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INSTRUCTIONS FOR DRAFTING A CONSENT FORM FOR ADULTS

FOR STUDIES IN THE U.S. AND INTERNATIONAL SETTINGS

This consent form template provides sample language for you to use. This is a Word Document; remove this instruction page and boxes after completing your form. As you draft the form, consider the following tips:

  • Use simple words and short sentences. It’s easier for participants to digest single concepts than multiple concepts in a string. Itemizing using bullet points or tables may also be helpful.
  • Think about what you, or one of your family members, would like to know if he or she considered joining the study.
  • If you have multiple types of participants, consider drafting a consent form (or assent form for minors) that directly addresses each of their roles in the study. For example, there may be participants, participant’s caretakers, teachers, etc. Label your document clearly with the identity of the person who will be providing consent for the study.
  • Complete all the sections that are mandatory, and select the sections from the “Optional” part of the form that are also appropriate to include.
  • To use the template, compose your own language and start typing below the section header. Remove the shaded instruction box by highlighting the box, including the line above it, and pressing delete.

Include mandatory sections highlighted in blue

Add relevant optional sections highlighted in gray

  • Review signature lines to make sure they match the context of your study. If you are not enrolling adults who lack capacity to provide informed consent, delete the “LAR” lines.
  • Be sure to provide the contact information of the local PI and local IRB for participants in the event of problems or concerns. If the study requires medical oversight, include the name of the clinician who will be available for calls from participants.
  • Use good document control practices to identify your document and its current version.
  • Delete this page, the instructions in the following pages, and the descriptive title to the form at the top of the next page.

JOHNS HOPKINS BLOOMBERG SCHOOL OF PUBLIC HEALTH

INFORMED CONSENT INSTRUCTIONAL TEMPLATE FOR INTERNATIONAL STUDIES

Insert Description of Consent form byParticipant Who Will Sign: “Adult”, “Caregiver”, “Provider”, Teacher, Parent, etc.

Study Title:

Principal Investigator:

IRB No.:

PI Version Date:

What you should know about this study

  • You are being asked to join a research study.
  • This consent form explains the research study and your part in the study.
  • Please read it carefully and take as much time as you need.
  • You are a volunteer. You maychoose not to take part at all, and if you join, you may quit at any time. There will be no penalty if you decide to quit the study.
  • During the study, we will tell you if we learn any new information that might affect whether you wish to continue to be in the study.

Purpose of research project

Start with an introductory sentence describing the primary aim of the study as stated in the research plan. “This research is being done to….” If your population is unlikely to understand the term “research” or “study”, use more appropriate language.
Explain what the study is designed to discover or establish. If this is a therapeutic study, describe how the study intervention is different from standard care. Identify any procedures, products or objectives that are experimental. If drugs or devices are unapproved by regulatory authorities, make that point clear.

Why we are asking you to participate

Describe the basic eligibility criteria for the study population and why you are asking the participant to join the study. “You are being asked to join this study because you….” You may include the approximate number of people expected to take part. If the study involves a screening procedure, explain that the screening will determine whether the participant will be eligible for the study intervention or interaction.

Study procedures

This section should explain to the subjects what will happen if they join the study. For example, “If you join this study, we will ask you to do the following things:…” Then, describe the procedures chronologically, using lay language and short sentences, or bullets and phrases. Keep paragraphs short. Make sure the procedures listed in the consent form are consistent with those in the research plan. If the procedures are lengthy, you may describe them generally here and attach a table or addendum to provide specific details.
  • Explain concepts like “randomization” using language like “flipping a coin”
  • Define and explain any medical or scientific terms in ordinary language, for example, use teaspoons instead of ml. as unit of measurement.
  • Specify the length of time for participation, frequency of procedures, and the location of the study intervention.
  • If placebo is used, clearly define what it is.
  • If participants must refrain from eating or taking medications, make that point clear.
  • If the participants must record information on diaries or electronic devices, make clear how often and what happens if the record is incomplete.
  • If applicable, explain whether study test results will be returned to the subject, and whether medical results will be provided to the subject’s health care provider. For contagious diseases, identify any regulatory reporting requirements of positive results.
  • If your study will include storing of samples for future research, use a separate consent form for that procedure. In it, explain who will store the specimens, for how long, how they might be used, and who may have access to the specimens, and under what conditions. Include any coding or other data security measures that will be taken to protect the identifiers.

