IRB Manual
      4.2 Basic Elements of Informed Consent
   


Unless specifically authorized by the IRB (see Section 4.6.1 Waivers)), investigators at a minimum must provide the following information to each subject:

4.2.1 Purpose of the Study

 
(1)   
An explicit statement that the study involves research and an identification of any procedures, including drugs, devices or biologics, that are experimental. You must use the word "research".

 
(2)   
Explain the purpose of the research:
     
  • Provide a general description of the purpose of the research.
  • If drugs are used, give generic and trade names.
  • If you are using an investigational drug or device, explain that it is not marketed in the United States but is used in research studies, and state that the purpose of the study includes an evaluation of the safety of the drug or device.
  • If you are using a marketed drug for a condition other than that for which it was approved, explain this here.
  • Number of subjects participating in study
4.2.2 Study Procedures

    Describe the actual events in which the subject will take part. Include the following:
 
  • The expected duration of the subject's involvement, the number of sessions, where they will take place, their frequency and duration (e.g., two three-hour sessions) and, when appropriate, the length of the protocol (e.g. six weeks of treatment).
  • A description of the procedures to be followed. Include all screening tests and blood tests (give amount either in familiar terms, e.g. teaspoons, or in comparison to the amount drawn when one donates blood).
  • If either washout or placebo are involved, explain clearly, including the chances of receiving a placebo and the duration. Explain what a placebo or washout is.
  • If subjects will be randomized explain clearly what randomization is.
  • Describe general subject areas to be covered in interviews.
  • If audio/videotaping is required, explain the purpose(s) the tapes will be used for, who will see or hear the tapes, that the tapes can be erased at any time either during or after the session, and how long tapes will be kept.
  • Identify any procedures which are experimental.
  • Provide information on any follow-up care or treatment.
  • Describe any use of medical records or other sources of private information.

4.2.3 Risks

   
Provide a description of any reasonably foreseeable risks or discomforts to the subject and the precautions that will be taken to minimize risks. (The IRB must weigh the severity of a risk and its probability when determining whether it is a 'reasonably foreseeable risk or discomfort'.) Risks include, but are not limited to:
     
  • breach of confidentiality
  • injury
  • side effects of medications
  • risks associated with taking placebo
  • discomfort (e.g. diet restriction, restriction of movement, potentially distressing questions)
  • risks to insurability and employment (financial risks)
  • risks that are currently unforeseeable, e.g., when an investigational drug or device is involved.

4.2.4 Benefits

    Provide a description of any benefits to the subject or to others that may reasonably be expected. The significance of knowledge that will be obtained should be briefly explained.

If no benefits to the subject are expected, this should be stated, e.g., "This study is not designed for your benefit."


4.2.5 Reimbursement

   
If the subjects are receiving payment for their participation, the amount and anticipated schedule of payment should be stated, together with effects on payment of premature study withdrawal. Explain if payment will be in cash, check or voucher, and if mailed, provide a time frame for receipt.


4.2.6 Alternative Treatment

   
Provide a disclosure of alternative procedures or courses of treatment, if any, that might be advantageous to the subject. If there are no standard alternative treatments, this should be stated.

For studies which do not involve treatment and subjects are not patients, the following statement may be used: "This is not a treatment study. Information is being collected for research purposes only."


4.2.7 Confidentiality

   
Include a statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained. You are obliged to tell the subject what you intend to do with respect to confidentiality. Include the following:
     
