Consent Form-Suggested Wording

This document provides an outline of sections which may need to be included in your consent form. Use your creativity to develop a functional format based on your study population. You may wish to use section titles, question/answer, letter, or other presentation formats. There is no required order and this list is designed as a resource. Suggested wording is displayed in italics and all sections may not be applicable but dependent on the study to be conducted. The first page should be on letterhead or space provided to print on school, department, or institution letterhead. Apply the required footer for IRB watermarking which is available from question 4.9 in the IRB application (OSIRIS).

1. HEADER: Consent to Act as a Participant in a Research Study / Consent to Act as a Participant in a Research Registry

2. STUDY TITLE:

3. PRINCIPAL INVESTIGATOR: Include contact information which may include the address, email address, telephone number, and possibly pager number

4. CO-INVESTIGATORS: You are not required to list investigators on the consent form (list in the IRB application) but if you do, include those who are qualified to address the participant’s questions and include contact information which should consist of the email address and/or, telephone number/, pager number.

5. QUESTIONS ABOUT THE STUDY:

  • This statement must be included in the consent: If you have any questions about your rights as a research subject or wish to talk to someone other the research team, please call the University of Pittsburgh Human Subjects Protection Advocate toll-free at 866-212-2668.
  • Depending on the nature of the study (e.g., a treatment study of a medically ill patient/subject), it may be necessary to provide a pager number so the research subject can contact a member of the research team as soon as possible.
    • Suggested wording may include: You can contact the study investigator if you have any questions about the study, concerns or complaints. Contact Principal Investigator, Dr. _________ at ___________ pager _____________ or the Study coordinator at _______________.

6. SOURCE OF SUPPORT: List all sources of support

7. SIGNIFICANT FINANCIAL CONFLICT OF INTEREST:

  • If an investigator has a Significant Financial Conflict of Interest, the conflict must be disclosed to the research participants, consistent with the COI Management Plan developed by the investigators with advice from the COI office, and approved by the IRB.

8. INTRODUCTION:

  • Explain why the research is being conducted and provide a brief discussion of the research as the specific procedures will be addressed later in the consent document
  • Indicate why the potential subject is being asked to participate (basic eligibility criteria)
  • Indicate the approximate number of subjects to be enrolled at this site and total number if multi-centered
  • Indicate the length of time for their participation and length of the study

9. WHEN THE INVESTIGATOR IS ALSO THE CARE-PROVIDER:

  • Suggested language:
    • Your physician is involved as an investigator in this research study. Before agreeing to participate, or at any time during your study participation, you may discuss your care with another doctor who is not associated with this research study. You are not under any obligation to participate in any research study offered by your physician.

10. RESEARCH ACTIVITIES:

  • Define all activities in lay terminology and present them in an understandable fashion
    • Consider using bullets , tables, and pictures
    • Use bold font for those ‘MUST READ’ sections
    • Indicate the approximate duration of the research activity, where the procedures will be performed, and who will be performing the procedures
  • Describe the research activities to be completed for research purposes only. Do not address procedures performed for the subject’s routine medical care but indicate you will be reviewing and recording results of these routine medical procedures, if applicable.
  • If your study requires intensive screening procedures, it may be appropriate to develop a separate screening consent form to lessen possible confusion due to the length of the document
  • Drug studies
    • Indicate the phase of the study and provide an explanation.
    • Include the FDA status of all drugs or devices used in this study for research and whether approved for the current use in this study (do not list those provided as part of their routine care as they are not research related; if randomized into arms then all drug/devices used in each arm become research).
      • Specify the route of administration, dose, frequency and duration
    • If the research involves a Phase I study to determine the maximum tolerated dose of an experiment drug, it should also be stated that subjects are expected to experience significant adverse effects based on the design of the study.
    • Specify if the experimental intervention will be available to the subject following study completion.

