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 Research using Humans as Subjects:

 Level 1 Application Guidance: The information below may be useful in completing the application for Level 1 review (that research that qualifies for exemption from IRB review per Miami policy and where applicable, federal regulations)



SECTION A. PERSONNEL

The Primary Contact (PC) is the person on the project responsible for communicating with the MREI (Miami Research Ethics and Integrity Office). The PC is responsible for ensuring the research methods employed in the future are consistent with the methods included on the application. It is the responsibility of the PC to ensure all other listed personnel and all future personnel have been adequately trained for their role in the research (at a minimum, CITI online training should be completed). The primary contact is also the signatory and submitter of the application. Persons in the role of students (undergradiuate and graduate) must list a faculty or staff advisor for the project (this includes staff members submitting an application in fulfillment of a course or academic program requirement). The faculty advisor must approve of and submit the application by email attachment from their MU email account (applications are not accepted directly from students). The faculty advisor for students need not be their academic advisor or graduate program advisor, rarther they are expected to provide advise regarding the conduct of research with humans as subjects.

Other personnel include faculty, staff, or students who will collect data or have access to data that includes information that could identify any subjects (names or other unique identifiers or demographic information that could identify individuals in a known sample population, e.g. a class). Initially this information will be used to determine the type of personnel involved as well as the adequacy of training. Please use the form available here to list personnel.

An "Other personnel" list should be appended to the application using the form included in the application packet (zip file)

 


SECTION B. PROJECT INFORMATION

Enter the title and anticipated beginning date for your research. If your research is being supported in full or in part by an external agency, please list the source. We need this information because as part of the agreement between some funding agencies and the researchers, the agencies may require a comparison between methods stated in the funded grant and the methods approved by the local oversight authority (MREI) to ensure they are in concordance. In some cases a research project will include multiple activities not all of which are included in a particular application to the MREI. For the organization of your records you may note the overall project title, however please include a unique title for this application/protocol/activity to distinguish between activities in our records.



SECTION C. RESEARCH OVERVIEW

This series of check boxes provides basic information about the project needed to frame the requirements per the regulations (45 CFR 46). These also orient the reviewer as well as the researcher regarding the project and the methods that need to be described and the materials that need to be included. Some projects are relatively simple and the correct check box is evident. More complex projects might require multiple check boxes that seemingly are conflicting. For example, to accuratley describe an ediucational study, data collected from teachees during interviews could place them at some risk and would not be anonymous whereas in the same study, data could be collected from students (minors) as normal curriculam materials that are obtained without names. Each type of data collection would have to be distinguished and addressed in the narratives (Section D).


SECTION D. RESEARCH DESCRIPTION

i) Purpose, Population, and Methods

General Research Question:

This question begins to address one of the issues fundamental to human subjects protection: Beneficence. The reviewer must understand the intended purpose and value of the study. Describe the nature, purpose, and significance of the study. While a literature review is not required, in some cases, a well selected citation demonstrating the need for the research may help the reviewer understand the relevance. What do you expect to learn from this research that is not already known in your field or could be learned from a well designed literature review/google search? If the primary value of the research is for a student researcher to learn how to conduct research, that is acceptable however, the risk associated with the activtity must be indexed to that level of benefit.

 


Research Subject Population:

Describe the target subject population and the approximate number of subjects (age, gender, ethnicity) and the measures that will be taken to avoid including unapproved subjects (e.g., during random interviews on a street corner, persons under 18 will not be included).

 


Research Methods:

Briefly describe the research methods you will use (e.g. survey on paper, online survey, interview, observation). You need to provide sufficient information for the reviewer to understand what you are planning to do and the description needs to be accurate and organized. Clearly delineate between the normal activities subjects are engaging in (those that would occur in the absence of the research) and the research activities. Also, please recognize when an activity is not a normal classroom activity and is being prescribed because of the existence of this research.

Confidentiality/Security Methods:

If the data includes subject identifiers, describe where and how the data will be stored and who will have access consistent with the provisions provided to the subjects in the consent information. Please briefly describe the intended fate of the results, that is, where, how, and in what form will you present or publish the results. For example you could be planning on presenting aggregate results (unidentifiable “average” data) to your colleagues at a conference or you could be planning on publishing the results in a thesis, dissertation, or journal.


ii) Consent Process

Invitation Content:

How potential subjects are invited to participated is part of the consent process. For example, the circumstances of the invitation could effect the sense of volunatariness. A subject could feel a social obligation to volunteer or that a failure to cooperate might result in some negative consequnce. Please describe the method(s) as well as the script/text that will be used. For an informal interview, the potential subjects might be approached in a public place and invited to enroll. For a scheduled program evaluation with minors, the invitation and consent might be sent home to parents prior to the program. The minors themselves would also need to agree (assent) and that process must also be described (e.g. a simple explanation at the beginning of the program/research activity).


Consent Presentation:

For an online survey, this might be the first page of the survey. However the subjects are to be provided with the information, the researchers need a plan and the reviewers need to understand that plan.

• Describe the process of informing the subjects/legal representatives, obtaining consent, and documenting consent.
• Include provisions for gaining assent from subjects under age 18.
• Describe the process for ensuring subjects are voluntarily participating in the research activities throughout the study (describe provisions for self-withdrawal).


