This template is adapted from the template made available by CTN Best Practices and can be found at ctnbestpractices.org.

Key

(MAN) = Mandatory—must appear verbatim

(VAR) = Variation—concept must appear, using verbatim or variation of wording

(I/A) = If Appropriate—use if appropriate for this specific study (verbatim or variation)

Remember

Delete all instructions before printing your final form.

Delete Readability Assessment Scores: Passive Sentences, Flesch Reading Ease, Flesch-Kincaid Reading Grade Level. See The Center for Health Studies Readability Toolkitat for a detailed explanation of how to evaluate readability. These paragraphs were evaluated with some instructions included and without study specific information. Therefore the readability scores indicated will vary once correct information is added.

Consent for Research Template

Title of Project: (complete title of the project as it appears on the protocol and abstract)

Principal Investigator: (only one person may be named as principal investigator)

Other Investigators:

Participant’s Printed Name:

(MAN) This is a research study. Research studies include only people who want to take part. This form gives you information about this research, which will be discussed with you. It may contain words or procedures that you donot understand. Please ask questions about anything that is unclear to you. Discuss it with your family and friends and take your time to make your decision.

Passive Sentences 16%

Flesch Reading Ease 65.6

Flesch-Kincaid Reading Grade Level 6.7

1. Purpose of the Research

  • Briefly summarize the purpose.
  • Indicate the FDA status of any drugs or devices that are being tested in the research.
  • Indicate the approximate anticipated enrollment at [institution]and studywideunless these numbersare not important to a decision to take part in the research.

(VAR)You are being offered the opportunity to take part in this research because [state why the participant was selected, e.g., disease diagnosis or healthy volunteer].

Passive Sentences 100%

Flesch Reading Ease 32.5

Flesch-Kincaid Reading Grade Level 12

(VAR)This research is being done to find out or The purpose of this research is toor The purpose of this research is to obtain information on the safety and effectiveness of [name of drug, device, etc.].

Passive Sentences 100%

Flesch Reading Ease 48

Flesch-Kincaid Reading Grade Level 12

(VAR)Approximately [number] people will take part in this research [nationwide or worldwide] and about [number] people are expected to take part at the [institution].

2. Procedures to Be Followed

  • Outline the procedures in lay terms in order of occurrence.
  • Be sure to include:
  • screening procedures that occur after signing the consent form
  • treatment assignment/randomization
  • procedures during treatment
  • final visit and follow-up
  • Use lists, tables or flow charts whenever possible.
  • Identify all drugs (dose, frequency, and route of administration), devices, and procedures that are experimental or that are used in an experimental manner. Include what is approved by the FDA and what is not.
  • Indicate which are standard procedures (standard of care) versus research procedures. Identify any procedures which are experimental.
  • Indicate whether the research will include any hospitalizations or outpatient clinic visits.
  • If the research involves blood collection, indicate how often and if any special preparation is required (e.g., fasting). Common blood and urine tests should be described as “common blood tests to determine your health status.” List any tests that are out of the ordinary for the specific condition being studied in the research.
  • If applicable, describe randomization procedures, probability for random assignment to each treatment, double-blinds, emergency unblinding, and use of placebo in lay terms.
  • If the study involves surveys or questionnaires, include a statement that the subject is free to skip any questions that he/she would prefer not to answer.
  • If the research involves a screening visit and includes tests or procedures that would not be done for clinical purposes, then consent must be obtained prior to the screening visit. Avoid wording such as “After the screening visit, if you are eligible to participate in the study, you will …” Rather, use wording such as “After the screening visit, if you are eligible to continue in the study, you will …” or “…if you are eligible to receive the study treatment, you will …”
  • Include what willhappen to any research specimens once the research is completed.

3. Discomforts and Risks:

  • Use lay terms for the risks and discomforts for each procedure and/or drug.
  • If possible, group the risks into categories such as expected, occasional, or rare and quantify these categories (e.g., 5 of 100 people who receive the drug).
  • Be sure to list all side effects.
  • The use of lists or a table format is strongly recommended.
  • Include risks of procedures that are done as part of follow-up that are not standard of care.
  • If addressing risks for standard-of-care procedures, identify these as “risks you would have with or without the research.”
  • If relevant, address the potential risks and precautions related to becoming pregnant or fathering a child.
  • If the risk profile or any research-related interventions is not well known or the research involves investigational drugs or devices, include a statement that the particular treatment or procedure may involve risks to the participant (or to the embryo or fetus, if the participant is or may become pregnant) that are currently unforeseeable.
  • If the research includes women of child bearing potential or pregnant women, and the risk profile of any research interventions or interactions on embryos and fetuses is not well known, include a statement that the particular treatment or procedure may involve risks to the embryo or fetus, if the participant is or may become pregnant, which are currently unforeseeable.

4. Possible Benefits:

a. Possible benefits to the participant:

(VAR)(For clinical research studies where direct benefit is possible) The possible benefit you may experience from the [research drug/device/procedure] described in this research includes [list any benefits that may be reasonably expected]. There is no guarantee that you will benefit from being in this research.

