----------------------------------------------- ----------------------------------- --- --------------------------------------- -----------------------------------------
  **Informed Consent Checklist:**                                                         **Examples:**                           

  []{#Menu                                        [**Basic                                ![](media/image1.png){width="0.125in"   **[Experimental
  .anchor}![](media/image1.png){width="0.125in"   Elements**](#basic-elements)            height="0.125in"}                       Procedures](#Experimental)**
  height="0.125in"}                                                                                                               

  ![](media/image1.png){width="0.125in"           [**Additional                           ![](media/image1.png){width="0.125in"   [**Confidentiality**](#confidentiality)
  height="0.125in"}                               Elements**](#additional-elements)       height="0.125in"}                       

                                                                                          ![](media/image1.png){width="0.125in"   [**Costs**](#Costs)
                                                                                          height="0.125in"}                       

                                                                                          ![](media/image1.png){width="0.125in"   [**Payment to Subjects**](#Payment)
                                                                                          height="0.125in"}                       

                                                                                          ![](media/image1.png){width="0.125in"   [**Research Related
                                                                                          height="0.125in"}                       Injury**](#research-related-injury)
  ----------------------------------------------- ----------------------------------- --- --------------------------------------- -----------------------------------------

![](media/image2.png){width="1.16875in" height="0.5986111111111111in"}

+-----------------------------------------------------------+----------+
| Program for Research Integrity Development & Education    | Version  |
| (PRIDE)                                                   | 1.9      |
|                                                           |          |
| <http://www1.va.gov/resdev/fr/PRIDE/>                     | 9-30-04  |
+-----------------------------------------------------------+----------+

