PROTECTING THE RIGHTS AND WELFARE OF HUMAN SUBJECTS IN RESEARCH

Central Beryllium Institutional Review Board (CBeIRB)

The purpose of this application (for Expedited or Full Board Review) is
to promote careful thought regarding the involvement and ethical
treatment of human subjects in research, ensure compliance with federal,
state, and corporate regulations, and to elicit from the Principal
Investigator (PI) pertinent information that will facilitate a rapid and
thorough review by the Central Beryllium Institutional Review Board
(CBeIRB).

Notes are provided as guidelines to help address specific questions.
Please answer each question or indicate that it is not applicable to the
research being conducted. Call the CBeIRB Administrator at (865)
576-1725 if you have questions or need help with this form.

**SUMMARY GUIDELINES**

The CBeIRB provides the Department of Energy (DOE), DOE contractors, and
other organizations engaged in research on beryllium (Be) exposure,
testing, or disease funded by DOE and/or involving the DOE work force
with a thorough and consistent review that is essential to protection of
the volunteer subjects in these programs as defined in Federal
Regulation 45 CFR 46.

Ongoing programs currently subject to review by the CBeIRB are: 1) all
Be-related research activities; 2) the Beryllium Workers Medical
Surveillance Program, and 3) the beryllium screening component of the
Former Workers Program (see website for list of DOE sites). **Protocols
[must]{.underline} receive written notice of CBeIRB approval before
research is initiated.** **Only the protocol and documents that bear the
CBeIRB approval stamp (Application for Review, consent process and form,
advertisement, questionnaires, etc.) may be used in the conduct of
research.**

[Any]{.underline} alteration or amendment to the protocol, consent form,
or supporting documentation must be approved by the CBeIRB before being
implemented. New findings (positive or negative) that may affect the
willingness of subjects to participate must also be submitted to the
CBeIRB. Changes or findings may be submitted on the CBeIRB form,
"Modification or New Finding."

When Be-related research is conducted in collaboration with other
institutions, each institution is responsible for providing assurance of
CBeIRB review unless other arrangements are made in advance and agreed
upon by all parties. Each institution is also responsible for providing
documentation that human subjects training has been successfully
completed by its key project staff. When indicated, each institution is
also responsible for complying with requests for information related to
conflict of interest.

The CBeIRB cannot approve a protocol for a period longer than 12 months
and cannot, **under any circumstances**, grant retroactive approval.
Continuing review is required at least once within every 12 month period
of the project, as determined by the CBeIRB at the time of approval. The
CBeIRB will provide a courtesy notice when an Application for
Continuation is due, but the PI is responsible for ensuring that an
application is submitted and approved before the expiration date to
maintain compliance with Federal regulations and conditions of the
original CBeIRB approval.

Checklist

**Application for Review**

(Any of the following may be submitted by fax or e-mail; signed copies
can be sent later)

**[Required Documentation for a New Application]{.underline}**

Application for Review (signed by the PI, Program Manager, and
Institutional Representative)

Complete Proposal/Protocol

Process of Consent

Consent Form(s)

Documentation of PI and key project staff human subjects training

PI/Co-PIs' CV (Brief)

PI and key staff resume (if first proposal to the CBeIRB)

Additional information that may be helpful to the CBeIRB

This list, individually identifying materials submitted and grouped in
order as listed

**[If Applicable]{.underline}**:

**Advertisement, flyers, solicitation for volunteers**

**Information Sheets/Brochures**

**Questionnaires/Surveys**

**Data Management Plan**

**Certificate of Confidentiality**

**IRB approval from collaborating institutions**

**Cooperative Agreement between participating institutions if
applicable**

**Report(s) of peer review of the proposal**

APPLICATION FOR THE USE OF HUMANS AS RESEARCH PARTICIPANTS

TO: Central Beryllium (Complete and return this application

> Institutional Review Board Becky Hawkins, CBeIRB Administrator
> ORAU-MS-44

Phone: (865) 576-1725 P.O. Box 117

Fax: (865) 576-9557 Oak Ridge, TN 37831-0117

**Note: All required signatures must be obtained prior to submitting a
protocol for review.**

  ----------------------- ---------------------------------------------------
  Principal Investigator:      

  Complete Mailing             
  Address:                

                               

                          

  Telephone/Fax/E-mail:                    