Passive Sentences 0%

Flesch Reading Ease 40.6

Flesch-Kincaid Reading Grade Level 12

(VAR)(For research with no direct benefit)You will not benefit from taking part in this research study.

Passive Sentences 0%

Flesch Reading Ease 72.6

Flesch-Kincaid Reading Grade Level 5.8

b. Possible benefits to others:

  • Address potential benefits to others (e.g., “The results of this research may guide the future treatment of… ” or “Medical science may gain further understanding of… ”).

5. Other Options that Could be Used Instead of this Research:

  • Clarify that the potential participant may decline to participate in the research.
  • Indicate if the research treatment(s) can be obtained without enrolling in the research.
  • List other alternative procedures or treatments, if any,that might be reasonable such as the standard of care and/or other research and/or the choice to receive supportive care. If applicable, include the important benefits and risks of these options.

(VAR)(If there are no alternative treatments)You do not have to take part in this research study.

Passive Sentences 0%

Flesch Reading Ease 95.6

Flesch-Kincaid Reading Grade Level 2.6

(VAR)(If there are alternative treatments)Instead of participating in this research, you could: [list alternatives] (If applicable) At this time you may choose to receive only supportive care to make you more comfortable instead of therapy. Before you decide whether or not to be in this research, your doctor will discuss the other options that are available to you and will tell you about the potential benefits and risks of these options.

Passive Sentences 0%

Flesch Reading Ease 39.7

Flesch-Kincaid Reading Grade Level 12

(VAR)(Explain whether or not the research therapy can be obtained off-study)The therapy offered in this research is available to you without taking part in this research study. OR Because it is experimental, the therapy offered in this research is only available to you if you take part in the research study.

Passive Sentences 0%

Flesch Reading Ease 45.7

Flesch-Kincaid Reading Grade Level 11.9

6. Time Duration of the Procedures and Study:

  • Explain the time commitment (i.e., time to complete questionnaires, duration of clinic visits, etc.).
  • Indicate the expected duration of the participant’s participation in the research (e.g. 10 weeks, 2 years, 10 weeks of therapy and follow-up contacts for the rest of your life).
  • If more than one visit or contact is involved in the study, give the total number of visits, approximate length of time for each visit, and length of time in between each visit.
  • If the study involves long-term follow-up, remember to include how long the subject will be followed, even if follow-up is based solely on clinical chart information with no direct subject contact.

(VAR)(For studies with time commitment for participants)If you agree to take part in this study, your involvement will last approximately [give length of time of participation]. You will be asked to return to the clinic ____ times. Each clinic visit will take approximately ____ minutes.

Passive Sentences 33%

Flesch Reading Ease 50.2

Flesch-Kincaid Reading Grade Level 9.3

(VAR)(For studies with no time commitment for participants)Participation in this study does not require any additional time on your part.

Passive Sentences 0%

Flesch Reading Ease 43.9

Flesch-Kincaid Reading Grade Level 10

7. Statement of Confidentiality:

a. Privacy and confidentiality measures

  • Explain how research data and/or tissue samples will be labeled and stored.
  • Include information about a Certificate of Confidentiality if applicable.
  • Explain how any video, audio recording or photographs are labeled and secured, who has access to these materials and when they will be destroyed.
  • The TMHAdministrative Policy and Procedure 40-6 must also be followed and the associated forms completed.

(VAR) Your research records that are reviewed, stored, and analyzed at [Institution] will be kept in a secured area in (list where records are stored). (Include the following if specimens are collected for research purposes.)Your samples collected for research purposes will be labeled with (list all that apply: a code number, your initials, etc.) and will be stored (list where the samples will be stored and how they are secured).

Passive Sentences 100%

Flesch Reading Ease 66.3

Flesch-Kincaid Reading Grade Level 8.4

(VAR)(For research records/samples that are sent outside of [Institution], describe methods that will be used to ensure confidentiality. If records and specimens are sent to different entities or labeled differently, describe their confidentiality measures separately)For research records [and specimens] sent to (outside entity), you will not be identified by name, social security number, address or phone number. The records [and specimens] may include (list all that apply: a code number, your initials, date of birth, etc.). The list that matches your name with the code number will be kept in a locked file in[note location, such as PI’s office].

Passive Sentences 33%

Flesch Reading Ease 68.3

Flesch-Kincaid Reading Grade Level 7.2

Or

For research records [and specimens] sent to (outside entity), you will be identified by (list all that apply: name, social security number, address, phone number, date of birth, [any other direct personal identifier], code number). The list that matches your name with the code number will be kept in a locked file in [note location, such as PI’s office].

(Remember to include separate descriptions for records and specimens if they are labeled differently or stored differently or sent to separate entities.)

Passive Sentences 0%

Flesch Reading Ease 66.4

Flesch-Kincaid Reading Grade Level 11.4

The following statement is MANDATORY FOR ALL RESEARCH STUDIES

(MAN)In the event of any publication or presentation resulting from the research, no personally identifiable information will be shared.

