to pay for any of the study procedures or treatments? If so, how much? Will my insurance pay?
    • When I am in the study, will the researchers work with my regular caregiver or doctor or teacher?
    • What if I am harmed by the study?
    • Will I be paid for participating in the study? What if I drop out of the study before it’s over?
    • Whom do I call if I have questions or problems?
  • What are the requirements for authorization when researchers wish to access patient information?

    The HIPAA regulations use the term \"authorization\" to describe the process through which a patient allows researchers to access protected health information (PHI). The information must include:

    • a description of the information to be used for research purposes;
    • who may use or disclose the information;
    • who may receive the information;
    • purpose of the use or disclosure;
    • expiration date or event (if the information will be kept indefinitely, the authorization states that there is no expiration date);
    • individual\'s signature and date;
    • right to revoke authorization;
    • right to refuse to sign authorization (if this happens, the individual may be excluded from the research and any treatment associated with the research);
    • if relevant, that the research subject\'s access rights are to be suspended while the clinical trial is in progress, and that the right to access PHI will be reinstated at the conclusion of the clinical trial.

    Blanket authorizations for research to be conducted in the future are not permitted. Each new use requires a specific authorization.

  • What happens if I have an emergency?

    A person who has an emergency during a study should immediately notify the treating doctor and/or available research staff. Personal care should always be available, even when the emergency may not be related to the treatment being given.

  • What if I am doing my research in another place or country?

    University of Washington researchers who are conducting research with human subjects that is funded by, or conducted by, the Department of Health and Human Services, and who are engaged in research at sites that are not UW-affiliated sites, must have an assurance of compliance with the HHS regulations for the protection of human subjects. Please see the topic: Federalwide Assurance for information on how to obtain this assurance.

  • What if I want to stop participating in the research study?

    You are free to stop participating in a research study or to “withdraw” at any time and for any reason. Your withdrawal will not affect other services you may be getting or are entitled to in the institution. If possible, you should talk with the research staff (investigators) about why you wish to stop participating – as this will help them to better understand what you have experienced and the reason(s) for your decision.

  • What is a Federalwide Assurance (FWA)?

    Under the Department of Health and Human Services (DHHS) human subjects protection regulations (at 45 C.F.R. 46.103), every institution engaged in human subjects research that is funded or conducted by DHHS must obtain an Assurance Of Compliance approved by the Office for Human Research Protections (OHRP). This Assurance Of Compliance, when granted, is called a Federalwide Assurance. Both "awardee" institutions and collaborating "performance site" institutions must file Assurances.

    The "awardee" is responsible for ensuring that all collaborating institutions engaged in the research hold an OHRP approved Assurance prior to their initiation of the research.

  • What is an IRB and who are its members?

    An Institutional Review Board (IRB) is the group or committee that is given the responsibility by an institution to review that institution’s research projects involving human participants. The primary purpose of the IRB review is to assure that the safety, rights, and welfare of the human participants are protected.

  • What is HIPAA?

    HIPAA is an acronym for the Health Insurance Portability and Accountability Act, passed by Congress in 1996. The purpose of the Act was to increase the ease with which people could transfer their health care information from one insurer or provider to the next. Congress, as part of HIPAA, required the development of privacy regulations to protect the confidentiality of individually identifiable health care information. The final (HIPAA) privacy rule was issued on August 14, 2002. As of April 14, 2003, The University of Washington is in compliance with the Privacy Rule.

  • What is Informed Consent?

    As it relates to the conduct of research within safe and ethical guidelines, informed consent is a person's voluntary agreement, based upon adequate knowledge and understanding of relevant information, to participate in the research described. In giving informed consent, research subjects may not waive or appear to waive any of their legal rights, or release or appear to release the investigator, the sponsor, the institution or agents thereof from liability for negligence [Federal Policy; 21 CFR 50.20 and 50.251].

    There are a very few instances in which the requirement to obtain informed consent or in which written documentation of consent might be waived. These might include, for example:

    • Instances in which an investigational drug or device might be used in an emergency situation, the circumstances of which make obtaining informed consent impossible.
    • Research in which information about a potentially illegal activity is being collected and the informed consent could, in and of itself, pose a risk to participants of identification and arrest.
    • In cases where the requirement for informed consent or for written consent is waived, additional protections for research subjects are considered and typically included in the research procedures.
  • What is needed to request a "Waiver of HIPAA Authorization?"

    The UW IRB Committees use specific criteria in reviewing requests for a waiver of HIPAA authorization for research. In completing the Human Subjects Review Application (UW 13-11), researchers should explain how:

    • The use or disclosure of protected health information involves no more than minimal risk to the privacy, safety, and welfare of the individual;
    • The research could not practicably be conducted without the waiver or alteration;
    • The research could not practicably be conducted without access to the protected health information;
    • There is an adequate plan to protect the identifiers from improper use or disclosure;
    • There is an adequate plan to destroy the identifiers at the earliest opportunity consistent with conduct of the research, unless there is a health or research justification for retaining the identifiers or such retention is otherwise required by law; and
    • There are adequate written assurances that the protected health information will not be re-used or disclosed to a third party except as required by law, for authorized oversight of the research, or as permitted by an authorization signed by the research subject

    In requesting this waiver, researchers should also provide the following information:

    • Detailed information about the types of protected health information that will be used, including how it will be used, who will have access to it, and when it will be destroyed;
    • What risks are posed by the use of the data, and how they have been minimized
    • The justification for access to the data and why they are necessary to conduct the research.
  • What is PHI?

