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Assume nothing - stay alert
Speak up - be a player
Know then decide - be critical
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Quick Tips - Essential Building Blocks of Protection
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| Here’s a list of six questions to help you learn about protection from research risks:
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1) What brief words of wisdom can be offered to me (recommended if nothing else is read)?
| A) Assume nothing, Speak up, Know - then decide (ASKSM). Know your motivation and compare it with the research of interest to you, as explained by the investigator. If possible, bring someone with you to listen to the investigator, take notes, and help you remember. Develop and maintain alertness throughout your research experience. Recognize changed roles (e.g., your clinician now as an investigator) that require more personal judgment by yourself. See Nutshell, Background, and Flowchart for more.
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| B) You must decide for yourself the importance of what is disclosed to you by your own review. The nature, degree, and certainty or uncertainty of risk to you is always important in making your decision. In addition, it may be others who benefit, not you. Therefore both the risks and benefits, and for whom, can affect your decision. Special caution is in order for normal healthy volunteers who consider participation in high risk research with no foreseeable personal benefit (i.e., high risk of severe harm with little or no possible benefit to themselves). There’s no personal upside and the downside could be significant, even fatal.
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| C) Offers to pay you to be a research subject should not be confused with research benefits. Payment to you to offset the costs of time, travel, and other incurred expenses are fair to minimize disincentives that could otherwise discourage any thought of participation. However, greater payments can be construed as coercive (i.e., unfair inducement that can conflict with your objective decision-making). Whatever the payment, it should be prorated to your participation (i.e., not held for all or no payment on condition of completion). There should be no penalty if you decide to withdraw before completion. See GRSSM Code for suggested standards of investigator conduct.
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| D) Your informed consent may be neither informed nor necessarily voluntary, if you either (1) don’t know or don't adequately understand important information or (2) permit yourself to go along because you either (a) sense an expectation by the investigator that you will consent or (b) are too timid to say no when you believe adequate reason exists to do so. See the Checklist to help in the review of issues before considering consent. Sample the thinking of others.
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| E) All things considered, the level of unavoidable risk you accept must be a personal decision. Overall, what’s important is that you have a sense that (1) no serious blind spots exist in your information that may place you in unexpected or unnecessary jeopardy and (2) that what you have discovered is truly understood. Ultimately, neither the investigator nor the IRB can decide for you.
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| 2) What, if anything, requires others to protect me before I decide about participation? The answer could be nothing. Minimum federal standards exist with which many research institutions comply (i.e., the federal Common Rule). Most federal departments and agencies are cosigners to these standards, known as the Common Rule. Institutions that are regulated by or receive research support from one or more of these federal departments and agencies are obligated to comply with them. Many other institutions, but not all, choose to comply even when not federally required. (more)
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| 3) What are necessary procedures by others to protect my interests? It is important for you to know that research (1) not regulated or supported by a federal department or agency bound by the Common Rule or (2) bound by the Common Rule because the investigator’s institution has volunteered to comply may not be bound by any standard of protection for research subjects other than those crafted by local institutions or imposed by state or local requirements, if any.
What’s necessary for prior planning and review procedures depends on the nature of the proposed research, who’s paying for it, and where it will be conducted. Even when these considerations require necessary prior planning and review procedures (such as those required by applicable federal regulations), they do not guarantee sufficient protection from all risk of harm. Why? By definition, they are minimum standards. However, without these procedures, suitable protections by others may be flawed or absent altogether. Your safety and well-being may be directly affected. This is particularly important for research that carries with it the possibility of more than minimal risk. (more)
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4) How can I verify the commitment by others to procedures taken for my protection? Consult publicly accessible records. All things considered, it is reasonable for you to expect that compliance with at least existing federal standards whether required or not has (1) preceded your investigator’s invitation to you for participation and (2) will be followed throughout your research experience. However, you should not necessarily assume or trust that these procedures have been or will be followed. Where possible, verify it for yourself. Check the available facts, as follows:
| A) Has my investigator’s institution assured OHRP in writing (called an Assurance) that it will abide by prevailing minimum federal standards to protect research subjects? You can check by visiting OHRP’s publicly accessible file of approved institutional Assurances. Any research institution can file an Assurance. However, filing is optional for institutions whose research is either only regulated by the FDA or not funded or supported by DHHS). If your research institution has not yet been required to file, ask it to consider doing so for the benefit of others in the future.
