HUMAN SUBJECTS RESEARCH FAQS 1 WHAT IS HUMAN SUBJECTS

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FACULTAD DE HUMANIDADES Y CIENCIAS DE LA EDUCACIÓN DEPARTAMENTO

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HUMAN SUBJECTS RESEARCH FAQs


  1. What is Human Subjects Research?

"Research" refers to a systematic investigation designed to develop or contribute to generalizable knowledge. This usually implies collection and analysis of data the researcher hopes to report in a scientific publication or at a professional meeting, but that isn’t always the case. "Human subject research" is research where the investigator obtains from a living human individual (1) data through intervention or interaction with the individual; or (2) identifiable private information. You should read SD 606 for a full explanation of Human Subject Research.


  1. What is “generalizable knowledge”?

“Generalizable knowledge” means that the intent of the research is to add information to your field of study; the results can be applied beyond the subject population to other settings. It doesn’t matter if the results will be published or not, if your research activity is designed with the aim of discovering information that can be applied in other settings, it can be considered research.


  1. What does “intervention or interaction with the individual” mean?

If you perform physical procedures on a person, manipulate the person, manipulate the person’s environment, communicate with a person, or have interpersonal contact with a person, you are engaged in an intervention or interaction with that person.


  1. What is “identifiable private information”?

For information to be considered “identifiable private information” two criteria must be true. First, the information must be private, meaning it is either about behavior that occurs in a context where the individual reasonably expects no observation is taking place or the individual has provided the information for a specific purpose and reasonably expects the information will not be made public. Second, the information must be individually identifiable, meaning the identity of the person is or may be readily ascertained by the investigator or the identity of the person is or may readily be associated with the information.


  1. How do I know if my research project needs to be reviewed?

All research involving human subjects must be reviewed by the Smithsonian’s Institutional Review Board (“IRB”) before the research can begin.


  1. Are there any examples of activities that aren’t considered Human Subjects Research?

The following are specifically excluded from the definition of Human Subject Research and do not need to be reviewed by the IRB:

• interviews used to provide quotes or illustrative statements, such as those used in journalism;

• collection(s) of oral histories and cultural expressions (e.g., stories, songs, customs, and traditions and accounts thereof) to document a specific historical event or the experience of individuals without intent to draw statistically or quantitatively-based conclusions or generalizations;

• gathering of information from a person to elucidate a particular item (or items) in a museum collection;

• gathering of information from a person to assess suitability for and/or supplement a public program, publication, or cultural performance; or

• survey procedures, interview procedures, or observations of public behavior that are conducted for Smithsonian internal purposes only, the results of which will not be published or presented in a public setting (e.g., at conferences or professional meetings).


  1. I think my project is an “oral history” and doesn’t need to be reviewed by the IRB. How can I be sure?

The hallmark of an oral history is that it stands alone as a unique perspective rather than an item of data that can be qualitatively analyzed to reach a general conclusion or explanation. If your intention is to interview people who have a unique perspective on a particular historical event or way of life, and you also intend to let the individuals’ stories stand alone, with no further analysis, the research is most likely oral history and you do not need to have the research reviewed by the IRB. However, if the surveys or interviews are conducted with the intention of comparing, contrasting, or establishing commonalities between different segments or among members of the same segment, it is safe to say your research will be regular survey/interview procedures, because you will be generalizing the results and your research may need IRB review.


  1. I know my project needs to be reviewed, what do I do first?

Fill out and submit the Application Form for Approval of Human Subjects Research, which is available from OSP http://prism.si.edu/osp/policies.htm#Compliance and return it and any necessary supporting materials (consent/assent forms, surveys, instruments, abstract, participant screening procedures, flyers/invitations, etc.) to [email protected].


  1. Smithsonian Directive 606 talks about “Exemptions” in the Process section. If my project fits one of the categories under “Exemptions” does this mean I don’t have to have it reviewed by the IRB?