+--------------------------------------+---+---+------------------------+
| #### Basic Elements                  | * | * | **Source**             |
|                                      | * | * |                        |
| **Does the IRB guidance/template or  | Y | N |                        |
| approved consent form include the    | * | * |                        |
| following?**                         | * | * |                        |
+--------------------------------------+---+---+------------------------+
| 1.  Name of the study.               |   |   | VHA Handbook 1200.5    |
|                                      |   |   | Appendix C-1           |
+--------------------------------------+---+---+------------------------+
| 2.  The name of the Principal        |   |   | VHA Handbook 1200.5    |
|     Investigator (PI).               |   |   | Appendix C-1           |
+--------------------------------------+---+---+------------------------+
| 3.  A statement that the study       |   |   | ICS Element 1A, Factor |
|     involves research.               |   |   | 1, Page 84; VHA        |
|                                      |   |   | Handbook 1200.5        |
|                                      |   |   | Appendix C-1           |
+--------------------------------------+---+---+------------------------+
| 4.  An explanation of the purposes   |   |   | ICS Element 1A, Factor |
|     of the research.                 |   |   | 2,Page 84; VHA         |
|                                      |   |   | Handbook 1200.5        |
|                                      |   |   | Appendix C-1           |
+--------------------------------------+---+---+------------------------+
| 5.  The expected duration of the     |   |   | ICS Element 1A, Factor |
|     subject's participation.         |   |   | 3, Page 84; VHA        |
|                                      |   |   | Handbook 1200.5        |
|                                      |   |   | Appendix C-1           |
+--------------------------------------+---+---+------------------------+
| 6.  A description of the procedures  |   |   | ICS Element 1A, Factor |
|     to be followed.                  |   |   | 4, Page 84; VHA        |
|                                      |   |   | Handbook 1200.5        |
|                                      |   |   | Appendix C-2           |
+--------------------------------------+---+---+------------------------+
| 7.  Identification of any            |   |   | ICS Element 1A, Factor |
|     experimental procedures.         |   |   | 5, Page 84; VHA        |
|                                      |   |   | Handbook 1200.5        |
|                                      |   |   | Appendix C-2           |
+--------------------------------------+---+---+------------------------+
| 8.  A description of any reasonably  |   |   | ICS Element 1A, Factor |
|     foreseeable risks or discomforts |   |   | 6, Page 84; VHA        |
|     to the subject.                  |   |   | Handbook 1200.5        |
|                                      |   |   | Appendix C-2           |
+--------------------------------------+---+---+------------------------+
| 9.  A description of any benefits to |   |   | ICS Element 1A, Factor |
|     the subject or to others, which  |   |   | 7, Page 84; VHA        |
|     may reasonably be expected from  |   |   | Handbook 1200.5        |
|     research.                        |   |   | Appendix C-2           |
+--------------------------------------+---+---+------------------------+
| 10. A disclosure of appropriate      |   |   | ICS Element 1A, Factor |
|     alternative procedures or        |   |   | 8, Page 84; VHA        |
|     courses of treatment (if any)    |   |   | Handbook 1200.5        |
|     that might be advantageous to    |   |   | Appendix C-2           |
|     the subject.                     |   |   |                        |
+--------------------------------------+---+---+------------------------+
| 11. A statement describing the       |   |   | ICS Element 1A, Factor |
|     extent (if any) to which         |   |   | 9, Page 84; VHA        |
|     confidentiality of records       |   |   | Handbook 1200.5        |
|     identifying the subject will be  |   |   | Appendix C-2           |
|     maintained.                      |   |   |                        |
+--------------------------------------+---+---+------------------------+
| 12. If appropriate, a statement that |   |   | VHA Handbook 1200.5    |
|     Federal agencies such as the     |   |   | Appendix C-2           |
|     Food and Drug Administration     |   |   |                        |
|     (FDA), the Office for Human      |   |   |                        |
|     Research Protection (OHRP) and   |   |   |                        |
|     the Government Accounting Office |   |   |                        |
|     (GAO) may have access to the     |   |   |                        |
|     records.                         |   |   |                        |
+--------------------------------------+---+---+------------------------+
| 13. If an FDA-regulated test article |   |   | ICS Element 1A, Factor |
|     is involved, a statement that    |   |   | 10, Page 84; VHA       |
|     the FDA may choose to inspect    |   |   | Handbook 1200.5        |
|     research records that include    |   |   | Appendix C- 2          |
|     the subject's individual medical |   |   |                        |
|     records.                         |   |   |                        |
+--------------------------------------+---+---+------------------------+
| 14. An explanation as to whether any |   |   | ICS Element 1A, Factor |
|     compensation exists if injury    |   |   | 11, Page 84; VHA       |
|     occurs.                          |   |   | Handbook 1200.5        |
|                                      |   |   | Appendix C-2           |
+--------------------------------------+---+---+------------------------+
| 15. An explanation of whom to        |   |   | ICS Element 1A,        |
|     contact for answers to questions |   |   | Factors 12 and 13,     |
|     about the research and research  |   |   | Page 84; VHA Handbook  |
|     subjects\' rights, and whom to   |   |   | 1200.5 Appendix C-3    |
|     contact in the event of          |   |   |                        |
|     research-related injury to the   |   |   |                        |
|     subject. At least one contact\'s |   |   |                        |
|     name and phone number must be    |   |   |                        |
|     someone other than the           |   |   |                        |
|     investigator\'s or study         |   |   |                        |
|     personnel.                       |   |   |                        |
+--------------------------------------+---+---+------------------------+
| 16. A statement that participation   |   |   | ICS Element 1A, Factor |
|     is voluntary.                    |   |   | 14, Page 84; VHA       |
|                                      |   |   | Handbook 1200.5        |
|                                      |   |   | Appendix C-3           |
+--------------------------------------+---+---+------------------------+
| 17. A statement that refusal to      |   |   | ICS Element 1A, Factor |
|     participate will involve no      |   |   | 15, Page 84; VHA       |
|     penalty or loss of benefits to   |   |   | Handbook 1200.5        |
|     which the subject is otherwise   |   |   | Appendix C-3           |
|     entitled.                        |   |   |                        |
+--------------------------------------+---+---+------------------------+
| 18. A statement that the subject may |   |   | ICS Element 1A, Factor |
|     discontinue participation at any |   |   | 16, Page 85; VHA       |
|     time without penalty or loss of  |   |   | Handbook 1200.5        |
|     benefits to which the subject is |   |   | Appendix C-3           |
|     otherwise entitled.              |   |   |                        |
+--------------------------------------+---+---+------------------------+