                          

  Co-Principal                 
  Investigator:           

  Complete Mailing             
  Address:                

                               

                          

  Telephone/Fax/e-mail:                    

                          

  Title of Project:            

                          

  Anticipated Sponsor:         

  Estimated Annual             
  Funding:                

  Estimated Start Date:        

  Type of Review          Expedited\* Full Board Date Submitted:      
  Requested:              

                          
  ----------------------- ---------------------------------------------------

\*Please see 10 CFR 745.110 for the definition of expedited review
categories

**\
**

Central Beryllium Institutional Review Board

**APPLICATION FOR THE USE OF HUMANS AS EXPERIMENTAL SUBJECTS**

**INSTITUTIONAL REVIEW AND APPROVAL**

  ---------------- ------------------------------------------------------
  **PROJECT        **     **
  TITLE:**         

  **STARTING       **     **
  DATE:**          

                   
  ---------------- ------------------------------------------------------

The principal investigator shall follow the procedures of the Central
Beryllium Institutional Review Board in obtaining \"informed consent\"
from the subjects under study. The investigator recognizes acceptance of
primary responsibility for safeguarding the interests of the
participants under study. If applicable by prior agreement, the
investigator is responsible for [immediately]{.underline} notifying the
Central Beryllium Institutional Review Board of any significant changes
in methods of procedure or of the development of unexpected risks.
Continuation of the Board\'s approval of the project is contingent upon
its approval of any such changes and acceptance of a progress report.

Principal Investigator

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  **     **                                                                   

  **^Name\ (please\ print\ or\ type)^**   **^Signature^**                     **^Date^**
  --------------------------------------- ----------------------------------- ------------

Co-Principal Investigator

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  **     **                                                                   

  **^Name\ (please\ print\ or\ type)^**   **^Signature^**                     **^Date^**
  --------------------------------------- ----------------------------------- ------------

**DIVISION or PROGRAM REVIEW:**

The application described herein has been reviewed and approved for
**submission** to the Central Beryllium Institutional Review Board.

  --------------------------------------- ----------------------------------- ------------
  **     **                                                                   

  **^Name\ (please\ print\ or\ type)^**   **^Signature^**                     **^Date^**
  --------------------------------------- ----------------------------------- ------------

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  **     **                                                   

  **^Title^**             **^Institution^**                   **^Date^**
  ----------------------- ----------------------------------- ------------

**INSTITUTIONAL APPROVAL:**

The application described herein has been reviewed and approved for
submission to the Central Beryllium Institutional Review Board.

  --------------------------------------- ----------------------------------- ------------
  **     **                                                                   

  **^Name\ (please\ print\ or\ type)^**   **^Signature^**                     **^Date^**
  --------------------------------------- ----------------------------------- ------------

  ----------------------- ----------------------------------- ------------
  **     **                                                   

  **^Title^**             **^Institution^**                   **^Date^**
  ----------------------- ----------------------------------- ------------

**Using non-technical lay language, please provide:**

**[Abstract]{.underline}**: This should be a brief overview of the
project [including]{.underline} how human subjects will be involved and
their rights protected. (no more than 1000 words).

*Note:.*

***     ***

**[Objectives of Study]{.underline}**: What hypotheses are being tested?

***     ***

**[Methods of Procedure]{.underline}:** What is the experimental design
and how is the study being conducted? ***     ***

-   What type of sample will be obtained (e.g., peripheral blood, urine,
    biopsy, x-ray, MRI)? ***     ***

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-   Will subjects be exposed to radiation, chemicals, pharmaceuticals,
    or other physical agents or procedures. ***     ***

-   Will subjects be recruited by a collaborating institution? (Give
    full contact information for collaborator, a copy of the
    collaborating institution's CBeIRB approval, and a copy of the
    collaborating institution's informed consent that will be used.)
    ***     ***