Consent Information:

Consent refers to a person's freely made decision to participate in a research project based on knowledge of relevant aspects of the project and its implications for the participant's welfare. It is an ongoing process in which participants are given an explanation of the research project in language that they can understand. Usually the consent information can be provided on much less than one full page. Templates for various types of research can be found here.

In most cases, subjects are provided with information about proposed research and the risks associated with the project via a written consent form. The consent form describes the project and its risks; it also provides contact information if the subject has questions about the project or his or her rights. The investigator must give the subject or the representative adequate opportunity to read the consent form and to have any questions about the study answered before a signature is collected or the research proceeds. A copy of the form is often given to the subject/parent to keep.

I. Basic Elements of Consent. Consent information includes the following basic elements written in language readily understandable by the subjects.

a. Description of the Research: The nature, purpose, and significance of the research.

b. Research Procedures: The procedures to be followed.

c. Time Required for Participation: The expected frequency and duration of each procedure and total amount of time required for participation.

d. Risks: Any reasonably foreseeable risks or discomforts to the subjects.

e. Benefits: Any benefits to the subject or others which may reasonably be expected from the research.

f. Confidentiality: The extent to which confidentiality of records identifying the subject will be maintained. Note: Data should not be described as anonymous if there are any identifying names, or numbers, or information about the individual through which individual subjects could be linked by the researcher or anyone else to his or her responses.

g. Voluntary Participation: A statement that:

• participation is voluntary,
• refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled,
• the subject may discontinue participation at any time or decline to answer specific questions without penalty or loss of benefits to which the subject is otherwise entitled.

h. Alternatives: If the potential subject or legal representative declines to participate, how might this effect the opportunities of the subject.

i. Compensation for Injury: an explanation as to whether any compensation or medical treatment is available if injury occurs, and, if so, what they consist of, or where additional information may be obtained.

j. Contact information: An offer to answer any questions about the procedures and an explanation of who to contact (the name, phone number and email address of the investigator and, in the case of student investigators, the staff advisor) for answers to pertinent questions about the research. A statement that subjects may contact the Miami Research Ethics and Integrity Office at (513) 529-3600) or <humansubjects@miamioh.edu> for questions or concerns about their rights as subjects.

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 may be used. The IRB must review a written summary of what is to be said to the subject or representative. A copy of the written statement about the research study and the short-form consent document is often given to the subject or representative.


II. Consent/Assent of Special Populations:

a. Subjects Under Age 18. When the subjects are younger than 18 years of age, including college students, a parent or legal guardian must sign a written consent form unless the requirement is waived by the IRB for this specific protol. In addition, the child should be asked to ‘assent’ to participate. For older children, e.g. older than 14, this assent information should be in a readable form.

For younger children, this assent should be verbal. Researchers need to provide a script of what will be said to children to seek their agreement to participate.

b. Vulnerable Adults. When subjects include individuals who are not legally or physically capable of giving documented informed consent because of mental incapacity, or inability to communicate, consent must be sought from a legal guardian as well as assent from the subjects themselves. The subjects should also be given an explanation of the procedures at a level appropriate to their condition and asked for their assent to participate in the research project. A written form to document assent may also be appropriate for mildly impaired adults.


III. Waiver of some elements of consent process:

Although the use of a written informed consent form is encouraged by the IRB, it is understood that there are situations in which the use of such a form creates problems and therefore the investigator may request a waiver to the requirement to document informed consent in writing. In these cases, the researcher should state in section 3C “I request a waiver to the requirement to document informed consent in writing” and provide the information the IRB needs to justify waiving the requirement. Examples of situations that the IRB will normally waive the requirement for signed written consent include:

a. Protecting the identity of participants. The requirement for a signed consent form may be waived when the only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality.

b. Cross cultural research. If the project involves people in a culture where signed consent forms are not appropriate, the researcher should propose alternative ways to assure that participants fully understand and willingly participate in the research. Usually, verbal consent is required by the IRB. A script describing the procedure should be included in the application.

 

 


iii) Appendices (info):

Essentially, anything the subjects see or hear, the reviewers need to review. Invitations and consent forms are needed to assess the adequacy of the information and the voluntariness of process. For surveys and interviews, the reviewers need to assess the degree of risk associated with the activity. Where interviews are concerned, we need to see the baseline interview questions you think you need to ask to answer your research or management question. We understand that there may be follow-up questions, but you should express the intention of adhering to the subjects reviewed and approved (that is, if the subject strays from the topic into areas that present greater risk than appropriate for your security, then the researchers should tae the appropriate action to mitigate the risk, e.g. delete the unsolicited information).

When the MREI or IRB approves survey questions, they approve specific questions and those questions need to be rcorded in our records. Thus, the questions need to be submitted with the application. Submitting a link to an online survey is not sufficient (the link can lead to a survey that can be changed at any time and it will not be clear what was and was not approved).

It would be wise to organize and label each of the appendices as well as combine them in a logical order in as few files as is possible. It would also be wise to rename the application for your own record keeping as well as clarity with the MREI office (e.g. an application should not be submitted as L1_00_Application.docx)




Please contact The Office for the Advancement of Research and Scholarship if you have questions about this web site: 513-529-3600
    or email Neal Sullivan at sullivnh@miamioh.edu or Jennifer Sutton at suttonja@miamioh.edu

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