+--------------------------------------+---+---+------------------------+
| #### Additional Elements             | * | * | **Source**             |
|                                      | * | * |                        |
| **Does the IRB guidance/template or  | Y | N |                        |
| approved consent form include the    | * | * |                        |
| following?**                         | * | * |                        |
+--------------------------------------+---+---+------------------------+
| 1.  A statement that the particular  |   |   | ICS Element 1B, Factor |
|     treatment or procedure may       |   |   | 1, Page 86; VHA        |
|     involve risks to the subjects    |   |   | Handbook 1200.5        |
|     (or to the embryo or fetus, if   |   |   | Appendix C-3           |
|     the subject is or may become     |   |   |                        |
|     pregnant) which are currently    |   |   |                        |
|     unforeseeable.                   |   |   |                        |
+--------------------------------------+---+---+------------------------+
| 2.  Anticipated circumstances under  |   |   | ICS Element 1B, Factor |
|     which the subject\'s             |   |   | 2, Page 86; VHA        |
|     participation may be terminated  |   |   | Handbook 1200.5        |
|     by the investigator without the  |   |   | Appendix C-3           |
|     subject\'s consent.              |   |   |                        |
+--------------------------------------+---+---+------------------------+
| 3.  Any additional costs to the      |   |   | ICS Element 1B, Factor |
|     subject that may result from     |   |   | 3, Page 86; VHA        |
|     participation in the research,   |   |   | Handbook 1200.5        |
|     consistent with the Federal laws |   |   | Appendix C-3           |
|     concerning veterans\'            |   |   |                        |
|     eligibility for medical care and |   |   |                        |
|     treatment.                       |   |   |                        |
+--------------------------------------+---+---+------------------------+
| 4.  The consequences of a subject\'s |   |   | ICS Element 1B, Factor |
|     decision to withdraw from the    |   |   | 4, Page 86; VHA        |
|     research and procedures for      |   |   | Handbook 1200.5        |
|     orderly termination of           |   |   | Appendix C-4           |
|     participation by the subject.    |   |   |                        |
+--------------------------------------+---+---+------------------------+
| 5.  A statement that significant new |   |   | ICS Element 1B, Factor |
|     findings developed during the    |   |   | 5, Page 86; VHA        |
|     course of the research which may |   |   | Handbook 1200.5        |
|     relate to the subject\'s         |   |   | Appendix C-4           |
|     willingness to continue          |   |   |                        |
|     participation will be provided   |   |   |                        |
|     to the subject.                  |   |   |                        |
+--------------------------------------+---+---+------------------------+
| 6.  The approximate number of        |   |   | ICS Element 1B, Factor |
|     subjects involved in the study.  |   |   | 6, Page 86; VHA        |
|                                      |   |   | Handbook 1200.5        |
|                                      |   |   | Appendix C-4           |
+--------------------------------------+---+---+------------------------+
| 7.  As appropriate, a statement      |   |   | ICS Element 1C, Factor |
|     regarding any payment the        |   |   | 1, Page 88; VHA        |
|     subject is to receive and how    |   |   | Handbook 1200.5        |
|     payment will be made.            |   |   | Appendix C-4           |
+--------------------------------------+---+---+------------------------+
| 8.  As appropriate, a statement      |   |   | ICS Element 1C, Factor |
|     concerning the schedule of       |   |   | 2, Page 88; VHA        |
|     payments to subjects.            |   |   | Handbook 1200.5        |
|                                      |   |   | Appendix C-4;          |
+--------------------------------------+---+---+------------------------+

### EXAMPLES

The examples used in this section were chosen because reports from the
field indicated that these are areas of confusion. The wording in these
examples is for demonstration purposes only. We do not wish to imply
that this specific language should be incorporated into local templates.
In the following five (5) sections, the problem is explained, applicable
regulations and guidance are cited, and examples are given.

When is a VA consent form required? This is a frequently asked question,
particularly if the study is being conducted at both the VA and its
affiliate university. Only those subjects that are actually entered into
the study at the VAMC and followed by the VA investigator at the VA need
to sign the VA consent form. Subjects entered into the study at the
affiliate and followed by a faculty investigator at the affiliate would
sign the affiliate's form. Some studies involve both the VAMC and the
affiliate, such as a study in which an investigator recruits at the
VAMC, and conducts the procedures at the affiliate. You will need to
establish written policies that are acceptable both to the VAMC and the
affiliate to handle these cases. The subject may be required to sign a
consent for the VAMC and an affiliate consent. Note that the consent
information cannot be combined into a single consent document that
addresses the issues of both the VAMC and the affiliate.