11. STUDY RISKS:

  • Include the risks for all research procedures during screening, experimental intervention, and follow-up:
    • It is recommended that language such as Common, Infrequent, or Other Risks be used instead of percentages when describing risks.
  • Include this statement for studies involving greater than minimal risk:
    •  As with any experimental procedure, there may be adverse events or side effects that are currently unknown and certain of these unknown risks could be permanent, severe or life-threatening.
  • If a risk exists to either the mother or fetus sufficient to exclude pregnant women from participation and avoid pregnancy or fathering a child during the course of a study, refer to the Guidance for Reproductive Risk Language for Consents for suggested language.
  • Suggested language for studies using any type of Internet communication to collect, transmit or store research data:
    • Although every reasonable effort has been taken, confidentiality during Internet communication activities cannot be guaranteed and it is possible that additional information beyond that collected for research purposes may be captured and used by others not associated with this study.
    • When text messages are used for research purposes, the consent must include a warning to participants that text messages are not encrypted or secure during their transmission, and could be intercepted.

12. STUDY BENEFITS:

  • Do not overstate the potential benefits of study participation. Some studies will provide no direct benefit and that should be clearly stated.
  • If it is possible that subjects may benefit directly from study participation, disclose this to the subject.
  • If the research study involves a placebo-controlled arm, state clearly that individuals assigned to the placebo group are expected to receive no direct benefit from study participation.

13. ALTERNATIVE TREATMENTS:

  • Disclose any currently available treatments or procedures that may be of potential benefit to the potential subject in lieu of participation in the research study.
    • Subjects should be made aware of the full range of options available to them which may include no further or additional treatment.
    • The investigators should offer their availability to discuss alternatives to research study participation and answer all questions.
  • If the research study involves the evaluation of a currently approved drug or device, indicate whether that the study drug or device is available outside of study participation.
  • Do not include this section if the only alternative is not to participate.

14. NEW INFORMATION:

  • Include the following language when each subject’s participation extends over multiple sessions and the study is more than minimal risk:
    • You will be promptly notified if any new information we learn during this research study may cause you to change your mind about continuing to participate in the study.

15. PRIVACY (Person) and CONFIDENTIALITY (Data):

  • Specify the procedures (e.g., coding of research data, storage of linkage code information in separate locked files, firewalls) that will be used to protect the confidentiality of the research subjects.
  • Access to Research Record:
    • Specify whether identifiable information will be placed into research records or medical records. Include the nature of the identifiable information.
    • Specify who will have access to either research or medical records. Examples of groups that may be included are:
      • University of Pittsburgh Research Conduct and Compliance Office
      • Study Sponsor: [list name of sponsor and/or external auditors]
      • U.S. Food and Drug Administration (FDA) [if applicable]
      • UPMC hospitals or other affiliated health care providers
  • If there are circumstances when the investigators might have to release identifiable information in response to an order from a court of law, this must be stated.
  • Indicate that per University of Pittsburgh policy all research records must be maintained for at least 7 years following final reporting or publication of a project. For projects involving children, records must be maintained for 5 years past age of majority (age 23 per PA State law) after study participation ends.

16. SUBJECT ACCESSS TO RESEARCH RESULTS IN MEDICAL RECORDS:

  • Specify any restrictions on the patient’s-subject’s access to medical information generated as a result of research participation
  • Indicate that such access will be granted at the end of the research study

Note that the UPMC does not generally permit investigators to include restrictions on patient-subject access to medical record information held by the UPMC or affiliated health care providers. The principal investigator must petition the Privacy Officer, UPMC, on a study-specific basis, if s/he wishes to restrict respective patient-subject access to his/her own medical record information. If the UPMC Privacy Officer grants such restrictions, it will be the principal investigator’s responsibility to clearly communicate to the UPMC hospitals or affiliated health care providers the restrictions that have been granted. This communication must include documentation of the Privacy Officer’s permission along with a copy of this signed consent form/authorization.

17. FDA Clinical Trial Registry [21 CFR 50.25]

  • The FDA requires language for “applicable” clinical trials. These are clinical trials that are registered on www.clinicaltrials.gov AND are conducted under a U.S. IND or are otherwise subject to FDA regulations.
    • Required verbatim: A description of this clinical trial will be available on http://www.clinicaltrials.gov, as required by US Law. This website will not include information that can identify you. At most, the website will include a summary of the results. You can search this website at any time.

