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IRB Consent Process

A major component of any proposal is the method by which the researchers will obtain voluntary and informed consent from subjects. Informed consent is a process, not just a form. Information must be presented to enable persons to voluntarily decide whether or not to participate as a research subject. The procedures used in obtaining informed consent should be designed to educate the subject population in terms that they can understand.

In seeking informed consent the following information should be provided to the subject:
1. A statement that the study involves research, an explanation of the purposes of the research and who will be conducting the research, expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental;
2. A description of any reasonably foreseeable risks or discomforts to the subject (again, these may be emotional or psychological or social or financial in addition to physical risks);
3. A description of any benefits to the subject or to others which may reasonably be expected from the research;
4. A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;
5. A description of how the confidentiality of records identifying the subject will be maintained;
6. For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained;
7. An explanation of whom to contact for answers to pertinent questions about the research (usually the investigators), research subjects' rights (usually the IRB Administrator), and whom to contact in the event of a research-related injury to the subject (usually the IRB Administrator);
8. A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.
When appropriate, one or more of the following elements should also be provided to each subject:
1. A statement that a particular treatment or procedure may involve risks to the subject (or the embryo or fetus, if the subject is or may become pregnant) which are currently unforeseeable;
2. Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent;
3. Any additional costs to the subject that may result from participation in the research;
4. The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject;
5. 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; and
6. The approximate number of subjects involved in the study.

Copies of signed consent forms must be retained for three years after completion of the research and must be available for IRB review if necessary.

IRB Cooperative Research Verification
The revised Common Rule [45 CFR 46.115(b)] allows for U.S. institutions engaged in cooperative research to rely upon approval from a single IRB. Each institution is responsible for safeguarding the rights and welfare of human subjects and for complying with policy. One institution will be responsible for submission to appropriate IRB and maintenance of IRB records for the cooperative research. If you are engaged in a cooperative research project that has obtained IRB permission from another institution’s IRB, you are required to submit the IRB Cooperative Research Verification form in addition to the cover sheet only to the MSUM IRB via IRBNet.

Developing consent forms and consent

Example Forms & Letters

It is your job as a researcher to make sure that each person thinking about being in your study has the information necessary to make an appropriate decision about participation. You may have struggled with a number of ways to speak to each participant in a language that they can understand. The consent process becomes informed when risks and benefits are known and when purposes are clear prior to making a decision about participation.

"When in doubt.......Inform"
Consent must be documented in some way. Written consent forms are most frequently used with adult participants. Written forms are signed by the participant and dated. A copy of the consent form should be given to the participant. If your study includes persons under the age of 18 you must receive documented approval from the parent or guardian of the child. The document you write is called a "Parental Permission Form". The form includes all the elements of an adult's consent form. Additionally, you must tell the children about the study and their rights. If this is done in writing, the form should be labeled "Assent Form." Keep the language simple and the idea paramount.

Tell about Your Research
Make a clear statement that you plan to do research. List the objectives of your study and a short description of your methods. Remember to keep the statements free of words that are long and complex.

Tell about the right not to be in the study
Make a clear statement that people have the right not to participate in the study. Continue by telling them that they have the right to withdraw at any time for any reason. Let the participants know that withdrawal from the study will not effect any benefits that would normally come to expect from you or the University.

Tell about what it means to take part in the study.
It is important to tell the participant about the estimated time involved to participate, the number of participants in the study, and the procedures to be done. This information will help participants understand what to expect.

In simple non-technical language, tell which parts of the study are experimental, and if there are alternatives to these procedures.

What are the risks of being in the study?
Every study has some form of risk to it even though the risks may be unforeseen and remote. List the risks that come with participation in your study. Risks may be discomfort or in some cases physical or psychological pain. Help define the cost of participation in a realistic manner. List how you intend to provide for, or minimize the potential risks. Share who is responsible for paying for treatment should adverse effects occur.

List the benefits of the study
List any of the benefits or compensation that can reasonably be expected by volunteers. If none can be foreseen, include a statement that no immediate or direct benefits may be expected. You may wish also to include benefits to society. Tell who will receive benefits from the study.

How may a volunteer leave the study?
All participants need to know that they can leave the study at any time, for any reason. This right should be prominent. Additionally, you should state conditions that would lead you to terminate the participation of a subject. Tell the participant that there are no negative consequences for leaving the study.

Arrange to answer questions.
You may not be able to answer all the questions about your study when you first meet with a participant. To help with questions that may occur later, list your name and how to contact you. For questions about subjects rights list the IRB administrator, as the appropriate person.