Risks/discomforts

Identify each reasonably foreseeable risk (physical, psychological, social, economic, legal, emotional) to participants or to others that might result from participation in this study. If the study involves sensitive personal issues that, if disclosed, could expose the subjects to risk of legal, economic, emotional, or any other personal risk, acknowledge that risk. If there are medical interventions, describe the potential risks of morbidity and/or mortality for each type. All possible risks need not be included, but those that are serious and most likely should be. Include information about probability of the risk occurring and reversibility. Include steps that will mitigate the most likely and most serious risks.
  • For all studies that collect and record personal information, there is a risk of a breach of confidentiality. Be clear about what information will be kept confidential and what information will be shared with others.
  • Include a section on risks related to pregnancy, if applicable.
  • If you are drawing blood from a participant, include the risks related to blood draw: “Taking blood may cause discomfort, bleeding or bruising where the needle enters the body. In rare cases, it may cause fainting. There is a small risk of infection.”
  • If you are changing a participant’s care regimen, address possible risks or discomforts.
  • Include reasonably forseeable risks and discomforts, including anticipated severity and duration. Provide some language as to the relative probability of such risks occurring
(e.g., “likely”, “less likely”, or “unlikely”, and “rare but serious”, especially for clinical risks.)
  • If your study involves exposing research participants to radiation, include the appropriate consent form language provided in the guidance, “Radiation Risk Language in JHSPH Consent Forms.” Include a reference to the risk of radiation for pregnant women, if appropriate.

Benefits

  • State the direct personal benefits, or the possibility of direct personal benefits, that are available through participation in the research. A direct personal benefit is one that a person would not have ready access to outside of the study. If there are no direct personal benefits, state: “There is no direct benefit to you from being in the study”.
NOTE: Financial rewards that will be offered in exchange for participation should go under the “Payment” heading. Results of tests that are available to the subject outside of the study should not be included.
  • Describe the social, scientific, or community benefits that could accrue from the study.

Payment

For studies that do not offer any financial payment, indicate “There is no payment for participation.”
For studies that do offer some kind of payment or token of appreciation, clarify the amount of compensation or what the token will be, when it will be delivered, and whether there will be a change in payment if a study subject leaves the study early.

Data Sharing

Authorized Disclosure of Research Data
  • Explain what data sharing is permitted, including who may have access to the consent documents, including the sponsor, study monitors, or reviewing ethics committees and regulatory bodies who are charged with making sure the study is properly conducted. Make clear what, if any, clinical research data that will be put into a participant’s medical record and could be seen by medical personnel outside the study. If there are mandatory reporting requirements for diagnostic tests that report positive results for contagious disease, make sure the participants are aware of such mandated reports. Explain all other mandatory reporting requirements.
  • If data will be shared after the study, explain how they will be shared and with whom. “Sharing” includes posting de-identified data on a website the access to which is not under the study team’s control. Because some studies focus on specific populations, there is a risk of group harm if data are shared in an individually-de-identified form but the group is still identifiable. We take the position that it is permissible to share de-identified data for research purposes consistent with, or within the scope of, the original purpose expressed in the consent form used for the original data collection. Data sharing proposals beyond that scope should be submitted for review by the IRB. Data use agreements are strongly recommended.

Data Confidentiality

Protecting Data against Unauthorized Disclosure
All studies include the risk of a breach of confidentiality from unpermitted disclosure of identifiable information to unauthorized individuals. Explain how the risk of a breach of confidentiality will be minimized through protection of study data and use of good security practices. If relevant, explain how the identifiers associated with each subject’s data will be protected.

Add the following sections,if applicable

If none are applicable, skip to section titled, “Who do I call if I have questions or problems?”