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| B) Has an Institutional Review Board (IRB) reviewed the research plan that applies to me and registered itself with the federal Office for Protection from Research Risks (OHRP)? Ask your investigator if IRB review and approval has occurred. If so, what is OHRP’s assigned IRB number? If desired, you can check by visiting OHRP’s publicly accessible records of registered IRBs. Please note that any IRB may register but not all are required to do so. If the IRB has not yet been required to register, ask that it consider doing so for the benefit of others in the future.
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| C) Is my investigator or his or her institution under some form of current federal penalty or restriction that I should know about? If desired, here are a few sources to search: FDA (debarments and otherwise), the DHHS Office of Research Integrity (ORI), and the federal Excluded Parties List System (EPLS). In addition, OHRP posts letters of determination that document resolved matters at institutions that may have involved named investigators.
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5) What can I do to help protect myself from unnecessary risk of research harm? Procedural protections are necessary but are they sufficient to satisfy you that reasonable efforts have been taken to protect your safety and well-being? Only you can know for sure. Now that the foundation of protections for you has been highlighted, what remains for follow-up review that is best done by you? Verify the following to your satisfaction prior to deciding about participation, including direct questioning of the investigator, as needed (also see Flowchart for a summary diagram):
| A) Is the proposed research right for me (is it consistent with my motivation)? |
| B) Has my investigator either promised or already explained the research experience about which I am considering participation? |
| C) What kind of risk to me is expected and how likely is it to occur? |
| D) What precautions are in place to minimize risk to me (i.e., what was dropped, changed, or added to reduce the nature and likelihood of harm)? |
| E) Why is the remaining risk to me unavoidable? |
| F) If precautions can't totally avoid the possibility of harm, what safeguards are in place to lessen the impact on me? |
| G) Will I be compensated for research-related injury, no questions asked, or will I be left on my own to fight for it? |
| H) In the event that I should not realistically expect to personally benefit, who will, where, and when? |
| I) If a clinical study, will a finder’s fee be paid either to the doctor who otherwise would have treated me without being in the proposed study and/or the investigator to whom I am referred? |
| A) Is the proposed research right for me (is it consistent with my motivation)? Is the proposed research right for you (is it consistent with your motivation)? That depends on two things: (1) your initial reason for interest (e.g., to get something of personal value out of it, achieve something for others, or simply not object) and (2) subsequent review of actions by others and yourself to promote protection from harm. If you intend to get something out of it for yourself, and most likely won’t, there’s little need for further analysis. The proposed research isn’t consistent with your interests and unlikely to be right for you.
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| B) Has my investigator either promised or already explained the research experience about which I am considering participation? Most often, a written summary of certain essential information should be offered to you to aid in consulting others and for your continuing reference (e.g., to ensure that changes are not made during the research without prior IRB approval that could result in new and possibly significant risks). That summary is called the informed consent document (ICD). The ICD should bear a stamp with the expiration date for IRB approval. If the expiration date has past, it may mean that either (1) IRB approval no longer exists or (2) newly required IRB changes have not been included. If the ICD does not bear a date stamp, it could mean that the research plan and ICD have not been reviewed at all. Although the date stamp is not a federal requirement, it is common practice and something you can reasonably expect will be undertaken in your interests.
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| C) What kind of risk to me is expected and how likely is it to occur? Risks can be physical, psychological, social, and/or economic. Risk of physical harm is not the only thing worth considering. Harm can arise from many causes. For example, a breach of confidentiality (e.g., inappropriate access to and/or misuse of your private information) could lead to loss of insurance, loss of employment, loss of social standing, and/or reduced peace of mind.