**Summary: Will this research involve any of the following?**

+------------------------------------+---------------------------------+
| Interview/Survey/Questionnaire     | Clinical Studies                |
|                                    |                                 |
| Data collected through             | Venipuncture                    |
| intervention or interaction with   |                                 |
| individuals                        | Investigational drugs, devices  |
|                                    | or materials                    |
| Private information readily        |                                 |
| identifiable with individuals      | Radiation, radioisotopes        |
|                                    |                                 |
| Existing data or documents         | Controlled substance            |
|                                    |                                 |
| Development of new data base from  | PI or alternate as attending    |
| this research                      | physician                       |
|                                    |                                 |
| Individual or group behavior or    | Tools developed specifically    |
| characteristics                    | for this study                  |
|                                    |                                 |
| Audio visual/tape recording or     | Waiver of consent               |
| photographing                      |                                 |
|                                    | Assent by Children              |
| Environmental alternations         |                                 |
| (habitat/lighting)                 | Deception                       |
|                                    |                                 |
| Moderate exercise by healthy       | Collaborative effort            |
| volunteers                         |                                 |
|                                    | International Issues            |
| Biological materials derived from  |                                 |
| humans                             | Cultural Issues                 |
|                                    |                                 |
| Diagnostic, pathologic or autopsy  | Classified Activities           |
| specimens                          |                                 |
|                                    | Development of commercial       |
| Human stem cells                   | products from human biological  |
|                                    | materials                       |
| Micro-organisms or recombinant DNA |                                 |
|                                    | Other                           |
| Exposure to chemicals              |                                 |
|                                    |                                 |
| Genetic research/analysis and/or   |                                 |
| notification                       |                                 |
|                                    |                                 |
| HIV/Aids                           |                                 |
|                                    |                                 |
| Human in vitro fertilization       |                                 |
+------------------------------------+---------------------------------+

**[Radioisotopes and New Drugs/Devices]{.underline} (Identify these, if
any. Are they FDA approved or is FDA approval being sought?):**

***     ***

**[Outcome]{.underline}:** What results do you anticipate? What are your
criteria for success or failure, and when will the study be terminated?

***     ***

**[Detailed description of protocol]{.underline}:** Give full details of
the exact protocol that will be followed.

-   For research involving surveys, questionnaires, etc., describe the
    setting and mode of administering the instrument (e.g., by
    telephone, one-on-one, or group) and the provisions for maintaining
    privacy and confidentiality. Include the duration, intervals of
    administration, and overall length of expected participation.
    Identify HIPAA status of the study/project and of the institution(s)
    involved. ***     ***

*Note: If interviews or the questionnaires are not yet designed, provide
a sample of the questions or describe the subject matter to be covered.
Draft versions may be submitted; however the final instruments must be
approved by the CBeIRB before they may be used.*

-   Explain in detail all risks to the subject and also include a
    description of these those risks in the consent form as well.
    ***     ***

-   Will subjects be notified of the results of their participation in
    this study? ***     *** How and by whom? ***     ***

**[Data Collection]{.underline}:**

-   Describe how and from whom data will be collected and recorded.
    ***     ***

-   Will it be associated with personal identifiers or coded to protect
    personal privacy? ***     ***

-   Describe the coding method. Who will have access to the data and
    codes? ***     ***

-   Where and how will the data be stored during the study, and how will
    it be secured? ***     ***

-   What will happen to the hard copy and computerized data after the
    study is completed? ***     ***

-   How long will data be kept after the project's completion?
    ***     *** What are the methods of disposal? ***     ***

-   Will the data be used for any purpose other than for this study? If
    yes, explain. (This information must be included in the Informed
    Consent.) ***     ***

-   Do you intend to create a new data base using the information from
    this study? ***     ***

-   Will identifying information be included in the new data base?
    ***     *** Has justification been provided for the use of
    identifying data, such as Social Security numbers and names?
    ***     ***

-   Will potential long-term health effects of the research be
    explained?       Do you plan to publish the results of this study?
    ***     ***

-   **Are the data subject to the DHHS Health Insurance and Portability
    Accounting Act (HIPAA)? If so, confirm that the institutions
    involved in this research are in compliance with the requirements of
    45 CFR Parts 160 and 164.**

**[Involvement of Human Subjects]{.underline}:** Provide a brief
description of the procedures involving human subjects. Please explain
potential risks, privacy, confidentiality, and consent issues, i.e., how
their rights and welfare will be protected. If personal identifiers are
to be removed from the data, explain how this will be done, who will
have the key, and how prevention of use of data for other purposes will
be ensured. ***     ***