  • Where records will be kept, who will have access to them, how privacy will be protected (e.g. by the use of codes, reporting only about aggregate data, etc.).
  • If this is a drug company sponsored study, state that the sponsor may also review the research records.
  • If the study is FDA regulated (investigational drug, device or biologic or some studies of marketed drugs for unlabeled indications) a statement that the FDA may inspect the records. Such access to the records by the FDA shall be conducted in accordance with 42 USC 29 dd-3, ee-3 and its promulgated regulations at 42 CFR 2, and Section 33.13 of the New York State Mental Hygiene Law. (For OASAS studies, additional consent, consistent with 42 CFR 2, must be obtained prior to participation to authorize FDA inspection of the records.)
  • When applicable, add a statement that all records will be kept confidential to the extent permitted by law.
  • Add the following statement: "There are legal advocacy organizations (groups that support patient's rights) that are authorized under state law to access otherwise confidential records, although they cannot re-disclose this information without your consent." Note: there are two exceptions to the legal advocacy group statement requirement: (1) If no identifiable information is retained the notification is not necessary; (2) If a Federal Certificate of Confidentiality has been obtained, the notification is not necessary. If a Certificate has been issued use language consistent with federal requirements. For example:
  • "A Federal Certificate of Confidentiality has been obtained for this study. This Certificate protects the investigators from having to release the names or other identifying characteristics of research subjects. Investigators so authorized may not be compelled in any Federal, State, or local, civil, criminal, administrative, legislative or other proceedings to provide identifying information about research participants even if subpoenaed." OR
  • "This research is covered by a Certificate of Confidentiality issued by the Department of Health and Human Services (DHHS). This Certificate will protect the investigators from being forced to release any research data in which you are identified, even under court order or subpoena, without your written consent. This protection, however, does not prohibit the investigator from voluntarily reporting information about suspected or known sexual or physical abuse of a child or a subject's threatened violence to self or others. If any member of the research staff has or is given such information they may report it to the appropriate authorities." OR
  • Alternate language provided by DHHS and approved by the IRB.
4.2.8 Medical Treatment and Compensation

   
For research involving more than minimal risk, an explanation of whether any treatment and/or compensation is available in the event of a research related injury. The subject must be told what it consists of or who to contact for further information.
The following paragraphs are required for all more than minimal risk studies:

"In the event that you experience an injury at _______________________(facility name) as a direct result of participating in this research, the facility will provide emergency medical care within its capabilities, arrange for such other emergency medical care as may be necessary and assist you in arranging follow up care. Neither ______________________(facility name) nor RFMH makes any commitment to pay for medical care, nor do they have programs to provide you with financial compensation for such injury."

"By agreeing to participate in this research and signing this consent form, you do not waive any legal rights nor do you release the research staff of _________________________(facility name) , ___________________________(the sponsor) from liability for negligence."

For studies where a sponsor has agreed to provide treatment and/or compensation, add a paragraph that explains what the sponsor has agreed to pay for. The language must be consistent with the language in the contract and must not include any exculpatory language through which the subject or representative is made to waive or appear to waive any of the subject's legal rights, or releases or appears to release the investigator, the sponsor, the institution or its agents from liability for negligence.

4.2.9 Other Required Information

 
(1)   
A statement that the investigator has answered to the best of his/her ability all questions posed by the subject and that he/she will answer to the best of his/her ability any questions that the subject may have in the future about the procedures or about the subject's response to the procedures (list principal investigator's name and telephone number).

 
(2)   
An explanation of who to contact in the event of a research-related injury and how to contact them.

 
(3)   
A statement of who to contact if the subject has questions about his/her rights as a research subject and how to contact them. This should be the chairperson of the IRB or another appropriate person who is not affiliated with the research.

 
(4)   
A statement that the subject will be given a copy of the Consent Form.

 
(5)   
A statement that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and that the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.

 
(6)   
Any other information which the subject should have in order to make an informed decision about whether to participate in the research.

 
(7)   

For all applicable clinical trials as defined in 21 CFR 50.25(c),1 the following statement must be included in the consent form:

“A description of this clinical trial will be available on http://www.ClinicalTrials.gov , as required by U.S. Law. This Web site will not include information that can identify you.  At most, the Web site will include a summary of the results. You can search this Web site at any time.” 

Note: You MUST use this exact language.

    1 More information can be found at: http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM291085.pdf

     


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