No, you still need IRB review. Exempt is a category of human subject research defined by Federal regulations. Only the IRB can determine if a research project fits one of the exceptions in the “Exemptions” category of SD 606. As long as your activity is considered research with human subjects, it needs to be submitted to the IRB.


  1. I’m not gathering names on my survey, does that mean it’s anonymous and doesn’t need to be reviewed because I won’t have “identifiable private information”?

Not necessarily. The Federal office that oversees research with human subjects has indicated that for purposes of determining anonymity, if there remains any possible linkage between the person and the data, the spirit (if not the definition of "anonymity") would be violated. In other words, anything that can link the research to an actual human individual would probably take it out of the realm of anonymity and the research would have to be reviewed by the IRB.


  1. Does research with pre-existing data require review?

If the data is available to the general public without restriction, the research does not require review. If access is limited, for example to persons with certain qualifications or to persons who pay a substantial fee, the research may require review. One key issue is whether the data contain personally identifiable information when acquired by the new researcher. If personally identifiable information is involved and your work fit’s the definition of research, you need to have the project reviewed by the IRB.


  1. I am working with a collaborator and my collaborator has had the project reviewed by the IRB at her institution, do I have to submit it to the Smithsonian’s IRB?

Yes. Any project that uses Smithsonian resources must be reviewed by the Smithsonian IRB. Smithsonian resources include Smithsonian employees, associates, property (including equipment), facilities and non-public information located anywhere in the world.


  1. I am overseeing a subgrant/subaward to another organization that will be conducting human subject research with the money. Does this project need Smithsonian IRB review?

The Smithsonian is responsible for all projects, regardless of performance site, for which Smithsonian resources are used. This includes projects where the Smithsonian is granting or awarding money to another organization or individual. All subgrant and subaward recipients who plan to use Smithsonian funds for human subject research activities, whether conducted at the Smithsonian or elsewhere, must submit their project to the Smithsonian IRB for review and complete the required human subjects training.


  1. I will be conducting interviews that I will audio or videotape and later transcribe. Does my study qualify for Exempt Review?

No. The use of audio and video equipment is not allowed in exempt human subject research.


  1. Can I share my research approval with a colleague working on a similar project or add a colleague to my project without IRB review or approval?

No. The IRB approves or makes exempt determinations for projects with the understanding that only the investigator and key personnel named in the application will conduct the work. If someone would like to work on your research project, you may modify your existing protocol to add them as co-investigator or key personnel by submitting an application along with the changes you want to make. Otherwise, every researcher must apply for his or her own IRB approval or exempt determination for each project.


  1. When should I submit my proposal for review by the IRB?

If you are applying for exempt determination or expedited review and approval, you should submit your application at least 30 days before you intend to start your research. This allows the IRB time to review it. By submitting it that far in advance, it will also give you time to make any changes that the IRB requests in a timely manner and still meet your start date. For projects requiring full IRB review, you should submit your application at least 60 days before you intend to start your research.


  1. How do I coordinate IRB review with my grant application?

You do not have to have IRB approval or exempt determination for your project before submitting a grant application, just before you actually begin your human subject research. However, you should bear in mind that the IRB needs time to review your application and make its determination. Therefore, you may want to begin the application process while your grant is under consideration in case you receive the funding and need or want to start your project right away.


  1. Does “Expedited Review” mean that it is fast?

No. “Expedited” is a specific category defined in Federal Regulations. In spite of the name, it is not a speedier review reserved for last minute. Research activities must fall into one of the nine federally defined categories to be considered “expedited”. This kind of research is reviewed by the Chair or an appointed Member of the IRB instead of the entire IRB membership at a convened meeting.


  1. The application that I have to submit for my research project says that Smithsonian employees and associates have to complete training in the protection of human subjects in research. Who exactly has to take this training?