Passive Sentences 100%

Flesch Reading Ease 4.9

Flesch-Kincaid Reading Grade Level 12

The following statement is for those studies that do not include section 7b.

(MAN only for those studies that do not include section 7b.)We will keep your participation in this research study confidential to the extent permitted by law. However, it is possible that other people may become aware of your participation in this study. For example, the following people/groups may inspect and copy records pertaining to this research.

Passive Sentences 0%

Flesch Reading Ease 34.3

Flesch-Kincaid Reading Grade Level 12

  • The Office of Human Research Protections in the U. S. Department of Health and Human Services (for drug/device studies, add the U.S. Food and Drug Administration and the sponsor
  • The Institutional Review Board at Tallahassee Memorial HealthCare, Inc.(a committee that reviews and approves research studies),[Institution] and
  • The [Institution] Human Subjects Protection Office

Passive Sentences 0%

Flesch Reading Ease 36.8

Flesch-Kincaid Reading Grade Level 12

Some of these records could contain information that personally identifies you. Reasonable efforts will be made to keep the personal information in your research record private and confidential but absolute confidentiality cannot be guaranteed.

Passive Sentences 50%

Flesch Reading Ease 5.4

Flesch-Kincaid Reading Grade Level 12

7b. The use of private health information:

  • Section 7b is mandatory if the research creates, obtains, uses, and/or discloses identifiablehealth information about the research participants. (The 18 identifiers are listed under HIPAA.)
  • Do not include any part of Section 7b unless the research fits the above criteria.

(VAR)Health information about you will be collected if you choose to be part of this research study. Health information is protected by law as explained in the [Institution not TMH] Privacy Notice. If you have not received this notice, please request a copy from the researcher. At[Institution not TMH] your information will only be used or shared as explained and authorized in this consent form or when required by law. It is possible that some of the other people/groups who receive your health information may not be required by Federal privacy laws to protect your information and may share it without your permission.

Passive Sentences 60%

Flesch Reading Ease 49.7

Flesch-Kincaid Reading Grade Level 11.3

(VAR)To participate in this research you must allow the research team to use your health information. If you do not want us to use your protected health information, you may not participate in this research.(When specific therapy is only available through the research, include these sentences: The research-related therapy is investigational; therefore, it is not available unless you allow the use of your health information that is collected during this research study.)

Passive Sentences 33%

Flesch Reading Ease 42.9

Flesch-Kincaid Reading Grade Level 11

(I/A)(For blinded studies)People usually have a right to access their medical records. However, while the research is in progress, you may not be allowed to see or copy certain information that is related to this research study. This is only for the period of the research. You will be allowed to see that information when the entire research project is complete.

Passive Sentences 50%

Flesch Reading Ease 52.7

Flesch-Kincaid Reading Grade Level 9.5

(VAR)Your permission for the use, retention, and sharing of your identifiable health information will (Describe the date or event that will trigger the expiration of this authorization (e.g., “expire upon completion of the research study” or “expire when FDA approval of the study drug is obtained” or “will continue for the period of time necessary for the preparation of a related follow-up research study” or “continue indefinitely” or “will continue until the sponsor notifies the investigator that the information is no longer needed.” ).)At that time the research information not already in your medical record will be destroyed (or “will be retained until ___ in order to ___” or “information identifying you will be removed from such research results at [Institution]”). Any research information in your medical record will be kept indefinitely.

Passive Sentences 0%

Flesch Reading Ease 7.6

Flesch-Kincaid Reading Grade Level 12

(MAN)If you choose to participate, you are free to withdraw your permission for the use and sharing of your health information (if applicable, add: and your samples)at any time. You must do this in writing. Write to Dr. [PI] and let [him/her] know that you are withdrawing from the research study. [His/Her] mailing address is [address].

Passive Sentences 0%

Flesch Reading Ease 69.5

Flesch-Kincaid Reading Grade Level 6.5

(MAN)If you withdraw your permission:

  • We will no longer use or share medical information about you (if applicable, add the following)[or your samples] for this research study, except when the law allows us to do so.
  • We are unable to take back anything we have already done or any information we have already shared with your permission.
  • We may continue using and sharing the information obtained prior to your withdrawal if it is necessary for the soundness of the overall research.
  • We will keep our records of the care that we provided to you as long as the law requires.

Passive Sentences 0%

Flesch Reading Ease 51.1

Flesch-Kincaid Reading Grade Level 12

(VAR)The research team may use the following sources of health information.(Use list format, NOT text format)

Passive Sentences 0%

Flesch Reading Ease 64.9

Flesch-Kincaid Reading Grade Level 6.9

  • (List any and all medical information collected from or about the participant in connection with this research study, e.g. blood and other tissue samples and related tests, your medical history as it relates to the research study, x-rays, MRIs, questionnaires, etc.)
  • Indicate the span of time from which the records are pulled, e.g., “since your diabetes was diagnosed”, “the last five years”, “only during the time span of the research study”.)

(MAN)Representatives of the following people/groups within [Institution] may use your health information and share it with other specific groups in connection with this research study.