[**Back to Main Menu**](#Menu)

[]{#Experimental .anchor}**EXPERIMENTAL PROCEDURES**

Many consent forms do not adequately describe what is experimental. It
may be implied from the procedures of the study described. However,
implication or inference is insufficient. There must be a clear
statement what is experimental or a statement that there are no
experimental procedures, if applicable.

**Regulations:**

> 1200.5 Appendix C, 2, a. (6): "Identification of any procedures that
> are experimental."
>
> 38 CFR 16.116 (a) (1): "A statement that the study involves research,
> an explanation of the purposes of the research and the expected
> duration of the subject's participation, a description of the
> procedures to be followed, and identification of any procedures which
> are experimental."

**Guidance:**

> OHRP Tips on Informed Consent
> ([http://www.hhs.gov/ohrp/humansubjects/guidance/ictips.htm]{.underline})

-   **Describe the overall experience that will be encountered**.
    Explain the research activity, how it is experimental (e.g., a new
    drug, extra tests, separate research records, or nonstandard means
    of management, such as flipping a coin for random assignment or
    other design issues).

FDA Information Sheet
([http://www.fda.gov/cder/guidance/index.htm]{.underline})

-   The statement that the study involves research is important because
    the relationship between patient-physician is different than that
    between subject-investigator. Any procedures relating solely to
    research (e.g., randomization, placebo control, additional tests)
    should be explained to the subjects. The procedures subjects will
    encounter should be outlined in the consent document, or an
    explanation of the procedures, such as a treatment chart, may be
    attached to and referenced in the consent document.

-   Consent documents for studies of investigational articles should
    include a statement that a purpose of the study includes an
    evaluation of the safety of the test article. Statements that test
    articles are safe or statements that the safety has been established
    in other studies are not appropriate when the purpose of the study
    includes determination of safety. In studies that also evaluate the
    effectiveness of the test article, consent documents should include
    that purpose, but should not contain claims of effectiveness.

## **Example #1:**

> There are situations where the difference between clinically indicated
> and experimental interventions must be explained for subjects in the
> section of the consent form that describes procedures. These sections
> should contain a clear statement regarding which procedures are
> experimental and which procedures are standard care. Consider the
> following example:
>
> *If you agree to participate in this research you will be asked to
> have a chest x-ray to make sure that you are healthy. The x-ray is
> performed on all patients with your condition whether or not they
> decide to participate in this research. Following the chest x-ray, you
> will be asked to provide ten (10) cc's (approximately one tablespoon)
> of blood (usually from a vein in your arm). This blood draw will be
> performed for the purpose of this research only.*

## **Example #2:**

> For complicated studies involving numerous interventions, a table may
> be used to help distinguish between experimental and/or standard care
> procedures in human research studies. When research procedures are
> instituted that are both experimental and standard care in different
> parts of the procedure, indicate the number of procedures for each
> respective intervention, if possible. A third column indicating
> procedures that are both standard care and experimental may also be
> used instead of attempting to numerate the number of procedures.

+------------------------------+---------------------------------------+
| **RESEARCH PROCEDURES FOR    |                                       |
| STUDY CSG**                  |                                       |
|                              |                                       |
| **29030**                    |                                       |
+------------------------------+---------------------------------------+
| Study-related Procedures     | Standard Care                         |
+------------------------------+---------------------------------------+
| Chest X-Ray                  | Blood Tests -- Complete Blood,        |
|                              | Chemistry Tests                       |
+------------------------------+---------------------------------------+
| Pregnancy Test               | Liver Function Tests                  |
+------------------------------+---------------------------------------+
| MRI (4)                      | MRI (2)                               |
+------------------------------+---------------------------------------+
| Urinalysis (4)               | Urinalysis (1)                        |
+------------------------------+---------------------------------------+
| Administration of Study Drug |                                       |
| SL-K                         |                                       |
+------------------------------+---------------------------------------+
| 14 Lab Sample Tests for Drug |                                       |
| SL-K                         |                                       |
+------------------------------+---------------------------------------+

## 

[**Back to Main Menu**](#Menu)

# CONFIDENTIALITY

It is not sufficient to say that information obtained in the study will
be kept confidential. The investigator should have clear guidelines as
to what information will be revealed to whom and under what
circumstances, and communicate these conditions to subjects in clear
language in the consent. It should also be remembered that strict
confidentiality cannot be guaranteed. VA Policy requires a note be
placed in the chart concerning the consent process, thus non-research VA
staff will have access to this information in the course of clinical
care. This section does not incorporate HIPAA language whereas specific
sites may wish to incorporate the HIPAA language in their
confidentiality section.

