DESCRIPTION OF STUDY

If you are submitting a protocol that is part of a larger center or cooperative study or is an industry-sponsored study, do not submit the pre-prepared materials in sole support of your request. You must abstract the research description and study design in answer to the sections below. Submitting protocols not prepared by the investigator and his local collaborators will result in the request being tabled until the IRB receives sufficient information. In the case of clinical drug trials, pre-prepared protocols from the study sponsor must be submitted in addition to the above. Student researchers: Please do not submit thesis or dissertation précis or chapters in lieu of or in addition to a Description of Study.

1. Insert pagination and a version date in the footer of each page;

2. Use each of the following major headings to supply the information requested below:

PURPOSE: Describe in detail the reason for conducting this research. That is, specify the research question or goal and the rationale for conducting the study.

PARTICIPANTS: Describe the target population of the study and the number of participants that will be recruited, including a description of all inclusion/exclusion criteria. When vulnerable populations (minors, persons who are cognitively impaired, persons who are not legally competent, pregnant women, prisoners, and persons who are economically or educationally disadvantaged) are involved, describe why they are necessary.

Specify if any of the listed investigators have relationships with the potential subjects that may be construed as a conflict of interest. Researchers must be able to demonstrate that they will minimize the possibility of coercion or undue influence in recruiting and conducting research with humans participating in research [45 CFR 46.116]. Examples potentially coercive situations include, but are not limited to a professor recruiting his/her students as research subjects and therapists recruiting his/her own clients as research subjects.

RECRUITMENT PROCEDURES: Describe in detail the procedures for inviting participants into the study [Attach all recruitment materials, including but not limited to flyers, invitation letters, recruitment scripts, and/or telephone scripts.].

INFORMED CONSENT: It is important to remember that informed consent is a process that begins with the initial contact/recruitment of participants. [Participants must receive a copy of the consent form for their records.]

Initial Consent: Describe in detail the process of obtaining informed consent, the person(s) who will be responsible for obtaining it, and where the informed consent forms will be stored. Attach consent form(s). Please see either biomedical or social behavioral model consent forms. [“Permission” rather “consent” is obtained from the parents/guardians of minor participants.]

Consider the following consent options when preparing the Informed Consent section:

Waiver of Informed Consent: An IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent set forth in this section, or waive the requirements to obtain informed consent provided the IRB finds and documents that [45 CFR 46.116(d)]:

(1) the research involves no more than minimal risk of harm to subjects,

(2) the waiver or alteration will not adversely affect the rights and welfare of the subjects;

(3) the research could not practicably be carried out without the waiver or alteration; and

(4) whenever appropriate, the subjects will be provided with additional pertinent information after participation. In cases in which the documentation requirement is waived, the IRB may require the investigator to provide participants with a written statement regarding the research.

Waiver of Documentation of Informed Consent (signed consent form): An IRB may waive the requirement for the investigator to obtain a signed consent form for some or all subjects if it finds either:

(1) That 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. Each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject's wishes will govern; or

(2) That the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context.

Ongoing Consent: Describe in detail how participants will remain apprised of any changes in the risks or developments in the study that may affect their willingness to continue in the study. [Any change in an approved consent form requires the investigators to re-obtain consent from participants currently enrolled in the study.]

Assent: Assent indicates a child's affirmative agreement to participate in research. Mere failure to object should not be construed as assent [45 CFR 46.402(b); 45 CFR 46.408]. Given that children have not reached their full intellectual and emotional capacities and are legally unable to give valid consent, involving children in research requires the permission of their parents or legally authorized representatives.

While children may be legally incapable of giving informed consent, they nevertheless may possess the ability to assent to or dissent from participation. Out of respect for children as developing persons, children must be asked whether or not they wish to participate in the research, particularly if the research: (1) does not involve interventions likely to be of benefit to the participants; and (2) the children can comprehend and appreciate what it means to be a volunteer for the benefit of others.

The child must be given an explanation of the proposed research procedures in a language that is appropriate to the child's age, experience, maturity, and condition. This explanation must include a discussion of any discomforts and inconveniences the child may experience if he or she agrees to participate. [A sample assent form is available upon request from the UNR Office of Human Research Protection.]