Before engaging in any human subject research, every person who serves as a principal investigator, designs research, directs research, enrolls research subjects (including obtaining subjects’ informed consent or screening potential subjects), makes decisions related to eligibility to participate in research, conducts study procedures, analyzes or reports research data, analyzes or reports adverse events, or authors manuscripts concerning the research for publication has to take the training and provide the IRB with a certificate of completion.


  1. Where can I get the training I need in order to engage in human subject research?

Free training in the protection of human subjects in research can be obtained at http://phrp.nihtraining.com/users/login.php and at http://www.citiprogram.org/. After completion of either of these training programs, you will be issued a certificate as proof that you have completed the training required by the Smithsonian. You should provide a copy of the certification to OSP.


  1. What special knowledge is expected for persons doing human subjects research?

Every researcher is expected to understand the policy set forth in SD 606 and the Federal regulations from which it is derived. It is also important for every researcher to have a basic understanding of the concerns the directive and regulations are designed to address, which the free training described in FAQ 19 provides. In addition to the general protections for human subjects of research, every researcher must comply with any professional, ethical, methodological and cultural standards specific to the subject area being investigated.


  1. I am confused about the informed consent requirements. Can you please explain how this works and what I have to do?

Except in certain situations, such as for exempt research, all research conducted at the Smithsonian must involve informed consent. This is the foundation of our respect for the rights and welfare of human subjects. The consent process allows the researcher to inform the potential subject about the research and ensure that the potential subject is aware of all the risks and is joining the study voluntarily. Any information that could reasonably affect a person's willingness to participate in the research must be disclosed in the consent process.


Usually the consent process will involve giving the potential subject a written form explaining in terms understandable to the subject who is doing the research, what the project is about and it’s goal, how the research is being done, any risks and potential benefits of the research and that participation is voluntary and can be withdrawn. If the subject agrees to participate in the research, he or she would sign the consent and would be given a copy to keep and you would retain a copy for your records.


However, in certain situations a different process will be called for. If you are working with subjects that do not read or read a language other than that written in your consent form, you may need to verbally explain in the subject’s language the information required for consent and obtain verbal consent witnessed by another person. The process is also different if you are working with children.


If you are working with children (defined by local law) you will need parental consent for the child to be involved, and assent (agreement) from the child to take part. Parental consent follows the structure of regular consent and involves informing the parent of the research and giving the parent the opportunity to allow or prohibit their child from participating. Assent of the child refers to the agreement of a child to participate in a research study and can be written or verbal, depending on the child’s maturity level.


If you need help preparing a consent form, samples are available at http://prism.si.edu/osp/policies.htm#Compliance.


  1. What is an IRB?

An Institutional Review Board (IRB) is an administrative body that oversees research with human subjects. Its role is to protect the rights, welfare and safety of the people who take part in research. Smithsonian has one IRB for all units except the Smithsonian Astrophysical Observatory, which has a separate IRB. The Smithsonian IRB used by all units except SAO has members from the Smithsonian as well as one member who is not affiliated with the Smithsonian. Members come from different units and not all are researchers or scientists; this ensures that multiple perspectives are considered when looking at research activities.


  1. How does the IRB work?

The members of the IRB review research activities and discuss, when necessary, whether the risks involved in the research outweigh the potential benefits. The IRB members may consult Federal guidelines or area of study experts to make this determination. Certain conditions must be satisfied before they can approve an activity.


  1. In what situations do I need to contact the IRB after my research has been approved?

If you want to make any significant changes in the research or encounter any unanticipated problems involving risk to participants or others, the IRB must be contacted.


  1. If I have more questions or need help completing an application to have my research reviewed by the IRB, who do I contact?

If you have additional questions or need help with forms, please contact OSP at 2-2633-7110 or [email protected].








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CENTRE FOR HUMAN RIGHTS –NIS SERBIA INDIVIDUAL CONTRIBUTION
CHAIR COMMISSIONERS JACK SHUMAN SARAH BAKER VICE CHAIR
EL DEPARTAMENTO DE RECURSOS HUMANOS U


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