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| D) What precautions are in place to minimize risk to me (i.e., what was dropped, changed, or added to reduce the nature and likelihood of harm)? For example, if private information about you will be collected and linked to you, (1) what security measures are required by the research plan to avoid disclosure to unauthorized persons and (2) will this information be destroyed upon conclusion of the research?
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| E) Why is the remaining risk to me unavoidable? For example, if a new drug is being tested, is its design essentially the same as existing drugs or are the risks truly justified by expected superior effectiveness? If not, is the goal to equal the effectiveness with fewer side-effects? You may be willing to assume some level of known risk to help develop a drug against a germ that has developed resistance to all existing drugs. The benefit to society, including yourself, is self-evident. You may be less willing if no such need or expectation is even contemplated.
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| F) If precautions can’t totally avoid the possibility of harm, what safeguards are in place to lessen the impact on me? For example, if you will risk the misuse of your personal information (like identity theft), mental stress (some kinds of psychology experiments can result in people learning things about themselves they’d just as leave not know), or physical jeopardy (like suffering ill effects from exertion) how will you be helped? Encryption, controlled access to identifiable information, scheduled destruction of information after completion of the research, counseling, and on-site emergency medical care are examples of safeguards to protect your security and safety.
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| G) Will I be compensated for research-related injury, no questions asked, or will I be left on my own to fight for it? Is there the equivalent of an insurance policy with subjects named as beneficiaries for damages beyond emergency medical care? If not, does the institution have an internal policy on record that it will self-insure to compensate for research-related injuries?
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| H) In the event that I should not realistically expect to personally benefit, who will, where, and when? It’s often the case that subjects themselves will not benefit. However, others with whom they can identify (e.g., other adolescents, the elderly, the tribe, or those with the same affliction) may eventually benefit from what’s learned. On the other hand, others may stand to benefit in more direct ways and long before application of advanced knowledge occurs. Investigators, institutions, and sponsors can have stakes in the research that are financial or otherwise of professional value. You should know. It can help you evaluate what is being proposed and adjust your level of alertness. They're not automatic reasons to decline.
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| I) If a clinical study, will a finder's fee be paid either to the doctor who otherwise would have treated me without being in the proposed study and/or the investigator to whom I am referred? A finder’s fee is a dollar amount (it might also be stock or stock options or something else of value) offered as an incentive by the study's sponsor for your participation. Incentives motivate potential sources of eligible subjects to be on the lookout. The more subjects that are added to a study in the shortest period of time, the greater the study’s efficiency in reaching an endpoint. However, incentives can also hold the potential to compete with other existing priorities, motivations, and specific clinical recommendations that effect you. Be alert. Ask if an incentive is involved and its dollar amount. Judge for yourself how this may affect the decision-making of those upon whom you are dependent and, if you decide to consent, the appropriate level of your continuing alertness.
Especially if an incentive is involved, ensure to your satisfaction that an alternate source of clinical expertise is available. This person should be independent from the interests of the research. You may feel the need to turn to such a person, initially and from time to time, to discuss, understand, and make continuing judgments about your clinical best interests. Making a big decision on short notice, under pressure, and/or without access to adequate independent expertise is less than desirable and should be avoided, if possible.
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Answers to the above questions should be acceptable to you!
If in doubt, act only when sure!
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| 6) What useful tools and information are available to help me think through my decision?
The GRS website has compiled an array of informational resources for your convenience (see Options). Various possibilities are grouped into handy categories. If you still don't find what you need, please tell us about it.
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 Please bookmark this website and tell others about it. There's nothing here for sale, just information, tools, and a helping hand. Use them to your advantage. Learn, be a little better prepared, and feel more confident if and when a decision to participate in research comes your way.
Please consider giving us some feedback. In addition, testimonials are welcome. If posted, your identity will be not shown (see Terms of Use) unless you grant permission.
You can address your e-mail to contact@getresearchsmart.org.
(04-07-06)
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