18. WITHDRAWAL FROM STUDY PARTICIPATION:

  • Suggested language if the subject decides to withdraw from the study:
    • You can, at any time withdraw from this research study; you can also withdraw your authorization for us to use your identifiable medical information for the purposes described above. This means that you will also be withdrawn from further participation in this research study. Any identifiable research or medical information obtained as part of this study prior to the date that you withdrew your consent will continue to be used and disclosed by the investigators for the purposes described above.
      • To formally withdraw from this research study, you should provide a written and dated notice of this decision to the principal investigator of this research study at the address listed on the first page of this form. Your decision to withdraw from this study will have no effect on your current or future relationship with the University of Pittsburgh. [when the study is a Pitt study]
      • Your decision to withdraw your consent for participation in this research study will have no effect on your current or future medical care at a UPMC hospital or affiliated health care provider or your current or future relationship with a health care insurance provider. [when the study is a UPMC study of patients]
      • If you decide to withdraw from study participation after you have received the study drug, you should participate in additional monitoring follow-up procedures that are being conducted to measure the safety of the study drug.
    • Investigator removes subject from study:
      • It is possible that you may be removed from the research study by the researchers if, for example, [provide example]
    • Investigator may request follow-up for safety reasons: If you are withdrawn from participation in this research study, you will asked to continue [specify procedures]because [reason].

19. COSTS:

  • If you participate in this research study, the cost of the experimental (indicate the device or drug, as applicable) and/or the costs of certain procedures performed for the purpose of the research study may be billed to your health insurance provider. You will be notified, in advance should your health insurance provider refuse to cover certain or all of these research costs and if any of these uncovered research costs will be billed directly to you.
    • In this situation, you will be provided with a price estimate for the uncovered research costs that will be billed to you. If you decide to continue your participation in this research study, you will be required to meet with a hospital financial counselor to arrange for your advance payment of these uncovered research costs. If you do not have health care insurance, you will be provided with a price estimate for the research costs that will be billed to you. If you decide to continue your participation in this research study, you will be required to meet with a hospital financial counselor to arrange for your advance payment of these research costs.

20. PAYMENTS:

  • It is important that the total payment for study completion or the payment schedule for partial study completion not be coercive to initial or continuing participation. It is acceptable, however, for the payment schedule to include a non-coercive, payment bonus for the completion of all parts of the study.
  • The Internal Revenue Service (IRS) requires that payments in excess of $600 per calendar year be reported on Form 1099-Misc. The filing of these forms require that the name and social security number of the participant be collected and released to the Accounting Office. It is important that the collection and release of this information must be addressed in the informed consent document so that it is clear to the participant that his or her identity will be released for the purpose of payment and reporting. IF SUBJECTS ARE RECEIVING MORE THAN $600/YEAR FOR PARTICIPATING IN THIS STUDY, THE FOLLOWING LANGUAGE, OR SOMETHING SIMILAR, SHOULD BE INCLUDED:
    • Since you are being compensated for your participation in this study, your name, address, and social security number will be released to the Accounting Office. If the total reimbursement for your participation in research is greater than $600 in a year, this will be reported to the Internal Revenue Service (IRS) as income.

21. COMPENSATION FOR INJURY:

  • Include the following language if the research is NOT commercially sponsored but is conducted at Pitt or UPMC facilities:
    • If you believe that the research procedures have resulted in an injury to you, immediately contact the Principal Investigator who is listed on the first page of this form. Emergency medical treatment for injuries solely and directly related to your participation in this research study will be provided to you by the hospitals of UPMC. Your insurance provider may be billed for the costs of this emergency treatment, but none of those costs will be charged directly to you. If your research-related injury requires medical care beyond this emergency treatment, you will be responsible for the costs of this follow-up care. At this time, there is no plan for any additional financial compensation. You do not, however, waive any legal rights by signing this form.
  • Include the following language if the research is NOT commercially sponsored and NOT conducted at Pitt or UPMC facilities:
    • If you believe you have been injured as a result of the procedures that are performed for research purposes, immediately contact the Principal Investigator or one of the researchers listed on the first page. Emergency medical treatment for injuries solely and directly related to your participation in this research study will be provided by UPMC hospitals. If you do not have access to a UPMC facility, you should seek emergency care from your local hospital and call the University of Pittsburgh Human Subject Protection Advocate (1-866-212-2668). It is possible that UPMC or our local hospital may bill your insurance provider for the costs of this emergency treatment, but none of these costs will be charged directly to you. If your research-related injury requires medical care beyond this emergency treatment, you will be responsible for the costs. At this time there is no plan for additional financial compensation. You do not, however, waive your legal rights by signing this form.
  • For research that is commercially sponsored and the protocol is provided by the sponsor, the sponsor should, at a minimum, provide adequate compensation for subject harm directly resulting from the research intervention that requires any emergency care. Some sponsors have plans for monetary compensation for non-emergency treatment, and, if they do, that additional compensation for harm should be included in the informed consent, but it is the responsibility of the investigator to ensure that the compensation for injury statement is consistent with the signed sponsor’s agreement. While some sponsors may not wish to provide any compensation for subject harm, the University of Pittsburgh will require, for studies involving its faculty or facilities, that sponsors at least provide emergency care.
    • The IRB will be provided a copy of the contract language related to subject injury from the University of Pittsburgh Office of Research in order to ensure consistency in the language.
  • This section may be omitted from certain minimal risk research studies (e.g., research limited to questionnaires/surveys) wherein injury associated with study participation is unlikely to occur.

