PARTICIPANT INFORMATION:
1) Explain who will be the human participants:
If only males or females are to be used, please provide rationale
a) Estimated number of participants involved:
(Number of participants must be sufficient to appropriately answer the research question. Single subject designs are acceptable if such designs adequately answer the research question.)
b) Age ranges of participants:
c) Estimated number of male participants:
and Female participants:
2)
Explain how participants will be recruited (advertisement, referred by someone, etc.)(Advertising Guidelines) If you advertise for participants, you must e-mail or mail a copy of ad to the IRB
Office
Keep in mind faculty cannot recruit students from their own classes.
3) Explain what participants will be asked to do (survey, treadmill
test, blood test) and provide a step by step explanation of the study procedures:
4) How long will participants be involved in this project (e.g., one session, multiple sessions)?
5) Inclusion and Exclusion criteria - Federal guidelines indicate that participants cannot be excluded from research on the basis of race, sex, age, language, or disability status. However, if research requires the exclusion of participants, please explain.
a) List the inclusion criteria for participants:
b) List the exclusion criteria for participants:
6) Does this study involve participants (or parents or guardians) who are not fluent in *English?
If yes, please submit both the English consent form and translation in the appropriate language(s). Participants (or parents or guardians) who do not read and/or speak English must have the consent form written and/or read to them in their native language. They must sign a form indicating that the informed consent has been explained to them, and all questions have been answered, in their native language.
*Participants may not be excluded from research based solely on language ability
7) Will the investigator be asking about individuals other than those from whom informed consent has been received? (e.g.,asking a parent about a child's behavior or a spouse about the other spouse?)
If yes, please explain:
If yes, can these people be identified?
8) Vulnerability of Participants - Participants who are vulnerable are often included in research even though they are in protected categories. If you answer yes to any of the items below, explain rationale for selecting vulnerable participants. If you check yes, please indicate if the use of such participants is a necessary part of the research or if such participants are included incidentally as members of a more general population.
Are participants younger than 18 years of age?
And are
If yes, explain rationale:
Are participants older than 65 years of age?
And are
If yes, explain rationale:
Are participants cognitively impaired?
And are
(Cognitive impairments can include learning disabilities)
If yes, explain rationale:
Do participants have a known physical or mental illness or condition that impairs their ability to consent?
And are
If yes, explain rationale:
Are participants potentially pregnant?
And are
(Most females over age 10 and under age 55 are potentially pregnant.)
If yes, explain rationale:
Are participants prisoners?
And are
If yes, explain rationale:
Are participants institutionalized or adjudicated?
And are
(in prison, in hospital, in other residential setting)
If yes, explain rationale:
Are participants at risk for coercion?
And are
(e.g. students in your class or your employees)
If yes, please explain how you will minimize the perception of coercion:
RISKS & BENEFITS (both risk &
benefit must be addressed):
(Risk Benefit Assessment)
1) What are the potential benefits to be gained from the study?
The IRB takes the position that research involving participants
is unethical if the research has no educational or scientific
value
2) What are the risks or discomforts to the participant(s)
and what measures will be taken to minimize the risks? What is the likelihood that a participant will experience a severe risk? All research has some risk, even if it is minimal. Risks may
include loss of confidentiality, anonymity, economic, social,
or psychological risks; or physical harms. Please address all relevant risk factors
1) How and where will the Informed consent be obtained? (E.g., verbally
for phone interview, via use of video tape, in person or via letter
sent to home) (Informed Consent Checklist)
2) Who will obtain the informed consent? (E.g., PI, research
assistant, teacher, counselor, parent)
CONFIDENTIALITY
1) Will the research participants be identifiable to the researchers?
If no, skip to REPORTING Section
The participants are identifiable when:
- The researcher or/colleague maintains a coded list
that could be used to match names and codes.
- Addresses or social security numbers or birth dates or other relatively specific information
is collected.
- Please realize that in a state, unit, or area with
a small population it is often very easy to identify participants
from data sets with relatively small sample sizes.
2) What measures will be taken to ensure participants confidentiality?
a.) How will documents be stored and who will have access to these documents? (Locked filing cabinet? Code
numbers with code locked up or destroyed?)
b.) How long will identifying information (if any) be kept?
3) Will electronic records be made (i.e. audio or video tapes, photographs, DVD, CD, etc.)? (If yes, list below all that apply)
a.) What measures will be taken to ensure confidentiality of
these records?
b.) When will these records be destroyed?
REPORTING
1) Is it possible you will discover a participant's previously unknown condition (e.g., disease, suicidal thoughts) as a result of the study procedures?
If yes, explain how you will deal with this:
2) Is it possible you will discover a participant is engaging in illegal activities? (e.g., child abuse, substance abuse, underage drinking)
If yes, explain how you will deal with this:
DECEPTION
(Deception Research checklist)
Does this project involve giving false or misleading information to participants or withholding information from them such that their "informed" consent is in question?
If deception is being used, provide a copy of the debriefing/disclosure statement to the IRB office.
HEALTH RECORDS
1) Will any of the data consist of collecting existing health records? (e.g., medical case notes, evaluations)
If No, then proceed to the CONFLICT OF INTEREST Section. If Yes,
a.) Are there any personal identifiers on these data? (personal identifiers include names, birth dates, social security numbers, specific medical chart numbers, etc.)
b.) Have the research participants given specific permission (authorization) for these data to be used?
BIOLOGICAL SPECIMENS
1) Will the research involve the collection of biological specimens (e.g., blood, saliva)
If Yes,
a.) Will these specimens be stored in some manner?
If Yes, please explain how and where specimens will be stored and how long they will be kept:
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