**NIEHS IRB STANDARD FORMAT FOR PROTOCOLS**

for submission with Initial Review Application (form NIH-1195)

a\. **[Precis]{.underline}.** In 400 words or fewer, provide a
description of the objectives, study population, design, and outcome
parameters.

b\. **[Introduction:]{.underline}** Describe the background, including
human subject or animal research and references that are relevant to the
design and conduct of the study. Where new techniques or procedures are
to be used, a description of preliminary or early work should be
provided. If an FDA Investigational New Drug (IND) is to be used, animal
data on the drug should be included. If the study is one for which a
Clinical Investigator\'s Brochure (CIB) is provided, one copy of the CIB
must be available to the IRB when the protocol is reviewed. A summary of
the relevant features of the CIB should be included in the protocol.

c\. **[Objectives]{.underline}**: State the objectives of the study,
whenever possible, as hypotheses.

d\. **[Study Design and Methods]{.underline}:** Describe the involvement
of human subjects (see section (h), below) including initial evaluation
procedures and screening tests, phases, procedures and sequence of the
study. Separate standard and experimental aspects of the study as much
as possible. Describe alternatives to experimental therapy if they
exist. Give detailed procedures for treatment, dose adjustments, etc.
Describe the randomization procedure, if applicable. Address the
experience of investigators if procedures are to be performed for which
the investigators have not been specifically credentialed.

e\. **[Inclusion and exclusion criteria]{.underline}:** These
[must]{.underline} be included in the protocol.

f\. **[Monitoring Subjects and Criteria for Withdrawal of Subjects from
the Study]{.underline}:** Describe the types, frequency and duration of
tests, admissions, outpatient visits. Consider specifying a monitor if
the study involves a blinded design. Define stop points and criteria for
withdrawing subjects from the study.

g\. **[Analysis of the Study]{.underline}:** Delineate the precise
outcomes to be measured and analyzed. Describe how these results will be
measured and statistically analyzed. Delineate methods used to estimate
the required number of subjects. Describe power calculations if the
study involves comparisons.

h\. **[Human Subject Protections]{.underline}:** Protocols without this
section will not be accepted for IRB review.

> i\. Rationale for Subject Selection:

The protocol must include (a) a rationale for research subject selection
based on a review of gender/ethnic/race categories at risk for the
disease/condition being studied; (b) strategies/procedures for
recruitment (including advertising, if applicable); and (c)
justification for exclusions, if any. If the protocol involves subject
enrollment at multiple sites, describe plans for ensuring appropriate
IRB review and approval at each site.

> Explain the rationale for the involvement of special classes of
> subjects, if any, such as fetuses, pregnant women, children,
> cognitively impaired individuals, prisoners or other institutionalized
> individuals, or others who are likely to be vulnerable. Reference the
> appropriate Clinical Center Medical Administrative Series (hyperlink
> to
> [http://ohsr.od.nih.gov/New/mpafwa_docmas.html](http://internal.cc.nih.gov/policies/list_policies.asp?index=med_sub))
> or Federal Regulations Subparts (hyperlink to
> <http://ohsr.od.nih.gov/guidelines/45cfr46.html>) as necessary when
> discussing the research involvement of these subjects. Discuss what,
> if any, procedures or practices will be used in the protocol to
> minimize their susceptibility to undue influences and unnecessary
> risks (physical, psychological, etc.) as research subjects.
>
> ii\. Evaluation of Benefits and Risks/Discomforts:
>
> Describe the potential benefits to subjects or to others that may
> reasonably be expected from the research. If volunteers are involved,
> specify compensation, if applicable.

Describe any potential risks \-- physical, psychological, social, legal,
or other \-- and assess their likelihood and seriousness. Where
appropriate, describe alternative treatments and procedures that might
be advantageous to the subjects. Describe the procedures for protecting
against or minimizing any potential risks, such as violations of
confidentiality, and assess their likely effectiveness. Where
appropriate, discuss provisions for ensuring necessary medical or
professional intervention in the event of adverse effects to the
subjects. Also, where appropriate, describe the provisions for
monitoring the data collected to ensure the safety of subjects.

> Discuss why the risks to subjects are reasonable in relation to the
> anticipated benefits and in relation to the importance of the
> knowledge that may reasonably be expected to result.
>
> iii\. Consent and Assent Processes and Documents
>
> Describe the consent procedures to be followed, including the
> circumstances in which consent will be sought and obtained, who will
> seek it (e.g., contract staff, Principal Investigator, etc.), the
> nature of the information to be provided to prospective subjects, and
> the method of documenting consent.
>
> The proposed consent document must be attached. It should be written
> in the second person, in language understandable to someone who has
> not completed high school. NIH form NIH-2514-1 (Consent to Participate
> in a Clinical Research Study:
> <http://www.cc.nih.gov/ccc/protomechanics/chap_3.html> ) is to be used
> for all subjects enrolled in research conducted at the Clinical
> Center. Research at sites other than the Clinical Center should
> contain similar language where appropriate.
>
> Children are generally not legally empowered to give consent, but
> depending on their age, they may have the ability to give assent
> (\"assent\" means a child\'s affirmative agreement to participate in
> research). Every protocol involving children (those individuals under
> age 18) should include a discussion of how assent will be obtained for
> the particular study. If an assent is to be obtained, use form
> NIH-2514-2.

i\. References. Include selected references which highlight methods,
controversies, and study outcomes.

j\. [Additional considerations]{.underline} (e.g., ionizing radiation;
collaborative research; IND, other. Discuss contract or study conduct
arrangements. State if these considerations do not apply). If a study is
being conducted under contract, describe the role of contract staff as
well as NIEHS staff.