**Regulations:**

> 1200.5 Appendix C, 2, a. (10): "A statement describing the extent to
> which confidentiality of records identifying the subject will be
> maintained. If appropriate, a statement that Federal agencies such as
> the Food and Drug Administration (FDA), the Office for Human Research
> Protection (OHRP) and the Government Accounting Office (GAO) may have
> access to the records. If an FDA-regulated test article is involved,
> the FDA requires a statement that the FDA may choose to inspect
> research records that include the subject's individual medical
> records."
>
> 38 CFR 16.116 (a) (5): "A statement describing the extent, if any, to
> which confidentiality of records identifying the subject will be
> maintained."

**Guidance:**

> OHRP Tips on Informed Consent
> ([http://www.hhs.gov/ohrp/humansubjects/guidance/ictips.htm]{.underline})

-   **The regulations insist that the subjects be told the extent to
    which their personally identifiable private information will be held
    in confidence**. For example, some studies require disclosure of
    information to other parties. Some studies inherently are in need of
    a Certificate of Confidentiality which protects the investigator
    from involuntary release (e.g., subpoena) of the names or other
    identifying characteristics of research subjects.

FDA Information Sheet
([http://www.fda.gov/cder/guidance/index.htm]{.underline})

-   Study subjects should be informed of the extent to which the
    institution intends to maintain confidentiality of records
    identifying the subjects. In addition, they should be informed that
    FDA may inspect study records (which include individual medical
    records). If any other entity, such as the sponsor of the study, may
    gain access to the study records, the subjects should be so
    informed. The consent document may, at the option of the IRB, state
    that subjects\' names are not routinely required to be divulged to
    FDA. When FDA requires subject names, FDA will treat such
    information as confidential, but on rare occasions, disclosure to
    third parties may be required. Therefore, absolute protection of
    confidentiality by FDA should not be promised or implied. Also,
    consent documents should not state or imply that FDA needs clearance
    or permission from the subject for access. When clinical
    investigators conduct a study for submission to FDA, they agree to
    allow FDA access to the study records. Informed consent documents
    should make it clear that, by participating in research, the
    subject\'s records automatically become part of the research
    database. Subjects do not have the option to keep their records from
    being audited/reviewed by FDA.

## **Example #1:**

> *Participation in this study will involve a loss of privacy, but
> information about you will be handled as confidentially as possible.
> Your research records will be labeled with a code number. The list
> that matches your name with the code number will be kept in a locked
> file in the research team's office. The research records will be kept
> in a password-protect computer file that only the study team has
> access to. Your information will be combined with information from
> other people taking part in the study. We will write about the
> combined information we have gathered. Any presentations or
> publications from this information will not identify you.*
>
> *We will keep confidential all research records that identify you to
> the extent allowed by law. However, you should know that there are
> some circumstances in which we may have to show your information to
> other people. For example, someone from the Food and Drug
> Administration, the Office of Human Research Protections, the VA
> Office of Research Oversight, the XYZ VA Medical Center Human Subjects
> Subcommittee, and the sponsor may look at or copy portions of records
> that identify you.*

**Example #2:**

> *By signing this consent form, you are allowing the use of
> identifiable health information about you in this study. This
> information comes from your VA medical record, research study-specific
> information that is to be added to the VA medical record, and research
> study-specific information that is stored elsewhere. Information that
> is collected during the study will be stored at the research site;
> paper copies will be kept in locked files and computer files will be
> protected by passwords.*
>
> The research team may also need to disclose the information (research
> study-specific information and your VA medical record) to others as
> part of the study process. The others may include the study sponsor,
> the FDA, the XZY VA Institutional Review Board that will monitor this
> study, the VA Office of Research Oversight, and the Office of Human
> Research Protections. When the results of this research study are
> published or discussed in conferences, no information will be included
> that would reveal your identity.
>
> [**Back to Main Menu**](#Menu)

[]{#Costs .anchor}

**COSTS**

There are two common errors made in consent forms regarding costs. The
first is to assume that there are no costs and therefore have no
statement included in the consent form. This is the error of inference.
If there is no extra cost for the study, this needs to be stated
explicitly. The second problem is if there are non-veteran subjects,
they will have to pay for all the costs of the research. As noted below
under bullet (c), the subject not eligible for VA benefits will not be
made to pay for research related medical services. However, the research
service will have to pay for those services. If there are medical
expenses incurred not related to the research study, the subject who is
not eligible for VA benefits can be asked to pay these expenses.

