Hackensack University Medical Center
Consent Form
Investigators must use consent forms in clinical investigations, with new procedures, investigational drugs and medical devices. All the required elements of consent are addressed below; all must appear in the consent form. Simple layman’s language must be used and must be at a 4th grade reading level. Bold-faced paragraphs should be written precisely the way that they appear; minor modifications of bold-faced paragraphs are acceptable. They should not remain bolded on the final draft of the consent form submitted to the IRB.
Title of Protocol
The title is the only place where technical language may be used.
Who is conducting this study?
The names of the principal investigator and co-investigators should appear here.
Sponsor: If no private sponsor HUMC should be used. No abbreviations should be used.
Why have I been asked to take part in this research study?
You have been asked to take part in this study because you have (state disease here and list why they are being asked):______
It is up to you to decide whether or not to take part in this study. Please read this entire consent form. This consent form may contain words that you do not understand. Please ask the study doctor or the study staff to explain any words or information that you do not clearly understand. You may take home an unsigned copy of this consent form to think about or discuss with family or friends before making your decision.
Why is this study being conducted?
The objectives and goals of the project need to be stated in lay terms.
How many people will participate in this study?
State how many participants are expected to participate at this site and worldwide.
What is involved in this study?
All procedures need to be clearly spelled out as to what is research or research related and what is standard of care.
Entry-level examinations, lab assessments, pregnancy test and history should be noted along with any drug washout period.
Randomization, crossover and/or double-blind design should be noted.
The route of administration must be noted.
If a drug or device is considered investigational by the FDA, participants must be told.
If a drug is FDA-approved, but for purposes of this study it is being used in a non-FDA-approved manner (higher dose, another indication than the PDR lists), its use in this research project, then, is considered investigational and should be noted as such.
If a drug, device, test or procedure employed in the course of the research study is considered part of routine clinical practice or standard patient care, this should be noted.
Conversely, if participation in the research project entails an extra spinal tap, endoscopy, EKG, chest x-ray, blood drawing, etc., this must also be noted.
If certain foods must be avoided, if specific medications are contra-indicated, please note.
Any videotaping should be noted; if participant is expected to keep a diary, wear a halter-monitor, respond to telephone queries, this information should appear.
If participants will undergo surgery, the administration of anesthesia should be included, as well as its use for procedures such as bronchoscopies.
A description should be given for procedures considered standard. Where applicable, indicate that the participant will receive a special consent form (cardiac catheterization, lumbar punctures, surgery, etc.) for the procedure, its risks and benefits are described in detail.
How long will I be in the study?
Many research projects involve treatment, as well as follow-up. Express the time period in terms of both; e.g., “The drug will be administered for three months, any participants will be followed for another six months.”
What are the risks involved in this study?
Include any risk and/or discomfort which participant may anticipate. Please list risks with frequency of occurrence such as less likely, more likely etc.
Items mentioned in the procedure section should be addressed here; e.g., anesthesia, medication, surgery.
With investigational drugs, note the possibility of unknown adverse reactions and potential side effects of all medications, including interactions with dietary &/or herbal supplements.
With investigational drugs or devices, there is always the possibility that the test drug or device will not be as effective as marketed agents.
Risks to fetus should be addressed. Also risks to children of nursing mothers. Where applicable, indicate that women and men of childbearing potential should use a medically accepted form of birth control.
Include a statement to safeguard medications from children and others who cannot read or understand the label.
The possibility, where applicable, of unknown synergistic effects should be noted.
Note as a risk of participation if the drug will not be available at the close of the study.
Lists risks from all drugs administered in the study.
Are there benefits to taking part in the study?
Any possible benefit that the participant might be expected to derive should be listed here.
Any additional monitoring, office visits or drugs received at no charge should be listed as a benefit.
If no personal benefit is to be derived, but the subject’s participation might result in increased medical knowledge, please note.
What other treatment options are there?
THIS SECTION MUST BE INCLUDED, EVEN IF THE ALTERNATIVE IS NOT TO PARTICIPATE!!
List specifically any medications or treatment modalities that participant might choose as an alternative to participation.
If the study involves a comparison between two drugs that are FDA-approved, the alternative is to receive either one without participating in the study.