**Please note any of the following subjects that will be involved in
this study.**

+----------------------------------+-----------------------------------+
| **Children\***                   | Terminally ill                    |
|                                  |                                   |
| **Pregnant women**\*             | Comatose                          |
|                                  |                                   |
| **Fetuses\***                    | Cancer patients                   |
|                                  |                                   |
| **Prisoners or parolees\***      | Non-English speaking              |
|                                  |                                   |
| **Workers/Employees\*\***        | Unable to give informed consent   |
|                                  |                                   |
| Elderly                          | Military personnel and/or         |
|                                  | immediate family                  |
| PI's, institutions, employees,   |                                   |
| or families                      | Tribal, Hispanic, Asian, or other |
|                                  | diverse subjects                  |
| Institutionalized                |                                   |
|                                  | Other                             |
| Genetically susceptible/impaired |                                   |
|                                  |                                   |
| Cognitively or psychologically   |                                   |
| impaired                         |                                   |
|                                  |                                   |
| Emergency patients               |                                   |
|                                  |                                   |
| Students                         |                                   |
+----------------------------------+-----------------------------------+

\*Vulnerable Subjects (45 CFR 46, subparts B, C, and D)

\*\*DOE considers workers to be vulnerable populations

**Provide a justification if you plan to involve vulnerable subjects
(\*).**

-   Are any inclusion/exclusion criteria based on age, gender,
    pregnancy, or childbearing potential or race/ethnic origin?
    ***     *** Explain and justify the criteria for inclusion or
    exclusion. ***     ***

*Note:*

-   How, and by whom, will the human subjects be identified and
    recruited? ***     ***

-   Attach a copy of any planned advertisements/notices and letters to
    potential subjects.

*Note:*

**[Biological Materials Derived from Humans (samples/tissues, cells/cell
lines)]{.underline}** (This information must be included in the Informed
Consent.)

-   In what form will materials be obtained? ***     ***

-   From whom are the materials obtained? ***     *** If another
    investigator, please explain and provide documentation of IRB
    approval from that institution. If purchased, provide the vendor's
    name(s) and FDA License/Registration number(s). ***     ***

-   How will materials be collected and recorded? ***     ***

-   Will the materials be identified? ***     ***

-   Will the materials be coded to protect privacy? ***     *** If yes,
    describe the coding method. Will link between code and personal
    identifier(s) be kept? ***     *** If yes, by who and how long?
    ***     ***

-   Where will the materials be stored during the study? ***     *** How
    will they be secured? ***     ***

-   Who will have access to the materials and/or to the codes?
    ***     ***

-   How long will the materials be retained? What will happen to them
    when the research has been completed? What is the method of
    disposal? ***     ***

-   Will the materials be used for any other purpose than this study?
    ***     *** If yes, describe any future potential use and the method
    for gaining informed consent for that use. ***     *** If
    identifiable materials will be released, specify the person or
    agency to whom they will be released. ***     ***

*Note:*

[**Risks and Benefits**:]{.underline} What are the potential
risks/discomforts associated with each intervention or research
procedure? ***     *** If data are available, estimate: a) the
probability that a given harm may occur, b) its severity, and c) its
potential reversibility. ***     ***

*Note:*

-   What potential benefits, if any, may individual subjects receive as
    a result of their participation in this research? ***     ***

-   What potential benefits to society may be expected from this
    research? ***     ***

-   What is the overall risk classification of the research: minimal,
    greater than minimal, significant, or unknown? ***     ***

*Note: According to DHHS/FDA regulations, minimal risk means "The
probability and magnitude of harm or discomfort anticipated in the
research are not greater in and of themselves than those ordinarily
encountered in daily life or during the performance of routine physical
or psychological examinations or tests." When the risks are unknown,
they cannot be classified as "minimal." Your estimation of risk
determines the Emergency Care and Compensation for research-related
injury clause in the informed consent form.*

-   What is the risk/benefit ratio of the research, compared with that
    of the available alternatives (e.g., clinical research)? ***     ***

*Note: The potential benefits of research must justify the risks to
human subjects. Some risks may not be reasonable no matter how important
the potential benefits. The risk/benefit ratio of the research must be
at least as favorable for the subjects as that presented by standard
treatments for their condition. When comparing the risk/benefit ratio of
research with that of available alternatives, the alternative of doing
nothing, or watchful waiting, should be included in the analysis.*

-   What specific steps will be taken to prevent/minimize any risks or
    discomfort? ***     ***