**Regulations:**

> 1200.5 Appendix C, 2, a. (14): "A statement that a veteran-subject
> will not be required to pay for care received as a subject in a VA
> research project except as follows:

(a) In accordance with Title 38 United States Code 1710 (f) and 1710(g)
    certain veterans are required to pay co-payments for medical care
    and services provided by VA. Veterans receiving medical care and
    services from VA that are not rendered as part of the VA-approved
    research study must pay any applicable co-payment for such care and
    services.

(b) Suggested wording for the consent form needs to note this
    requirement. For example: "Some veterans are required to pay
    co-payments for medical care and services provided by VA. These
    co-payments requirements will continue to apply to medical care and
    services provided by VA that are not part of this study."

(c) Investigators need to note, pursuant to 38 CFR 17.102, charges will
    not be made for medical services, including transportation,
    furnished as part of a VA-approved research study. Section 17.102
    requires that if services are furnished to a person who is not
    eligible for the services as a veteran, the medical care
    appropriation will be reimbursed from the research appropriation.

> 38 CFR 16.116 (b) (3): "Any additional costs to the subject that may
> result from participation in the research."

## **Example #1:**

> *You will not be charged for any treatments or procedures that are
> part of this study. However, if you are required to make co-payments
> for services provided by the VA or if you receive treatment that is
> part of your usual medical care, you or your third-party payor (e.g.,
> insurance company) may be billed.*

## **Example #2:**

> *There will be no costs to you for any of the treatment or testing
> done as part of this research study. However, medical care and
> services provided by the VA that are not part of this study (e.g.,
> normal hospital and prescription expenses which are not part of the
> research study) may require co-payments if your VA-eligibility
> category requires co-payment for VA services.*

[**Back to Main Menu**](#Menu)

[]{#Payment .anchor}**PAYMENT TO SUBJECTS**

The issue commonly seen with describing payment to subjects is an
inadequate description of how the payment will be made. A related issue
comes up regarding method of payment. If the subject is being paid by VA
check submitted through Austin, note that the social security number is
required to process the check AND payments of any amount will be
reported to the IRS and may be counted as income. Both of these issues
should be disclosed in the consent form.

**Regulations:**

> 1200.5 Appendix C, 2, b. (7): "As appropriate, a statement regarding
> any payment the subject is to receive and how payment will be made."
> **AND**
>
> 1200.5 12, a. VA policy prohibits paying human subjects to participate
> in research when the research is integrated with a patient's medical
> care and when it makes no special demands on the patient beyond those
> of usual medical care. Payment may be permitted, with IRB approval, in
> the following circumstances:

(1) **No Direct Subject Benefit**. When the study to be performed is not
    directly intended to enhance the diagnosis or treatment of the
    medical condition for which the volunteer subject is being treated,
    and when the standard of practice in affiliated non-VA institutions
    is to pay subjects in this situation.

(2) **Others Being Paid**. In multi-institutional studies, when human
    subjects at a collaborating non-VA institution are to be paid for
    the same participation in the same study at the same rate proposed.

(3) **Comparable Situations**. In other comparable situations in which,
    in the opinion of the IRB, payment of subjects is appropriate.

(4) **Transportation Expenses**. When transportation expenses are
    incurred by the subject that would not be incurred in the normal
    course of receiving treatment and which are not reimbursed by any
    other mechanism.

**Guidance:**

FDA Information Sheet
([http://www](http://www/)[.fda.gov/cder/guidance/index.htm]{.underline})

-   It is not uncommon for subjects to be paid for their participation
    in research, especially in the early phases of investigational drug,
    biologic or device development. Payment to research subjects for
    participation in studies is not considered a benefit, it is a
    recruitment incentive. Financial incentives are often used when
    health benefits to subjects are remote or non-existent. The amount
    and schedule of all payments should be presented to the IRB at the
    time of initial review. The IRB should review both the amount of
    payment and the proposed method and timing of disbursement to assure
    that neither is coercive or present undue influence \[21 CFR
    50.20\].

