The purpose of this document is to assist investigators and research personnel in drafting language for consent documents. The instructions are in blue and suggested language is in black. 

*Typically not relevant for exempt studies.

Study Activities

*Placebo:  We may give you a placebo during this study.  A placebo is a neutral ingredient. 

Randomization:  This study involves a process called randomization.  Randomization means that you are put into one of the groups by chance.  It is like flipping a coin {modify if more than two groups (e.g., like drawing names from a hat.} .   Neither you nor the people doing the study will choose what group you will be in. You will have a {insert chance – equal, one in three, etc.} chance of being placed in any group. 

*Blood draws:  We will draw about {insert teaspoons/tablespoons and cc} of blood by putting a needle into a vein in your arm. This is the standard method used to obtain blood for tests.  If more than one draw will occur insert the following sentence:   We will take a total of {insert teaspoons/tablespoons and cc} of blood over the course of this study.

*Significant new findings: If applicable, insert a statement that significant new findings developed during the course of the research which may relate to the subject's willingness to continue participation will be provided to the subject.

Storage and Future use of data or samples: If you plan to store samples, explain how long they will be retained (i.e., indefinitely, five years, destroyed when the study is completed), how they will be stored (i.e., with or without identifiers), what they will be used for, and whether subject permission will be sought for future studies.

Sample language for biological samples: We may store your {blood, urine, saliva, etc.} sample indefinitely.  Because it is not possible for us to know what studies may be a part of our future work, we ask that you give permission now for us to use your sample without being contacted about each future study.   Future use of your sample will be limited to studies about {insert appropriate disease, condition, or specific field of study}.   We will not pay you for the use of your sample or any products, patents, or licenses that result from these samples.  If you agree now to future use of your samples, but decide in the future that you would like to have them removed from research tests, please contact {name and contact information for PI}.  

Sample language for data: Because it is not possible for us to know what studies may be a part of our future work, we ask that you give permission now for us to use your personal information without being contacted about each future study.  Future use of your information will be limited to studies about {insert appropriate disease, condition, or specific field of study}.   If you agree now to future use of your personal information, but decide in the future that you would like to have your personal information removed from the research database, please contact {name and contact information for PI}.   If identifiable information will be destroyed prior to the destruction of the data, insert the following statement: We will be destroying all identifying information {insert timeline for destruction of identifiers}. Once the identifying information is destroyed, we will not be able to remove your information from the larger dataset.


*Certificate of Confidentiality: When a researcher obtains a Certificate of Confidentiality, the subjects must be told about protections afforded by the Certificate and any exceptions to those protections - i.e., the circumstances in which the investigators plan to disclose, voluntarily, identifying information about research participants (e.g., child abuse, harm to self or others, etc.). This information should be included in the consent form.  The researchers should eliminate provisions in the consent form template that may be inconsistent with the Certificate protections (such as references to disclosures required by law, since the Certificate enables researchers to resist disclosures that would otherwise be compelled by law).  Researchers may not represent the Certificate as an endorsement of the research project by the DHHS.

If your study involves highly sensitive information, and you have obtained, or plan to obtain a Certificate of Confidentiality, insert the following paragraph:

To help us protect your privacy, we have obtained a Certificate of Confidentiality from the National Institutes of Health (NIH). Under some circumstances, this Certificate may help researchers to resist demands for information that would identify you.  The Certificate cannot be used to resist a demand for information from the U.S. Government that is used for auditing or evaluation of federally funded projects.

*Studies which may reveal violence, abuse, neglect, or self-inflicted injury: Under Oregon law, researchers are required to report to the appropriate authorities any information concerning child abuse or neglect. The researchers may also report threats of harm to self or to others. 

*Genetic Research:

Sample language: Participation in this study may indicate that you are a carrier of the specific gene under study.  The results of the genetic analysis performed for purposes of this research study will not appear in your medical record.  We will not release information about you unless you authorize us to do so or unless we are required to do so by law.  However, if you tell your family doctor about participating in this study, this information may then become part of your medical record.  Insurance companies commonly have access to medical records.

A Federal law called the Genetic Information Nondiscrimination Act (GINA), makes it illegal for health insurance companies, group health plans, and most employers to discriminate against you based on your genetic information.  

This law does not protect you against genetic discrimination by companies that sell life insurance, disability insurance, or long-term care insurance.  GINA also does not protect you against discrimination if you have already been diagnosed with the genetic condition being tested.

We will make every effort to protect your identity but there is a risk that information which identifies you could be accidentally disclosed. 