For some research activities, the IRB may require that either an advocate for the child be present during the assent and permission procedures to verify the child's understanding and to support the child's preferences. The IRB may also require that the parent(s) or a close family member be present during the research, especially if a young child will be exposed to significant discomfort or inconvenience, or if the child will be required to spend time in an unfamiliar place.

PERFORMANCE SITES: Specify where participants will be recruited and where data will be collected. For investigator-initiated research (research that is developed locally by University faculty or/or students), provide a letter from each performance site granting permission to conduct this research at their facility.

METHODS and PROCEDURES: Describe in detail the research methods and procedures of the study. This description should include: 1) a detailed discussion of what the participants will experience during their participation in the study (including their time commitment and all procedures); 2) the purpose and use of all instruments (e.g. surveys, questionnaires, etc.) [Attach instruments to the protocol application]; and 3) the purpose and use of video taping, audio taping, and/or photographs [Attach separate consent form for video taping and/or photographs].

If incomplete disclosure (deception) is used, describe the rationale for using it, how it will be used, and how the participants will be debriefed [Attach a copy of the debriefing statement].

Federal regulations require researchers to attach the associated federal grant application(s). Submit two copies of the associated federal, state, or local grant application(s), one for the primary reviewer and one for the permanent file with this protocol application.

Non-clinical laboratory projects involving exposure of UNR personnel to human blood (or components), unfixed tissue, or cell culture, must be covered by a Memorandum of Understanding and Agreement (MOUA) approved by the UNR Institutional Biosafety Committee. MOUA forms are available at: http://www.ehs.unr.edu/programs/lab_safety/biosafety/biosafety.asp, under ”Forms”, then “Biological Safety Forms”. For information contact Ben Owens of EH&S at (775) 327-5196 or at bowens@unr.edu.

RISKS: Describe any potential risks to the participants (physical, psychological, social, or legal) and assess the likelihood and seriousness of those risks. If the methods of research create potential risks, describe other methods, if any, that were considered and why they will not be used. Describe procedures, including confidentiality standards, for minimizing potential risks.

BENEFITS: Since benefits cannot be guaranteed in a research study, a statement indicating that there may be no direct benefits to participants must be included in this section. Describe the anticipated benefits of the research to the individual participants, to the particular group from which the participant population is drawn, and to society in general. [Compensation such as extra credit, money, or gifts does not qualify as a benefit. However, such compensation must be specified in the Costs/Compensation section below.]

RISK-BENEFITS RATIO: State whether or not the benefits outweigh the risks of the research. If the risks outweigh the benefits to the participants, explain why the research should be conducted.

COSTS/COMPENSATIONS TO PARTICIPANTS: If the investigation involves the possibility of added expense to the participants or to a third party (such as an insurer), longer hospitalization, extra laboratory tests, travel, time missed from work, specify what the sponsor will cover and/or how the participants will be compensated. If the research may lead to the development of commercial products, state whether or not the participant will be compensated for the use of their bodily fluids, tissues, or cells. Be sure this is included in the consent form. [Time is not considered a cost to participants; however, time requirements must be specified in the Procedures section above.]

For some protocols, compensation such as payment, gifts, or extra credit may be offered. Include that information here. Because the UNR Controller’s Office requires identifying information to issue checks, cash, or gift certificates to payees, the Confidentiality section of the consent form must inform participants that they will be asked to provide their Social Security Number and verification of U.S Citizenship or Permanent Resident Status to receive compensation.

If veteran participants are recruited: Provide information regarding Department of Veterans Affairs coverage of participant costs incurred as the result of problems/adverse events that may arise during their participation in this study.

DISCLOSURE OF FINANCIAL INTERESTS: To protect research from bias due to the conflict of interest, investigators are required to disclose any significant financial interests (and those of his/her spouse and dependent children) that would reasonably appear to be affected by the proposed funded research.

CONFIDENTIALITY: Describe all procedures used to insure confidentiality. State who will have access to the data resulting from the research, including the University of Nevada, Reno Biomedical or Social Behavioral Institutional Review Board.

For investigator-initiated research, specify where data will be stored, how long it will be stored, and what will happen to it after the storage period elapses. Specify coding procedures, if applicable. Personal identifiers or portions of personal identifiers such as social security numbers, date of birth, mother’s maiden name, etc. must not be used for coding purposes. [Consent forms, data, and master code sheets must be stored separately.]