Protecting your privacy during data collection

“Privacy” is the expectation of personal control over information about oneself or one’s family. Researchers have an obligation to respect and protect each participant’s right to privacy. If data collection involves asking people about personal matters in a public setting or activities that involve a potential invasion of personal privacy (e.g., a physical examination, a home visit, disclosure of personal information where other people may overhear) explain how you will protect the subject from embarrassment or invasion of personal or family privacy.

Your alternatives to joining the study

For studies that involve access to care, include a statement that the individual does not have to join the study, and if applicable, that “your care will not be affected by this decision.”
If other treatments are available to the subject outside the study, include this language:
“If you decide not to join this study, other options are available. You do not have to join this study to get care. You may access care outside the study <describe treatments.” If appropriate, state that the study team will provide referrals to the potential participant to help them obtain care outside the study.

Biological specimens

This provision should be included in all consent forms for studies which collect biological specimens as it establishes ownership of the data/specimens that will be used in the study. If you plan to store the specimens for future research, you may submit a separate biobank consent form or create a separate section for this consent form providing a future storage option. Include below the appropriate name for the biological material you will collect and use for the study.

The < insert specimen nameand data collected from you during this study are important to science. You will not own the < insert specimen name or data after you give it to the study. You will not receive any financial benefit from any product or idea created by the investigators using the data or materials collected from you. If we share your biospecimens with other researchers, we will use appropriate measures to protect your identity.

Cost of participation in the study

If the study provides medical care, clarify whether the cost of that care will be provided by the study or is the responsibility of the subject and the subject’s health care insurer. Beyond the care costs, identify any foreseeable additional costs that the participants may incur, such as loss of wages or transportation costs

What happens if you leave the study early?

A participant may leave a study early either because it is his or her choice, or it is the decision of the PI and/or the sponsor. For example, a participant may no longer meet study eligibility criteria, or may not be compliant with study procedures. Make clear the kind of foreseeable situations that could lead to a participant’s withdrawal from the study and the consequences. If a participant is excused by the PI, the reasons for that decision should be explained to the participant with information about any follow-up or referrals for care. Explain whether data collected prior to study departure will continue to be used.

Genomic Data Sharing/Genome-Wise Association Studies

For studies that propose collecting biospecimens and using them for genetic/genomic analysis with participation in a genome-wide association study database, it is important to explain what this means. For NIH Genomic Data Sharing Studies and other NIH funded studies, the language below is suggested.

What is Genomic Data Sharing?

Genomic studies, including genome-wide association studies (GWAS), examine genetic differences in the entire human genome (the complete set of human genes) and the association between these genetic differences and health conditions. As part of this study, we will collect information about your health and your individual genes. This information will be sent to a National Institutes of Health (NIH) - designated data repository that includes all kinds of genomic data from studies funded by the NIH. Combining these data from many studies makes more powerful research possible.

The aim of collecting this information is to look for genetic connections that:

  • may increase the likelihood of getting a certain disease (such as asthma, cancer, diabetes, heart disease or mental illness) or a condition (such as high blood pressure or obesity)
  • may affect the progress of a certain disease or condition
  • may affect treatments (medicines, etc.) that work for certain diseases in some people, but not in others.

We will remove direct identifiers (such as your name) and instead code your information before sending it to the repository. NIH will never get this code or the identifiers we have removed.

The repository is a controlled-access repository. Controlled-access data is only available to researchers and companies who apply to the NIH.

The NIH will review data requests for scientific merit and for methods to protect data and methods to ensure data will be used for the approved purpose. We will not know what types of health-related research will be done with the data that are sent to the repository.

What are the risks to your privacy?

There may be risks to your privacy and the privacy of your relatives from storing your information in the repository. Although the NIH takes measures to protect privacy, we do not know how likely it is that your identity could become re-connected with your genetic and health information. If your genetic information were re-identified, personal information about you, your health and your risk of disease could become known to others. This could present unknown risks. Current federal law will help protect you from genetic discrimination in health insurance and employment.

Are there benefits to sharing your genetic information?

There is no direct benefit to you from placing your genetic information in the repository. Allowing researchers to study your genetic information may lead to a better understanding of how genes affect health. This may help other people in the future.