    Protected Health Information is any information pertaining to:

    • the past, present, or future physical or mental health or condition of an individual;
    • the provision of health care to an individual; or
    • the past, present, or future payment for the provision of health care to an individual.

    PHI may be information that is recorded electronically, on paper, or orally. PHI may concern living people or dead people (referred to in the law as "decedents"). PHI does NOT include de-identified information or biological tissue with no accompanying information, such as an accession number or code number that may be linked to an identifier.

  • What is research?

    "Research" means a systematic investigation designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute "research" for the purposes of the regulations that guide and govern how research is conducted in the United States, whether or not they are supported or funded under a program which is considered research for other purposes. For example, some "demonstration" and "service" programs may include research activities. It may be important to understand the following about research:

    • It is basically a study that is done to answer a question.
    • Scientists do research because they don't know for sure what works best or to better understand why or how things happen.
    • Some other words that describe research are clinical trial, protocol, survey, or experiment.
    • Research is not the same as treatment.
  • What is the IRB review process?

    The “Life Cycle” of a Human Subjects Application can be described as having six phases:

    1. Researcher Preparation
    2. Department Review and Approval
    3. IRB Review and Determinations/Actions
    4. Conduct of Research and Reporting
    5. Continuing Review
    6. Ending the Study

    A diagram of the Human Subjects Application Life Cycle describes what happens within each phase.

  • What kind of research and researchers are affected by the HIPAA regulations?

    Any kind of research conducted under the auspices of the UW and UW Medicine that creates or uses protected health information is subject to the HIPAA regulations. This includes such research activities as clinical trials, chart reviews, epidemiological studies, behavioral, and social science studies, as well as basic science research activities. It includes research that involves the provision of treatment as well as research that provides neither treatment nor diagnosis.

    All researchers, whether or not they are directly connected with UW Medicine, who wish to conduct research involving protected health information must complete HIPAA training before they will be allowed to have access to individually identifiable health information in any form.

  • What protection exists for research subjects?

    Many "checkpoints" ensure that research meets strict scientific guidelines for safety and ethical conduct and follows rules to protect the participants. Several groups who are not part of the research team examine the scientific plan and the study procedures to protect the interests of participants. This must be done before an investigator may begin the research. For example, each proposed study, including the steps to be taken for the protection of human subjects and its consent form, must be approved by the Institutional Review Board (IRB). Every organization that conducts research with human subjects, for example, a university or hospital, must have an IRB. As a research participant, you also may stop participating in a study at any time, bring concerns to the researcher and research staff, or bring to the IRB issues of safety and/or ethics.

  • What should my consent form contain?

    Guidance is available regarding consent, including sample forms, on the Consent, Assent and Waivers topic page.

  • Who is affected by HIPAA?

    All researchers (faculty, staff, or students) at the UW who access or create Protected Health Information (PHI) preceding or during the conduct of their research must comply with the HIPAA regulations.

  • Who participates in research studies?

    Anyone can participate in a research study. Some studies will ask that participants meet certain criteria: such as being an adult or a child, male or female; having a specific condition or experience; or, belonging to an identified group of people, such as a specific ethnic, cultural, or social group.

  • Who should be listed on consent forms?

    The principal investigator should always be identified on the consent form. Also listed should be the name and phone number of the contact person for research subjects.

  • Who should sign as the investigator on the consent form?

    Consent forms should be signed by the person actually administering consent, at the time consent is administered. The person who administers consent, if that person is not the principal investigator, is acting as the agent of the principal investigator and must be able to represent the study with full knowledge and authority to prospective subjects; this person should be listed as an investigator in the Investigators' Information section of the consent form. The principal investigator is ultimately responsible for any defects in the consent process, and the chain of responsibility must be clear.

  • Who will review research use of HIPAA-regulated information?

    HIPAA rules require a Privacy Board or Institutional Review Board (IRB) to review the research use of HIPAA-regulated health information. All studies involving creation or use of Protected Health Information (PHI) must be reviewed and approved in advance by an IRB Committee with the UW's Human Subjects Division (HSD).

  • Will I be told the results of the research?

    You may always ask to be informed of the results of the study you participated in. These results sum up the responses of everyone who took part in the study. Sometimes the results of the study are published. In some instances, researchers routinely share what is learned from the study with participants. The researcher may discuss with you any results that relate to your diagnosis or that may be useful in deciding on the best treatment for you – but, this is not always the case and depends upon the individual study. Keep in mind that oftentimes it takes years before the results of a study are available. This is because of the time it takes to conduct the study, including getting enough people in the study to make the results meaningful.

  • Will my participation in research be kept private?

    Yes, researchers are required to keep all information confidential. One way of protecting participants is by assigning identification numbers so that names do not appear on any forms. Only staff directly related to the study should have access to the information. It is mandatory for researchers to ask for the participants' permission if they want to use any part of the information for other purposes, such as education or training.