Submit Consent Documents in Microsoft WordONLY
Leave blank for IRB Office Use. / IRB Office Use Only:
Approval Date:
Approved Consent IRB Version No.:
PI Name:
IRB No.

INSTRUCTIONS FOR DRAFTING A CONSENT/AUTHORIZATION FORM FOR

STUDIES BASED IN A U.S. COVERED ENTITY

This consent/authorization 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, children, parents, teachers, etc. Label your document clearly with the identity of the person who will be providing consent or assent for the study.
  • If your study involves study drugs, consider taking out the drug risks from the consent form and describing them on a separate form.
  • 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; if you are not enrolling children, delete the parental signature lines.
  • Use good document control practices to identify your document and its current version.

JOHNS HOPKINS BLOOMBERG SCHOOL OF PUBLIC HEALTH

INFORMED CONSENT/HIPAA AUTHORIZATION INSTRUCTIONAL TEMPLATE FOR STUDIES IN U.S. COVERED ENTITIES

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….”
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.
  • If HIV or Hepatitis testing will be performed, provide language appropriate to the site. For example, if the testing will take place in Maryland, provide the following:
“As part of the study, you will be tested for HIV virus (the virus that causes AIDS). You will be given a separate State of Maryland HIV consent form as part of that process. It means that you will need further testing, and you will receive counseling. The law requires us to report positive tests to the health department.”

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
(For studies using Privacy Authorization language in the section below, be alert for redundancies.)
  • 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.
For U.S. based, NIH funded studies, that collect personal identifiers, insert the following Certificate of Confidentiality language:
Your study informationis protected by a Certificate of Confidentiality. This Certificate allows us, in some cases, to refuse to give out your informationeven if requestedusinglegalmeans.
It does not protect information thatwe have toreportby law, such as child abuse or some infectious diseases.The Certificate does not prevent us from disclosing your informationif we learn of possible harm to yourself or others, or if you need medical help.
Disclosures that you consent to in this document are not protected.This includes putting research data in the medical record orsharing research datafor this study or future research.Disclosures that you make yourself are also not 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. If you are recruiting participants from Johns Hopkins Hospital or affiliates, and your study procedures include billable clinical services, you may need to submit your study through the SOM IRB. Contact the JHSPH IRB Directorto discuss.

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.

Conflict of Interest

A conflict of interest occurs when a researcher or the University has a financial or other interest that might affect the researcher’s judgment when conducting a research study. In some situations, the results of a study might lead to a financial gain for the investigator(s) and/or Johns Hopkins. All such conflicts must be disclosed to the COI Committee.
  • Insert language as suggested by the JHSPH Conflict of Interest Committee.

Payment of treatment costs for injury or illness from study participation

For studies involving a clinical intervention or services at a Johns Hopkins facility, follow the language included in the SOM IRB consent template. Submit to the SOM IRB (contact the IRB Director for information) (). For other studies, explain what, if any, provisions are made for care of participants injured or ill from study participation.

Clinical Trial Registration

For U.S. investigational drug/device trials, you must insert the following language for any “applicable clinical trial”, see information at . Other clinical trials not mandated to be listed may be registered on clinicaltrials.gov.

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.

Authorization for Disclosure of Protected Health Information for Research

For U.S. based studies enrolling participants from “covered entities”, you must insert the following language if a HIPAA Authorization is required.