-   Any credit for payment should accrue as the study progresses and not
    be contingent upon the subject completing the entire study. Unless
    it creates undue inconvenience or a coercive practice, payment to
    subjects who withdraw from the study may be made at the time they
    would have completed the study (or completed a phase of the study)
    had they not withdrawn. For example, in a study lasting only a few
    days, an IRB may find it permissible to allow a single payment date
    at the end of the study, even to subjects who had withdrawn before
    that date.

-   While the entire payment should not be contingent upon completion of
    the entire study, payment of a small proportion as an incentive for
    completion of the study is acceptable to FDA, providing that such
    incentive is not coercive. The IRB should determine that the amount
    paid as a bonus for completion is reasonable and not so large as to
    unduly induce subjects to stay in the study when they would
    otherwise have withdrawn. All information concerning payment,
    including the amount and schedule of payment(s), should be set forth
    in the informed consent document.

**Example #1:**

## *In return for your time and inconvenience, you will be paid \$100 for your participation in this study. If you do not complete the study, you will be paid \$40 for each week of participation. You will be mailed a check approximately three (3) weeks after the study has ended. Note that we will require your social security number to process the check. In addition, it is VA policy that the amount you receive from this study will be reported to the Internal Revenue Service (IRS) and may be considered taxable income.*

## **Example #2:**

> *You will be compensated for your time and effort for participating in
> this research project. You will be paid \$20.00 for each blood
> draw/session that you complete. You will receive the payment at the
> end of each blood draw/session.*

## **Example #3:**

> *You will not be paid for your participation in this research study.*

[**Back to Main Menu**](#Menu)

# Research Related Injury

There has been much confusion about research-related injury statements.
The most common error is that while medical care is covered,
compensation is not. Both issues must be addressed in the consent form.
The statement regarding available compensation must be declarative, so
the subject can ascertain whether compensation is available. Stating
that compensation may be available based on VA eligibility is not
acceptable. Another error commonly made is to refer questions regarding
compensation for injury to either the investigator or the IRB office.
This is a legal question that is best referred to the research office or
the appropriate legal authority for the facility. Finally, non-veteran
subjects must be provided the same indemnity for medical treatment as
veteran subjects.

**Regulations:**

> 1200.5 Appendix C, 2, a. (11): "For research involving more than
> minimal risk an explanation as to whether any compensation is
> available and an explanation as to whether any medical treatments are
> available if injury occurs and if so, what they consist of, or where
> further information may be obtained.

(a) According to Title 38 CFR 17.85 "Treatment of Research --Related
    Injuries to Human Subjects," VA must provide necessary medical
    treatment of a research subject injured by participation in a
    research project approved by a VA R&D Committee and conducted under
    the supervision of one or more VA employees. Except in limited
    circumstances, the necessary care must be provided in VA medical
    facilities. Exceptions include: situations where VA facilities are
    not capable of furnishing economical care; situations where VA
    facilities are not capable of furnishing the care or services
    required; and situations involving a non-veteran research subject.
    Under these circumstances, Directors may contract for such care.
    This requirement does not apply to treatment for injuries that
    result form non-compliance by a research subject with study
    procedures. The informed consent form needs to include language
    explaining VA's authority to provide medical treatment to research
    subjects injured by participation in a VA research project.

(b) The regulation at 38 CFR 17.85 does not apply to research conducted
    for VA under a contract with an individual or a non-VA institution
    (although veterans injured as a result of participation in such
    research may nevertheless be eligible for care from VA under other
    statutory and regulator provisions). Information on the
    responsibility for research-related injury under such circumstances
    must be included in the consent form."

> 38 CFR 16.116 (a) (6): "For research involving more than minimal risk,
> an explanation as to whether any medical treatments are available if
> injury occurs and, if so, what they consist of, or where further
> information may be obtained."

