A clinical trial is a research study designed to answer specific questions about vaccines or new therapies or new ways of using known treatments. Clinical trials (also called medical research or research studies) serve to determine whether new drugs or treatments are both safe and effective.

An informed consent form is a document that describes the rights of the clinical trial participants and includes key information about the study, including but not limited to: purpose, duration, required procedures, reasonably foreseeable risks, reasonably expected benefits, contacts, and any compensation or reimbursement information. Department of Health and Human Services (HHS) regulations at 45 C.F.R. 46.116 generally requires the administrators of clinical trials involving human subjects to obtain the participants’ signed informed consent. 

An IRB is a committee of physicians, statisticians, researchers, community advocates, and others responsible for ensuring that a clinical trial is ethical and protects the participants. In the United States, an IRB must approve the clinical trial before the trial begins.

The “Orphan Drug Act”, Public Law 97-414, promotes the development of drugs for rare diseases and conditions.

A rare disease, also known as an “orphan” disease, is generally any disease or condition that affects less than 200,000 people in the United States. Certain conditions that affect more than 200,000 people may be considered orphan diseases if they meet other criteria in the “Orphan Drug Act”.

There are five types of clinical trials:

1. a. 

   Diagnostic trials look for better tests or procedures for diagnosing a particular disease or condition;

2. b. 

   Quality of Life trials (or Supportive Care trials) explore ways to improve comfort and the quality of life for individuals with a chronic illness;

3. c. 

   Prevention trials look for better ways to prevent disease in people who have never had the disease or to prevent a disease from returning. These approaches may include medicines, vaccines, vitamins, minerals, or lifestyle changes;

4. d. 

   Screening trials test the best way to detect certain diseases or health conditions; and

5. e. 

   Treatment trials test experimental treatments, new combinations of drugs, or new approaches to surgery or radiation therapy.

Effective April 3, 2011, exclude from income the first $2,000 paid during a calendar year to an SSI beneficiary, spouse, or deemor as compensation for participation in a clinical trial, but only if the clinical trial meets the following requirements:

• •

  must be reviewed and approved by an IRB;

• •

  must involve research and testing of medical treatments; and

• •

  must target a rare disease or condition.

Do not exclude from income any compensation received prior to April 3, 2011, for participation in clinical trials that meet the criteria in SI 00830.735C.1. (in this section). Apply regular SSI income counting rules to those payments.

For instructions on developing unearned income, see General Rules for Developing Unearned Income in SI 00830.005.

The income exclusion for clinical trial compensation does not apply to payments received as reimbursement for expenses incurred while participating in a clinical trial. Exclude reimbursement payments following the instructions in SI 00815.250, Rebates and Refunds. Some examples of reimbursable expenses are travel to and from research location, meals, etc.

Payments to reimburse clinical trial participants for expenses incurred while participating in the trial do not reduce the $2,000 calendar year maximum.

HHS regulations dictate that IRBs must approve all informed consents; therefore, we can accept an informed consent form as proof that an IRB reviewed and approved the clinical trial.

To determine if the clinical trial meets the other exclusion requirements, review the informed consent form and follow the instructions in this table:

If the “informed consent form” is unavailable as evidence, request any of the following information from the clinical trial participant:

• •

  name and location of the clinical trial,

• •

  name of disease or condition, or

• •

  name, phone, and address of the clinical trial administrator.

Clinical Trials.gov provides key information about clinical trials in the United States, such as purpose and contact information. Use the information provided to locate the clinical trial in the Clinical Trials.gov website.

If the clinical trial appears in the Clinical Trials.gov website, assume an IRB approved the clinical trial. All clinical trials in the United States involving human subjects must meet federal regulations by having an IRB review and approve the research.

To determine if the clinical trial meets the other two exclusion requirements, look for the following details in the clinical trial information:

• •

  type of clinical trial, which is usually listed under the primary purpose, the title, or stated in the purpose summary; and

• •

  name of the condition.

Follow the instructions in this table:

Request verification of date, frequency, and amount of payments (e.g. check stubs, payment receipts, informed consent form, etc). If payment documentation is unavailable, accept the individual’s allegation and exclude the clinical trial compensation without further development. Follow the next steps using MSSICS:

1. a. 

   document the payment information as “Other Income Or Support Not Previously Mentioned”;

2. b. 

   select “Other”, number 34, in the “IOTH” screen;

3. c. 

   enter the following explanation under “If Type Is Other Explain”: clinical trials act; and

   •  

     IMPORTANT: Enter the explanation phrase exactly as it appears. The exact phrase is necessary to gather critical management information pertaining to these provisions.

4. d. 

   annotate the Report of Contact page with the procedure and evidence used to apply the income exclusion and lock it. For example, document the Report of Contact page with all the pertinent information gathered from the informed consent form, such as disease type, amount paid, and time of participation. For more information on electronic evidence documentation and retention, see GN 00301.286.

   For non-MSSICS use the EVID screen under the Shared Processes Menu to document this exclusion.

NOTE: Fax a copy of the informed consent form, or form from the administrator of the clinical trial, into the Certified Electronic Folder (CEF). For more information on faxing documents into the CEF, see DI 81010.090.