*Note: All risks and discomfort must be minimized to the greatest extent
possible by using procedures such as appropriate monitoring and
withdrawal of the subject upon evidence of a specific adverse event or
clinical sign(s). This section should reflect that all appropriate steps
will be taken to protect subjects from harm.*

**[Adverse Events]{.underline}:** How and who will handle adverse
events? Are facilities and equipment adequate to handle adverse events?
***     ***

**[Therapeutic Alternatives (clinical research):]{.underline}** What
therapeutic alternatives are reasonably available in the non-research or
research context that might benefit potential subjects? ***     ***

*Note: This section should include a reasonably detailed description of
the therapeutic alternative that could be used to treat the patient
should they elect not to participate in the protocol, as well as other
options to participating in this study/project to be eligible for
benefits, if applicable. Explain other options whereby benefits may be
accessed, e.g., private Be-sensitization testing.*

[**Financial Considerations**:]{.underline} Describe all plans to pay
subjects, in cash or in kind. State if no payment is planned. Will they
be reimbursed for travel and other expenses? Will they receive services
or other benefits instead of cash? What conditions must be fulfilled to
receive full or partial payment? ***     ***

*Note: The FDA encourages a prorated system of payment whereby subjects
who do not finish the protocol are paid in proportion to the part
completed. The amount of payment must be justified and not constitute
undue inducement of the subject to participate in the research. If a
non-prorated system of payment will be used, it should be justified in
this section.*

-   What financial obligations will subjects incur as a result of
    participating in the study? Will subjects have to pay for any of the
    treatment(s) they receive or for tests performed in the research?
    ***     ***

*Note: This section should clarify who will pay for procedures
associated with the study as well as financial responsibility for
routine clinical care (e.g., diagnostic tests, hospitalization,
follow-up). Insurance and other third-party payers may not cover
procedures associated with participation in research (even if they might
have paid for some of the procedures in connection with standard
therapy). Consequently, subjects' costs may be increased as a result of
additional follow-up examinations and/or tests required by the
research.*

-   Emergency Care and Compensation for Research-Related Injury: If the
    research presents greater than minimal risk, what emergency care is
    available in case of research-related injury? ***     *** Who will
    be responsible for the cost of such care? ***     *** Will subjects
    be compensated for out-of-pocket expenses or lost wages if they
    suffer a research-related injury? ***     ***

*Note:*

**[Informed Consent]{.underline}:** Describe the full process of consent
including plans for advertising, recruiting, and how and where the
consent process will take place. Explain how it will be structured to
enhance independent and thoughtful decision-making? What steps will be
taken to avoid coercion or undue influence? What will the person
obtaining consent say? ***     ***

*Note: Consider: a) the environment and location where informed consent
will be solicited; b) the timing of the process (e.g., in relation to
hospital admission, work situation, stressful events); c) involvement of
someone other than the investigators to help explain the research; and
d) opportunity (ample time) for the prospective subjects/representative
to discuss participation in the research with family, friends, or their
advisors before signing the consent form.*

-   Capacity to Consent: Will all adult subjects have the capacity to
    consent? ***     *** If not, describe the likely range of impairment
    and explain how, and by whom, their capacity to consent will be
    determined. ***     *** Describe how children will be assented and
    their authorized guardian consented. ***     ***

*Note: In research involving more than minimal risk, capacity to consent
should be determined by a psychiatrist, clinical psychologist, or other
qualified professional not otherwise involved in the research.
Individuals who lack the capacity to consent may participate in research
only if consent is given on their behalf by a legally authorized
representative*.

-   Personnel Inviting Participants: How, and by whom, will informed
    consent be obtained? ***     *** Identify by name and training the
    individual(s) authorized to describe the research to
    subjects/representatives and to invite their participation.
    ***     ***

-   Comprehension of the Information Provided: How, and by whom, will it
    be determined if the subject or their legally authorized
    representative understands the information provided? ***     ***

*Note: This section should clearly document that the investigator has an
adequate plan in place to ensure existence of an acceptable level of
comprehension before consent is documented. Willingness to sign the
consent form is not an adequate demonstration of their understanding.
Some investigators try to determine the level of prospective subjects'
comprehension by questioning them about the research. This approach is
useful with children and adolescents, as well as with adults of
uncertain capacity to consent.*

-   Translation: Is translation of the consent form required?
    ***     *** Will subjects be able to comprehend the information
    provided without translation? ***     *** How, and by whom, will it
    be determined whether the subjects or their legally authorized
    representatives understand the information? ***     ***

-   Information Withheld from Subjects (Deception?): Will any
    information about the research be withheld from potential or
    participating subjects? ***     *** If so, explain and justify the
    nondisclosure and describe plans for post-study debriefing.