Assent

Research involving minors may require their assent, i.e., the minor's agreement or willingness to participate in the study. This is in addition to parental or guardian permission. Assent may only come from children capable of making this decision. Parental permission may suffice when a child is not capable of making this decision. Regardless of the situation, investigators are required to provide a method of assent with their IRB proposals involving minors. This may include, but not limited to the following: 1) letter of assent signed by the minor; 2) statement of assent read or communicated to the minor; 3) a procedure whereby assent is implied by the child's active participation; and 4) a statement explaining why assent is not necessary. In the latter case, a minor's assent may not be required, e.g., minors involved in classroom activities that are part of their required curriculum and instruction.

Regardless of the method of assent used by the investigator, minors may not be coerced, actively or passively, into participating in a study. Furthermore, any statement, written or expressed verbally, must be communicated in ways that the minor will understand.

Consent special circumstances

Children or minors as research subjects
Permission is required from parent or guardian. In addition, assent should also be obtained from the subjects. This will require explaining what their participation means and their rights in age appropriate language.

Other vulnerable populations as research subjects
Vulnerable/special populations include those subjects who, as outlined in state and federal regulations, must be provided extra protection. This includes, but is not limited to minors, prisoners, fetuses/pregnant women, elderly and cognitively impaired.

FDA guidelines broaden the scope of different types of "vulnerable subjects" to include: "individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, of a retaliatory. response from senior members of the hierarchy or institution in case of refusal to participate. Examples are members of a group with a hierarchical structure, such as medical, pharmacy, dental, and nursing students, subordinate hospital and laboratory personnel, employees of the pharmaceutical industry, members of the armed forces, and persons kept in detention. Other vulnerable subjects may include patients with incurable diseases, persons in nursing homes, unemployed or impoverished persons, patients in emergency rooms, ethnic minority groups, homeless persons, refugees, children, and those incapable of giving consent."

Other groups, such as racial minorities, the economically disadvantaged, the very sick and the institutionalized are described as vulnerable populations by the Belmont Report and are therefore provided similar protection when used as research subjects. Some groups, such as racial minorities, are not considered vulnerable populations if included in a general population.

Whenever potential subjects are persons of diminished capacity and capable of giving assent, the researcher must obtain their assent in addition to obtaining permission to participate in research from their guardian before involving the individual in a study.

Surveys and questionnaires
For surveys and questionnaires that do not involve sensitive topics or minors return of the questionnaire can be taken as implying consent. However, a cover letter must be included which contains the elements of consent and gives enough information about the survey that the subjects can choose to participate or not. In surveys volunteer subjects deserve to know the purpose of the survey and the uses to which their data will be put. The argument that the results would be seriously biased if subjects are informed is not an adequate justification for failing to inform.

Sensitive questions
Questions or items on the following topics will require additional protection of subjects' privacy. Parents or guardians and subjects must be informed of the sensitive questions before they give permission or consent to participate. Generally information on these topics will be gathered anonymously.

Other participating institutions or sites
In cases where subjects are recruited from other institutions (hospitals, community agencies, physicians, schools etc.), the first contact with potential subjects should be made by institutional staff who, after outlining the researcher's interest and obtaining the potential subject's permission, will refer the person to the researcher or vice versa. A letter may also do this from the researcher that is distributed by the institution. If other institutions are cooperating with the researcher a letter from the institution indicating the nature of that cooperation should be included with the IRB proposal

Access to subjects' medical and educational records
A researcher may have access to institutional records, i.e., hospital, health service agency, etc., if the institution agrees in writing to the accessing and conforms to state guidelines for such access.

Audiotaping, videotaping and photographing subjects

Subjects must be advised that their participation includes the use of audio/video taping or photographing;
Before consenting to being taped (audio or video) or photographed, subjects should be informed of the current and planned use of the materials including storage and access by persons other than the researcher. Subjects must be advised when tapes or photographs will be erased or destroyed;
This permission will normally be included in the consent form. If consent forms are not used, the elements of informed consent must be explained to the subjects and an appropriate release must be obtained. This release statement may be included as a preamble to the taped procedure;
The researcher must make proper arrangements for secure storage of all audio and video tapes and assure that their use complies with the guidelines outlined in the informed consent/release form. Plans may include storage, erasing, or destroying after a given time period.

Research using electronic methods

Researchers must take added precautions to protect the identities of their research participants when using electronic methods for obtaining and/or storing information and data. A MSUM (mnstate) account designated as a secure site must be used for any research:

Conducted on the Internet (e.g. survey research)
That uses email addresses
Using email as a method of communication