Additional information which may be provided includes whether or not participants have the option of knowing the results of their genetic analysis, whether incidental findings will be shared with subjects, whether or not genetic counseling would be available and who would pay for such counseling.

Recruiting from the Center for Healthy Aging Research (CHAR) LIFE Registry: CHAR requires that researchers who recruit from the LIFE Registry provide them with a list of participants who were recruited from the Registry. If participants will be recruited from the Registry, please insert the following paragraph:

If we contacted you through the Center for Healthy Aging Research (CHAR) LIFE Registry, we will be providing CHAR with any updates to your contact information. We will also tell them whether or not you chose to participate in this research study.


Required vs Optional questions: If the study involves interviews, surveys, or questionnaires, with optional questions, include a statement that the participant is free to skip any questions that he/she would prefer not to answer.  If answering all questions is required, clearly state that while study participation is voluntary, all questions must be answered in order for their individual responses to be included in the study results.

Participation terminated by investigator: If there are any circumstances under which a subject's participation may be terminated by the investigator without regard to the subject's consent, please describe them here (e.g., subject does not come in for critical visits or does not follow instructions for study activities, etc.

Research during class time: If study activities take place during class time, explain what participants will do during that time if they choose not to participate.

*Prisoners:  Choosing to take part or choosing not to take part in this study will not impact the length of your sentence, your parole, or any other aspect of your incarceration.

Students: If students will be enrolled, insert the following statement: Your decision to take part or not take part in this study will not affect your grades, your relationship with your professors, or standing in the University.

Employees: Your decision to take part or not take part in this study will not affect your job.

When the researchers have a pre-existing relationship with potential participants: Your decision to take part or not take part in this study will not affect your relationship with the researcher.


*Breach of Confidentiality:  There is a chance that we could accidentally disclose information that identifies you.

*Focus Groups: We will ask members of the focus group to maintain the confidentiality of comments made during the discussion.  However, there is still a risk that comments you make during the discussion may be shared outside of the group.

*Unforeseeable risks: There may be risks related to the study procedures that are not yet known to the researchers.

*Internet and/or email:  The security and confidentiality of information collected from you online cannot be guaranteed.  Confidentiality will be kept to the extent permitted by the technology being used.  Information collected online can be intercepted, corrupted, lost, destroyed, arrive late or incomplete, or contain viruses. 

*Pregnancy: Insert explanation of any study activities that may involve risks to the subject, or to an embryo or fetus if the subject is or may become pregnant.

Sample language: If you are a woman of childbearing potential, we will do a pregnancy test before {describe the testing or intervention method}. This study involves activities that are not safe for pregnant women. – AND/OR – There may be a risk of harm to an unborn child.  You must use an effective form of pregnancy prevention while you are enrolled in this study.  We will discuss the risk with you in more detail.  Notify the study team immediately if you think or know that you have become pregnant during the course of this study.

*Studies involving radiation exposure: Describe the equipment that will be used, how much radiation dose subjects will receive for each set of scans performed and for the cumulative dose from the study using mrems and a lay comparison.

*Pregnancy and studies involving radiation exposure:  If you are a woman, you may not participate in {the aspect of the study causing the radiation exposure/bone scan} if you are pregnant or suspect you may be pregnant.   If you are a woman of childbearing potential, {the aspect of the study causing the radiation exposure/bone scan} must be performed within the first few days of the beginning of your last menses to reduce the risk of performing the scan on a developing embryo.  Notify the study team immediately if you think or know that you have become pregnant during the course of this study.

*Blood draws: The risks of having blood drawn from your arm include some pain when the needle goes in and a small risk of bruising and/or infection at that site.  Some people get lightheaded, nauseous, or faint.  You are less likely to have these problems if you drink at least 2 glasses of water and have a snack before the blood draw{Modify for fasting draws}.  The American Red Cross recommends that you do not donate more than 1 pint (32 tablespoons) of blood within a 2 month period.  Tell the study team if you have recently had your blood drawn for any reason.

*VO2max Testing

  • Acute exercise may present a risk of sudden death
  • Cardiovascular event (i.e., heart attack or cardiac arrhythmia)
    • Overall risk of cardiac events is about 6 events per 10,000 tests
  • Serious injury
  • Falling
  • Physical discomfort from the test and equipment
  • Fatigue
  • Muscle aches, cramps, joint pain
  • Muscle strain and/or joint injury
  • Delayed muscle soreness
  • Abnormal blood pressure/heart rate
  • Shortness of breath
  • Lightheadedness, fainting
  • Dizziness
  • Nausea