22. VOLUNTARY PARTICIPATION:

  • Your participation in this research study is entirely voluntary. You may want to discuss this study with your family and friends and your personal physician before agreeing to participate. If there are any words you do not understand, feel free to ask us. The investigators will be available to answer your current and future questions.
  • Whether or not you provide your consent for participation in this research study will have no effect on your current or future relationship with the University of Pittsburgh. Whether or not you provide your consent for participation in this research study will have no effect on your current or future medical care at a UPMC hospital or affiliated health care provider or your current or future relationship with a health care insurance provider.
  • If the subject’s doctor is an investigator in the study include the following:
    • As both your doctor and a research investigator, s/he is interested both in your medical care and the conduct of this research study. Before agreeing to participate in this research study, or at any time during your study participation, you may discuss your care with another doctor who is not associated with this research study. You are not under any obligation to participate in any research study offered by your doctor.
  • If HIPAA applies to the study, include this language:
    • To formally withdraw your consent for participation in this research study you should provide a written and dated notice of this decision to the principal investigator of this research study at the address listed on the first page of this form.

23. RIGHT TO WITHDRAW:

  • Do not include statements that mandate that subjects who desire to withdraw from study participation must complete certain study withdrawal procedures.
    • Address other study termination requests such as the return of unused study drug or supplies
    • Specify possible reasons why a subject may be withdrawn from study participation by the investigators
    • Indicate what steps will be taken to ensure the subject’s safety upon his/her termination from study participation
    • Indicate the steps that will be taken with regard to continued treatment of the subject’s disease or condition should s/he be withdrawn from study participation

24. CONSENT TO PARTICIPATE:

  • Include the following statement or a closely related version:
    • The above information has been explained to me and all of my current questions have been answered. I understand that I am encouraged to ask questions, voice concerns or complaints about any aspect of this research study during the course of this study, and that such future questions, concerns or complaints will be answered by a qualified individual or by the investigator(s) listed on the first page of this consent document at the telephone number(s) given.
    • I understand that I may always request that my questions, concerns or complaints be addressed by a listed investigator. I understand that I may contact the Human Subjects Protection Advocate of the IRB Office, University of Pittsburgh (1-866-212-2668) to discuss problems, concerns, and questions; obtain information; offer input; or discuss situations that occurred during my participation. By signing this form I agree to participate in this research study. A copy of this consent form will be given to me.

25. VERIFICATION OF EXPLANATION: This section should be utilized in the event that subjects are unable to provide direct consent for study participation such as in studies involving children or an adult with decisional impairment.

I certify that I have carefully explained the purpose and nature of this research study to the above-named participant in appropriate language. He/she has had an opportunity to discuss it with me in detail. I have answered all his/her questions and he/she has provided affirmative agreement (i.e., assent) to participate in this study.
______________________________            __________________
Investigator’s Signature                                Date (Time if placed in medical record)

26. INVESTIGATOR CERTIFICATION:

I certify that I have explained the nature and purpose of this research study to the above-named individual(s), and I have discussed the potential benefits and possible risks of study participation. Any questions the individual(s) have about this study have been answered, and we will always be available to address future questions, concerns or complaints as they arise. I further certify that no research component of this protocol was begun until after this consent form was signed.
___________________________________        ________________________
Printed Name of Person Obtaining Consent          Role in Research Study
_________________________________            ____________
Signature of Person Obtaining Consent                Date (Time if placed in medical record)