In a dose-ranging study, or in most non-treatment studies, there is no clear alternative. State simply that the alternative is not to participate.
How will information about me be kept private?
Your identity and participation are confidential to the extent permitted by law. If investigational drugs and/or medical devices subject to U.S. Food and Drug Administration regulation (FDA) are involved, however, it may be necessary for this consent form and other medical records to be reviewed by representatives of the FDA. In addition the sponsor (list the name of the sponsor), representatives of the sponsor, the Director of Research or designee, or the Institutional Review Board will be granted direct access to your original medical records for verification of clinical trial procedures and/or data without violating your confidentiality to the extent permitted by applicable laws and regulations. By signing this consent you or your legally acceptable representative is authorizing such access.
Records identifying you will be kept confidential to the extent permitted by applicable law. If the results of the trial are published your identity will remain confidential.
What are the costs?
Participants must be told if costs will increase as a result of their participation, being specific about the differences between ‘standard of care’ vs. study-required testing, procedures office visits, etc. If insurance carriers generally pay/reimburse for the tests, procedures, etc., include it in the methodology, please note. Wherever possible be specific; e.g., “the drug will be provided at no charge as well as blood tests to determine drug levels. Office visits, however, will be the responsibility of the participant.” If costs are expected to decrease as a result of participation, this fact should be stated. If insurance will not pay, the patient must be made aware that they will be responsible for payment. Will the participant receive payment?If participants will be paid, note the specific amount and the conditions required for payment.
What are my rights as a research participant?
Your decision to take part in this study is voluntary. If you decide not to participate or if you choose to withdraw after beginning the study, you will not lose any benefitsassociated with your medical care. You are encouraged to ask questions beforedeciding whether you wish to participate and at any time during the course of the project. Your participation may be terminated by the investigator or sponsorwithout regard to your consent. You will be told of any new findings that may influence your decision to continueto participate in this research project. If information becomes available that mayinfluence your decision to take part in this study you will be asked to sign a revisedconsent or consent addendum. This will be at the discretion of the Institutional Review Board.In the case of physical injury resulting from participation in the study, treatmentdetermined by a physician will be made available to you. This care will be billedto you/your insurance company in the usual and customary manner. There willbe no monetary compensation by Hackensack University Medical Center.(If the sponsor is willing to provide treatment, compensation, etc., this information should be reflected).
Who can I call if I have questions or problems?
For questions concerning this research project and/or research subjects’ rights, you should call The Research Integrity Office at 551-996-2255. In the event that medical assistance is required, you are instructed to call ______at (insert phone number here ###-###-####). A description of this clinical trial will be available on 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.
Financial Disclosure
The Principal investigator is/ is not receiving payment from the study sponsor for his for his/her participation in this protocol. Add only if applicable: The principal investigator has disclosed a financial interest or other compensation from the study sponsor.
If you have questions about this disclosure please call the Research Integrity Office at (551) 996-2255.
* (This paragraph needs to reflect a financial disclosure from any sub-investigators who has a financial relationship with the sponsor)
Examples: Shareholder Consultant Speaker
Consent
- I have read this consent form or it has been read to me.
- All of the questions that I had were answered to my satisfaction.
- I have been told that I will receive a signed copy of this consent form for my records.
- By signing this consent form I have not waived any of the legal rights which I otherwise
would have as a participant in a research study.
I hereby consent to participate.
Subject’s Name
______/______
Signature of SubjectDate Time
Name of Legally Authorized Representative [when applicable]
______/______
Signature of Legally Authorized Representative [when applicable] Date Time
Name of Person Conducting Informed Consent Discussion
______/______
Signature of Person Conducting Date Time
Informed Consent Discussion
[Include only for limited or non-readers]
If this consent form is read to the subject because the subject (or legally authorized representative) is unable to read the form, an impartial witness not affiliated with the research or investigator must be present for the consent and sign the following statement:
I confirm that the information in the consent form and any other written information was accurately explained to, and apparently understood by, the subject (or the subject’s legally authorized representative). The subject (or the subject’s legally authorized representative) freely consented to be in the research study.
______/______
Signature of Impartial WitnessDate Time
Page - 1 - of 6Pt. Initials______
Version II Dec. 2002 CD, 06/03
Application packet Version 6/03
Revised 01/12PD