**Guidance:**

OHRP Tips on Informed Consent
(<http://www.hhs.gov/ohrp/humansubjects/guidance/ictips.htm>)

-   **If research-related injury (i.e. physical, psychological, social,
    financial, or otherwise) is possible in research that is more than
    minimal risk (see 45 CFR 46.102\[g\]), an explanation must be given
    of whatever voluntary compensation and treatment will be provided**.
    Note that the regulations do not limit injury to \"physical
    injury\". This is a common misinterpretation.

```{=html}
<!-- -->
```
-   **The regulations prohibit waiving or appearing to waive any legal
    rights of subjects**. Therefore, for example, consent language must
    be carefully selected that deals with what the institution is
    [voluntarily]{.underline} willing to do under circumstances, such as
    providing for compensation beyond the provision of immediate or
    therapeutic intervention in response to a research-related injury.
    In short, subjects should not be given the impression that they have
    agreed to and are without recourse to seek satisfaction beyond the
    institution\'s [voluntarily]{.underline} chosen limits.

```{=html}
<!-- -->
```
-   **The regulations provide for the identification of contact persons
    who would be knowledgeable to answer questions of subjects about the
    [research]{.underline}, [rights as a research subject]{.underline},
    and [research-related injuries]{.underline}. These three areas must
    be explicitly stated and addressed in the consent process and
    documentation.** Furthermore, a single person is not likely to be
    appropriate to answer questions in all areas. This is because of
    potential conflicts of interest or the appearance of such. Questions
    about the research are frequently best answered by the
    investigator(s). However, questions about the rights of research
    subjects or research-related injuries (where applicable) may best be
    referred to those not on the research team. These questions could be
    addressed to the IRB, an ombudsman, an ethics committee, or other
    informed administrative body. Therefore, each consent document can
    be expected to have at least two names with local telephone numbers
    for contacts to answer questions in these specified areas.

FDA Information Sheet (<http://www.fda.gov/cder/guidance/index.htm>)

-   Informed consent documents should describe any compensation or
    medical treatments that will be provided if injury occurs. If
    specific statements cannot be made (e.g., each case is likely to
    require a different response), the subjects should be informed where
    further information may be obtained. The consent should also
    indicate whether subjects will be billed for the cost of such
    medical treatments. When costs will be billed, statements such as
    \"will be billed to you or your insurer in the ordinary manner,\"
    \"the sponsor has set some funds aside for medical costs related
    to\.... Here\'s how to apply for reimbursement if you think you
    might be eligible\" or \"no funds have been set aside\...\" are
    preferred. Statements such as: \"will be the responsibility of you
    or your insurance company\" or \"compensation is not available,\"
    could appear to relieve the sponsor or investigator of liability for
    negligence, see 21 CFR 50.20.

-   The consent document must explain whether there is compensation
    available in case of injury but must not waive or appear to waive
    the rights of the subject or release or appear to release those
    conducting the study from liability for negligence. When no system
    has been set up to provide funds, the preferred wording is: \"no
    funds have been set aside for\" \"\[the cost\] will be billed to you
    or your insurance,\" or similar wording that explains the provisions
    or the process. Wording such as: \"will be your responsibility or
    that of your third-party payor\" has been erroneously interpreted by
    some subjects to mean the insurance company is required to pay.

## 

## **Example #1:**

> *In the event that you sustain an injury or illness as a result of
> your participation in this VA approved research study, all medical
> treatment (emergency as well as medical treatment beyond emergency
> care) will be provided by the VA. You will be treated for the injury
> at no cost to you. However, no additional compensation has been set
> aside. You have not waived any legal rights or released the hospital
> or its agents from liability for negligence by signing this form.*
>
> *In the event of a research-related injury or if you experience an
> adverse reaction, please immediately contact your study doctor at
> (XXX) XXX-XXXX during the day and (XXX) XXX-XXXX after business hours.
> If you need emergency hospitalization in a private hospital because
> you are unable to come to the VA, have a family member or friend
> contact your study doctor so that the VA can coordinate care with the
> private hospital.*

## **Example #2:**

> *The VA will provide necessary medical treatment should you be injured
> by participation in this study. You will be treated for the injury at
> no cost to you, but no additional compensation is available.*
>
> *In case there are any medical problems or questions, you can call Dr.
> XXX at XXX-XXX-XXXX during the day, or XXX-XXX-XXXX after hours. In
> the event of illness or injury that you believe to be related to the
> study, or if you have any questions about your rights as a research
> subject, you can also contact the Chairperson of the Human Studies
> Subcommittee at XXX-XXX-XXXX.*
>
> *No promises have been given to you since the results and the risks of
> a research study are not always known in advance. However, every
> reasonable safety measure will be taken to protect your well-being.
> You have not released this institution from liability for negligence.*

[**Back to Main Menu**](#Menu)