*Note: Any nondisclosure must be approved by the CBeIRB, and may not
exclude information that a reasonable person would want to know in
deciding whether to participate in the research. In addition, the
alteration must be approved under 45 CFR 46.116(d) to ensure: 1) the
research involves no more than minimal risk to the 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) when appropriate, the subjects
will be provided with pertinent information after participation.*

Does the informed consent provide the following in simple lay language
(or as appropriate to the expected level of comprehension)?

-   A statement that the study involves research and a clear explanation
    for the purpose of the research.

-   A statement that participation is voluntary, that refusal to
    participate or discontinue will involve no penalty or loss of
    benefits to which the subject is otherwise entitled.

-   Clear description (chronological order) of the procedures in which
    the subjects will participate, including expected duration.

-   Identification of any experimental procedures.

-   Reasonably foreseeable risks or discomforts.

-   Benefits to the subject or to others which may reasonably be
    expected to result from the research.

-   Appropriate alternative procedures or treatment, if any, that might
    be advantageous to the subject.

-   Compensation for full or partial participation, the method, and
    timing of payment.

-   The extent, if any, to which confidentiality of records will be
    maintained.

-   A description of emergency treatment and compensation if injury
    occurs.

-   Contacts for general questions, subject rights or emergencies,
    including chairs of site and CBe IRBs.

-   A statement to be signed by the person obtaining consent confirming
    that the necessary information has been provided.

**[Additional elements of consent may include:]{.underline}**

-   Potential risks to subjects (embryo or fetus) which are currently
    unforeseeable.

-   Circumstances under which a subject may be terminated by the
    investigator.

-   Additional costs to subject that may result from participation in
    the research.

-   Consequences of, and procedures for, a subject's early withdrawal
    from the study.

-   Process subjects shall follow to notify PI of intention to withdraw
    from study.

-   Significant new findings that might impact a subject's willingness
    to continue participation.

-   Approximate number of subjects, where that knowledge might impact a
    subject's participation.

-   Documentation of the method for informing subject of the results of
    participation in the research.

**[Involvements of Other Institutions]{.underline}:** Describe
arrangements or agreements with other institutions that directly affect
the involvement of human subjects in this research. Is a letter of
cooperation between the IRBs required? ***     *** Is human subjects
review required at other institutions? ***     *** Please explain and
provide documentation of other institutional IRB review. ***     ***

**[Conflict of Interest]{.underline}:** Does any investigator on the
protocol (including his/her immediate family members) have a significant
financial conflict of interest with the sponsor of this protocol? Yes:
No: If yes, explain below: ***     ***

*Note: Conflict of interest* *is defined as: a) salary or payment for
services exceeding \$10,000 per year (not including funds for this or
other research); b) an equity interest with a fair market value over
\$10,000 or which represents more than 5% ownership; or c) intellectual
property rights (patents, copyrights, royalties, etc.).*

**[Unusual Aspects of this Research]{.underline}:** Please note any
unusual aspects, if any, of this research which should be called to the
attention of the CBeIRB. ***     ***

**[Human Subjects Training]{.underline}:** Documentation of human
subjects training for all key project staff must be completed before
this application will be accepted for review.

Documentation of human subjects training for all key project staff is:

> Attached to this application:
>
> Current and on File in the CBeIRB Office:

**Administrative Requirements:**

-   All contact documents (consent forms, letters, etc.) must be
    paginated in a footer in the style of "1 of n," where "n" is the
    total number of pages in the document. Dates should be included in
    this footer to reflect the most recent revisions.

-   Names of **ALL** signatories on the Application, consents, etc.,
    must be printed or typed.

-   **ALL** signatures must be dated.

-   All contact documents (consents, letters, informational materials)
    must be in size 10 font or greater.

-   Double-sided printing is recommended for all final versions of
    contact documents, consents, and letters.